Regulatory assessment of chemical mixtures: Requirements, current approaches and future perspectives.

PubMed

Kienzler, Aude; Bopp, Stephanie K; van der Linden, Sander; Berggren, Elisabet; Worth, Andrew

2016-10-01

This paper reviews regulatory requirements and recent case studies to illustrate how the risk assessment (RA) of chemical mixtures is conducted, considering both the effects on human health and on the environment. A broad range of chemicals, regulations and RA methodologies are covered, in order to identify mixtures of concern, gaps in the regulatory framework, data needs, and further work to be carried out. Also the current and potential future use of novel tools (Adverse Outcome Pathways, in silico tools, toxicokinetic modelling, etc.) in the RA of combined effects were reviewed. The assumptions made in the RA, predictive model specifications and the choice of toxic reference values can greatly influence the assessment outcome, and should therefore be specifically justified. Novel tools could support mixture RA mainly by providing a better understanding of the underlying mechanisms of combined effects. Nevertheless, their use is currently limited because of a lack of guidance, data, and expertise. More guidance is needed to facilitate their application. As far as the authors are aware, no prospective RA concerning chemicals related to various regulatory sectors has been performed to date, even though numerous chemicals are registered under several regulatory frameworks. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Learning to Eat: Behavioral and Psychological Aspects.

PubMed

Birch, Leann L

2016-01-01

Because infants are totally dependent upon parents (or other caregivers) for care and sustenance, parents' feeding practices are a key feature of the family environments in which infants and young children learn about food and eating. Feeding practices include not only what the child is fed, but also the how, when, why and how much of feeding. Extensive evidence indicates that parenting behavior influences a variety of child outcomes, including cognitive and socioemotional development, as well as the development of self-regulatory skills. The focus of this chapter is on what is known about how parenting, particularly feeding practices, influences the early development of several aspects of children's eating behavior, including the acquisition of food preferences, self-regulatory skills, children's reactivity to food cues, satiety responsiveness and 'picky eating'. It is argued that traditional feeding practices, which evolved to protect children from environmental threats and ensure adequate intake in the context of food scarcity, can be maladaptive in current environments. An evidence base is needed to inform public policy to reduce early obesity risk in current environments, where too much palatable food is a major threat to child health. Results of recent research provides evidence that promoting responsive feeding practices can alter the development of eating behavior, sleep patterns and early self-regulatory skills, as well as reduce early obesity risk. © 2016 Nestec Ltd., Vevey/S. Karger AG, Basel.

7 CFR 4279.131 - Credit quality.

Code of Federal Regulations, 2011 CFR

2011-01-01

... from the current trends. The regulatory environment surrounding the particular business or industry... Regulations of the Department of Agriculture (Continued) RURAL BUSINESS-COOPERATIVE SERVICE AND RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE GUARANTEED LOANMAKING Business and Industry Loans § 4279.131...

Q&A: How do gene regulatory networks control environmental responses in plants?

PubMed

Sun, Ying; Dinneny, José R

2018-04-11

A gene regulatory network (GRN) describes the hierarchical relationship between transcription factors, associated proteins, and their target genes. Studying GRNs allows us to understand how a plant's genotype and environment are integrated to regulate downstream physiological responses. Current efforts in plants have focused on defining the GRNs that regulate functions such as development and stress response and have been performed primarily in genetically tractable model plant species such as Arabidopsis thaliana. Future studies will likely focus on how GRNs function in non-model plants and change over evolutionary time to allow for adaptation to extreme environments. This broader understanding will inform efforts to engineer GRNs to create tailored crop traits.

Mandatory safety belt use legislation : alternatives for Virginia lawmakers : final report.

DOT National Transportation Integrated Search

1986-01-01

This report discusses the current environment which would influence the consideration of a mandatory safety belt use law in Virginia. First, the regulatory context fostered by the U. S. Department of Transportation's issuance of federal motor vehicle...

Competition and deregulation in the electric industry. A study of organizational change: The New York State Public Service Commission

NASA Astrophysics Data System (ADS)

Ashley, Deborah J. Cordaro

2000-11-01

Public organizations are formed in response to societal needs. They collect taxes, educate children, enforce laws and provide protection to the environment, the nation and consumers. One such organization is the New York State Public Service Commission. In 1907, legislation was passed to form the New York State Public Service Commission the first regulatory body of its kind in the United States. Its mission was to provide safe, reliable and reasonably priced electricity. Subsequently, this became the model that was implemented in every state in the nation. The past decade heralds an era of competition and a lessening of regulatory control. The telephone, natural gas and airline industries are in various stages of deregulation, and the electric industry is beginning down this path as well. In an environment such as this, are regulatory organizations necessary, and if they are, how can they organize to meet the new societal requirements? The case of the New York State Public Service Commission at this point in time offers a real time study of a regulatory body immersed in an environment that is calling for competition and an end to big government. Utilizing case studies of industries that have deregulated, or are in the process of deregulating, indicates a future societal need for regulations. This result does not lead to a conclusion that organizational change is unnecessary. This Dissertation will lay out the current organizational structure of the Public Service Commission, give an overview of the environmental signals, describe the mission/core values, and illustrate general political and employee factors that are indigenous to public service. Utilizing both classic and current organizational theory, an evaluation will be made of the Commission's need for change, their ability to change, and obstacles they may encounter.

Hospital discharge costs in competitive and regulatory environments.

PubMed

Weil, T P

1996-05-01

To study the efficacy of America's current market-driven approaches to constrain health care expenditures, an analysis was undertaken of 1993 hospital discharge costs and related data of the 15 states in the United States with the highest percent of HMO market penetration. What is proposed herein to enhance hospital cost containment efforts is for a state to almost simultaneously use both market-driven and regulatory strategies similar to what was implemented in California over the last three decades and in Germany for the last 100 years.

Deciphering RNA Regulatory Elements Involved in the Developmental and Environmental Gene Regulation of Trypanosoma brucei.

PubMed

Gazestani, Vahid H; Salavati, Reza

2015-01-01

Trypanosoma brucei is a vector-borne parasite with intricate life cycle that can cause serious diseases in humans and animals. This pathogen relies on fine regulation of gene expression to respond and adapt to variable environments, with implications in transmission and infectivity. However, the involved regulatory elements and their mechanisms of actions are largely unknown. Here, benefiting from a new graph-based approach for finding functional regulatory elements in RNA (GRAFFER), we have predicted 88 new RNA regulatory elements that are potentially involved in the gene regulatory network of T. brucei. We show that many of these newly predicted elements are responsive to both transcriptomic and proteomic changes during the life cycle of the parasite. Moreover, we found that 11 of predicted elements strikingly resemble previously identified regulatory elements for the parasite. Additionally, comparison with previously predicted motifs on T. brucei suggested the superior performance of our approach based on the current limited knowledge of regulatory elements in T. brucei.

Analysis of the performance of the CONTOUR® TS Blood Glucose Monitoring System: when regulatory performance criteria are met, should we have confidence to use a medical device with all patients?

PubMed

Lyon, Martha E; Lyon, Andrew W

2011-01-01

The article entitled, Performance of the CONTOUR® TS Blood Glucose Monitoring System, by Frank and colleagues in this issue of Journal of Diabetes Science and Technology, demonstrates that the CONTOUR® TS glucose meter exceeds current regulatory expectations for glucose meter performance. However, the appropriateness of current regulatory expectations, such as International Organization for Standardization (ISO) 15197:2003, is being reevaluated because of increasing concern regarding the reliability of glucose meters in ambulatory and hospitalized environments. Between 2004 and 2008, 12,673 serious adverse events with glucose meters that met the ISO 15197 expectations were reported in the Food and Drug Administration-Manufacturer and User Facility Device Experience surveillance database. Should different glucose meter performance criteria be applied to ambulatory versus critical care patients? © 2010 Diabetes Technology Society.

Pre-anthropocene mercury residues in North American freshwater fish.

PubMed

Hope, Bruce K; Louch, Jeff

2014-04-01

Mercury (Hg) has been entering the environment from both natural and anthropogenic sources for millennia, and humans have been influencing its environmental transport and fate from well before the Industrial Revolution. Exposure to Hg (as neurotoxic monomethylmercury [MeHg]) occurs primarily through consumption of finfish, shellfish, and marine mammals, and regulatory limits for MeHg concentrations in fish tissue have steadily decreased as information on its health impacts has become available. These facts prompted us to consider 2 questions: 1) What might the MeHg levels in fish tissue have been in the pre-Anthropocene, before significant human impacts on the environment? and 2) How would these pre-Anthropocene levels have compared with current regulatory criteria for MeHg residues in fish tissue? We addressed the first question by estimating pre-Anthropocene concentrations of MeHg in the tissues of prey and predatory fish with an integrated Hg speciation, transport, fate, and food web model (SERAFM), using estimated Hg concentrations in soil, sediment, and atmospheric deposition before the onset of significant human activity (i.e., ≤2000 BCE). Model results show MeHg residues in fish varying depending on the characteristics of the modeled water body, which suggests that Hg in fish tissue is best considered at the scale of individual watersheds or water bodies. We addressed the second question by comparing these model estimates with current regulatory criteria and found that MeHg residues in predatory (but not prey) fish could have approached or exceeded these criteria in some water bodies during the pre-Anthropocene. This suggests that the possibility of naturally occurring levels of Hg in fish below which it is not possible to descend, regardless of where those levels stand with respect to current regulatory limits. Risk management decisions made under these circumstances have the potential to be ineffectual, frustrating, and costly for decision makers and stakeholders alike, suggesting the need for regulatory flexibility when addressing the issue of Hg in fish. © 2013 SETAC.

Clinical trials bureaucracy: unintended consequences of well-intentioned policy.

PubMed

Califf, Robert M

2006-01-01

As randomized controlled trials have become the 'gold standard' for medical research, a complex regulatory structure for the conduct of clinical trials has emerged. However, this structure has not been adequately assessed to ensure that regulations governing human subjects research actually produce the desired effects. Our purpose is to identify some of the major shortcomings in the current regulatory system of human clinical trials oversight, and to propose some potential solutions to these problems. We discuss the evolution of the current US regulatory environment and its application in the context of several widely-used drug therapies. Despite numerous randomized controlled trials, performed within a structure of extensive documentation and data collection, serious shortcomings in a number of pharmaceutical therapies were not detected until after the drugs were approved and widely adopted by clinicians. The current system of regulatory bureaucracy in clinical trials has led to an extremely expensive research paradigm that, in spite of complex systems of oversight and exhaustive data collection, cannot be shown to adequately ensure the integrity of the research process and the protection of human research subjects. Some parts of the system, including Research Ethics Review Boards, may not be well-suited to carrying out their core mission of overseeing research conduct, and other aspects of clinical trials regulatory structure, such as monitoring/auditing review and adverse event reporting, may constitute a waste of money and resources. Misdirected data collection and adverse events reporting divert valuable resources and hamper development of large, simple clinical trials powered to definitively answer important research questions. Careful scrutiny of the utility of current or proposed regulatory schemes is required to ensure the integrity of human subjects research and to enhance the effectiveness of research dollars.

Social Moderation, Assessment and Assuring Standards for Accounting Graduates

ERIC Educational Resources Information Center

Watty, Kim; Freeman, Mark; Howieson, Bryan; Hancock, Phil; O'Connell, Brendan; de Lange, Paul; Abraham, Anne

2014-01-01

Evidencing student achievement of standards is a growing imperative worldwide. Key stakeholders (including current and prospective students, government, regulators and employers) want confidence that threshold learning standards in an accounting degree have been assured. Australia's new higher education regulatory environment requires that student…

Current Status and Regulatory Aspects of Pesticides Considered to be Persistent Organic Pollutants (POPs) in Taiwan

PubMed Central

Tsai, Wen-Tien

2010-01-01

Organochlorine pesticides (OCPs) are capable of persisting in the environment, transporting between phase media and accumulating to high levels, implying that they could pose a risk of causing adverse effects to human health and the environment. Consequently, most OCPs are designated as persistent organic pollutants (POPs) and even as endocrine disrupting chemicals (EDCs). The objective of this paper was to review the current status of pesticide POPs in Taiwan, including aldrin, chlordane, chlordecone, DDT, dieldrin, endrin, heptachlor, hexachlorobenzene, α/β-hexachlorocyclohexanes, lindane, mirex, pentachloro-benzene, and toxaphene. The information about their environmental properties, banned use, carcinogenic toxicity and environmental levels, can be connected with the regulatory infrastructure, which has been established by the joint-venture of the central competent authorities (i.e., Environmental Protection Administration, Department of Health, Council of Agriculture, and Council of Labor Affairs). The significant progress to be reported is that the residual levels of these pesticide-POPs, ranging from trace amounts to a few ppb, have declined notably in recent years. PMID:21139852

Current status and regulatory aspects of pesticides considered to be persistent organic pollutants (POPs) in Taiwan.

PubMed

Tsai, Wen-Tien

2010-10-01

Organochlorine pesticides (OCPs) are capable of persisting in the environment, transporting between phase media and accumulating to high levels, implying that they could pose a risk of causing adverse effects to human health and the environment. Consequently, most OCPs are designated as persistent organic pollutants (POPs) and even as endocrine disrupting chemicals (EDCs). The objective of this paper was to review the current status of pesticide POPs in Taiwan, including aldrin, chlordane, chlordecone, DDT, dieldrin, endrin, heptachlor, hexachlorobenzene, α/β-hexachlorocyclohexanes, lindane, mirex, pentachloro-benzene, and toxaphene. The information about their environmental properties, banned use, carcinogenic toxicity and environmental levels, can be connected with the regulatory infrastructure, which has been established by the joint-venture of the central competent authorities (i.e., Environmental Protection Administration, Department of Health, Council of Agriculture, and Council of Labor Affairs). The significant progress to be reported is that the residual levels of these pesticide-POPs, ranging from trace amounts to a few ppb, have declined notably in recent years.

Regulatory genes and their roles for improvement of antibiotic biosynthesis in Streptomyces.

PubMed

Lu, Fengjuan; Hou, Yanyan; Zhang, Heming; Chu, Yiwen; Xia, Haiyang; Tian, Yongqiang

2017-08-01

The numerous secondary metabolites in Streptomyces spp. are crucial for various applications. For example, cephamycin C is used as an antibiotic, and avermectin is used as an insecticide. Specifically, antibiotic yield is closely related to many factors, such as the external environment, nutrition (including nitrogen and carbon sources), biosynthetic efficiency and the regulatory mechanisms in producing strains. There are various types of regulatory genes that work in different ways, such as pleiotropic (or global) regulatory genes, cluster-situated regulators, which are also called pathway-specific regulatory genes, and many other regulators. The study of regulatory genes that influence antibiotic biosynthesis in Streptomyces spp. not only provides a theoretical basis for antibiotic biosynthesis in Streptomyces but also helps to increase the yield of antibiotics via molecular manipulation of these regulatory genes. Currently, more and more emphasis is being placed on the regulatory genes of antibiotic biosynthetic gene clusters in Streptomyces spp., and many studies on these genes have been performed to improve the yield of antibiotics in Streptomyces. This paper lists many antibiotic biosynthesis regulatory genes in Streptomyces spp. and focuses on frequently investigated regulatory genes that are involved in pathway-specific regulation and pleiotropic regulation and their applications in genetic engineering.

Regulatory Considerations for Physiological Closed-Loop Controlled Medical Devices Used for Automated Critical Care: Food and Drug Administration Workshop Discussion Topics.

PubMed

Parvinian, Bahram; Scully, Christopher; Wiyor, Hanniebey; Kumar, Allison; Weininger, Sandy

2018-06-01

Part of the mission of the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration is to facilitate medical device innovation. Therefore, CDRH plays an important role in helping its stakeholders such as manufacturers, health care professionals, patients, patient advocates, academia, and other government agencies navigate the regulatory landscape for medical devices. This is particularly important for innovative physiological closed-loop controlled (PCLC) devices used in critical care environments, such as intensive care units, emergency settings, and battlefield environments. CDRH's current working definition of a PCLC medical device is a medical device that incorporates physiological sensor(s) for automatic manipulation of a physiological variable through actuation of therapy that is conventionally made by a clinician. These emerging devices enable automatic therapy delivery and may have the potential to revolutionize the standard of care by ensuring adequate and timely therapy delivery with improved performance in high workload and high-stress environments. For emergency response and military applications, automatic PCLC devices may play an important role in reducing cognitive overload, minimizing human error, and enhancing medical care during surge scenarios (ie, events that exceed the capability of the normal medical infrastructure). CDRH held an open public workshop on October 13 and 14, 2015 with the aim of fostering an open discussion on design, implementation, and evaluation considerations associated with PCLC devices used in critical care environments. CDRH is currently developing regulatory recommendations and guidelines that will facilitate innovation for PCLC devices. This article highlights the contents of the white paper that was central to the workshop and focuses on the ensuing discussions regarding the engineering, clinical, and human factors considerations.

Medical Waste Management Implications for Small Medical Facilities.

ERIC Educational Resources Information Center

Byrns, George; Burke, Thomas

1992-01-01

Discusses the implications of the Medical Waste Management Act of 1988 for small medical facilities, public health, and the environment. Reviews health and environmental risks associated with medical waste, current regulatory approaches, and classifications. Concludes that the health risk of medical wastes has been overestimated; makes…

WATERBORNE DISEASES AND MICROBIAL QUALITY MONITORING FOR RECREATIONAL WATER BODIES USING REGULATORY METHODS

EPA Science Inventory

This chapter will provide the reader with a historical perspective of microbial water quality and monitoring of recreational waters, with special attention to marine environments. It will review the regulations that are currently in effect in the United States and discuss critic...

Decision Analysis for a Sustainable Environment, Economy, and Society: A Participatory Framework for Ecosystem Services-Based Decision-Making

EPA Science Inventory

There is an increasing understanding that top-down regulatory and technology driven responses are not sufficient to address current and emerging environmental challenges such as climate change, sustainable communities, and environmental justice. The vast majority of environmenta...

Non-Mendelian determinants of morphology in fungi.

PubMed

Malagnac, Fabienne; Silar, Philippe

2003-12-01

Morphological plasticity is a hallmark of eumycetes. In addition to genes and environment, epigenetic factors control cell, colony and thallus forms in many species, by creating reversible switches. Current knowledge indicates that the different shapes are due to structural or regulatory heritable states of cytoplasmic components. Cellular physiology differs in the various forms, permitting adaptation to fluctuation in the environment. These switches are part of the adaptation repertoire that fungi exhibit to colonize most niches.

Chemistry, toxicity, and bioavailability of copper and its relationship to regulation in the marine environment. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Seligman, P.E.; Zirino, A.

1998-11-01

This document details issues addressed at a June 1997 workshop attended by Navy and regulatory representatives and scientific experts. Objectives discussed were: (1) define the current status and future direction of copper (Cu) regulations, (2) define problems and issues associated with the introduction of copper into the estuarine environment, and (3) discuss and evaluate the relationship between copper speciation, bio-availability, and toxicity.

Radio-ecological characterization and radiological assessment in support of regulatory supervision of legacy sites in northwest Russia.

PubMed

Sneve, M K; Kiselev, M; Shandala, N K

2014-05-01

The Norwegian Radiation Protection Authority has been implementing a regulatory cooperation program in the Russian Federation for over 10 years, as part of the Norwegian government's Plan of Action for enhancing nuclear and radiation safety in northwest Russia. The overall long-term objective has been the enhancement of safety culture and includes a special focus on regulatory supervision of nuclear legacy sites. The initial project outputs included appropriate regulatory threat assessments, to determine the hazardous situations and activities which are most in need of enhanced regulatory supervision. In turn, this has led to the development of new and updated norms and standards, and related regulatory procedures, necessary to address the often abnormal conditions at legacy sites. This paper presents the experience gained within the above program with regard to radio-ecological characterization of Sites of Temporary Storage for spent nuclear fuel and radioactive waste at Andreeva Bay and Gremikha in the Kola Peninsula in northwest Russia. Such characterization is necessary to support assessments of the current radiological situation and to support prospective assessments of its evolution. Both types of assessments contribute to regulatory supervision of the sites. Accordingly, they include assessments to support development of regulatory standards and guidance concerning: control of radiation exposures to workers during remediation operations; emergency preparedness and response; planned radionuclide releases to the environment; development of site restoration plans, and waste treatment and disposal. Examples of characterization work are presented which relate to terrestrial and marine environments at Andreeva Bay. The use of this data in assessments is illustrated by means of the visualization and assessment tool (DATAMAP) developed as part of the regulatory cooperation program, specifically to help control radiation exposure in operations and to support regulatory analysis of management options. For assessments of the current radiological situation, the types of data needed include information about the distribution of radionuclides in environmental media. For prognostic assessments, additional data are needed about the landscape features, on-shore and off-shore hydrology, geochemical properties of soils and sediments, and possible continuing source terms from continuing operations and on-site disposal. It is anticipated that shared international experience in legacy site characterization can be useful in the next steps. Although the output has been designed to support regulatory evaluation of these particular sites in northwest Russia, the methods and techniques are considered useful examples for application elsewhere, as well as providing relevant input to the International Atomic Energy Agency's international Working Forum for the Regulatory Supervision of Legacy Sites. Copyright © 2013 Elsevier Ltd. All rights reserved.

Protection of people and environment from radiation risk through good regulatory practice

NASA Astrophysics Data System (ADS)

Jais, Azlina Mohammad; Hassan, Najwa

2017-01-01

The term "good regulatory practice" has seen growing frequency of usage worldwide, especially since the 2011 Fukushima nuclear incident. However, the term appears quite ambiguous as it may mean differently to different people. This leads us to the first important question: what does "good regulatory practice" actually mean? When used in conjunction with the Fukushima incident, do we imply that there is an absence of "good regulatory practice" in the Japanese' Nuclear and Industry Safety Agency (NISA)? This is quite troubling. It is clear that the term should be defined formally so that our understanding of "good regulatory practice" can be standardized. There is still another important question beyond agreeing on what "good regulatory practice" is: is "good regulatory practice" specific to a region, or is it global? And is it applicable only to nuclear regulators, or to all types of regulators per se? This paper aims to deliberate on the above mentioned questions. Specifically, we hope to discuss the "good regulatory practice" for atomic energy activities in order to protect the people and the environment from radiation risk of such activities. By understanding what "good regulatory practice" truly means, a newcomer country such as Malaysia can quickly learn and adopt these practices so as to assure a competent national nuclear regulatory authority who will be responsible in ensuring the safety, security and safeguards of peaceful atomic energy activities in the country including nuclear liability. In understanding this concept, a holistic approach will be taken by looking into example of advanced and newcomer countries of various nuclear regulatory authorities all around the world. Then the paper will focus on the challenges that the current nuclear regulatory authority in Malaysia which is Atomic Energy Licensing Board has, its challenges to follow the concept of "good regulatory practice" and its ways to overcome it. This study explore the initiatives could be considered by nuclear regulatory authority and the necessary criteria of an "ideal" how nuclear regulatory authority should implement the "good regulatory practice" approach.

UK medicines regulation: responding to current challenges

PubMed Central

Richards, Natalie

2016-01-01

The medicines regulatory environment is evolving rapidly in response to the changing environment. Advances in science and technology have led to a vast field of increasingly complicated pharmaceutical and medical device products; increasing globalization of the pharmaceutical industry, advances in digital technology and the internet, changing patient populations, and shifts in society also affect the regulatory environment. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood products to protect and improve public health, and supports innovation through scientific research and development. It works closely with other bodies in a single medicines network across Europe and takes forward UK health priorities. This paper discusses the range of initiatives in the UK and across Europe to support innovation in medicines regulation. The MHRA leads a number of initiatives, such as the Innovation Office, which helps innovators to navigate the regulatory processes to progress their products or technologies; and simplification of the Clinical Trials Regulations and the Early Access to Medicines Scheme, to bring innovative medicines to patients faster. The Accelerated Access Review will identify reforms to accelerate access for National Health Service patients to innovative medicines and medical technologies. PRIME and Adaptive Pathways initiatives are joint endeavours within the European regulatory community. The MHRA runs spontaneous reporting schemes and works with INTERPOL to tackle counterfeiting and substandard products sold via the internet. The role of the regulator is changing rapidly, with new risk‐proportionate, flexible approaches being introduced. International collaboration is a key element of the work of regulators, and is set to expand. PMID:27580254

UK medicines regulation: responding to current challenges.

PubMed

Richards, Natalie; Hudson, Ian

2016-12-01

The medicines regulatory environment is evolving rapidly in response to the changing environment. Advances in science and technology have led to a vast field of increasingly complicated pharmaceutical and medical device products; increasing globalization of the pharmaceutical industry, advances in digital technology and the internet, changing patient populations, and shifts in society also affect the regulatory environment. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood products to protect and improve public health, and supports innovation through scientific research and development. It works closely with other bodies in a single medicines network across Europe and takes forward UK health priorities. This paper discusses the range of initiatives in the UK and across Europe to support innovation in medicines regulation. The MHRA leads a number of initiatives, such as the Innovation Office, which helps innovators to navigate the regulatory processes to progress their products or technologies; and simplification of the Clinical Trials Regulations and the Early Access to Medicines Scheme, to bring innovative medicines to patients faster. The Accelerated Access Review will identify reforms to accelerate access for National Health Service patients to innovative medicines and medical technologies. PRIME and Adaptive Pathways initiatives are joint endeavours within the European regulatory community. The MHRA runs spontaneous reporting schemes and works with INTERPOL to tackle counterfeiting and substandard products sold via the internet. The role of the regulator is changing rapidly, with new risk-proportionate, flexible approaches being introduced. International collaboration is a key element of the work of regulators, and is set to expand. © 2016 The British Pharmacological Society.

TECHNOLOGY REQUIRED FOR ALTERNATIVE ANALYSES FOR A CHANGING ENVIRONMENT (TRACE) IN SUPPORT OF THE CLEAN WATER ACT

EPA Science Inventory

Recent trends in current and evolving environmental regulatory strategies dictate that EPA will have to rely more heavily on predictive modeling technologies in carrying out the increasingly complex array of exposure and risk assessments necessary in developing scientifically def...

Regulatory environment and its impact on the market value of investor-owned electric utilities

NASA Astrophysics Data System (ADS)

Vishwanathan, Raman

While other regulated industries have one by one been exposed to competitive reform, electric power, for over eighty years, has remained a great monopoly. For all those years, the vertically integrated suppliers of electricity in the United States have been assigned exclusive territorial (consumer) franchises and have been closely regulated. This environment is in the process change because the electric power industry is currently undergoing some dramatic adjustments. Since 1992, a number of states have initiated regulatory reform and are moving to allow retail customers to choose their energy supplier. There has also been a considerable federal government role in encouraging competition in the generation and transmission of electricity. The objective of this research is to investigate the reaction of investors to the prevailing regulatory environment in the electric utility industry by analyzing the market-to-book value for investor-owned electric utilities in the United States as a gauge of investor concern or support for change. In this study, the variable of interest is the market valuation of utilities, as it captures investor confidence to changes in the regulatory environment. Initially a classic regression model is analyzed on the full sample (of the 96 investor-owned utilities for the years 1992 through 1996), providing a total number of 480 (96 firms over 5 years) observations. Later fixed- and random-effects models are analyzed for the same full-sample model specified in the previous analysis. Also, the analysis is carried forward to examine the impact of the size of the utility and its degree of reliability on nuclear power generation on market values. In the period of this study, 1992--1996, the financial security markets downgraded utilities that were still operating in a regulated environment or had a substantial percentage of their power generation from nuclear power plants. It was also found that the financial market was sensitive to the size of the electric utility. The negative impact of the regulatory environment declined with the increase in the size of the utility, indicating favorable treatment for larger utilities by financial markets. Similarly, for the electric utility industry as a whole, financial markets reacted negatively to nuclear power generation.

Nitrogen modulation of legume root architecture signaling pathways involves phytohormones and small regulatory molecules.

PubMed

Mohd-Radzman, Nadiatul A; Djordjevic, Michael A; Imin, Nijat

2013-10-01

Nitrogen, particularly nitrate is an important yield determinant for crops. However, current agricultural practice with excessive fertilizer usage has detrimental effects on the environment. Therefore, legumes have been suggested as a sustainable alternative for replenishing soil nitrogen. Legumes can uniquely form nitrogen-fixing nodules through symbiotic interaction with specialized soil bacteria. Legumes possess a highly plastic root system which modulates its architecture according to the nitrogen availability in the soil. Understanding how legumes regulate root development in response to nitrogen availability is an important step to improving root architecture. The nitrogen-mediated root development pathway starts with sensing soil nitrogen level followed by subsequent signal transduction pathways involving phytohormones, microRNAs and regulatory peptides that collectively modulate the growth and shape of the root system. This review focuses on the current understanding of nitrogen-mediated legume root architecture including local and systemic regulations by different N-sources and the modulations by phytohormones and small regulatory molecules.

Use of physiologically relevant biopharmaceutics tools within the pharmaceutical industry and in regulatory sciences: Where are we now and what are the gaps?

PubMed

Flanagan, Talia; Van Peer, Achiel; Lindahl, Anders

2016-08-25

Regulatory interactions are an important part of the drug development and licensing process. A survey on the use of biopharmaceutical tools for regulatory purposes has been carried out within the industry community of the EU project OrBiTo within Innovative Medicines Initiative (IMI). The aim was to capture current practice and experience in using in vitro and in silico biopharmaceutics tools at various stages of development, what barriers exist or are perceived, and to understand the current gaps in regulatory biopharmaceutics. The survey indicated that biorelevant dissolution testing and physiologically based modelling and simulation are widely applied throughout development to address a number of biopharmaceutics issues. However, data from these in vitro and in silico predictive biopharmaceutics tools are submitted to regulatory authorities far less often than they are used for internal risk assessment and decision making. This may prevent regulators from becoming familiar with these tools and how they are applied in industry, and limits the opportunities for biopharmaceutics scientists working in industry to understand the acceptability of these tools in the regulatory environment. It is anticipated that the advanced biopharmaceutics tools and understanding delivered in the next years by OrBiTo and other initiatives in the area of predictive tools will also be of value in the regulatory setting, and provide a basis for more informed and confident biopharmaceutics risk assessment and regulatory decision making. To enable the regulatory potential of predictive biopharmaceutics tools to be realized, further scientific dialogue is needed between industry, regulators and scientists in academia, and more examples need to be published to demonstrate the applicability of these tools. Copyright © 2016 Elsevier B.V. All rights reserved.

20180311 - Development of a Tool for Systematic Integration of Traditional and New Approach Methods for Prioritizing Chemical Lists (SOT)

EPA Science Inventory

Multiple chemical regulatory bodies (US EPA, ECHA, OECD, Health Canada) are currently tasked with prioritizing chemicals for in-depth risk assessments. These prioritization efforts are driven by the fact that there are many chemicals in commerce, or in the environment for which d...

Development of a Tool for Systematic Integration of Traditional and New Approach Methods for Prioritizing Chemical Lists

EPA Science Inventory

Multiple chemical regulatory bodies (US EPA, ECHA, OECD, Health Canada) are currently tasked with prioritizing chemicals for in-depth risk assessments. These prioritization efforts are driven by the fact that there are many chemicals in commerce, or in the environment for which d...

77 FR 22720 - Service Rules for Advanced Wireless Services in the 2000-2020 MHz and 2180-2200 MHz Bands, etc.

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-17

..., encourage innovation and investment in mobile broadband, and provide a stable regulatory environment in... of this spectrum, to encourage innovation and investment in mobile broadband, and to provide a stable... service, technical, assignment, and licensing rules for flexible terrestrial use of spectrum currently...

Development of archetypes for non-ranking classification and comparison of European National Health Technology Assessment systems.

PubMed

Allen, Nicola; Pichler, Franz; Wang, Tina; Patel, Sundip; Salek, Sam

2013-12-01

European countries are increasingly utilising health technology assessment (HTA) to inform reimbursement decision-making. However, the current European HTA environment is very diverse, and projects are already underway to initiate a more efficient and aligned HTA practice within Europe. This study aims to identify a non-ranking method for classifying the diversity of European HTA agencies process and the organisational architecture of the national regulatory review to reimbursement systems. Using a previously developed mapping methodology, this research created process maps to describe national processes for regulatory review to reimbursement for 33 European jurisdictions. These process maps enabled the creation of 2 HTA taxonomic sets. The confluence of the two taxonomic sets was subsequently cross-referenced to identify 10 HTA archetype groups. HTA is a young, rapidly evolving field and it can be argued that optimal practices for performing HTA are yet to emerge. Therefore, a non-ranking classification approach could objectively characterise and compare the diversity observed in the current European HTA environment. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Steering healthcare service delivery: a regulatory perspective.

PubMed

Prakash, Gyan

2015-01-01

The purpose of this paper is to explore regulation in India's healthcare sector and makes recommendations needed for enhancing the healthcare service. The literature was reviewed to understand healthcare's regulatory context. To understand the current healthcare system, qualitative data were collected from state-level officials, public and private hospital staff. A patient survey was performed to assess service quality (QoS). Regulation plays a central role in driving healthcare QoS. India needs to strengthen market and institutional co-production based approaches for steering its healthcare in which delivery processes are complex and pose different challenges. This study assesses current healthcare regulation in an Indian state and presents a framework for studying and strengthening regulation. Agile regulation should be based on service delivery issues (pull approach) rather than monitoring and sanctions based regulatory environment (push approach). Healthcare pitfalls across the world seem to follow similar follies. India's complexity and experience is useful for emerging and developed economies. The author reviewed around 70 publications and synthesised them in healthcare regulatory contexts. Patient's perception of private providers could be a key input towards steering regulation. Identifying gaps across QoS dimensions would be useful in taking corrective measures.

40 CFR 73.86 - State regulatory autonomy.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 16 2010-07-01 2010-07-01 false State regulatory autonomy. 73.86 Section 73.86 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... regulatory autonomy. Nothing in this subpart shall preclude a State or State regulatory authority from...

Status of market, regulation and research of genetically modified crops in Chile.

PubMed

Sánchez, Miguel A; León, Gabriel

2016-12-25

Agricultural biotechnology and genetically modified (GM) crops are effective tools to substantially increase productivity, quality, and environmental sustainability in agricultural farming. Furthermore, they may contribute to improving the nutritional content of crops, addressing needs related to public health. Chile has become one of the most important global players for GM seed production for counter-season markets and research purposes. It has a comprehensive regulatory framework to carry out this activity, while at the same time there are numerous regulations from different agencies addressing several aspects related to GM crops. Despite imports of GM food/feed or ingredients for the food industry being allowed without restrictions, Chilean farmers are not using GM seeds for farming purposes because of a lack of clear guidelines. Chile is in a rather contradictory situation about GM crops. The country has invested considerable resources to fund research and development on GM crops, but the lack of clarity in the current regulatory situation precludes the use of such research to develop new products for Chilean farmers. Meanwhile, a larger scientific capacity regarding GM crop research continues to build up in the country. The present study maps and analyses the current regulatory environment for research and production of GM crops in Chile, providing an updated overview of the current status of GM seeds production, research and regulatory issues. Copyright © 2016 Elsevier B.V. All rights reserved.

Climate Change Education: Preparing Future and Current Business Leaders--A Workshop Summary

ERIC Educational Resources Information Center

Storksdieck, Martin

2014-01-01

Climate change poses challenges as well as opportunities for businesses and, broadly speaking for the entire economy. Businesses will be challenged to provide services or products with less harmful influence on the climate; respond to a changing policy, regulatory, and market environment; and provide new services and products to help address the…

Regulation of Cell and Gene Therapy Medicinal Products in Taiwan.

PubMed

Lin, Yi-Chu; Wang, Po-Yu; Tsai, Shih-Chih; Lin, Chien-Liang; Tai, Hsuen-Yung; Lo, Chi-Fang; Wu, Shiow-Ing; Chiang, Yu-Mei; Liu, Li-Ling

2015-01-01

Owing to the rapid and mature development of emerging biotechnology in the fields of cell culture, cell preservation, and recombinant DNA technology, more and more cell or gene medicinal therapy products have been approved for marketing, to treat serious diseases which have been challenging to treat with current medical practice or medicine. This chapter will briefly introduce the Taiwan Food and Drug Administration (TFDA) and elaborate regulation of cell and gene therapy medicinal products in Taiwan, including regulatory history evolution, current regulatory framework, application and review procedures, and relevant jurisdictional issues. Under the promise of quality, safety, and efficacy of medicinal products, it is expected the regulation and environment will be more flexible, streamlining the process of the marketing approval of new emerging cell or gene therapy medicinal products and providing diverse treatment options for physicians and patients.

Regulating the unknown: Managing the occupational health risks of nanomedical technologies and nanopharmaceuticals in the research laboratory

NASA Astrophysics Data System (ADS)

Ersin, Ozlem Hacer

Novel technologies and their resultant products demand fresh ways of thinking about pre-market risk analysis and post-market surveillance. A regulatory framework that is responsive to emerging knowledge about the hazards of novel technologies offers repeatable and transparent processes and remains economically and socially feasible. Workers are an especially vulnerable population who are exposed to unknown hazards of novel technologies and serve often as unwitting sentinels of impending risks. This Grounded Theory-based case study identifies gaps in our current ability to regulate novel technologies so as to minimize occupational health risks and offers necessary modifications for an environment that is conducive to proper regulation. Nanopharmaceuticals and the nano-based technologies at their base are used by way of exemplar technologies that are currently taxing the ability of the regulatory system to provide adequate oversight. Ambiguities of definition, absence of a tracking system (of who is doing nanotechnology research), and the paucity of scientific evidence to support risk management efforts are among the findings of the study and need to be addressed as ameliorative steps toward an effective regulatory structure.

Defining a caring hospital by using currently implemented survey tools.

PubMed

Jennings, Nancy

2010-09-01

Health care organizations are constantly striving to provide a more cost-effective and higher quality treatment within a caring environment. However, balancing the demands of regulatory agencies with the holistic needs of the patient is challenging. Further challenging is how to define those hospitals that provide an exceptional caring environment for their patients. By using survey tools that are already being administered in hospital settings, the opportunity exists to analyze the results obtained from these tools to define a hospital as a caring organization without the added burden of separate data collection.

Current State of the Regulatory Trajectory for Whole Slide Imaging Devices in the USA

PubMed Central

Abels, Esther; Pantanowitz, Liron

2017-01-01

The regulatory field for digital pathology (DP) has advanced significantly. A major milestone was accomplished when the FDA allowed the first vendor to market their device for primary diagnostic use in the USA and published in the classification order that this device, and substantially equivalent devices of this generic type, should be classified into class II instead of class III as previously proposed. The Digital Pathology Association (DPA) regulatory task force had a major role in the accomplishment of getting the application request for Whole Slide Imaging (WSI) Systems recommended for a de novo. This article reviews the past and emerging regulatory environment of WSI for clinical use in the USA. A WSI system with integrated subsystems is defined in the context of medical device regulations. The FDA technical performance assessment guideline is also discussed as well as parameters involved in analytical testing and clinical studies to demonstrate that WSI devices are safe and effective for clinical use. PMID:28584684

Current State of the Regulatory Trajectory for Whole Slide Imaging Devices in the USA.

PubMed

Abels, Esther; Pantanowitz, Liron

2017-01-01

The regulatory field for digital pathology (DP) has advanced significantly. A major milestone was accomplished when the FDA allowed the first vendor to market their device for primary diagnostic use in the USA and published in the classification order that this device, and substantially equivalent devices of this generic type, should be classified into class II instead of class III as previously proposed. The Digital Pathology Association (DPA) regulatory task force had a major role in the accomplishment of getting the application request for Whole Slide Imaging (WSI) Systems recommended for a de novo . This article reviews the past and emerging regulatory environment of WSI for clinical use in the USA. A WSI system with integrated subsystems is defined in the context of medical device regulations. The FDA technical performance assessment guideline is also discussed as well as parameters involved in analytical testing and clinical studies to demonstrate that WSI devices are safe and effective for clinical use.

Genetically engineered crops for biofuel production: regulatory perspectives.

PubMed

Lee, David; Chen, Alice; Nair, Ramesh

2008-01-01

There are numerous challenges in realizing the potential of biofuels that many policy makers have envisioned. The technical challenges in making the production of biofuels economical and on a scale to replace a significant fraction of transportation fuel have been well described, along with the potential environmental concerns. The use of biotechnology can potentially address many of these technical challenges and environmental concerns, but brings significant regulatory hurdles that have not been discussed extensively in the scientific community. This review will give an overview of the approaches being developed to produce transgenic biofuel feedstocks, particularly cellulosic ethanol, and the regulatory process in the United States that oversees the development and commercialization of new transgenic plants. We hope to illustrate that the level of regulation for transgenic organisms is not proportional to their potential risk to human health or the environment, and that revisions to the regulatory system in the U.S. currently under consideration are necessary to streamline the process.

Micro-CT imaging: Developing criteria for examining fetal skeletons in regulatory developmental toxicology studies - A workshop report.

PubMed

Solomon, Howard M; Makris, Susan L; Alsaid, Hasan; Bermudez, Oscar; Beyer, Bruce K; Chen, Antong; Chen, Connie L; Chen, Zhou; Chmielewski, Gary; DeLise, Anthony M; de Schaepdrijver, Luc; Dogdas, Belma; French, Julian; Harrouk, Wafa; Helfgott, Jonathan; Henkelman, R Mark; Hesterman, Jacob; Hew, Kok-Wah; Hoberman, Alan; Lo, Cecilia W; McDougal, Andrew; Minck, Daniel R; Scott, Lelia; Stewart, Jane; Sutherland, Vicki; Tatiparthi, Arun K; Winkelmann, Christopher T; Wise, L David; Wood, Sandra L; Ying, Xiaoyou

2016-06-01

During the past two decades the use and refinements of imaging modalities have markedly increased making it possible to image embryos and fetuses used in pivotal nonclinical studies submitted to regulatory agencies. Implementing these technologies into the Good Laboratory Practice environment requires rigorous testing, validation, and documentation to ensure the reproducibility of data. A workshop on current practices and regulatory requirements was held with the goal of defining minimal criteria for the proper implementation of these technologies and subsequent submission to regulatory agencies. Micro-computed tomography (micro-CT) is especially well suited for high-throughput evaluations, and is gaining popularity to evaluate fetal skeletons to assess the potential developmental toxicity of test agents. This workshop was convened to help scientists in the developmental toxicology field understand and apply micro-CT technology to nonclinical toxicology studies and facilitate the regulatory acceptance of imaging data. Presentations and workshop discussions covered: (1) principles of micro-CT fetal imaging; (2) concordance of findings with conventional skeletal evaluations; and (3) regulatory requirements for validating the system. Establishing these requirements for micro-CT examination can provide a path forward for laboratories considering implementing this technology and provide regulatory agencies with a basis to consider the acceptability of data generated via this technology. Published by Elsevier Inc.

Pharmaceuticals and personal care products in the aquatic environment in China: a review.

PubMed

Bu, Qingwei; Wang, Bin; Huang, Jun; Deng, Shubo; Yu, Gang

2013-11-15

Pharmaceuticals and personal care products (PPCPs) have been detected as contaminants of emerging concern ubiquitously in the aquatic environment in China and worldwide. A clear picture of PPCP contamination in the Chinese aquatic environment is needed to gain insight for both research and regulatory needs (e.g. monitoring, control and management). The occurrence data of 112 PPCPs in waters and sediments in China has been reviewed. In most cases, the detected concentration of these PPCPs in waters and sediments were at ng/L and ng/g levels, which were lower than or comparable to those reported worldwide. A screening level risk assessment (SLERA) identified six priority PPCPs in surface waters, namely erythromycin, roxithromycin, diclofenac, ibuprofen, salicylic acid and sulfamethoxazole. The results of SLERA also revealed that the hot spots for PPCP pollution were those river waters affected by the megacities with high density of population, such as Beijing, Tianjin, Guangzhou and Shanghai. Limitations of current researches and implications for future research in China were discussed. Some regulatory issues were also addressed. Copyright © 2013 Elsevier B.V. All rights reserved.

Manganese biomining: A review.

PubMed

Das, A P; Sukla, L B; Pradhan, N; Nayak, S

2011-08-01

Biomining comprises of processing and extraction of metal from their ores and concentrates using microbial techniques. Currently this is used by the mining industry to extract copper, uranium and gold from low grade ores but not for low grade manganese ore in industrial scale. The study of microbial genomes, metabolites and regulatory pathways provide novel insights to the metabolism of bioleaching microorganisms and their synergistic action during bioleaching operations. This will promote understanding of the universal regulatory responses that the biomining microbial community uses to adapt to their changing environment leading to high metal recovery. Possibility exists of findings ways to imitate the entire process during industrial manganese biomining endeavor. This paper reviews the current status of manganese biomining research operations around the world, identifies factors that drive the selection of biomining as a processing technology, describes challenges in exploiting these innovations, and concludes with a discussion of Mn biomining's future. Copyright © 2011 Elsevier Ltd. All rights reserved.

PathCase-SB architecture and database design

PubMed Central

2011-01-01

Background Integration of metabolic pathways resources and regulatory metabolic network models, and deploying new tools on the integrated platform can help perform more effective and more efficient systems biology research on understanding the regulation in metabolic networks. Therefore, the tasks of (a) integrating under a single database environment regulatory metabolic networks and existing models, and (b) building tools to help with modeling and analysis are desirable and intellectually challenging computational tasks. Description PathCase Systems Biology (PathCase-SB) is built and released. The PathCase-SB database provides data and API for multiple user interfaces and software tools. The current PathCase-SB system provides a database-enabled framework and web-based computational tools towards facilitating the development of kinetic models for biological systems. PathCase-SB aims to integrate data of selected biological data sources on the web (currently, BioModels database and KEGG), and to provide more powerful and/or new capabilities via the new web-based integrative framework. This paper describes architecture and database design issues encountered in PathCase-SB's design and implementation, and presents the current design of PathCase-SB's architecture and database. Conclusions PathCase-SB architecture and database provide a highly extensible and scalable environment with easy and fast (real-time) access to the data in the database. PathCase-SB itself is already being used by researchers across the world. PMID:22070889

Toward refined environmental scenarios for ecological risk assessment of down-the-drain chemicals in freshwater environments.

PubMed

Franco, Antonio; Price, Oliver R; Marshall, Stuart; Jolliet, Olivier; Van den Brink, Paul J; Rico, Andreu; Focks, Andreas; De Laender, Frederik; Ashauer, Roman

2017-03-01

Current regulatory practice for chemical risk assessment suffers from the lack of realism in conventional frameworks. Despite significant advances in exposure and ecological effect modeling, the implementation of novel approaches as high-tier options for prospective regulatory risk assessment remains limited, particularly among general chemicals such as down-the-drain ingredients. While reviewing the current state of the art in environmental exposure and ecological effect modeling, we propose a scenario-based framework that enables a better integration of exposure and effect assessments in a tiered approach. Global- to catchment-scale spatially explicit exposure models can be used to identify areas of higher exposure and to generate ecologically relevant exposure information for input into effect models. Numerous examples of mechanistic ecological effect models demonstrate that it is technically feasible to extrapolate from individual-level effects to effects at higher levels of biological organization and from laboratory to environmental conditions. However, the data required to parameterize effect models that can embrace the complexity of ecosystems are large and require a targeted approach. Experimental efforts should, therefore, focus on vulnerable species and/or traits and ecological conditions of relevance. We outline key research needs to address the challenges that currently hinder the practical application of advanced model-based approaches to risk assessment of down-the-drain chemicals. Integr Environ Assess Manag 2017;13:233-248. © 2016 SETAC. © 2016 SETAC.

[Anti-doping control and public health: limits to the exposure of human health to risk in the name of sporting glory].

PubMed

Aith, Fernando Mussa Abujamra

2013-10-01

Given the current regulatory environment surrounding doping in the world, and in view of the recurring scandals linking leading athletes in a variety of sports with doping, this paper aims to provide some thoughts on the relationship between doping and public health, taking as base reference the risks doping poses to health and considering the regulatory options that have been adopted by the international community and the sports federations to control and supervise this unsporting and risky practice. The text seeks to reflect on the necessary balance between sport and health, as well as on the role of the state in preserving this balance.

Military vaccines in today's environment.

PubMed

Schmaljohn, Connie S; Smith, Leonard A; Friedlander, Arthur M

2012-08-01

The US military has a long and highly distinguished record of developing effective vaccines against pathogens that threaten the armed forces. Many of these vaccines have also been of significant benefit to civilian populations around the world. The current requirements for force protection include vaccines against endemic disease threats as well as against biological warfare or bioterrorism agents, to include novel or genetically engineered threats. The cost of vaccine development and the modern regulatory requirements for licensing vaccines have strained the ability of the program to maintain this broad mission. Without innovative vaccine technologies, streamlined regulatory strategies, and coordinating efforts for use in civilian populations where appropriate, the military vaccine development program is in jeopardy.

Early thermal testing of type B radioactive material packages in USA to environments beyond regulatory package thermal test standards

DOE PAGES

Yoshimura, H. R.; Pope, R. B.; Kubo, M.

2007-06-01

Three separate fire test programmes exposing casks beyond the regulatory thermal test requirements were performed by Sandia National Laboratories during the late 1970s and mid 1980s. The results of these test programmes can be used to assist in addressing the adequacy of the regulatory thermal test of fully engulfing exposure at 800°C for 30 min and how that test might relate to real accident thermal environments. The test programmes were undertaken on obsolete and new casks on behalf of the US Department of Energy (DOE), the US Department of Transportation (DOT) and the Japanese Power Reactor and Nuclear Fuel Developmentmore » Corporation (PNC), currently known as the Japan Atomic Energy Agency. Two of the tests involved exposure of casks in damaged transport vehicles to fully engulfing fires for 72–125 min, and the other test involved four exposures of a cask to torch environments for 30 min. Much of the original documentation regarding these tests and their results is no longer readily available. The documents relating to these tests have been surveyed; this paper presents summaries from this survey of the tests and their results. Specifically, for the pool fire exposures, the temperatures measured in the flames of both exceeded the flame temperature required by the Transport Regulations; yet an obsolete 67 t cask endured 90 min of exposure before evidence of failure was detected, and a new cask endured the 72 min exposure while retaining its containment integrity. For the exposure of a modified obsolete cask to four different torch environments, the integrity of the cask was retained and the relative temperature increases within the cask were well within acceptable limits and well below the values that could be expected if the cask was exposed to the regulatory thermal test. In this paper, a review of these three thermal test programmes, establishes that the two older cask designs and one new cask design have the ability to survive environments that were different from (the torch environments) or more severe than the environment specified by the existing thermal test requirement in the Transport Regulations. Finally, these results can be extrapolated to apply to modern casks that generally have more robust designs as well as better quality assurance applied during the manufacturing process.« less

[Future Regulatory Science through a Global Product Development Strategy to Overcome the Device Lag].

PubMed

Tsuchii, Isao

2016-01-01

Environment that created "medical device lag (MDL)" has changed dramatically, and currently that term is not heard often. This was mainly achieved through the leadership of three groups: government, which determined to overcome MDL and took steps to do so; medical societies, which exhibited accountability in trial participation; and MD companies, which underwent a change in mindset that allowed comprehensive tripartite cooperation to reach the current stage. In particular, the global product development strategy (GPDS) of companies in a changing social environment has taken a new-turn with international harmonization trends, like Global Harmonization Task Force and International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. As a result, this evolution has created opportunities for treatment with cutting-edge MDs in Japanese society. Simultaneously, it has had a major impact on the planning process of GPDS of companies. At the same time, the interest of global companies has shifted to emerging economies for future potential profit since Japan no longer faces MDL issue. This economic trend makes MDLs a greater problem for manufacturers. From the regulatory science viewpoint, this new environment has not made it easy to plan a global strategy that will be adaptable to local societies. Without taking hasty action, flexible thinking from the global point of view is necessary to enable the adjustment of local strategies to fit the situation on the ground so that the innovative Japanese medical technology can be exported to a broad range of societies.

Are better sleepers more engaged workers? A self-regulatory approach to sleep hygiene and work engagement.

PubMed

Barber, Larissa; Grawitch, Matthew J; Munz, David C

2013-10-01

Previous research has emphasized facets of both the organizational environment and individual differences as predictors of work engagement. This study explored sleep hygiene as another important behavioural factor that may be related to work engagement. With a sample of 328 adult workers, we tested a multiple mediator model in which sleep hygiene predicts work engagement through one's appraisals of resource depletion stemming from demands (psychological strain) and general self-regulatory capacity (self-control). Results indicated that individuals who frequently engaged in poor sleep hygiene behaviours had lower self-regulatory capacity, experienced higher subjective depletion and were less engaged at work. Additionally, the path from poor sleep hygiene to decreased work engagement was attributed to perceptions of personal resources that are needed to exert self-regulatory energy at work. This is consistent with current self-regulatory theories suggesting that individuals have a limited amount of resources to allocate to demands and that the depletion of these resources can lead to stress and lower self-regulatory functioning in response to other demands. Specifically, poor sleep hygiene results in the loss of self-regulatory resources needed to be engaged in work tasks by impairing the after-work recovery process. Practical and research implications regarding sleep hygiene interventions for well-being and productivity improvement are discussed. Copyright © 2012 John Wiley & Sons, Ltd.

Policy instruments for pollution control in developing countries.

PubMed

Eskeland, G S; Jimenez, E

1992-07-01

Economic development in developing countries must be accomplished in a manner that does not harm the environment with pollution. Pollution harms human health and productivity. Thus appropriate strategies must be developed that promote growth, reduce poverty, and protect the environment. A review of the current literature is performed with attention paid to cost-effective interventions i.e., comparisons of regulatory and fiscal instruments that can reduce pollution. Both direct instruments (like effluent charges, tradable permits, deposit refund systems, emission regulations and regulatory agency funding for purification, cleanup, waste disposal, and enforcement) and indirect instruments (like input/output taxes and subsidies, substitution subsidies, abatement inputs, regulation of equipment and processes, and development of clean technologies) are examined. Examples are used to show how indirect instruments can be successful when monitoring and enforcement is too costly. A careful examination of distributive concerns illustrate how the effect on the poor may need particular consideration and how groups with vested interests can help evaluate the probable success of such interventions.

Potential Upstream Strategies for the Mitigation of Pharmaceuticals in the Aquatic Environment: a Brief Review.

PubMed

Blair, Benjamin D

2016-06-01

Active pharmaceutical ingredients represent a class of pollutants of emerging concern, and there is growing evidence that these pollutants can cause damage to the aquatic environment. As regulations to address these concerns are expected in developed nations, decision-makers are looking to the scientific community for potential solutions. To inform these regulatory efforts, further information on the potential strategies to reduce the levels of pharmaceuticals entering the aquatic environment is needed. End-of-pipe (i.e., wastewater treatment) technologies that can remove pharmaceuticals exist; however, they are costly to install and operate. Thus, the goal of this brief review is to look beyond end-of-pipe solutions and present various upstream mitigation strategies discussed within the scientific literature. Programs such as pharmaceutical take-back programs currently exist to attempt to reduce pharmaceutical concentrations in the environment, although access and coverage are often limited for many programs. Other potential strategies include redesigning pharmaceuticals to minimize aquatic toxicity, increasing the percent of the pharmaceuticals metabolized in the body, selecting less harmful pharmaceuticals for use, starting new prescriptions at lower dosages, selecting pharmaceuticals with lower excretion rates, and implementing source treatment such as urine separating toilets. Overall, this brief review presents a summary of the upstream preventative recommendations to mitigate pharmaceuticals from entering the aquatic environment with an emphasis on regulatory efforts in the USA and concludes with priorities for further research.

The Regulatory Environment in Long Day Care: A "Double-Edged Sword" for Early Childhood Professional Practice

ERIC Educational Resources Information Center

Fenech, Marianne; Sumsion, Jennifer; Goodfellow, Joy

2006-01-01

While early childhood professionals in NSW are accountable to a substantial collection of regulatory requirements, little research has explored the outcomes of this regulatory environment, both intended and otherwise. This paper presents findings from a NSW study and shows how early childhood professionals working in long day care centres perceive…

40 CFR 142.304 - For which of the regulatory requirements is a small system variance available?

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 23 2011-07-01 2011-07-01 false For which of the regulatory requirements is a small system variance available? 142.304 Section 142.304 Protection of Environment... REGULATIONS IMPLEMENTATION Variances for Small System General Provisions § 142.304 For which of the regulatory...

78 FR 717 - ENE (Environment Northeast); Greater Boston Real Estate Board; National Consumer Law Center...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-04

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [ Docket No. EL13-33-000] ENE (Environment Northeast); Greater Boston Real Estate Board; National Consumer Law Center; NEPOOL Industrial... Federal Energy Regulatory Commission (Commission), 18 CFR 385.206, ENE (Environment Northeast), Greater...

Pesticide authorization in the EU-environment unprotected?

PubMed

Stehle, Sebastian; Schulz, Ralf

2015-12-01

Pesticides constitute an integral part of high-intensity European agriculture. Prior to their authorization, a highly elaborated environmental risk assessment is mandatory according to EU pesticide legislation, i.e., Regulation (EC) No. 1107/2009. However, no field data-based evaluation of the risk assessment outcome, i.e., the regulatory acceptable concentrations (RACs), and therefore of the overall protectiveness of EU pesticide regulations exists. We conducted here a comprehensive meta-analysis using peer-reviewed literature on agricultural insecticide concentrations in EU surface waters and evaluated associated risks using the RACs derived from official European pesticide registration documents. As a result, 44.7 % of the 1566 cases of measured insecticide concentrations (MICs) in EU surface waters exceeded their respective RACs. It follows that current EU pesticide regulations do not protect the aquatic environment and that insecticides threaten aquatic biodiversity. RAC exceedances were significantly higher for insecticides authorized using conservative tier-I RACs and for more recently developed insecticide classes, i.e., pyrethroids. In addition, we identified higher risks, e.g., for smaller surface waters that are specifically considered in the regulatory risk assessment schemes. We illustrate the shortcomings of the EU regulatory risk assessment using two case studies that contextualize the respective risk assessment outcomes to field exposure. Overall, our meta-analysis challenges the field relevance and protectiveness of the regulatory environmental risk assessment conducted for pesticide authorization in the EU and indicates that critical revisions of related pesticide regulations and effective mitigation measures are urgently needed to substantially reduce the environmental risks arising from agricultural insecticide use.

Genetically modified organisms: an analysis of the regulatory framework currently employed within the European Union.

PubMed

Gent, R N

1999-09-01

Genetic engineering technology is starting to bring many commercial products to the market. These genetically modified organisms (GMOs) and their derived products are subject to topical debate as to their benefits and risks. The strengths and weaknesses of the regulatory framework that controls their development and application is central to the question of whether this technology poses significant risk to the public health during this critical phase of its evolution. A critical review was carried out of the legal framework regulating the contained use, deliberate release and some aspects of consumer protection relevant to the control of GMOs in Europe and the United Kingdom. The current legal framework is failing to provide a speed of adaptation commensurate with the development of the science of genetic engineering; failing to properly respond to democratic control; failing to resolve significant conflict between the protection of free markets and protection of public health and the environment; and failing to implement obligations on biodiversity. The present legal framework must be replaced. Current European Union proposals for new standards of regulation are welcome, but provide only for further incremental change, and do not address some significant fundamental flaws in our current laws.

Implementation of the 3Rs (refinement, reduction, and replacement): validation and regulatory acceptance considerations for alternative toxicological test methods.

PubMed

Schechtman, Leonard M

2002-01-01

Toxicological testing in the current regulatory environment is steeped in a history of using animals to answer questions about the safety of products to which humans are exposed. That history forms the basis for the testing strategies that have evolved to satisfy the needs of the regulatory bodies that render decisions that affect, for the most part, virtually all phases of premarket product development and evaluation and, to a lesser extent, postmarketing surveillance. Only relatively recently have the levels of awareness of, and responsiveness to, animal welfare issues reached current proportions. That paradigm shift, although sluggish, has nevertheless been progressive. New and alternative toxicological methods for hazard evaluation and risk assessment have now been adopted and are being viewed as a means to address those issues in a manner that considers humane treatment of animals yet maintains scientific credibility and preserves the goal of ensuring human safety. To facilitate this transition, regulatory agencies and regulated industry must work together toward improved approaches. They will need assurance that the methods will be reliable and the results comparable with, or better than, those derived from the current classical methods. That confidence will be a function of the scientific validation and resultant acceptance of any given method. In the United States, to fulfill this need, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and its operational center, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), have been constituted as prescribed in federal law. Under this mandate, ICCVAM has developed a process and established criteria for the scientific validation and regulatory acceptance of new and alternative methods. The role of ICCVAM in the validation and acceptance process and the criteria instituted toward that end are described. Also discussed are the participation of the US Food and Drug Administration (FDA) in the ICCVAM process and that agency's approach to the application and implementation of ICCVAM-recommended methods.

75 FR 36445 - Draft Regulatory Guide, DG-4018, “Constraint on Releases of Airborne Radioactive Materials To the...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-25

... Releases of Airborne Radioactive Materials To the Environment for Licensees Other Than Power Reactors... Regulatory Guide (DG)-4018, ``Constraint on Releases of Airborne Radioactive Materials to the Environment for..., ``Constraint on Releases of Airborne Radioactive Materials to the Environment for Licensees Other than Power...

Regulatory trends in the battery industry

NASA Astrophysics Data System (ADS)

McColl, K. G.

1994-02-01

The scope of regulations in the battery industry is extensive and also complex. In the future, regulations will become more demanding and will encompass issues not currently considered. Increased focus on environmental issues by government bodies, environmental groups, local communities will result in more strict compliance standards. The USA is currently leading the world's battery industries in the scope and compliance level of regulations. By studying trends in the USA, the rest of the battery industry can prepare itself for the future operating environment. This paper reviews the most critical areas of air pollution, blood-lead levels and recycling. The paper concludes that the battery industry must adopt a culture of exceeding current compliance standards.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Metzler, D.; Gibb, J.P.; Glover, W.A.

Compliance with the mandate of the Uranium Mill Tailings Radiation Control Act (UMTRCA) at Uranium Mill Tailings Remedial Action (UMTRA) Project sites requires implementation of a groundwater remedial action plan that meets the requirements of Subpart B of the US Environmental Protection Agency`s proposed groundwater protection standards (40 CFR 192). The UMTRA Groundwater Project will ensure that unacceptable current risk or potential risk to the public health, safety and the environment resulting from the groundwater contamination attributable to the UMTRA sites, is mitigated in a timely and cost-efficient manner. For each UMTRA processing site and vicinity property where contamination exists,more » a groundwater remedial action plan must be developed that identifies hazardous constituents and establishes acceptable concentration limits for the hazardous constituents as either (a) alternate concentration limits (ACL), (b) maximum concentration limits (MCLs), (c) supplemental standards, or (d) background groundwater quality levels. Project optimization is a strategy that will aggressively work within the current regulatory framework using all available options to meet regulatory requirements. This strategy is outlined within.« less

Use of nonintrusive sensor-based information and communication technology for real-world evidence for clinical trials in dementia.

PubMed

Teipel, Stefan; König, Alexandra; Hoey, Jesse; Kaye, Jeff; Krüger, Frank; Robillard, Julie M; Kirste, Thomas; Babiloni, Claudio

2018-06-21

Cognitive function is an important end point of treatments in dementia clinical trials. Measuring cognitive function by standardized tests, however, is biased toward highly constrained environments (such as hospitals) in selected samples. Patient-powered real-world evidence using information and communication technology devices, including environmental and wearable sensors, may help to overcome these limitations. This position paper describes current and novel information and communication technology devices and algorithms to monitor behavior and function in people with prodromal and manifest stages of dementia continuously, and discusses clinical, technological, ethical, regulatory, and user-centered requirements for collecting real-world evidence in future randomized controlled trials. Challenges of data safety, quality, and privacy and regulatory requirements need to be addressed by future smart sensor technologies. When these requirements are satisfied, these technologies will provide access to truly user relevant outcomes and broader cohorts of participants than currently sampled in clinical trials. Copyright © 2018. Published by Elsevier Inc.

A regulatory perspective on the radiological impact of NORM industries: the case of the Spanish phosphate industry.

PubMed

García-Talavera, M; Matarranz, J L M; Salas, R; Ramos, L

2011-01-01

Radioactive and chemical risks coexist in NORM industries although they are usually addressed separately by regulations. The European Union (EU) has developed extensive legislation concerning both matters, which has been diversely reflected in national policies. We consider the case of the Spanish phosphate industry and analyse to which extent regulatory mandates have reduced the historical and ongoing radiological impact on the environment of phosphate facilities. Although no specific radiological constraints on effluent monitoring and release or on waste disposal have yet been imposed on NORM industries in Spain, other environmental regulations have achieved a substantial reduction on the phosphate industry impact. Nevertheless, a more efficient control could be established by eliminating the current conceptual and practical separation of chemical and radioactive risks in NORM industries. We highlight research needs to accomplish so and propose shorter-term measures that require active cooperation among the regulatory bodies involved. Copyright © 2010. Published by Elsevier Ltd.

The Role of Maternal Dietary Proteins in Development of Metabolic Syndrome in Offspring

PubMed Central

Jahan-Mihan, Alireza; Rodriguez, Judith; Christie, Catherine; Sadeghi, Marjan; Zerbe, Tara

2015-01-01

The prevalence of metabolic syndrome and obesity has been increasing. Pre-natal environment has been suggested as a factor influencing the risk of metabolic syndrome in adulthood. Both observational and experimental studies showed that maternal diet is a major modifier of the development of regulatory systems in the offspring in utero and post-natally. Both protein content and source in maternal diet influence pre- and early post-natal development. High and low protein dams’ diets have detrimental effect on body weight, blood pressure191 and metabolic and intake regulatory systems in the offspring. Moreover, the role of the source of protein in a nutritionally adequate maternal diet in programming of food intake regulatory system, body weight, glucose metabolism and blood pressure in offspring is studied. However, underlying mechanisms are still elusive. The purpose of this review is to examine the current literature related to the role of proteins in maternal diets in development of characteristics of the metabolic syndrome in offspring. PMID:26561832

ARTIST (Asian regional tobacco industry scientist team): Philip Morris' attempt to exert a scientific and regulatory agenda on Asia

PubMed Central

Tong, E; Glantz, S

2004-01-01

Objective: To describe how the transnational tobacco industry has collaborated with local Asian tobacco monopolies and companies to promote a scientific and regulatory agenda. Methods: Analysis of previously secret tobacco industry documents. Results: Transnational tobacco companies began aggressively entering the Asia market in the 1980s, and the current tobacco industry in Asia is a mix of transnational and local monopolies or private companies. Tobacco industry documents demonstrate that, in 1996, Philip Morris led an organisation of scientific representatives from different tobacco companies called the Asian Regional Tobacco Industry Science Team (ARTIST), whose membership grew to include monopolies from Korea, China, Thailand, and Taiwan and a company from Indonesia. ARTIST was initially a vehicle for PM's strategies against anticipated calls for global smoke-free areas from a World Health Organization secondhand smoke study. ARTIST evolved through 2001 into a forum to present scientific and regulatory issues faced primarily by Philip Morris and other transnational tobacco companies. Philip Morris' goal for the organisation became to reach the external scientific and public health community and regulators in Asia. Conclusion: The Asian tobacco industry has changed from an environment of invasion by transnational tobacco companies to an environment of participation with Philip Morris' initiated activities. With this participation, tobacco control efforts in Asia face new challenges as Philip Morris promotes and integrates its scientific and regulatory agenda into the local Asian tobacco industry. As the local Asian tobacco monopolies and companies can have direct links with their governments, future implementation of effective tobacco control may be at odds with national priorities. PMID:15564214

ARTIST (Asian regional tobacco industry scientist team): Philip Morris' attempt to exert a scientific and regulatory agenda on Asia.

PubMed

Tong, E K; Glantz, S A

2004-12-01

To describe how the transnational tobacco industry has collaborated with local Asian tobacco monopolies and companies to promote a scientific and regulatory agenda. Analysis of previously secret tobacco industry documents. Transnational tobacco companies began aggressively entering the Asia market in the 1980s, and the current tobacco industry in Asia is a mix of transnational and local monopolies or private companies. Tobacco industry documents demonstrate that, in 1996, Philip Morris led an organisation of scientific representatives from different tobacco companies called the Asian Regional Tobacco Industry Science Team (ARTIST), whose membership grew to include monopolies from Korea, China, Thailand, and Taiwan and a company from Indonesia. ARTIST was initially a vehicle for PM's strategies against anticipated calls for global smoke-free areas from a World Health Organization secondhand smoke study. ARTIST evolved through 2001 into a forum to present scientific and regulatory issues faced primarily by Philip Morris and other transnational tobacco companies. Philip Morris' goal for the organisation became to reach the external scientific and public health community and regulators in Asia. The Asian tobacco industry has changed from an environment of invasion by transnational tobacco companies to an environment of participation with Philip Morris' initiated activities. With this participation, tobacco control efforts in Asia face new challenges as Philip Morris promotes and integrates its scientific and regulatory agenda into the local Asian tobacco industry. As the local Asian tobacco monopolies and companies can have direct links with their governments, future implementation of effective tobacco control may be at odds with national priorities.

The responding relationship between plants and environment is the essential principle for agricultural sustainable development on the globe.

PubMed

Zhou, Yi; Shao, Hong-Bo

2008-04-01

The mutual-responding relationship between plants and environment is involved in all life processes, which are the essential bases for different types of sustainable development on the globe, particularly the critical basis for agricultural sustainable development. How to regulate the above relationship between plants and the corresponding environment (in particular soil environment) is the key problem to modern sustainable agriculture development under global climate change, which is one of the hot topics in the field of plant biology. Detailed dissection of this responding relationship is also important for conducting global eco-environmental restoration and construction. Although powerful methodology and dataset related to genomics, post-genomics, and metabolomics have provided some insights into this relationship, crop physiological measures are also critical for crop full performance in field. With the increase of tested plants (including model plants) and development of integrated molecular biology, a complete understanding of the relationship at different scales under biotic and abiotic stresses will be accelerated. In the current paper, we will cover some important aspects in combination with the recent work from our laboratory and related advances reflected by international academic journals, as follows: plant physiological function performance under natural condition, plant gene regulatory network system under abiotic stresses, gene regulatory network system and drought resistance improvement, summary of the related work from our laboratory, conclusions, and acknowledgement.

White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals.

PubMed

Wilks, M F; Roth, N; Aicher, L; Faust, M; Papadaki, P; Marchis, A; Calliera, M; Ginebreda, A; Andres, S; Kühne, R; Schüürmann, G

2015-07-15

The vision of a sustainable and safe use of chemicals to protect human health, preserve the environment and maintain the ecosystem requires innovative and more holistic approaches to risk assessment (RA) in order to better inform decision making. Integrated risk assessment (IRA) has been proposed as a solution to current scientific, societal and policy needs. It is defined as the mutual exploitation of environmental risk assessment (ERA) for human health risk assessment (HHRA) and vice versa in order to coherently and more efficiently characterize an overall risk to humans and the environment for better informing the risk analysis process. Extrapolating between species which are relevant for HHRA and ERA requires a detailed understanding of pathways of toxicity/modes of action (MoA) for the various toxicological endpoints. Significant scientific advances, changes in chemical legislation, and increasing environmental consciousness have created a favourable scientific and regulatory environment to develop and promote the concept and vision of IRA. An initial proof of concept is needed to foster the incorporation of IRA approaches into different chemical sectorial regulations and demonstrate their reliability for regulatory purposes. More familiarity and confidence with IRA will ultimately contribute to an overall reduction in in vivo toxicity testing requirements. However, significant progress will only be made if long-term support for MoA-related research is secured. In the short term, further exchange and harmonization of RA terminology, models and methodologies across chemical categories and regulatory agencies will support these efforts. Since societal values, public perceptions and cultural factors are of increasing importance for the acceptance of risk analysis and successful implementation of risk mitigation measures, the integration of socio-economic analysis and socio-behavioural considerations into the risk analysis process may help to produce a more effective risk evaluation and consideration of the risks and benefits associated with the use of chemicals. Copyright © 2015 Elsevier B.V. All rights reserved.

Current perspectives on biomedical waste management: Rules, conventions and treatment technologies.

PubMed

Capoor, Malini R; Bhowmik, Kumar Tapas

2017-01-01

Unregulated biomedical waste management (BMWM) is a public health problem. This has posed a grave threat to not only human health and safety but also to the environment for the current and future generations. Safe and reliable methods for handling of biomedical waste (BMW) are of paramount importance. Effective BMWM is not only a legal necessity but also a social responsibility. This article reviews the current perspectives on BMWM and rules, conventions and the treatment technologies used worldwide. BMWM should ideally be the subject of a national strategy with dedicated infrastructure, cradle-to-grave legislation, competent regulatory authority and trained personnel. Improving the management of biomedical waste begins with waste minimisation. These standards, norms and rules on BMWM in a country regulate the disposal of various categories of BMW to ensure the safety of the health-care workers, patients, public and environment. Furthermore, developing models for the monitoring of hospital health-care waste practices and research into non-burn eco-friendly sustainable technologies, recycling and polyvinyl chloride-free devices will go in long way for safe carbon environment. Globally, greater research in BMWM is warranted to understand its growing field of public health importance.

Small Business and Strategic Sourcing: Lessons from Past Research and Current Data

DTIC Science & Technology

2014-01-01

from www.rand.org as a public service of the RAND Corporation. CHILDREN AND FAMILIES EDUCATION AND THE ARTS ENERGY AND ENVIRONMENT HEALTH AND HEALTH...Susan M., and Kristin J. Leuschner, eds., In the Name of Entrepreneurship ? The Logic and Effects of Special Regulatory Treatment for Small Business...Well They Perform, and How We Can Learn More About Them,” International Review of Entrepreneurship , Vol. 8, No. 3, 2010, pp. 1–32. Hanks, Christopher

Models and strategies for electricity distribution companies in emerging economies

NASA Astrophysics Data System (ADS)

Zaragocin Espinosa, Leonardo Vicente

Unbundling and privatization have become key elements of restructuring in the Electric Power Industry of Emerging Economies. These processes have concentrated on the Generation and Transmission areas, leaving Distribution as lower priority. Based on a comparison between the old role of Distribution Companies (DISCOS) and its new potential role this study identifies the main issues and challenges that DISCOS will face in the new environment once structural and ownership changes are completed. For the specific case of DISCOS in Emerging Economies, regulatory policies are reviewed and strategies identified in order to facilitate the transition and to assist in the integration of DISCOS with other agents in the evolving electric power market. Of particular importance in this research is the analysis of the role of Energy Efficiency (EE) in the new structural and governance environment. A theoretical study of the effects of energy efficiency measures, specifically loss reduction, on price regulation is developed within a proposed regulatory regime of privatization together with Price-Cap Regulation. This theoretical benchmark is then used as a starting point for a case study, the Electric System of Ecuador, where an analysis of the current Ecuadorian price regulation scheme (the Distribution Value Added Charge, VAD, scheme) is presented and analyzed in detail. General recommendations for improving the application of the VAD pricing approach are advanced, with special reference to the current situation in Ecuador.

Current limitations and recommendations to improve testing ...

EPA Pesticide Factsheets

In this paper existing regulatory frameworks and test systems for assessing potential endocrine-active chemicals are described, and associated challenges discussed, along with proposed approaches to address these challenges. Regulatory frameworks vary somewhat across organizations, but all basically evaluate whether a chemical possesses endocrine activity and whether this activity can result in adverse outcomes either to humans or the environment. Current test systems include in silico, in vitro and in vivo techniques focused on detecting potential endocrine activity, and in vivo tests that collect apical data to detect possible adverse effects. These test systems are currently designed to robustly assess endocrine activity and/or adverse effects in the estrogen, androgen, and thyroid hormonal pathways; however, there are some limitations of current test systems for evaluating endocrine hazard and risk. These limitations include a lack of certainty regarding: 1)adequately sensitive species and life-stages, 2) mechanistic endpoints that are diagnostic for endocrine pathways of concern, and 3) the linkage between mechanistic responses and apical, adverse outcomes. Furthermore, some existing test methods are resource intensive in regard to time, cost, and use of animals. However, based on recent experiences, there are opportunities to improve approaches to, and guidance for existing test methods, and to reduce uncertainty. For example, in vitro high throughput

Autologous cell therapies: challenges in US FDA regulation.

PubMed

McAllister, Todd N; Audley, David; L'Heureux, Nicolas

2012-11-01

Cell-based therapies (CBTs) have been hailed for the last two decades as the next pillar of healthcare, yet the clinical and commercial potential of regenerative medicine has yet to live up to the hype. While recent analysis has suggested that regenerative medicine is maturing into a multibillion dollar industry, examples of clinical and commercial success are still relatively rare. With 30 years of laboratory and clinical efforts fueled by countless billions in public and private funding, one must contemplate why CBTs have not made a greater impact. The current regulatory environment, with its zero-risk stance, stymies clinical innovation while fueling a potentially risky medical tourism industry. Here, we highlight the challenges the US FDA faces and present talking points for an improved regulatory framework for autologous CBTs.

CO2Explorer: Conducting Greenhouse-Gas Measurements of Landfills using a Small Fixed-wing UAV

NASA Astrophysics Data System (ADS)

Hollingsworth, Peter; Allen, Grant; Kabbabe, Khristopher; Pitt, Joseph

2017-04-01

Quantifying inventories of Greenhouse gas emissions, primarily Methane and Carbon Dioxide, from distributed sources such as a landfill has historically been undertaken using one of several ground based measurement techniques. These methods are either time and/or resource intensive. As a result regulatory agencies have started looking at the potential of using small-unmanned aircraft to supplement or supplant the current methods. The challenge of using a UAV to perform these tasks is the trade-off between accuracy, operational flexibility and operational productivity. This is driven by the state-of-the-art in measurement instruments, the operating environment at landfills and the regulatory/safety environment surrounding UAV operations. This work describes the development of the operational concept, and associated UAV measurement platform for the CO2Explorer. It looks at the scientific, engineering and possible policy trades and compares the use of small rotary and fixed-wing UAVs from both an operational and measurement perspective. This work also makes recommendations on system development and operation for users lacking in both systems engineering and operational experience.

Fungal Genes in Context: Genome Architecture Reflects Regulatory Complexity and Function

PubMed Central

Noble, Luke M.; Andrianopoulos, Alex

2013-01-01

Gene context determines gene expression, with local chromosomal environment most influential. Comparative genomic analysis is often limited in scope to conserved or divergent gene and protein families, and fungi are well suited to this approach with low functional redundancy and relatively streamlined genomes. We show here that one aspect of gene context, the amount of potential upstream regulatory sequence maintained through evolution, is highly predictive of both molecular function and biological process in diverse fungi. Orthologs with large upstream intergenic regions (UIRs) are strongly enriched in information processing functions, such as signal transduction and sequence-specific DNA binding, and, in the genus Aspergillus, include the majority of experimentally studied, high-level developmental and metabolic transcriptional regulators. Many uncharacterized genes are also present in this class and, by implication, may be of similar importance. Large intergenic regions also share two novel sequence characteristics, currently of unknown significance: they are enriched for plus-strand polypyrimidine tracts and an information-rich, putative regulatory motif that was present in the last common ancestor of the Pezizomycotina. Systematic consideration of gene UIR in comparative genomics, particularly for poorly characterized species, could help reveal organisms’ regulatory priorities. PMID:23699226

40 CFR 256.22 - Recommendations for State regulatory powers.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 25 2014-07-01 2014-07-01 false Recommendations for State regulatory powers. 256.22 Section 256.22 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...

40 CFR 256.22 - Recommendations for State regulatory powers.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 26 2013-07-01 2013-07-01 false Recommendations for State regulatory powers. 256.22 Section 256.22 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...

40 CFR 256.21 - Requirements for State regulatory powers.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 26 2013-07-01 2013-07-01 false Requirements for State regulatory powers. 256.21 Section 256.21 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...

40 CFR 256.21 - Requirements for State regulatory powers.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 26 2012-07-01 2011-07-01 true Requirements for State regulatory powers. 256.21 Section 256.21 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...

40 CFR 256.21 - Requirements for State regulatory powers.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 25 2014-07-01 2014-07-01 false Requirements for State regulatory powers. 256.21 Section 256.21 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...

40 CFR 256.22 - Recommendations for State regulatory powers.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 26 2012-07-01 2011-07-01 true Recommendations for State regulatory powers. 256.22 Section 256.22 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...

40 CFR 256.62 - Requirements for public participation in State regulatory development.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 26 2012-07-01 2011-07-01 true Requirements for public participation in State regulatory development. 256.62 Section 256.62 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE...

40 CFR 256.62 - Requirements for public participation in State regulatory development.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 25 2014-07-01 2014-07-01 false Requirements for public participation in State regulatory development. 256.62 Section 256.62 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE...

40 CFR 256.62 - Requirements for public participation in State regulatory development.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 26 2013-07-01 2013-07-01 false Requirements for public participation in State regulatory development. 256.62 Section 256.62 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE...

40 CFR 256.62 - Requirements for public participation in State regulatory development.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 25 2011-07-01 2011-07-01 false Requirements for public participation in State regulatory development. 256.62 Section 256.62 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE...

78 FR 76751 - Safety Zone; Vessel Launch; Menominee River; Marinette, WI

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-19

... Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The... consensus standards. 14. Environment We have analyzed this rule under Department of Homeland Security... significant effect on the human environment. This rule involves the establishment of a safety zone and...

40 CFR 256.62 - Requirements for public participation in State regulatory development.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Requirements for public participation in State regulatory development. 256.62 Section 256.62 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE...

40 CFR 92.6 - Regulatory structure.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Regulatory structure. 92.6 Section 92... Regulations for Locomotives and Locomotive Engines § 92.6 Regulatory structure. This section provides an overview of the regulatory structure of this part. (a) The regulations of this part 92 are intended to...

40 CFR 94.6 - Regulatory structure.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Regulatory structure. 94.6 Section 94... for Compression-Ignition Marine Engines § 94.6 Regulatory structure. This section provides an overview of the regulatory structure of this part. (a) The regulations of this Part 94 are intended to control...

Factors affecting the retirement of commercial transport jet aircraft

NASA Technical Reports Server (NTRS)

Spencer, F. A.

1979-01-01

The historical background of the technology and economics of aircraft replacement and retirement in the prejet era is reviewed in order to determine whether useful insights can be obtained applicable to the jet era. Significant differences between the two periods are noted. New factors are identified and examined. Topics discussed include concern over current policies regarding deregulation, regulatory reform, and retroactive noise regulations; financing and compliance legislation; aging; economic environment and inflation; technological progress; fuel efficiency and cost; and a financial perspective of replacement decisions.

Challenges and lessons learned in conducting comparative-effectiveness trials.

PubMed

Herrick, Linda M; Locke, G Richard; Zinsmeister, Alan R; Talley, Nicholas J

2012-05-01

The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication.

Challenges and Lessons Learned in Conducting Comparative-Effectiveness Trials

PubMed Central

Herrick, Linda M.; Locke, G. Richard; Zinsmeister, Alan R.; Talley, Nicholas J.

2014-01-01

The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication. PMID:22552235

40 CFR 97.87 - Change in regulatory status.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Change in regulatory status. 97.87 Section 97.87 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) FEDERAL NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS Individual Unit Opt-ins...

Beryllium in the environment: a review.

PubMed

Taylor, Tammy P; Ding, Mei; Ehler, Deborah S; Foreman, Trudi M; Kaszuba, John P; Sauer, Nancy N

2003-02-01

Beryllium is an important industrial metal because of its unusual material properties: it is lighter than aluminum and six times stronger than steel. Often alloyed with other metals such as copper, beryllium is a key component of materials used in the aerospace and electronics industries. Beryllium has a small neutron cross-section, which makes it useful in the production of nuclear weapons and in sealed neutron sources. Unfortunately, beryllium is one of the most toxic elements in the periodic table. It is responsible for the often-fatal lung disease, Chronic Beryllium Disease (CBD) or berylliosis, and is listed as a Class A EPA carcinogen. Coal-fired power plants, industrial manufacturing and nuclear weapons production and disposal operations have released beryllium to the environment. This contamination has the potential to expose workers and the public to beryllium. Despite the increasing use of beryllium in industry, there is surprisingly little published information about beryllium fate and transport in the environment. This information is crucial for the development of strategies that limit worker and public exposure. This review summarizes the current understanding of beryllium health hazards, current regulatory mandates, environmental chemistry, geochemistry and environmental contamination.

Reconstructing regulatory networks from the dynamic plasticity of gene expression by mutual information

PubMed Central

Wang, Jianxin; Chen, Bo; Wang, Yaqun; Wang, Ningtao; Garbey, Marc; Tran-Son-Tay, Roger; Berceli, Scott A.; Wu, Rongling

2013-01-01

The capacity of an organism to respond to its environment is facilitated by the environmentally induced alteration of gene and protein expression, i.e. expression plasticity. The reconstruction of gene regulatory networks based on expression plasticity can gain not only new insights into the causality of transcriptional and cellular processes but also the complex regulatory mechanisms that underlie biological function and adaptation. We describe an approach for network inference by integrating expression plasticity into Shannon’s mutual information. Beyond Pearson correlation, mutual information can capture non-linear dependencies and topology sparseness. The approach measures the network of dependencies of genes expressed in different environments, allowing the environment-induced plasticity of gene dependencies to be tested in unprecedented details. The approach is also able to characterize the extent to which the same genes trigger different amounts of expression in response to environmental changes. We demonstrated the usefulness of this approach through analysing gene expression data from a rabbit vein graft study that includes two distinct blood flow environments. The proposed approach provides a powerful tool for the modelling and analysis of dynamic regulatory networks using gene expression data from distinct environments. PMID:23470995

Strengthening the Canadian alcohol advertising regulatory system.

PubMed

Heung, Carly M; Rempel, Benjamin; Krank, Marvin

2012-05-24

Research evidence points to harmful effects from alcohol advertising among children and youth. In particular, exposure to alcohol advertising has been associated with adolescents drinking both earlier and heavier. Although current federal and provincial guidelines have addressed advertising practices to prevent underage drinking, practice has not been supported by existing policy. While protective measures such as social marketing campaigns have the potential for counteracting the effects from alcohol advertising, the effectiveness of such measures can be easily drowned out with increasing advertising activities from the alcohol industry, especially without effective regulation. Research reviewed by the European Focus on Alcohol Safe Environment (FASE) Project has identified a set of key elements that are necessary to make alcohol advertising policy measures effective at protecting children and youth from the harmful effects of alcohol marketing. Using these key elements as an evaluation framework, there are critical components in the Canadian alcohol advertising regulatory system that clearly require strengthening. To protect impressionable children and youth against the harmful effects of alcohol advertising, 13 recommendations to strengthen current alcohol advertising regulations in Canada are provided for Canadian policy-makers, advertising standard agencies, and public health groups.

Current Status of Regulatory Science Education in Faculties of Pharmaceutical Science in Japan.

PubMed

Tohkin, Masahiro

2017-01-01

I introduce the current pharmaceutical education system in Japan, focusing on regulatory science. University schools or faculties of pharmaceutical science in Japan offer two courses: a six-year course for pharmacists and a four-year course for scientists and technicians. Students in the six-year pharmaceutical course receive training in hospitals and pharmacies during their fifth year, and those in the four-year life science course start research activities during their third year. The current model core curriculum for pharmaceutical education requires them to "explain the necessity and significance of regulatory science" as a specific behavior object. This means that pharmacists should understand the significance of "regulatory science", which will lead to the proper use of pharmaceuticals in clinical practice. Most regulatory science laboratories are in the university schools or faculties of pharmaceutical sciences; however, there are too few to conduct regulatory science education. There are many problems in regulatory science education, and I hope that those problems will be resolved not only by university-based regulatory science researchers but also by those from the pharmaceutical industry and regulatory authorities.

Getting to the Root of Things: Spatiotemporal Regulatory Networks (JGI Seventh Annual User Meeting 2012: Genomics of Energy and Environment)

ScienceCinema

Brady, Siobhan

2018-02-12

Siobhan Brady from University of California, Davis, gives a talk titled "Getting to the Root of things: Spatiotemporal Regulatory Networks" at the JGI 7th Annual Users Meeting: Genomics of Energy & Environment Meeting on March 22, 2012 in Walnut Creek, California.

Getting to the Root of Things: Spatiotemporal Regulatory Networks (JGI Seventh Annual User Meeting 2012: Genomics of Energy and Environment)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brady, Siobhan

2012-03-22

Siobhan Brady from University of California, Davis, gives a talk titled "Getting to the Root of things: Spatiotemporal Regulatory Networks" at the JGI 7th Annual Users Meeting: Genomics of Energy & Environment Meeting on March 22, 2012 in Walnut Creek, California.

Regulatory Fit and Systematic Exploration in a Dynamic Decision-Making Environment

ERIC Educational Resources Information Center

Otto, A. Ross; Markman, Arthur B.; Gureckis, Todd M.; Love, Bradley C.

2010-01-01

This work explores the influence of motivation on choice behavior in a dynamic decision-making environment, where the payoffs from each choice depend on one's recent choice history. Previous research reveals that participants in a regulatory fit exhibit increased levels of exploratory choice and flexible use of multiple strategies over the course…

Measuring and Modeling the U.S. Regulatory Ecosystem

NASA Astrophysics Data System (ADS)

Bommarito, Michael J., II; Katz, Daniel Martin

2017-09-01

Over the last 23 years, the U.S. Securities and Exchange Commission has required over 34,000 companies to file over 165,000 annual reports. These reports, the so-called "Form 10-Ks," contain a characterization of a company's financial performance and its risks, including the regulatory environment in which a company operates. In this paper, we analyze over 4.5 million references to U.S. Federal Acts and Agencies contained within these reports to measure the regulatory ecosystem, in which companies are organisms inhabiting a regulatory environment. While individuals across the political, economic, and academic world frequently refer to trends in this regulatory ecosystem, far less attention has been paid to supporting such claims with large-scale, longitudinal data. In this paper, in addition to positing a model of regulatory ecosystems, we document an increase in the regulatory energy per filing, i.e., a warming "temperature." We also find that the diversity of the regulatory ecosystem has been increasing over the past two decades. These findings support the claim that regulatory activity and complexity are increasing, and this framework contributes an important step towards improving academic and policy discussions around legal complexity and regulation.

Underground storage tank management plan, Oak Ridge Y-12 Plant, Oak Ridge, Tennessee

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1997-09-01

The Underground Storage Tank (UST) Program at the Oak Ridge Y-12 Plant was established to locate UST systems at the facility and to ensure that all operating UST systems are free of leaks. UST systems have been removed or upgraded in accordance with Tennessee Department of Environment and Conservation (TDEC) regulations and guidance. With the closure of a significant portion of the USTs, the continuing mission of the UST Management Program is to manage the remaining active UST systems and continue corrective actions in a safe regulatory compliant manner. This Program outlines the compliance issues that must be addressed, reviewsmore » the current UST inventory and compliance approach, and presents the status and planned activities associated with each UST system. The UST Program provides guidance for implementing TDEC regulations and guidelines for petroleum UST systems. The plan is divided into three major sections: (1) regulatory requirements, (2) active UST sites, and (3) out-of-service UST sites. These sections describe in detail the applicable regulatory drivers, the UST sites addressed under the Program, and the procedures and guidance for compliance.« less

Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects

PubMed Central

Sabata, Roger; Verges, Josep; Zugaza, José L.; Ruiz, Adolfina; Clares, Beatriz

2016-01-01

Mesenchymal stem cells (MSCs) are one of the main stem cells that have been used for advanced therapies and regenerative medicine. To carry out the translational clinical application of MSCs, their manufacturing and administration in human must be controlled; therefore they should be considered as medicine: stem cell-based medicinal products (SCMPs). The development of MSCs as SCMPs represents complicated therapeutics due to their extreme complex nature and rigorous regulatory oversights. The manufacturing process of MSCs needs to be addressed in clean environments in compliance with requirements of Good Manufacturing Practice (GMP). Facilities should maintain these GMP conditions according to international and national medicinal regulatory frameworks that introduce a number of specifications in order to produce MSCs as safe SCMPs. One of these important and complex requirements is the environmental monitoring. Although a number of environmental requirements are clearly defined, some others are provided as recommendations. In this review we aim to outline the current issues with regard to international guidelines which impact environmental monitoring in cleanrooms and clean areas for the manufacturing of MSCs. PMID:27999600

Management of Excess Reactive Nitrogen in the Environment

NASA Astrophysics Data System (ADS)

Galloway, J. N.; Theis, T.; Doering, O.

2011-12-01

Managing the impacts of excessive reactive nitrogen (Nr) in the environment is a complex problem that begins with the recognition of the obligate dietary need for Nr by all living populations. The human solution to this need has been to devise ways to bring Nr into the biosphere (via the Haber-Bosch process) to grow food. Other Nr is created as a by-product of fossil-fuel combustion. The net result is the introduction of more than five times the Nr created by natural processes in the U.S., only a fraction of which is converted back to diatomic nitrogen through denitrification. This presentation summarizes findings and recommendations of the newly-released US EPA Science Advisory Board's Integrated Nitrogen Committee report, "Reactive Nitrogen in the United States: An Analysis of Flows, Consequences, and Management Options", that deal specifically with approaches for solving the excess Nr problem. These can be grouped into four general areas: (1) Recognition of the Problem. Until there is recognition that excess Nr is a serious problem with economic, health, and societal consequences, there will be little willingness to expend resources on this issue. Education, communication and outreach are critically important to engender in regulators, and the public at large, sufficient will to undertake the large scale effort needed to reduce Nr in the environment. (2) Development of Integrated Regulatory Approaches. Given what is known about the way Nr behaves, efforts to deal with excess Nr must be organized in a way that reflects the nature of the problem. Unfortunately, most approaches tend to conceive of Nr issues within a narrowly focused disciplinary model, and our policy and regulatory institutions are often bound by enabling legislation that stresses source-by-source, chemical-by-chemical, and media-by-media. The resulting regulatory structure that has evolved for problems such as Nr that affect human health and the environment is apt to miss the complex nature of the problem. Such silos have to be broken down if the excess Nr problem is to be dealt with holistically. (3) Essential Monitoring and Research. The Committee recommends improved monitoring and research to enhance our understanding of Nr in the environment. In some cases our knowledge has such wide margins of error that we cannot identify or quantify important concentrations or flows sufficiently for necessary decisions. In other cases there is incomplete knowledge about the indirect impacts of Nr, while in still others there is a need for much better understanding of the efficacy of actions that might be taken to control Nr. (4) Setting Goals for Action. In spite of knowledge gaps identified by the Committee, there is sufficient understanding of the Nr problem to enable the responsible regulatory agencies to begin to decrease excess Nr entering the environment. The Committee suggests actions that might be taken by EPA or other management authorities using current technologies and regulatory authority to decrease Nr in the environment by 25% over the near (10-20 year) term, without negatively impacting dietary needs or economic trends.

Trends in E-Cigarette Awareness, Trial, and Use Under the Different Regulatory Environments of Australia and the United Kingdom.

PubMed

Yong, Hua-Hie; Borland, Ron; Balmford, James; McNeill, Ann; Hitchman, Sara; Driezen, Pete; Thompson, Mary E; Fong, Geoffrey T; Cummings, K Michael

2015-10-01

E-cigarettes (ECs) have gained significant attention in recent years. They have been introduced in jurisdictions with divergent existing laws that affect their legality. This provides the opportunity for natural experiments to assess effects of such laws in some cases independent of any formulated government policy. We compare patterns of EC awareness and use over a 3 year period in Australia where laws severely restrict EC availability, with awareness and use in the United Kingdom where ECs are readily available. Data analyzed come from Waves 8 and 9 (collected in 2010 and 2013, respectively) of the International Tobacco Control surveys in Australia and the United Kingdom (approximately 1,500 respondents per wave per country). Across both waves, EC awareness, trial, and use among current and former smokers were significantly greater in the United Kingdom than in Australia, but all 3 of these measures increased significantly between 2010 and 2013 in both countries, and the rate of increase was equivalent between countries. Seventy-three percent of U.K. respondents reported that their current brands contained nicotine as did 43% in Australia even though sale, possession and/or use of nicotine-containing ECs without a permit are illegal in Australia. EC use was greater among smokers in both countries, at least in part due to less uptake by ex-smokers. EC awareness and use have risen rapidly between 2010 and 2013 among current and former smokers in both Australia and the United Kingdom despite different EC regulatory environments. Substantial numbers in both countries are using ECs that contain nicotine. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Regulatory system reform of occupational health and safety in China.

PubMed

Wu, Fenghong; Chi, Yan

2015-01-01

With the explosive economic growth and social development, China's regulatory system of occupational health and safety now faces more and more challenges. This article reviews the history of regulatory system of occupational health and safety in China, as well as the current reform of this regulatory system in the country. Comprehensive, a range of laws, regulations and standards that promulgated by Chinese government, duties and responsibilities of the regulatory departments are described. Problems of current regulatory system, the ongoing adjustments and changes for modifying and improving regulatory system are discussed. The aim of reform and the incentives to drive forward more health and safety conditions in workplaces are also outlined.

Regulatory system reform of occupational health and safety in China

PubMed Central

WU, Fenghong; CHI, Yan

2015-01-01

With the explosive economic growth and social development, China’s regulatory system of occupational health and safety now faces more and more challenges. This article reviews the history of regulatory system of occupational health and safety in China, as well as the current reform of this regulatory system in the country. Comprehensive, a range of laws, regulations and standards that promulgated by Chinese government, duties and responsibilities of the regulatory departments are described. Problems of current regulatory system, the ongoing adjustments and changes for modifying and improving regulatory system are discussed. The aim of reform and the incentives to drive forward more health and safety conditions in workplaces are also outlined. PMID:25843565

Networking Omic Data to Envisage Systems Biological Regulation.

PubMed

Kalapanulak, Saowalak; Saithong, Treenut; Thammarongtham, Chinae

To understand how biological processes work, it is necessary to explore the systematic regulation governing the behaviour of the processes. Not only driving the normal behavior of organisms, the systematic regulation evidently underlies the temporal responses to surrounding environments (dynamics) and long-term phenotypic adaptation (evolution). The systematic regulation is, in effect, formulated from the regulatory components which collaboratively work together as a network. In the drive to decipher such a code of lives, a spectrum of technologies has continuously been developed in the post-genomic era. With current advances, high-throughput sequencing technologies are tremendously powerful for facilitating genomics and systems biology studies in the attempt to understand system regulation inside the cells. The ability to explore relevant regulatory components which infer transcriptional and signaling regulation, driving core cellular processes, is thus enhanced. This chapter reviews high-throughput sequencing technologies, including second and third generation sequencing technologies, which support the investigation of genomics and transcriptomics data. Utilization of this high-throughput data to form the virtual network of systems regulation is explained, particularly transcriptional regulatory networks. Analysis of the resulting regulatory networks could lead to an understanding of cellular systems regulation at the mechanistic and dynamics levels. The great contribution of the biological networking approach to envisage systems regulation is finally demonstrated by a broad range of examples.

77 FR 59702 - Promoting U.S. EC Regulatory Compatibility

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-28

... TRADE REPRESENTATIVE Promoting U.S. EC Regulatory Compatibility AGENCY: Office of the United... and European Commission (EC) share the goal of reducing excessive regulatory costs, unjustified..., safety, welfare, and the environment. Promoting this goal will help businesses to grow, create jobs, and...

Genetic toxicology in the 21st century: Reflections and future ...

EPA Pesticide Factsheets

A symposium at the 40th anniversary of the Environmental Mutagen Society, held from October 24–28, 2009 in St. Louis, MO, surveyed the current status and future directions of genetic toxicology. This article summarizes the presentations and provides a perspective on the future. An abbreviated history is presented, highlighting the current standard battery of genotoxicity assays and persistent challenges. Application of computational toxicology to safety testing within a regulatory setting is discussed as a means for reducing the need for animal testing and human clinical trials, and current approaches and applications of in silico genotoxicity screening approaches across the pharmaceutical industry were surveyed and are reported here. The expanded use of toxicogenomics to illuminate mechanisms and bridge genotoxicity and carcinogenicity, and new public efforts to use high-throughput screening technologies to address lack of toxicity evaluation for the backlog of thousands of industrial chemicals in the environment are detailed. The Tox21 project involves coordinated efforts of four U.S. Government regulatory/research entities to use new and innovative assays to characterize key steps in toxicity pathways, including genotoxic and nongenotoxic mechanisms for carcinogenesis. Progress to date, highlighting preliminary test results from the National Toxicology Program is summarized. Finally, an overview is presented of ToxCast™, a related research program of the

Characterization of the radiation environment for a large-area interim spent-nuclear-fuel storage facility

NASA Astrophysics Data System (ADS)

Fortkamp, Jonathan C.

Current needs in the nuclear industry and movements in the political arena indicate that authorization may soon be given for development of a federal interim storage facility for spent nuclear fuel. The initial stages of the design work have already begun within the Department of Energy and are being reviewed by the Nuclear Regulatory Commission. This dissertation addresses the radiation environment around an interim spent nuclear fuel storage facility. Specifically the dissertation characterizes the radiation dose rates around the facility based on a design basis source term, evaluates the changes in dose due to varying cask spacing configurations, and uses these results to define some applicable health physics principles for the storage facility. Results indicate that dose rates from the facility are due primarily from photons from the spent fuel and Co-60 activation in the fuel assemblies. In the modeled cask system, skyshine was a significant contribution to dose rates at distances from the cask array, but this contribution can be reduced with an alternate cask venting system. With the application of appropriate health physics principles, occupation doses can be easily maintained far below regulatory limits and maintained ALARA.

Evolving PBPK applications in regulatory risk assessment: current situation and future goals

EPA Science Inventory

The presentation includes current applications of PBPK modeling in regulatory risk assessment and discussions on conflicts between assuring consistency with experimental data in current situation and the desire for animal-free model development.

Small Unmanned Aerial Systems: Implications of the Evolving Legal Context for Use in Natural Resources Science and Management

NASA Astrophysics Data System (ADS)

Walker, M. J.

2016-12-01

Small unmanned aerial systems (sUAS, also known as drones) potentially provide researchers and managers with the capacity to enhance temporal and spatial resolution of data sets for natural resources science and management. sUAS have been used for many types of data collection and have a partial definition in mass of the aircraft, ranging from 0.5 to <55 lbs (0.2 to <24.9 kg). Aircraft within this range of mass can present a collision hazard to other aircraft. The Federal Aviation Administration (FAA) recently faced the challenge of removing regulatory barriers to sUAS application while minimizing risk in the national airspace. The regulatory and legal framework developed for using sUAS in natural resources science and management has evolved from a very conservative approach prior in the first decade of the 21st century. FAA's recently revised operating rules for sUAS, significantly changing pilot certification requirements and operating rules in the national airspace. The next 2-5 years will bring advances in sUAS applications for science and management, building upon the accomplishments of users who complied with the former regulatory environment. We review the current operating rules (49 CFR, part 107) that apply specifically to sUAS and discuss the implications for researchers and managers. While part 107 relaxed many restrictions, it is important to understand the regulatory framework currently in place that encourages development of applications for sUAS while adhering to the mandate that the national airspace be safe and secure. We consider potential applications for natural resources science and management in the context of the recently released operating rules, especially with respect to training requirements and protocols for use.

Signal Correlations in Ecological Niches Can Shape the Organization and Evolution of Bacterial Gene Regulatory Networks

PubMed Central

Dufour, Yann S.; Donohue, Timothy J.

2015-01-01

Transcriptional regulation plays a significant role in the biological response of bacteria to changing environmental conditions. Therefore, mapping transcriptional regulatory networks is an important step not only in understanding how bacteria sense and interpret their environment but also to identify the functions involved in biological responses to specific conditions. Recent experimental and computational developments have facilitated the characterization of regulatory networks on a genome-wide scale in model organisms. In addition, the multiplication of complete genome sequences has encouraged comparative analyses to detect conserved regulatory elements and infer regulatory networks in other less well-studied organisms. However, transcription regulation appears to evolve rapidly, thus, creating challenges for the transfer of knowledge to nonmodel organisms. Nevertheless, the mechanisms and constraints driving the evolution of regulatory networks have been the subjects of numerous analyses, and several models have been proposed. Overall, the contributions of mutations, recombination, and horizontal gene transfer are complex. Finally, the rapid evolution of regulatory networks plays a significant role in the remarkable capacity of bacteria to adapt to new or changing environments. Conversely, the characteristics of environmental niches determine the selective pressures and can shape the structure of regulatory network accordingly. PMID:23046950

Regulatory cross-cutting topics for fuel cycle facilities.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Denman, Matthew R.; Brown, Jason; Goldmann, Andrew Scott

This report overviews crosscutting regulatory topics for nuclear fuel cycle facilities for use in the Fuel Cycle Research & Development Nuclear Fuel Cycle Evaluation and Screening study. In particular, the regulatory infrastructure and analysis capability is assessed for the following topical areas: Fire Regulations (i.e., how applicable are current Nuclear Regulatory Commission (NRC) and/or International Atomic Energy Agency (IAEA) fire regulations to advance fuel cycle facilities) Consequence Assessment (i.e., how applicable are current radionuclide transportation tools to support risk-informed regulations and Level 2 and/or 3 PRA) While not addressed in detail, the following regulatory topic is also discussed: Integrated Security,more » Safeguard and Safety Requirement (i.e., how applicable are current Nuclear Regulatory Commission (NRC) regulations to future fuel cycle facilities which will likely be required to balance the sometimes conflicting Material Accountability, Security, and Safety requirements.)« less

Regulatory T cells in Allergic Diseases

PubMed Central

Rivas, Magali Noval; Chatila, Talal A.

2016-01-01

The pathogenesis of allergic diseases entails an ineffective tolerogenic immune response towards allergens. Regulatory T cells (TReg) cells play a key role in sustaining immune tolerance to allergens, yet mechanisms by which TReg cells fail to maintain tolerance in allergic diseases are not well understood. We review current concepts and established mechanisms regarding how TReg cells regulate different components of allergen-triggered immune responses to promote and maintain tolerance. We will also discuss more recent advances that emphasize the “dual” functionality of TReg cells in allergic diseases: how TReg cells are essential in promoting tolerance to allergens but also how a pro-allergic inflammatory environment can skew TReg cells towards a pathogenic phenotype that aggravates and perpetuates disease. These advances highlight opportunities for novel therapeutic strategies that aim to re-establish tolerance in chronic allergic diseases by promoting TReg cell and stability function. PMID:27596705

Impact of government regulation on health care technology

NASA Astrophysics Data System (ADS)

Berkowitz, Robert D.

1994-12-01

Increased government regulation of the medical device industry produces higher expenses, a longer time to return investment capital, and greater uncertainty. As a result there are fewer new ventures and reduced efforts to develop new technology in established companies. The current federal regulatory framework has shifted from monitoring the product to monitoring the process. The inability to reach perfect performance in such a regulated environment subject to continuous and fluid interpretation guarantees non-compliance and growing ethical tension. Without new medical technology, we may be unable to maintain quality medical coverage in the face of rising demand. The author proposes risk assessment to set regulatory priorities; the conversion of a national weapons lab to a national device testing lab; the establishment of device standards and the monitoring of in-use performance against these standards; and the education of patients and users as to the results of these examinations.

Assessment of public perception and environmental compliance at a pulp and paper facility: a Canadian case study.

PubMed

Hoffman, Emma; Bernier, Meagan; Blotnicky, Brenden; Golden, Peter G; Janes, Jeffrey; Kader, Allison; Kovacs-Da Costa, Rachel; Pettipas, Shauna; Vermeulen, Sarah; Walker, Tony R

2015-12-01

Communities across Canada rely heavily on natural resources for their livelihoods. One such community in Pictou County, Nova Scotia, has both benefited and suffered, because of its proximity to a pulp and paper mill (currently owned by Northern Pulp). Since production began in 1967, there have been increasing impacts to the local environment and human health. Environmental reports funded by the mill were reviewed and compared against provincial and federal regulatory compliance standards. Reports contrasted starkly to societal perceptions of local impacts and independent studies. Most environmental monitoring reports funded by the mill indicate some levels of compliance in atmospheric and effluent emissions, but when compliance targets were not met, there was a lack of regulatory enforcement. After decades of local pollution impacts and lack of environmental compliance, corporate social responsibility initiatives need implementing for the mill to maintain its social licence to operate.

Analysis of French generic medicines retail market: why the use of generic medicines is limited.

PubMed

Dylst, Pieter; Vulto, Arnold; Simoens, Steven

2014-12-01

The market share of generic medicines in France is low compared to other European countries. This perspective paper provides an overview of the generic medicines retail market in France and how the current policy environment may affect the long-term sustainability. Looking at the French generic medicines retail market and the surrounding regulatory framework, all conditions seem to be in place to create a healthy generic medicines market: the country has well-respected regulatory authorities, generic medicines enter the market in a timely manner and prices of generic medicines are competitive compared with other European countries. Despite the success of the demand-side policies targeted at pharmacists and patients, those targeted at physicians were less successful due to a lack of enforcement and a lack of trust in generic medicines by French physicians. Recommendations to increase the use of generic medicines in France round off this perspective paper.

A comparative evaluation of the regulation of GM crops or products containing dsRNA and suggested improvements to risk assessments.

PubMed

Heinemann, Jack A; Agapito-Tenfen, Sarah Zanon; Carman, Judy A

2013-05-01

Changing the nature, kind and quantity of particular regulatory-RNA molecules through genetic engineering can create biosafety risks. While some genetically modified organisms (GMOs) are intended to produce new regulatory-RNA molecules, these may also arise in other GMOs not intended to express them. To characterise, assess and then mitigate the potential adverse effects arising from changes to RNA requires changing current approaches to food or environmental risk assessments of GMOs. We document risk assessment advice offered to government regulators in Australia, New Zealand and Brazil during official risk evaluations of GM plants for use as human food or for release into the environment (whether for field trials or commercial release), how the regulator considered those risks, and what that experience teaches us about the GMO risk assessment framework. We also suggest improvements to the process. Copyright © 2013 Elsevier Ltd. All rights reserved.

Assessing the assessments: Pharmaceuticals in the environment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Enick, O.V.; Moore, M.M.

2007-11-15

The relatively new issue of pharmaceutical contamination of the environment offers the opportunity to explore the application of values to the construction, communication and management of risk. The still-developing regulatory policies regarding environmental contamination with pharmaceuticals provide fertile ground for the introduction of values into the definition and management of risk. In this report, we summarize the current knowledge regarding pharmaceutical contamination of the environment and discuss specific attributes of pharmaceuticals that require special consideration. We then present an analysis showing that if values are incorporated into assessing, characterizing and managing risk, the results of risk assessments will more accuratelymore » reflect the needs of various stakeholders. Originating from an acknowledgement of the inherent uncertainty and value-laden nature of risk assessment, the precautionary principle (and later, the multi-criteria, integrated risk assessment), provides a direction for further research and policy development.« less

The stress and underground environment

NASA Astrophysics Data System (ADS)

Chama, A.

2009-04-01

Currently,the program of prevention in occupational health needs mainly to identify occupational hazards and strategy of their prevention.Among these risks,the stress represents an important psycho-social hazard in mental health,which unfortunately does not spare no occupation.My Paper attempts to highlight and to develop this hazard in its different aspects even its regulatory side in underground environment as occupational environment.In the interest of better prevention ,we consider "the information" about the impact of stress as the second prevention efficient and no expensive to speleologists,hygienists and workers in the underground areas. In this occasion of this event in Vienna,we also highlight the scientific works on the stress of the famous viennese physician and endocrinologist Doctor Hans Selye (1907-1982),nicknamed "the father of stress" and note on relation between biological rhythms in this underground area and psychological troubles (temporal isolation) (Jurgen Aschoff’s works and experiences out-of time).

[Environmental health: the evolution of Colombia's current regulatory framework].

PubMed

García-Ubaque, Cesar A; García-Ubaque, Juan C; Vaca-Bohórquez, Martha L

2013-01-01

This essay presents an analysis of the evolution of environmental health management in Colombia, covering the period from the introduction of the Colombian Healthcare Code (1979) to laws 99 and 100 in 1993 and the introduction of Environmental Health Policy in Bogotá DC (2011). It proposes a conceptual model for environmental health management at three levels: proximal (physical, chemical and biological setting), intermediate (natural and cultural environment) and distal (economic, political and social structures). Relevant aspects of environmental health policy in Bogotá are analysed based on the proposed model.

The pedestrian watchmaker: Genetic clocks from engineered oscillators

PubMed Central

Cookson, Natalie A.; Tsimring, Lev S.; Hasty, Jeff

2010-01-01

The crucial role of time-keeping has required organisms to develop sophisticated regulatory networks to ensure the reliable propagation of periodic behavior. These biological clocks have long been a focus of research; however, a clear understanding of how they maintain oscillations in the face of unpredictable environments and the inherent noise of biological systems remains elusive. Here, we review the current understanding of circadian oscillations using Drosophila melanogaster as a typical example and discuss the utility of an alternative synthetic biology approach to studying these highly intricate systems. PMID:19903483

Quality of institution and the FEG (forest, energy intensity, and globalization) -environment relationships in sub-Saharan Africa.

PubMed

Amuakwa-Mensah, Franklin; Adom, Philip Kofi

2017-07-01

The current share of sub-Saharan Africa in global carbon dioxide emissions is negligible compared to major contributors like Asia, Americas, and Europe. This trend is, however, likely to change given that both economic growth and rate of urbanization in the region are projected to be robust in the future. The current study contributes to the literature by examining both the direct and the indirect impacts of quality of institution on the environment. Specifically, we investigate whether the institutional setting in the region provides some sort of a complementary role in the environment-FEG relationships. We use the panel two-step system generalized method of moments (GMM) technique to deal with the simultaneity problem. Data consists of 43 sub-Saharan African countries. The result shows that energy inefficiency compromises environmental standards. However, the quality of the institutional setting helps moderate this negative consequences; countries with good institutions show greater prospects than countries with poor institutions. On the other hand, globalization of the region and increased forest size generate positive environmental outcomes in the region. Their impacts are, however, independent of the quality of institution. Afforestation programs, promotion of other clean energy types, and investment in energy efficiency, basic city infrastructure, and regulatory and institutional structures, are desirable policies to pursue to safeguard the environment.

40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

Code of Federal Regulations, 2011 CFR

2011-07-01

... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

Code of Federal Regulations, 2014 CFR

2014-07-01

... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

Code of Federal Regulations, 2012 CFR

2012-07-01

... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

Code of Federal Regulations, 2013 CFR

2013-07-01

... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

Code of Federal Regulations, 2010 CFR

2010-07-01

... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

The Regulatory Framework for Privacy and Security

NASA Astrophysics Data System (ADS)

Hiller, Janine S.

The internet enables the easy collection of massive amounts of personally identifiable information. Unregulated data collection causes distrust and conflicts with widely accepted principles of privacy. The regulatory framework in the United States for ensuring privacy and security in the online environment consists of federal, state, and self-regulatory elements. New laws have been passed to address technological and internet practices that conflict with privacy protecting policies. The United States and the European Union approaches to privacy differ significantly, and the global internet environment will likely cause regulators to face the challenge of balancing privacy interests with data collection for many years to come.

Analysis of currently available data for characterising the risk of engineered nanomaterials to the environment and human health--lessons learned from four case studies.

PubMed

Aschberger, Karin; Micheletti, Christian; Sokull-Klüttgen, Birgit; Christensen, Frans M

2011-08-01

Production volumes and the use of engineered nanomaterials in many innovative products are continuously increasing, however little is known about their potential risk for the environment and human health. We have reviewed publicly available hazard and exposure data for both, the environment and human health and attempted to carry out a basic risk assessment appraisal for four types of nanomaterials: fullerenes, carbon nanotubes, metals, and metal oxides (ENRHES project 2009(1)). This paper presents a summary of the results of the basic environmental and human health risk assessments of these case studies, highlighting the cross cutting issues and conclusions about fate and behaviour, exposure, hazard and methodological considerations. The risk assessment methodology being the basis for our case studies was that of a regulatory risk assessment under REACH (ECHA, 2008(2)), with modifications to adapt to the limited available data. If possible, environmental no-effect concentrations and human no-effect levels were established from relevant studies by applying assessment factors in line with the REACH guidance and compared to available exposure data to discuss possible risks. When the data did not allow a quantitative assessment, the risk was assessed qualitatively, e.g. for the environment by evaluating the information in the literature to describe the potential to enter the environment and to reach the potential ecological targets. Results indicate that the main risk for the environment is expected from metals and metal oxides, especially for algae and Daphnia, due to exposure to both, particles and ions. The main risks for human health may arise from chronic occupational inhalation exposure, especially during the activities of high particle release and uncontrolled exposure. The information on consumer and environmental exposure of humans is too scarce to attempt a quantitative risk characterisation. It is recognised that the currently available database for both, hazard and exposure is limited and there are high uncertainties in any conclusion on a possible risk. The results should therefore not be used for any regulatory decision making. Likewise, it is recognised that the REACH guidance was developed without considering the specific behaviour and the mode of action of nanomaterials and further work in the generation of data but also in the development of methodologies is required. Copyright © 2011 Elsevier Ltd. All rights reserved.

Online versus conventional shopping: consumers' risk perception and regulatory focus.

PubMed

van Noort, Guda; Kerkhof, Peter; Fennis, Bob M

2007-10-01

In two experiments, the impact of shopping context on consumers' risk perceptions and regulatory focus was examined. We predicted that individuals perceive an online (vs. conventional) shopping environment as more risky and that an online shopping environment, by its risky nature, primes a prevention focus. The findings in Study 1 demonstrate these effects by using self-report measures for risk perception and prevention focus. In Study 2, we replicated these findings and demonstrated that the effect of an online shopping environment carries over to behavior in a domain unrelated to shopping.

Application of decision-making theory to the regulation of muscular work rate during self-paced competitive endurance activity.

PubMed

Renfree, Andrew; Martin, Louise; Micklewright, Dominic; St Clair Gibson, Alan

2014-02-01

Successful participation in competitive endurance activities requires continual regulation of muscular work rate in order to maximise physiological performance capacities, meaning that individuals must make numerous decisions with regards to the muscular work rate selected at any point in time. Decisions relating to the setting of appropriate goals and the overall strategic approach to be utilised are made prior to the commencement of an event, whereas tactical decisions are made during the event itself. This review examines current theories of decision-making in an attempt to explain the manner in which regulation of muscular work is achieved during athletic activity. We describe rational and heuristic theories, and relate these to current models of regulatory processes during self-paced exercise in an attempt to explain observations made in both laboratory and competitive environments. Additionally, we use rational and heuristic theories in an attempt to explain the influence of the presence of direct competitors on the quality of the decisions made during these activities. We hypothesise that although both rational and heuristic models can plausibly explain many observed behaviours in competitive endurance activities, the complexity of the environment in which such activities occur would imply that effective rational decision-making is unlikely. However, at present, many proposed models of the regulatory process share similarities with rational models. We suggest enhanced understanding of the decision-making process during self-paced activities is crucial in order to improve the ability to understand regulation of performance and performance outcomes during athletic activity.

Responding to Regulatory Jolts in the English Higher Education Sector

ERIC Educational Resources Information Center

Abreu Pederzini, Gerardo

2016-01-01

Throughout the world universities are having to face constantly changing environments. A particular type of important change is public policy reforms or regulatory jolts. The English higher education sector is an example of the latter, where constant regulatory jolts have been seen in past decades. Leaders at universities have needed to interpret…

The Dessau workshop on bioaccumulation: state of the art, challenges and regulatory implications.

PubMed

Treu, Gabriele; Drost, Wiebke; Jöhncke, Ulrich; Rauert, Caren; Schlechtriem, Christian

2015-01-01

Bioaccumulation plays a vital role in understanding the fate of a substance in the environment and is key to the regulation of chemicals in several jurisdictions. The current assessment approaches commonly use the octanol-water partition coefficient (log K OW ) as an indicator for bioaccumulation and the bioconcentration factor (BCF) as a standard criterion to identify bioaccumulative substances show limitations. The log K OW does not take into account active transport phenomena or special structural properties (e.g., amphiphilic substances or dissociating substances) and therefore additional screening criteria are required. Regulatory BCF studies are so far restricted to fish and uptake through the gills. Studies on (terrestrial) air-breathing organisms are missing. Though there are alternative tests such as the dietary exposure bioaccumulation fish test described in the recently revised OECD test guideline 305, it still remains unclear how to deal with results of alternative tests in regulatory decision-making processes. A substantial number of bioaccumulation fish tests are required in regulation. The development of improved test systems following the 3R principles, namely to replace, reduce and refine animal testing, is thus required. All these aspects stress the importance to further develop the assessment of bioaccumulation. The Dessau Workshop on Bioaccumulation which was held from June 26th to 27th 2014, in Dessau, Germany, provided a comprehensive overview of the state of the art of bioaccumulation assessment, provided insights into the problems and challenges addressed by the regulatory authorities and described new research concepts and their regulatory implications. The event was organised by UBA (Dessau, Germany) and Fraunhofer IME (Schmallenberg, Germany). About 50 participants from industry, regulatory bodies and academia listened to 14 lectures on selected topics and joined the plenary discussions.

Industry perceptions of barriers to commercialization of regenerative medicine products in the UK.

PubMed

Plagnol, Anke C; Rowley, Emma; Martin, Paul; Livesey, Finbarr

2009-07-01

Regenerative medicine is an emerging field with the potential to provide widespread improvement in healthcare and patient wellbeing via the delivery of therapies that can restore, regenerate or repair damaged tissue. As an industry, it could significantly contribute to economic growth if products are successfully commercialized. However, to date, relatively few products have reached the market owing to a variety of barriers, including a lack of funding and regulatory hurdles. The present study analyzes industry perceptions of the barriers to commercialization that currently impede the success of the regenerative medicine industry in the UK. The analysis is based on 20 interviews with leading industrialists in the field. The study revealed that scientific research in regenerative medicine is thriving in the UK. Unfortunately, lack of access to capital, regulatory hurdles, lack of clinical evidence leading to problems with reimbursement, as well as the culture of the NHS do not provide a good environment for the commercialization of regenerative medicine products. Policy interventions, including increased translational government funding, a change in NHS and NICE organization and policies, and regulatory clarity, would likely improve the general outcomes for the regenerative medicine industry in the UK.

Bite the apple, get driven out of the garden: A risky story telling at the ASME town meeting

DOE Office of Scientific and Technical Information (OSTI.GOV)

Majumdar, K.C.

1994-11-01

Risk, the all-encompassing four-letter word became a widely used household cliche and an institutional mantra in the nineties. Risk analysis models from the Garden of Eden to the Capitol Hill lawn have made a number of sharp paradigm shifts to evolve itself as a decision-making tool from individual risk perception to societal risk-based regulatory media. Risk always coexists with benefit and is arbitrated by costs. Risk-benefit analysis has been in use in business and industry in economic ventures for a long time. Only recently risk management in its current state of development, evolved as a regulatory tool for controlling largemore » technological systems that have potential impacts on the health and safety of the public and on the sustainability of the ecology and the environment. This paper summarizes the evolution of the risk management concepts and models in industry and the regulatory agencies in the US over the last three decades. It also discusses the benefits and limitations of this evolving discipline as it is applied to high-risk technologies from the nuclear power plant and petrochemical industry, etc. to nuclear weapons technology.« less

Alternative approaches to myeloid suppressor cell therapy in transplantation: comparing regulatory macrophages to tolerogenic DCs and MDSCs

PubMed Central

2012-01-01

Several types of myeloid suppressor cell are currently being developed as cell-based immunosuppressive agents. Despite detailed knowledge about the molecular and cellular functions of these cell types, expert opinions differ on how to best implement such therapies in solid organ transplantation. Efforts in our laboratory to develop a cell-based medicinal product for promoting tolerance in renal transplant patients have focused on a type of suppressor macrophage, which we call the regulatory macrophage (M reg). Our favoured clinical strategy is to administer donor-derived M regs to recipients one week prior to transplantation. In contrast, many groups working with tolerogenic dendritic cells (DCs) advocate post-transplant administration of recipient-derived cells. A third alternative, using myeloid-derived suppressor cells, presumably demands that cells are given around the time of transplantation, so that they can infiltrate the graft to create a suppressive environment. On present evidence, it is not possible to say which cell type and treatment strategy might be clinically superior. This review seeks to position our basic scientific and early-stage clinical studies of human regulatory macrophages within the broader context of myeloid suppressor cell therapy in transplantation. PMID:23369628

Balancing regulatory control, scientific knowledge, and public understanding.

PubMed

Kingsbury, D T

1988-01-01

In summary, I would like to emphasize the continued need for broad and vigorous basic research, with a balance between the fundamental work that may eventually lead to commercial products and the fundamental work that is necessary for an understanding of the interaction of many types of organisms within the environment. I would like also to reiterate the need for balance in the regulatory approach so that we do not repress innovation in research and development. Over-regulation has many side effects. In addition to repressing innovation and not taking advantage of our research base, over-regulation leads to reluctance by the capital markets to invest in the future of our new industries, thereby halting their development at an early stage. At the same time, under-regulation leads to lack of confidence by the public and paralysis of the industry based on public outcry and legal proceedings. It is my personal belief that the combination of a sound approach to regulatory practice, based on current scientific knowledge, combined with appropriate communication with the public regarding the new products, will lead to an exciting future for all sectors of industry that use the new biotechnology.

Shewregdb: Database and visualization environment for experimental and predicted regulatory information in Shewanella oneidensis mr-1

PubMed Central

Syed, Mustafa H; Karpinets, Tatiana V; Leuze, Michael R; Kora, Guruprasad H; Romine, Margaret R; Uberbacher, Edward C

2009-01-01

Shewanella oneidensis MR-1 is an important model organism for environmental research as it has an exceptional metabolic and respiratory versatility regulated by a complex regulatory network. We have developed a database to collect experimental and computational data relating to regulation of gene and protein expression, and, a visualization environment that enables integration of these data types. The regulatory information in the database includes predictions of DNA regulator binding sites, sigma factor binding sites, transcription units, operons, promoters, and RNA regulators including non-coding RNAs, riboswitches, and different types of terminators. Availability http://shewanella-knowledgebase.org:8080/Shewanella/gbrowserLanding.jsp PMID:20198195

Molecular mechanisms of system responses to novel stimuli are predictable from public data

PubMed Central

Danziger, Samuel A.; Ratushny, Alexander V.; Smith, Jennifer J.; Saleem, Ramsey A.; Wan, Yakun; Arens, Christina E.; Armstrong, Abraham M.; Sitko, Katherine; Chen, Wei-Ming; Chiang, Jung-Hsien; Reiss, David J.; Baliga, Nitin S.; Aitchison, John D.

2014-01-01

Systems scale models provide the foundation for an effective iterative cycle between hypothesis generation, experiment and model refinement. Such models also enable predictions facilitating the understanding of biological complexity and the control of biological systems. Here, we demonstrate the reconstruction of a globally predictive gene regulatory model from public data: a model that can drive rational experiment design and reveal new regulatory mechanisms underlying responses to novel environments. Specifically, using ∼1500 publically available genome-wide transcriptome data sets from Saccharomyces cerevisiae, we have reconstructed an environment and gene regulatory influence network that accurately predicts regulatory mechanisms and gene expression changes on exposure of cells to completely novel environments. Focusing on transcriptional networks that induce peroxisomes biogenesis, the model-guided experiments allow us to expand a core regulatory network to include novel transcriptional influences and linkage across signaling and transcription. Thus, the approach and model provides a multi-scalar picture of gene dynamics and are powerful resources for exploiting extant data to rationally guide experimentation. The techniques outlined here are generally applicable to any biological system, which is especially important when experimental systems are challenging and samples are difficult and expensive to obtain—a common problem in laboratory animal and human studies. PMID:24185701

75 FR 45685 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-03

... list (see current List 7 titled Misrepresentation/Omissions, List 9 titled Negligence/Breach of... claims alleging misrepresentation/ omissions (see current List 8, Item 1), negligence/breach of fiduciary... claims alleging misrepresentation/ omission (see current List 8, Item 2), negligence/breach of fiduciary...

Are regulations more consumer-friendly when boards of nursing are the sole regulators of nurse practitioners?

PubMed

Rudner Lugo, Nancy; O'Grady, Eileen T; Hodnicki, Donna; Hanson, Charlene

2010-01-01

The widely varied regulations in the 50 states often limit consumer access to nurse practitioners (NPs). In 22 states, the Board of Nursing (BON) must share NP regulatory authority with another profession, usually physicians. This study examines the relationship between the BON as the sole authority regulating NPs or sharing that authority with another profession and the NP regulatory environment. Independent t tests compared the NP regulatory environments for consumer access and choice in states with sole BON regulation with those in states with involvement of another profession. The states' NP regulatory environments were quantified with an 11-measure tool assessing domains of consumer access to NPs, NP patients' access to service, and NP patients' access to prescription medications. BON-regulated states were less restrictive (P < .01, effect size 1.02) and supported NP professional autonomy. Entry into practice regulations did not differ in the two groups of states. Having another profession involved in regulation correlates with more restrictions on consumer access to NPs and more restrictions to the full deployment of NPs. Copyright 2010 Elsevier Inc. All rights reserved.

A system-level model for the microbial regulatory genome.

PubMed

Brooks, Aaron N; Reiss, David J; Allard, Antoine; Wu, Wei-Ju; Salvanha, Diego M; Plaisier, Christopher L; Chandrasekaran, Sriram; Pan, Min; Kaur, Amardeep; Baliga, Nitin S

2014-07-15

Microbes can tailor transcriptional responses to diverse environmental challenges despite having streamlined genomes and a limited number of regulators. Here, we present data-driven models that capture the dynamic interplay of the environment and genome-encoded regulatory programs of two types of prokaryotes: Escherichia coli (a bacterium) and Halobacterium salinarum (an archaeon). The models reveal how the genome-wide distributions of cis-acting gene regulatory elements and the conditional influences of transcription factors at each of those elements encode programs for eliciting a wide array of environment-specific responses. We demonstrate how these programs partition transcriptional regulation of genes within regulons and operons to re-organize gene-gene functional associations in each environment. The models capture fitness-relevant co-regulation by different transcriptional control mechanisms acting across the entire genome, to define a generalized, system-level organizing principle for prokaryotic gene regulatory networks that goes well beyond existing paradigms of gene regulation. An online resource (http://egrin2.systemsbiology.net) has been developed to facilitate multiscale exploration of conditional gene regulation in the two prokaryotes. © 2014 The Authors. Published under the terms of the CC BY 4.0 license.

Pharmaceuticals in the environment: scientific evidence of risks and its regulation

PubMed Central

Küster, Anette; Adler, Nicole

2014-01-01

During the past two decades scientists, regulatory agencies and the European Commission have acknowledged pharmaceuticals to be an emerging environmental problem. In parallel, a regulatory framework for environmental risk assessment (ERA) of pharmaceutical products has been developed. Since the regulatory guidelines came into force the German Federal Agency (UBA) has been evaluating ERAs for human and veterinary pharmaceutical products before they are marketed. The results show that approximately 10% of pharmaceutical products are of note regarding their potential environmental risk. For human medicinal products, hormones, antibiotics, analgesics, antidepressants and antineoplastics indicated an environmental risk. For veterinary products, hormones, antibiotics and parasiticides were most often discussed as being environmentally relevant. These results are in good correlation with the results within the open scientific literature of prioritization approaches for pharmaceuticals in the environment. UBA results revealed that prospective approaches, such as ERA of pharmaceuticals, play an important role in minimizing problems caused by pharmaceuticals in the environment. However, the regulatory ERA framework could be improved by (i) inclusion of the environment in the risk–benefit analysis for human pharmaceuticals, (ii) improvement of risk management options, (iii) generation of data on existing pharmaceuticals, and (iv) improving the availability of ERA data. In addition, more general and integrative steps of regulation, legislation and research have been developed and are presented in this article. In order to minimize the quantity of pharmaceuticals in the environment these should aim to (i) improve the existing legislation for pharmaceuticals, (ii) prioritize pharmaceuticals in the environment and (iii) improve the availability and collection of pharmaceutical data. PMID:25405974

Ignoring Adjuvant Toxicity Falsifies the Safety Profile of Commercial Pesticides

PubMed Central

Mesnage, Robin; Antoniou, Michael N.

2018-01-01

Commercial formulations of pesticides are invariably not single ingredients. Instead they are cocktails of chemicals, composed of a designated pesticidal “active principle” and “other ingredients,” with the latter collectively also known as “adjuvants.” These include surfactants, antifoaming agents, dyes, etc. Some adjuvants are added to influence the absorption and stability of the active principle and thus promote its pesticidal action. Currently, the health risk assessment of pesticides in the European Union and in the United States focuses almost exclusively on the stated active principle. Nonetheless, adjuvants can also be toxic in their own right with numerous negative health effects having been reported in humans and on the environment. Despite the known toxicity of adjuvants, they are regulated differently from active principles, with their toxic effects being generally ignored. Adjuvants are not subject to an acceptable daily intake, and they are not included in the health risk assessment of dietary exposures to pesticide residues. Here, we illustrate this gap in risk assessment by reference to glyphosate, the most used pesticide active ingredient. We also investigate the case of neonicotinoid insecticides, which are strongly suspected to be involved in bee and bumblebee colony collapse disorder. Authors of studies sometimes use the name of the active principle (for example glyphosate) when they are testing a commercial formulation containing multiple (active principle plus adjuvant) ingredients. This results in confusion in the scientific literature and within regulatory circles and leads to a misrepresentation of the safety profile of commercial pesticides. Urgent action is needed to lift the veil on the presence of adjuvants in food and human bodily fluids, as well as in the environment (such as in air, water, and soil) and to characterize their toxicological properties. This must be accompanied by regulatory precautionary measures to protect the environment and general human population from some toxic adjuvants that are currently missing from risk assessments. PMID:29404314

Impact of regulatory assessment on clinical studies in Brazil.

PubMed

Russo, Luis Augusto Tavares; Eliaschewitz, Freddy Goldberg; Harada, Vitor; Trefiglio, Roberta Pereira; Picciotti, Raffaella; Machado, Paula Goulart Pinheiro; Kesselring, Gustavo Luiz Ferreira

2016-01-01

Despite the recent expansion of clinical studies allocated to Brazil, the delay of local regulatory deadlines directly impacts their completion. This article examines the allocation process of clinical studies to Brazil in comparison with other countries, as well as the financial impact of studies not completed due to interruption caused by the delay in the regulatory process. The allocation processes of studies were compared in nine countries with similar stages of economic development and countries in Latin America using the websites http://data.worldbank.org/data-catalog/GDP-rankings-table and http://worldpopulationreview.com and clinicaltrials.gov, comprising 185 countries. The 46 studies sponsored by the pharmaceutical industry underwent an analysis of the regulatory review process. 46 studies sponsored by the industry and submitted in the country between June 2007 and June 2013 were analyzed; 18 (39%) were discontinued due to the delay in obtaining the necessary approvals. For the approved studies, patient recruitment began an average of 11 months after the other countries. It is estimated that 530 Brazilians patients did not have the opportunity to participate in these studies. Financial losses were to the order of 14.6 million dollars for the country, including patient, medication and supplies costs, and expenses. Brazil has enormous potential for the realization of clinical studies. Researchers, associations of disabled people and patients with chronic diseases, sponsors and the authorities must work together to develop an approval process that is efficient, predictable and, most of all, transparent. The current regulatory environment must and can be improved and optimized in order to result in tangible benefits for patients, society and the country's scientific development.

The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices

PubMed Central

Morrison, Tina M.; Dreher, Maureen L.; Nagaraja, Srinidhi; Angelone, Leonardo M.; Kainz, Wolfgang

2018-01-01

The total product life cycle (TPLC) of medical devices has been defined by four stages: discovery and ideation, regulatory decision, product launch, and postmarket monitoring. Manufacturers of medical devices intended for use in the peripheral vasculature, such as stents, inferior vena cava (IVC) filters, and stent-grafts, mainly use computational modeling and simulation (CM&S) to aid device development and design optimization, supplement bench testing for regulatory decisions, and assess postmarket changes or failures. For example, computational solid mechanics and fluid dynamics enable the investigation of design limitations in the ideation stage. To supplement bench data in regulatory submissions, manufactures can evaluate the effects of anatomical characteristics and expected in vivo loading environment on device performance. Manufacturers might also harness CM&S to aid root-cause analyses that are necessary when failures occur postmarket, when the device is exposed to broad clinical use. Once identified, CM&S tools can then be used for redesign to address the failure mode and re-establish the performance profile with the appropriate models. The Center for Devices and Radiological Health (CDRH) wants to advance the use of CM&S for medical devices and supports the development of virtual physiological patients, clinical trial simulations, and personalized medicine. Thus, the purpose of this paper is to describe specific examples of how CM&S is currently used to support regulatory submissions at different phases of the TPLC and to present some of the stakeholder-led initiatives for advancing CM&S for regulatory decision-making. PMID:29479395

The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices.

PubMed

Morrison, Tina M; Dreher, Maureen L; Nagaraja, Srinidhi; Angelone, Leonardo M; Kainz, Wolfgang

2017-01-01

The total product life cycle (TPLC) of medical devices has been defined by four stages: discovery and ideation, regulatory decision, product launch, and postmarket monitoring. Manufacturers of medical devices intended for use in the peripheral vasculature, such as stents, inferior vena cava (IVC) filters, and stent-grafts, mainly use computational modeling and simulation (CM&S) to aid device development and design optimization, supplement bench testing for regulatory decisions, and assess postmarket changes or failures. For example, computational solid mechanics and fluid dynamics enable the investigation of design limitations in the ideation stage. To supplement bench data in regulatory submissions, manufactures can evaluate the effects of anatomical characteristics and expected in vivo loading environment on device performance. Manufacturers might also harness CM&S to aid root-cause analyses that are necessary when failures occur postmarket, when the device is exposed to broad clinical use. Once identified, CM&S tools can then be used for redesign to address the failure mode and re-establish the performance profile with the appropriate models. The Center for Devices and Radiological Health (CDRH) wants to advance the use of CM&S for medical devices and supports the development of virtual physiological patients, clinical trial simulations, and personalized medicine. Thus, the purpose of this paper is to describe specific examples of how CM&S is currently used to support regulatory submissions at different phases of the TPLC and to present some of the stakeholder-led initiatives for advancing CM&S for regulatory decision-making.

Cogeneration feasibility: Otis Elevator Company and Polychrome Corporation. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1982-05-01

The purpose of this study was to assess the feasibility of cogeneration at Otis Elevator Company and Polychrome Corporation located in Westchester County, New York. Each plant and its associated thermal and electrical load is reviewed. Three basic cycles for the cogeneration are investigated: power only, power generation with waste heat recovery, and combined cycle. Each case was assessed economically, beginning with a screening method to suggest those configurations most likely to be implemented and continuing through an assessment of the regulatory environment for cogeneration and an analysis of rate structures for buy back power, displaced power, and supplementing service.more » It is concluded that: for a plant designed to supply the combined loads of the two corporations, interconnection costs coupled to the coincidence of load result in unfavorable economics; for separate cogeneration plants, owned and operated by each individual corporation, energy consumption patterns and the current regulatory environment, in particular the existing and proposed cogeneration system rate structures, do not permit viable economics for the proposed plants; but if the proposed cycle were owned and operated by a new entity (neither Otis/Polychrome nor the utility), an economic scheme with marginal financial benefits can be developed and may be worthy of further study. (LEW)« less

Steam Generator tube integrity -- US Nuclear Regulatory Commission perspective

DOE Office of Scientific and Technical Information (OSTI.GOV)

Murphy, E.L.; Sullivan, E.J.

1997-02-01

In the US, the current regulatory framework was developed in the 1970s when general wall thinning was the dominant degradation mechanism; and, as a result of changes in the forms of degradation being observed and improvements in inspection and tube repair technology, the regulatory framework needs to be updated. Operating experience indicates that the current U.S. requirements should be more stringent in some areas, while in other areas they are overly conservative. To date, this situation has been dealt with on a plant-specific basis in the US. However, the NRC staff is now developing a proposed steam generator rule asmore » a generic framework for ensuring that the steam generator tubes are capable of performing their intended safety functions. This paper discusses the current U.S. regulatory framework for assuring steam generator (SG) tube integrity, the need to update this regulatory framework, the objectives of the new proposed rule, the US Nuclear Regulatory Commission (NRC) regulatory guide (RG) that will accompany the rule, how risk considerations affect the development of the new rule, and some outstanding issues relating to the rule that the NRC is still dealing with.« less

Leveraging Cancer Therapeutics for the HIV Cure Agenda: Current Status and Future Directions

PubMed Central

Polizzotto, Mark N.; Chen, Grace; Tressler, Randall L.; Godfrey, Catherine

2015-01-01

Despite effective antiretroviral therapy (ART) and undetectable HIV RNA in the plasma, latent replication-competent HIV persists indefinitely in long-lived cells. Cessation of ART results in rebound of HIV from these persistent reservoirs. While this was thought to be an insurmountable obstacle to viral eradication, recent cases suggest otherwise. To date one patient has been “cured” of HIV and several others have been able to interrupt ART without viral rebound for prolonged periods. These events have sparked renewed interest in developing strategies that will allow eradication of HIV in infected individuals. We review the current knowledge of HIV latency and the viral reservoir, describe the potential utility of emerging cancer therapeutics in HIV cure research with an emphasis on pathways implicated in reservoir persistence, and outline opportunities and challenges in the context of the current clinical trial and regulatory environment. PMID:26224205

Leveraging Cancer Therapeutics for the HIV Cure Agenda: Current Status and Future Directions.

PubMed

Polizzotto, Mark N; Chen, Grace; Tressler, Randall L; Godfrey, Catherine

2015-09-01

Despite effective antiretroviral therapy (ART) and undetectable HIV RNA in the plasma, latent replication-competent HIV persists indefinitely in long-lived cells. Cessation of ART results in rebound of HIV from these persistent reservoirs. While this was thought to be an insurmountable obstacle to viral eradication, recent cases suggest otherwise. To date one patient has been "cured" of HIV and several others have been able to interrupt ART without viral rebound for prolonged periods. These events have sparked renewed interest in developing strategies that will allow eradication of HIV in infected individuals. We review the current knowledge of HIV latency and the viral reservoir, describe the potential utility of emerging cancer therapeutics in HIV cure research with an emphasis on pathways implicated in reservoir persistence, and outline opportunities and challenges in the context of the current clinical trial and regulatory environment.

The plight of the not-for-profit.

PubMed

Owens, Bramer

2005-01-01

Recent controversies in the hospital sector have questioned whether the levels of charity care, community benefit, and executive compensation provided by not-for-profit hospitals are consistent with mandates of their tax-exempt status and mission statements. This article demonstrates that these recent controversies stem from a combination of historical influences, regulatory inequities, and competitive disadvantages, which are suffocating many not-for-profit hospitals across the nation. Once the current environment is described, the article discusses each threat and offers actionable recommendations to quell current attacks faced by the industry. First, to address the current probe by the Internal Revenue Service, hospitals must begin to link their executive compensation with their organizational mission. Second, to address recent lawsuits, the article presents a standardized definition of community benefit and recommends an alternative model to classify charity care. Finally, to address recent congressional hearings, the article offers a plan for hospitals to gauge their expected benefit to the community they serve.

Reassessment of the NRC`s program for protecting allegers against retaliation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1994-01-01

On July 6, 1993, the Nuclear Regulatory Commission`s (NRC`s) Executive Director for Operations established a review team to reassess the NRC`s program for protecting allegers against retaliation. The team evaluated the current system, and solicited comments from various NRC offices, other Federal agencies, licensees, former allegers, and the public. This report is subject to agency review. The report summarizes current processes and gives an overview of current problems. It discusses: (1) ways in which licensees can promote a quality-conscious work environment, in which all employees feel free to raise concerns without fear of retaliation; (2) ways to improve the NRC`smore » overall handling of allegations; (3) the NRC`s involvement in the Department of Labor process; (4) related NRC enforcement practices; and (5) methods other than investigation and enforcement that may be useful in treating allegations of potential or actual discrimination. Recommendations are given in each area.« less

DOE Office of Scientific and Technical Information (OSTI.GOV)

Grabaskas, David; Bucknor, Matthew; Jerden, James

A mechanistic source term (MST) calculation attempts to realistically assess the transport and release of radionuclides from a reactor system to the environment during a specific accident sequence. The U.S. Nuclear Regulatory Commission (NRC) has repeatedly stated its expectation that advanced reactor vendors will utilize an MST during the U.S. reactor licensing process. As part of a project to examine possible impediments to sodium fast reactor (SFR) licensing in the U.S., an analysis was conducted regarding the current capabilities to perform an MST for a metal fuel SFR. The purpose of the project was to identify and prioritize any gapsmore » in current computational tools, and the associated database, for the accurate assessment of an MST. The results of the study demonstrate that an SFR MST is possible with current tools and data, but several gaps exist that may lead to possibly unacceptable levels of uncertainty, depending on the goals of the MST analysis.« less

[Big Data- challenges and risks].

PubMed

Krauß, Manuela; Tóth, Tamás; Hanika, Heinrich; Kozlovszky, Miklós; Dinya, Elek

2015-12-06

The term "Big Data" is commonly used to describe the growing mass of information being created recently. New conclusions can be drawn and new services can be developed by the connection, processing and analysis of these information. This affects all aspects of life, including health and medicine. The authors review the application areas of Big Data, and present examples from health and other areas. However, there are several preconditions of the effective use of the opportunities: proper infrastructure, well defined regulatory environment with particular emphasis on data protection and privacy. These issues and the current actions for solution are also presented.

Evolution of regulatory networks towards adaptability and stability in a changing environment

NASA Astrophysics Data System (ADS)

Lee, Deok-Sun

2014-11-01

Diverse biological networks exhibit universal features distinguished from those of random networks, calling much attention to their origins and implications. Here we propose a minimal evolution model of Boolean regulatory networks, which evolve by selectively rewiring links towards enhancing adaptability to a changing environment and stability against dynamical perturbations. We find that sparse and heterogeneous connectivity patterns emerge, which show qualitative agreement with real transcriptional regulatory networks and metabolic networks. The characteristic scaling behavior of stability reflects the balance between robustness and flexibility. The scaling of fluctuation in the perturbation spread shows a dynamic crossover, which is analyzed by investigating separately the stochasticity of internal dynamics and the network structure differences depending on the evolution pathways. Our study delineates how the ambivalent pressure of evolution shapes biological networks, which can be helpful for studying general complex systems interacting with environments.

Working with Policy and Regulatory Factors to Implement Universal Design in the Built Environment: The Australian Experience.

PubMed

Larkin, Helen; Hitch, Danielle; Watchorn, Valerie; Ang, Susan

2015-07-15

Built environments that are usable by all provide opportunities for engagement in meaningful occupations. However, enabling them in day to day design processes and practice is problematic for relevant professions. The purpose of this phenomenological study was to gain greater understanding of the policy and regulatory influences that promote or hinder the uptake of universal design in built environments, to inform better future design. Focus groups or telephone interviews were undertaken with 28 key building industry and disability stakeholders in Australia. Four themes were identified: the difficulties of definition; the push or pull of regulations and policy; the role of formal standards; and, shifting the focus of design thinking. The findings highlight the complexity of working within policy and regulatory contexts when implementing universal design. Occupational therapists working with colleagues from other professions must be aware of these influences, and develop the skills to work with them for successful practice.

Duke Surgery Research Central: an open-source Web application for the improvement of compliance with research regulation.

PubMed

Pietrobon, Ricardo; Shah, Anand; Kuo, Paul; Harker, Matthew; McCready, Mariana; Butler, Christeen; Martins, Henrique; Moorman, C T; Jacobs, Danny O

2006-07-27

Although regulatory compliance in academic research is enforced by law to ensure high quality and safety to participants, its implementation is frequently hindered by cost and logistical barriers. In order to decrease these barriers, we have developed a Web-based application, Duke Surgery Research Central (DSRC), to monitor and streamline the regulatory research process. The main objective of DSRC is to streamline regulatory research processes. The application was built using a combination of paper prototyping for system requirements and Java as the primary language for the application, in conjunction with the Model-View-Controller design model. The researcher interface was designed for simplicity so that it could be used by individuals with different computer literacy levels. Analogously, the administrator interface was designed with functionality as its primary goal. DSRC facilitates the exchange of regulatory documents between researchers and research administrators, allowing for tasks to be tracked and documents to be stored in a Web environment accessible from an Intranet. Usability was evaluated using formal usability tests and field observations. Formal usability results demonstrated that DSRC presented good speed, was easy to learn and use, had a functionality that was easily understandable, and a navigation that was intuitive. Additional features implemented upon request by initial users included: extensive variable categorization (in contrast with data capture using free text), searching capabilities to improve how research administrators could search an extensive number of researcher names, warning messages before critical tasks were performed (such as deleting a task), and confirmatory e-mails for critical tasks (such as completing a regulatory task). The current version of DSRC was shown to have excellent overall usability properties in handling research regulatory issues. It is hoped that its release as an open-source application will promote improved and streamlined regulatory processes for individual academic centers as well as larger research networks.

Duke Surgery Research Central: an open-source Web application for the improvement of compliance with research regulation

PubMed Central

Pietrobon, Ricardo; Shah, Anand; Kuo, Paul; Harker, Matthew; McCready, Mariana; Butler, Christeen; Martins, Henrique; Moorman, CT; Jacobs, Danny O

2006-01-01

Background Although regulatory compliance in academic research is enforced by law to ensure high quality and safety to participants, its implementation is frequently hindered by cost and logistical barriers. In order to decrease these barriers, we have developed a Web-based application, Duke Surgery Research Central (DSRC), to monitor and streamline the regulatory research process. Results The main objective of DSRC is to streamline regulatory research processes. The application was built using a combination of paper prototyping for system requirements and Java as the primary language for the application, in conjunction with the Model-View-Controller design model. The researcher interface was designed for simplicity so that it could be used by individuals with different computer literacy levels. Analogously, the administrator interface was designed with functionality as its primary goal. DSRC facilitates the exchange of regulatory documents between researchers and research administrators, allowing for tasks to be tracked and documents to be stored in a Web environment accessible from an Intranet. Usability was evaluated using formal usability tests and field observations. Formal usability results demonstrated that DSRC presented good speed, was easy to learn and use, had a functionality that was easily understandable, and a navigation that was intuitive. Additional features implemented upon request by initial users included: extensive variable categorization (in contrast with data capture using free text), searching capabilities to improve how research administrators could search an extensive number of researcher names, warning messages before critical tasks were performed (such as deleting a task), and confirmatory e-mails for critical tasks (such as completing a regulatory task). Conclusion The current version of DSRC was shown to have excellent overall usability properties in handling research regulatory issues. It is hoped that its release as an open-source application will promote improved and streamlined regulatory processes for individual academic centers as well as larger research networks. PMID:16872540

Impact on environment, ecosystem, diversity and health from culturing and using GMOs as feed and food.

PubMed

Tsatsakis, Aristidis M; Nawaz, Muhammad Amjad; Tutelyan, Victor A; Golokhvast, Kirill S; Kalantzi, Olga-Ioanna; Chung, Duck Hwa; Kang, Sung Jo; Coleman, Michael D; Tyshko, Nadia; Yang, Seung Hwan; Chung, Gyuhwa

2017-09-01

Modern agriculture provides the potential for sustainable feeding of the world's increasing population. Up to the present moment, genetically modified (GM) products have enabled increased yields and reduced pesticide usage. Nevertheless, GM products are controversial amongst policy makers, scientists and the consumers, regarding their possible environmental, ecological, and health risks. Scientific-and-political debates can even influence legislation and prospective risk assessment procedure. Currently, the scientifically-assessed direct hazardous impacts of GM food and feed on fauna and flora are conflicting; indeed, a review of literature available data provides some evidence of GM environmental and health risks. Although the consequences of gene flow and risks to biodiversity are debatable. Risks to the environment and ecosystems can exist, such as the evolution of weed herbicide resistance during GM cultivation. A matter of high importance is to provide precise knowledge and adequate current information to regulatory agencies, governments, policy makers, researchers, and commercial GMO-releasing companies to enable them to thoroughly investigate the possible risks. Copyright © 2017 Elsevier Ltd. All rights reserved.

Building Synergy between Regulatory and HTA Agencies beyond Processes and Procedures-Can We Effectively Align the Evidentiary Requirements? A Survey of Stakeholder Perceptions.

PubMed

Wang, Ting; McAuslane, Neil; Liberti, Lawrence; Leufkens, Hubert; Hövels, Anke

2018-06-01

To evaluate the current practice of companies and agencies to assess the changes made in aligning regulatory and health technology assessment (HTA) stakeholders; to identify areas of commonality of evidentiary requirements that could occur; and to identify strategic issues and trends of regulatory and HTA synergy. Two separate questionnaires were developed to assess stakeholders' perceptions on regulatory and HTA alignment, one for pharmaceutical companies and the other for regulatory and HTA agencies. The responses were analyzed using descriptive statistics. Seven regulatory and 8 HTA agencies from Australia, Canada, and Europe and 19 international companies developing innovative medicine responded to the survey. This study provided a snapshot of the current regulatory and HTA landscape. Changes made over the past 5 years were reflected in three main areas: there is an increasing interaction between regulatory and HTA agencies; current conditional regulatory approvals are not always linked with flexible HTA approaches; and companies are more supportive of joint scientific advice. Four types of evidentiary requirements were identified as building blocks for better alignment: acceptable primary end points, inclusion of an active comparator, use of patient-reported outcomes, and choice and use of surrogate end point. The study showed that the gap between regulatory and HTA requirements has narrowed over the past 5 years. All respondents supported synergy between regulatory and HTA stakeholders, and the study provided several recommendations on how to further improve evidentiary alignment including the provision of joint scientific advice, which was rated as a key strategy by both agencies and companies. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Chemical contaminants entering the marine environment from sea-based sources: A review with a focus on European seas.

PubMed

Tornero, Victoria; Hanke, Georg

2016-11-15

Anthropogenic contaminants reach the marine environment mostly directly from land-based sources, but there are cases in which they are emitted or re-mobilized in the marine environment itself. This paper reviews the literature, with a predominant focus on the European environment, to compile a list of contaminants potentially released into the sea from sea-based sources and provide an overview of their consideration under existing EU regulatory frameworks. The resulting list contains 276 substances and for some of them (22 antifouling biocides, 32 aquaculture medicinal products and 34 warfare agents) concentrations and toxicity data are additionally provided. The EU Marine Strategy Framework Directive Descriptor 8, together with the Water Framework Directive and the Regional Sea Conventions, provides the provisions against pollution of marine waters by chemical substances. This literature review should inform about the current state of knowledge regarding marine contaminant sources and provide support for setting-up of monitoring approaches, including hotspots screening. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Arousal regulation and affective adaptation to human responsiveness by a robot that explores and learns a novel environment.

PubMed

Hiolle, Antoine; Lewis, Matthew; Cañamero, Lola

2014-01-01

In the context of our work in developmental robotics regarding robot-human caregiver interactions, in this paper we investigate how a "baby" robot that explores and learns novel environments can adapt its affective regulatory behavior of soliciting help from a "caregiver" to the preferences shown by the caregiver in terms of varying responsiveness. We build on two strands of previous work that assessed independently (a) the differences between two "idealized" robot profiles-a "needy" and an "independent" robot-in terms of their use of a caregiver as a means to regulate the "stress" (arousal) produced by the exploration and learning of a novel environment, and (b) the effects on the robot behaviors of two caregiving profiles varying in their responsiveness-"responsive" and "non-responsive"-to the regulatory requests of the robot. Going beyond previous work, in this paper we (a) assess the effects that the varying regulatory behavior of the two robot profiles has on the exploratory and learning patterns of the robots; (b) bring together the two strands previously investigated in isolation and take a step further by endowing the robot with the capability to adapt its regulatory behavior along the "needy" and "independent" axis as a function of the varying responsiveness of the caregiver; and (c) analyze the effects that the varying regulatory behavior has on the exploratory and learning patterns of the adaptive robot.

Pharmaceuticals in the environment: scientific evidence of risks and its regulation.

PubMed

Küster, Anette; Adler, Nicole

2014-11-19

During the past two decades scientists, regulatory agencies and the European Commission have acknowledged pharmaceuticals to be an emerging environmental problem. In parallel, a regulatory framework for environmental risk assessment (ERA) of pharmaceutical products has been developed. Since the regulatory guidelines came into force the German Federal Agency (UBA) has been evaluating ERAs for human and veterinary pharmaceutical products before they are marketed. The results show that approximately 10% of pharmaceutical products are of note regarding their potential environmental risk. For human medicinal products, hormones, antibiotics, analgesics, antidepressants and antineoplastics indicated an environmental risk. For veterinary products, hormones, antibiotics and parasiticides were most often discussed as being environmentally relevant. These results are in good correlation with the results within the open scientific literature of prioritization approaches for pharmaceuticals in the environment. UBA results revealed that prospective approaches, such as ERA of pharmaceuticals, play an important role in minimizing problems caused by pharmaceuticals in the environment. However, the regulatory ERA framework could be improved by (i) inclusion of the environment in the risk-benefit analysis for human pharmaceuticals, (ii) improvement of risk management options, (iii) generation of data on existing pharmaceuticals, and (iv) improving the availability of ERA data. In addition, more general and integrative steps of regulation, legislation and research have been developed and are presented in this article. In order to minimize the quantity of pharmaceuticals in the environment these should aim to (i) improve the existing legislation for pharmaceuticals, (ii) prioritize pharmaceuticals in the environment and (iii) improve the availability and collection of pharmaceutical data. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

Government regulation to promote healthy food environments--a view from inside state governments.

PubMed

Shill, J; Mavoa, H; Allender, S; Lawrence, M; Sacks, G; Peeters, A; Crammond, B; Swinburn, B

2012-02-01

Food policy interventions are an important component of obesity-prevention strategies and can potentially drive positive changes in obesogenic environments. This study sought to identify regulatory interventions targeting the food environment, and barriers/facilitators to their implementation at the Australian state government level. In-depth interviews were conducted with senior representatives from state/territory governments, statutory authorities and non-government organizations (n =45) to examine participants' (i) suggestions for regulatory interventions for healthier food environments and (ii) support for pre-selected regulatory interventions derived from a literature review. Data were analysed using thematic and constant comparative analyses. Interventions commonly suggested by participants were regulating unhealthy food marketing; limiting the density of fast food outlets; pricing reforms to decrease fruit/vegetable prices and increase unhealthy food prices; and improved food labelling. The most commonly supported pre-selected interventions were related to food marketing and service. Primary production and retail sector interventions were least supported. The dominant themes were the need for whole-of-government and collaborative approaches; the influence of the food industry; conflicting policies/agenda; regulatory challenges; the need for evidence of effectiveness; and economic disincentives. While interventions such as public sector healthy food service policies were supported by participants, marketing restrictions and fiscal interventions face substantial barriers including a push for deregulation and private sector opposition. © 2011 The Authors. obesity reviews © 2011 International Association for the Study of Obesity.

Application of Non-Human Biota Assessment Methodologies to the Assessment of Potential Impacts from a Nuclear Waste Repository

DOE Office of Scientific and Technical Information (OSTI.GOV)

Smith, K.L.; Robinson, C.A.; Ikonen, A.T.K.

2007-07-01

The protection of the environment from the effects of ionising radiation has become increasingly more topical over the last few years as the intentions enshrined in international principles and agreements have become more binding through national and international law. For example, the Directive on impact of certain projects on the environment (EIA Directive 85/337/EEC) [CEC, 1985], amended in 1997 [CEC, 1997], places a mandatory requirement on all EU Member States to conduct environmental impact assessments for a range of project having potential impact on the environment, including radioactive waste disposal. Such assessments must consider humans, fauna and flora, the abioticmore » environment (soil, water, air), material assets and cultural heritage as well as the interactions between these factors. In Finland, Posiva Oy are responsible for the overall repository programme for spent nuclear fuel and, as such, are conducting the Safety Case Assessment for a proposed geological repository for nuclear waste. Within the European legislation framework, the Finnish regulatory body requires that the repository safety case assessment should include not only human radiological safety, but also an assessment of the potential impact upon populations of non-human biota. Specifically, the Safety Case should demonstrate that there will be: - no decline in the biodiversity of currently living populations; - no significant detriment to populations of fauna and flora; and, - no detrimental effects on individuals of domestic animals and rare plants and animals. At present, there are no internationally agreed criteria that explicitly address protection of the environment from ionising radiation. However, over recent years a number of assessment methodologies have been developed including, at a European level, the Framework for the Assessment of Environmental impact (FASSET) and Environmental Risks from Ionising Contaminants (ERICA). The International Committee on Radiation Protection (ICRP) have also proposed an approach to allow for assessments of potential impacts on non-human species, in its report in 2003. This approach is based on the development and use of a small set of reference animals and plants, with their associated dose models and data sets. Such approaches are broadly applicable to the Posiva Safety Case. However, the specific biota of concern and the current climatic conditions within Finland present an additional challenge to the assessment. The assessment methods most applicable to the Posiva Safety Case have therefore been reviewed in consideration of the regulatory requirements for the assessment and recommendations made on a suitable assessment approach. This has been applied within a test case and adaptations to the overall assessment method have been made to enable both population and individual impacts to be assessed where necessary. The test case has been undertaken to demonstrate the application of the recommended methodology, but also to identify data gaps, uncertainties and other specific issues associated with the application of an assessment method within the regulatory context. (authors)« less

Safe use of vaccines and vaccine compliance with food safety requirements.

PubMed

Grein, K; Papadopoulos, O; Tollis, M

2007-08-01

Advanced technologies and regulatory regimes have contributed to the availability of veterinary vaccines that have high quality and favourable safety profiles in terms of potential risks posed to the target animals, the persons who come into contact with the vaccine, the consumers of food derived from vaccinated animals and the environment. The authorisation process requires that a range of safety studies are provided to evaluate the products. The design and production of vaccines, and their safe use, are primarily assessed by using data gathered from extensive pre-marketing studies performed on target animals and specific quality tests. The current post-marketing safeguards include good manufacturing practices, batch safety testing, inspections and pharmacovigilance. In addition to hazard identification, a full benefit/risk evaluation needs to be undertaken. The outcome of that evaluation will determine options for risk management and affect regulatory decisions on the safety of the vaccine; options might, for example, include special warnings on package inserts and labels.

A report from CPhI Worldwide 2013, Fifth Annual Pre-Connect Conference (October 22-24, 2013 - Frankfurt, Germany).

PubMed

Kuhrt, K; Gilpatrick, J

2013-11-01

A day before the start of the 2013 Conference on Pharmaceutical Ingredients (CPhI) Worldwide, the world's leading pharmaceutical networking event, a number of attendees gathered for the Fifth Annual Pre-Connect Conference to discuss trends in business development, manufacturing and regulatory arenas. Of the six modules presented at the meeting, one was dedicated to the sourcing environment in emerging markets, with special attention paid to developments in India and China. Other modules evaluated the current trends in the creation of generics and supergenerics in emerging markets. Additionally, there were updates on issues surrounding the regulatory and development hurdles that biosimilars and biobetters are facing today. Common themes for both discussions include appropriate pricing and erosion demographics for generics and biosimilars, licensing scenarios, commercialization strategies, and how to stay competitive and find novel innovations within new delivery systems, improved formulations and modifications to create better quality active pharmaceutical ingredients. Copyright 2013 Prous Science, S.A.U. or its licensors. All rights reserved.

Protecting the public or setting the bar too high? Understanding the causes and consequences of regulatory actions of front-line regulators and specialized drug shop operators in Kenya.

PubMed

Wafula, Francis; Molyneux, Catherine; Mackintosh, Maureen; Goodman, Catherine

2013-11-01

The problem of poor regulatory compliance has been widely reported across private health providers in developing countries. Less known are the underlying reasons for poor compliance, especially with regards to the roles played by front-line regulatory staff, and the regulatory institution as a whole. We designed a qualitative study to address this gap, with the study questions and tools drawing on a conceptual framework informed by theoretical literature on regulation. Data were collected from specialized drug shops (SDSs) in two rural districts in Western Kenya in 2011 through eight focus group discussions, and from regulatory staff from organizations governing the pharmaceutical sector through a total of 24 in-depth interviews. We found that relationships between front-line regulators and SDS operators were a strong influence on regulatory behaviour, often resulting in non-compliance and perverse outcomes such as corruption. It emerged that separate regulatory streams operated in urban and rural locations, based mainly on differing relationships between the front-line regulators and SDS operators, and on broader factors such as the competition environment and community expectations. Effective incentive structures for regulatory staff were either absent, or poorly linked to performance in regulatory organizations, resulting in divergences between the purposes of the regulatory organization and activities of front-line staff. Given the rural-urban differences in the practice environment, the introduction of lower retail practice requirements for rural SDSs could be considered. This would allow illegally operated shops to be brought within the regulatory framework, facilitating good quality provision of essential commodities to marginalized areas, without lowering the practice requirements for the better complying urban SDSs. In addition, regulatory organizations need to devise incentives that better link the level of effort to rewards such as professional advancement of regulatory staff. Copyright © 2013 Elsevier Ltd. All rights reserved.

Protecting the public or setting the bar too high? Understanding the causes and consequences of regulatory actions of front-line regulators and specialized drug shop operators in Kenya

PubMed Central

Wafula, Francis; Molyneux, Catherine; Mackintosh, Maureen; Goodman, Catherine

2013-01-01

The problem of poor regulatory compliance has been widely reported across private health providers in developing countries. Less known are the underlying reasons for poor compliance, especially with regards to the roles played by front-line regulatory staff, and the regulatory institution as a whole. We designed a qualitative study to address this gap, with the study questions and tools drawing on a conceptual framework informed by theoretical literature on regulation. Data were collected from specialized drug shops (SDSs) in two rural districts in Western Kenya in 2011 through eight focus group discussions, and from regulatory staff from organizations governing the pharmaceutical sector through a total of 24 in-depth interviews. We found that relationships between front-line regulators and SDS operators were a strong influence on regulatory behaviour, often resulting in non-compliance and perverse outcomes such as corruption. It emerged that separate regulatory streams operated in urban and rural locations, based mainly on differing relationships between the front-line regulators and SDS operators, and on broader factors such as the competition environment and community expectations. Effective incentive structures for regulatory staff were either absent, or poorly linked to performance in regulatory organizations, resulting in divergences between the purposes of the regulatory organization and activities of front-line staff. Given the rural-urban differences in the practice environment, the introduction of lower retail practice requirements for rural SDSs could be considered. This would allow illegally operated shops to be brought within the regulatory framework, facilitating good quality provision of essential commodities to marginalized areas, without lowering the practice requirements for the better complying urban SDSs. In addition, regulatory organizations need to devise incentives that better link the level of effort to rewards such as professional advancement of regulatory staff. PMID:24016728

Fronting Integrated Scientific Web Applications: Design Features and Benefits for Regulatory Environments

EPA Science Inventory

Integrated decision support systems for regulatory applications benefit from standardindustry practices such as code reuse, test-driven development, and modularization. Theseapproaches make meeting the federal government’s goals of transparency, efficiency, and quality assurance ...

Toxicogenomics and the Regulatory Framework

EPA Science Inventory

Toxicogenomics presents regulatory agencies with the opportunity to revolutionize their analyses by enabling the collection of information on a broader range of responses than currently considered in traditional regulatory decision making. Analyses of genomic responses are expec...

75 FR 22868 - Withdrawal of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-30

... Characterization of Seismic Sources and Determination of Safe Shutdown Earthquake Ground Motion.'' FOR FURTHER.... Nuclear Regulatory Commission (NRC) is withdrawing RG 1.165, ``Identification and Characterization of... alter the licensing basis of any currently operating reactor or any of the currently issued early site...

Current limitations and recommendations to improve testing for the environmental assessment of endocrine active substances

USGS Publications Warehouse

Coady, Katherine K.; Biever, Ronald C.; Denslow, Nancy D.; Gross, Melanie; Guiney, Patrick D.; Holbech, Henrik; Karouna-Renier, Natalie K.; Katsiadaki, Ioanna; Krueger, Hank; Levine, Steven L.; Maack, Gerd; Williams, Mike; Wolf, Jeffrey C.; Ankley, Gerald T.

2017-01-01

In the present study, existing regulatory frameworks and test systems for assessing potential endocrine active chemicals are described, and associated challenges are discussed, along with proposed approaches to address these challenges. Regulatory frameworks vary somewhat across geographies, but all basically evaluate whether a chemical possesses endocrine activity and whether this activity can result in adverse outcomes either to humans or to the environment. Current test systems include in silico, in vitro, and in vivo techniques focused on detecting potential endocrine activity, and in vivo tests that collect apical data to detect possible adverse effects. These test systems are currently designed to robustly assess endocrine activity and/or adverse effects in the estrogen, androgen, and thyroid hormone signaling pathways; however, there are some limitations of current test systems for evaluating endocrine hazard and risk. These limitations include a lack of certainty regarding: 1) adequately sensitive species and life stages; 2) mechanistic endpoints that are diagnostic for endocrine pathways of concern; and 3) the linkage between mechanistic responses and apical, adverse outcomes. Furthermore, some existing test methods are resource intensive with regard to time, cost, and use of animals. However, based on recent experiences, there are opportunities to improve approaches to and guidance for existing test methods and to reduce uncertainty. For example, in vitro high-throughput screening could be used to prioritize chemicals for testing and provide insights as to the most appropriate assays for characterizing hazard and risk. Other recommendations include adding endpoints for elucidating connections between mechanistic effects and adverse outcomes, identifying potentially sensitive taxa for which test methods currently do not exist, and addressing key endocrine pathways of possible concern in addition to those associated with estrogen, androgen, and thyroid signaling. 

Data disclosure for chemical evaluations.

PubMed

Lutter, Randall; Barrow, Craig; Borgert, Christopher J; Conrad, James W; Edwards, Debra; Felsot, Allan

2013-02-01

Public disclosure of scientific data used by the government to make regulatory decisions for chemicals is a practical step that can enhance public confidence in the scientific basis of such decisions. We reviewed the U.S. Environmental Protection Agency's (EPA) current practices regarding disclosure of data underlying regulatory and policy decisions involving chemicals, including pesticides. We sought to identify additional opportunities for the U.S. EPA to disclose data and, more generally, to promote broad access to data it uses, regardless of origin. We recommend that when the U.S. EPA proposes a regulatory determination or other policy decision that relies on scientific research, it should provide sufficient underlying raw data and information about methods to enable reanalysis and attempts to independently reproduce the work, including the sensitivity of results to alternative analyses. This recommendation applies regardless of who conducted the work. If the U.S. EPA is unable to provide such transparency, it should state whether it had full access to all underlying data and methods. A timely version of submitted data cleared of information about confidential business matters and personal privacy should fully meet the standards of transparency described below, including public access sufficient for others to undertake an independent reanalysis. Reliable chemical evaluation is essential for protecting public health and the environment and for ensuring availability of useful chemicals under appropriate conditions. Permitting qualified researchers to endeavor to independently reproduce the analyses used in regulatory determinations of pesticides and other chemicals would increase confidence in the scientific basis of such determinations.

Clinical translation and regulatory aspects of CAR/TCR-based adoptive cell therapies-the German Cancer Consortium approach.

PubMed

Krackhardt, Angela M; Anliker, Brigitte; Hildebrandt, Martin; Bachmann, Michael; Eichmüller, Stefan B; Nettelbeck, Dirk M; Renner, Matthias; Uharek, Lutz; Willimsky, Gerald; Schmitt, Michael; Wels, Winfried S; Schüssler-Lenz, Martina

2018-04-01

Adoptive transfer of T cells genetically modified by TCRs or CARs represents a highly attractive novel therapeutic strategy to treat malignant diseases. Various approaches for the development of such gene therapy medicinal products (GTMPs) have been initiated by scientists in recent years. To date, however, the number of clinical trials commenced in Germany and Europe is still low. Several hurdles may contribute to the delay in clinical translation of these therapeutic innovations including the significant complexity of manufacture and non-clinical testing of these novel medicinal products, the limited knowledge about the intricate regulatory requirements of the academic developers as well as limitations of funds for clinical testing. A suitable good manufacturing practice (GMP) environment is a key prerequisite and platform for the development, validation, and manufacture of such cell-based therapies, but may also represent a bottleneck for clinical translation. The German Cancer Consortium (DKTK) and the Paul-Ehrlich-Institut (PEI) have initiated joint efforts of researchers and regulators to facilitate and advance early phase, academia-driven clinical trials. Starting with a workshop held in 2016, stakeholders from academia and regulatory authorities in Germany have entered into continuing discussions on a diversity of scientific, manufacturing, and regulatory aspects, as well as the benefits and risks of clinical application of CAR/TCR-based cell therapies. This review summarizes the current state of discussions of this cooperative approach providing a basis for further policy-making and suitable modification of processes.

Regulation of phosphate starvation responses in higher plants.

PubMed

Yang, Xiao Juan; Finnegan, Patrick M

2010-04-01

Phosphorus (P) is often a limiting mineral nutrient for plant growth. Many soils worldwide are deficient in soluble inorganic phosphate (P(i)), the form of P most readily absorbed and utilized by plants. A network of elaborate developmental and biochemical adaptations has evolved in plants to enhance P(i) acquisition and avoid starvation. Controlling the deployment of adaptations used by plants to avoid P(i) starvation requires a sophisticated sensing and regulatory system that can integrate external and internal information regarding P(i) availability. In this review, the current knowledge of the regulatory mechanisms that control P(i) starvation responses and the local and long-distance signals that may trigger P(i) starvation responses are discussed. Uncharacterized mutants that have P(i)-related phenotypes and their potential to give us additional insights into regulatory pathways and P(i) starvation-induced signalling are also highlighted and assessed. An impressive list of factors that regulate P(i) starvation responses is now available, as is a good deal of knowledge regarding the local and long-distance signals that allow a plant to sense and respond to P(i) availability. However, we are only beginning to understand how these factors and signals are integrated with one another in a regulatory web able to control the range of responses demonstrated by plants grown in low P(i) environments. Much more knowledge is needed in this agronomically important area before real gains can be made in improving P(i) acquisition in crop plants.

Commissions as educating organizations: How to educate the public regarding the mission of the public utilities commission in the new regulatory environment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sevel, F.

1996-12-31

Numerous authors have discussed the massive changes in the new regulatory environment and the necessary impact of these changes on the roles, responsibilities, structure, function, and mission of the public utility commission. In fact, when public utility commissioners gathered in Denver for the NRRI/NARUC Commissioners Summit in April 1995, {open_quotes}they made it clear that they embraced change as necessary to effective commission functioning in new regulatory environments and made it clear that they were prepared to direct that change.{close_quotes} The Commissioners identified the following trends of change: (1) Dichotomy of customers in core and noncore groupings. (2) Unbundling and newmore » service offerings. (3) Deregulation of certain services and markets. (4) Increased use of market-based pricing and incentive ratemaking. (5) Large users seeking lowest-cost service providers. (6) Shift from old regulatory compact [of] territorial exclusivity and assured recovery. (7) Changing obligation to serve. (8) Utility diversification into other businesses and use of holding company structures. (9) Increased business risk for utilities. (10) Uncertainty as to continued attention to social goals. In response to these changes, they identified five clusters of core missions for public utility commissions: (1) Protection of those customers who would not reap the full benefits of competition. (2) Support of competition balanced with an interest in fair and effective competition. (3) The provision of timely and clear decisions to utility managers and allowing utilities the flexibility to adapt to new conditions. (4) Preserving the commitment to social goals compatible with the competitive market. (5) Addressing the impact of new corporate structures, jurisdictional changes, necessary change in regulatory methods, and customer protection in the new environment.« less

40 CFR 63.851 - Regulatory authority review procedures.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 11 2014-07-01 2014-07-01 false Regulatory authority review procedures... PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Primary Aluminum Reduction Plants...

40 CFR 63.851 - Regulatory authority review procedures.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 10 2011-07-01 2011-07-01 false Regulatory authority review procedures... PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Primary Aluminum Reduction Plants...

40 CFR 63.851 - Regulatory authority review procedures.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 11 2013-07-01 2013-07-01 false Regulatory authority review procedures... PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Primary Aluminum Reduction Plants...

40 CFR 63.851 - Regulatory authority review procedures.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 11 2012-07-01 2012-07-01 false Regulatory authority review procedures... PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES (CONTINUED) National Emission Standards for Hazardous Air Pollutants for Primary Aluminum Reduction Plants...

Regulatory and Methodical Support of the Transition to the BATs in Heat Power Engineering

NASA Astrophysics Data System (ADS)

Roslyakov, P. V.; Kondrat'eva, O. E.; Borovkova, A. M.

2018-05-01

Federal Law no. 219-FZ of July 21, 2014, "On the Amendments to the Federal Law On Environmental Protection and Certain Legislative Acts" of the Russian Federation established new principles of environmental policy aimed at significantly reducing the negative anthropogenic impact on the environment. Currently, active work is under way to harmonize the Russian environmental legislation with regard to the transition to a system of technological regulation of impacts using the best available technologies (BATs). A national regulatory system based on BATs can be developed only through the implementation of integrated measures that are adopted and regulated at different levels (from decisions of the government of the Russian Federation to normative documents). For this purpose, more than 50 sectoral information and technical reference books on BATs have been developed that include descriptions of BATs for particular types of activities and their technological indicators. Starting on January 1, 2019, an integrated environmental permit will be introduced for enterprises with the greatest negative impact on the environment (category I enterprises). In addition, these enterprises will have to implement automatic systems for continuous control and metering of contaminants emissions (ASCCMCEs) into the atmosphere. Therefore, the development and adoption of the preliminary national standard of the Russian Federation PNS 187-2017, which is to come into force on January 1, 2018, will significantly accelerate and facilitate the implementation of ASCCMCEs of thermal power plants (TPPs) in accordance with Federal Law no. 219-FZ. The main goal of implementing ASCCMCEs on TPPs is to consistently reduce the negative impact of thermal power plants on the environment.

Regulatory aspects of nanotechnology in the agri/feed/food sector in EU and non-EU countries.

PubMed

Amenta, Valeria; Aschberger, Karin; Arena, Maria; Bouwmeester, Hans; Botelho Moniz, Filipa; Brandhoff, Puck; Gottardo, Stefania; Marvin, Hans J P; Mech, Agnieszka; Quiros Pesudo, Laia; Rauscher, Hubert; Schoonjans, Reinhilde; Vettori, Maria Vittoria; Weigel, Stefan; Peters, Ruud J

2015-10-01

Nanotechnology has the potential to innovate the agricultural, feed and food sectors (hereinafter referred to as agri/feed/food). Applications that are marketed already include nano-encapsulated agrochemicals or nutrients, antimicrobial nanoparticles and active and intelligent food packaging. Many nano-enabled products are currently under research and development, and may enter the market in the near future. As for any other regulated product, applicants applying for market approval have to demonstrate the safe use of such new products without posing undue safety risks to the consumer and the environment. Several countries all over the world have been active in examining the appropriateness of their regulatory frameworks for dealing with nanotechnologies. As a consequence of this, different approaches have been taken in regulating nano-based products in agri/feed/food. The EU, along with Switzerland, were identified to be the only world region where nano-specific provisions have been incorporated in existing legislation, while in other regions nanomaterials are regulated more implicitly by mainly building on guidance for industry. This paper presents an overview and discusses the state of the art of different regulatory measures for nanomaterials in agri/feed/food, including legislation and guidance for safety assessment in EU and non-EU countries. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

The expanding regulatory universe of p53 in gastrointestinal cancer.

PubMed

Fesler, Andrew; Zhang, Ning; Ju, Jingfang

2016-01-01

Tumor suppresser gene TP53 is one of the most frequently deleted or mutated genes in gastrointestinal cancers. As a transcription factor, p53 regulates a number of important protein coding genes to control cell cycle, cell death, DNA damage/repair, stemness, differentiation and other key cellular functions. In addition, p53 is also able to activate the expression of a number of small non-coding microRNAs (miRNAs) through direct binding to the promoter region of these miRNAs.  Many miRNAs have been identified to be potential tumor suppressors by regulating key effecter target mRNAs. Our understanding of the regulatory network of p53 has recently expanded to include long non-coding RNAs (lncRNAs). Like miRNA, lncRNAs have been found to play important roles in cancer biology.  With our increased understanding of the important functions of these non-coding RNAs and their relationship with p53, we are gaining exciting new insights into the biology and function of cells in response to various growth environment changes. In this review we summarize the current understanding of the ever expanding involvement of non-coding RNAs in the p53 regulatory network and its implications for our understanding of gastrointestinal cancer.

Nuclear power and probabilistic safety assessment (PSA): past through future applications

NASA Astrophysics Data System (ADS)

Stamatelatos, M. G.; Moieni, P.; Everline, C. J.

1995-03-01

Nuclear power reactor safety in the United States is about to enter a new era -- an era of risk- based management and risk-based regulation. First, there was the age of `prescribed safety assessment,' during which a series of design-basis accidents in eight categories of severity, or classes, were postulated and analyzed. Toward the end of that era, it was recognized that `Class 9,' or `beyond design basis,' accidents would need special attention because of the potentially severe health and financial consequences of these accidents. The accident at Three Mile Island showed that sequences of low-consequence, high-frequency events and human errors can be much more risk dominant than the Class 9 accidents. A different form of safety assessment, PSA, emerged and began to gain ground against the deterministic safety establishment. Eventually, this led to the current regulatory requirements for individual plant examinations (IPEs). The IPEs can serve as a basis for risk-based regulation and management, a concept that may ultimately transform the U.S. regulatory process from its traditional deterministic foundations to a process predicated upon PSA. Beyond the possibility of a regulatory environment predicated upon PSA lies the possibility of using PSA as the foundation for managing daily nuclear power plant operations.

A Review of the Environmental Impacts for Marine and Hydrokinetic Projects to Inform Regulatory Permitting: Summary Findings from the 2015 Workshop on Marine and Hydrokinetic Technologies, Washington, D.C.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Baring-Gould, E. Ian; Christol, Corrie; LiVecchi, Al

In 2014 and 2015, the U.S. Department of Energy initiated efforts to develop and implement technology- and application-focused marine and hydrokinetic (MHK) workshops to share the global experience and knowledge base on evolving MHK technologies, observed and not-observed impacts, monitoring and measurement methods, and regulatory needs. The resulting MHK Regulator Workshops engaged resource managers and other decision makers at key regulatory organizations, scientists, researchers, facilitators, and technical experts and provided an opportunity to examine the risks of single-device and small-scale deployments, explore what can be learned and observed from single devices and small-scale arrays, and consider requirements for projects atmore » varying scales of deployment. Experts and stakeholders identified key remaining information gaps. Initial discussions focused on differentiating between monitoring required for single or small-scale deployments and MHK impact research that, although important, goes beyond what is feasible or should be needed to meet specific project regulatory requirements but is appropriate for broader research and development. Four areas of identified potential environmental impacts provided the focus for the workshop: acoustic output impacts, electromagnetic field (EMF) emissions, physical interactions, and environmental effects of MHK energy development on the physical environment. Discussions also focused on the regulatory process and experience, adaptive management, industry drivers, and lessons that can be learned from the wind energy industry. The discussion was set in the context of the types of MHK technologies that are currently proposed or planned in the United States. All presentations and the following discussions are summarized in this document.« less

Gaps, inexperience, inconsistencies, and overlaps: crisis in the regulation of genetically modified plants and animals.

PubMed

Mandal, Gregory N

2004-04-01

The regulation of genetically modified products pursuant to statutes enacted decades prior to the advent of biotechnology has created a regulatory system that is passive rather than proactive about risks, has difficulty adapting to biotechnology advances, and is highly fractured and inefficient--transgenic plants and animals are governed by at least twelve different statutes and five different agencies or services. The deficiencies resulting from this piecemeal approach to regulation unnecessarily expose society and the environment to adverse risks of biotechnology and introduce numerous inefficiencies into the regulatory system. These risks and inefficiencies include gaps in regulation, duplicative and inconsistent regulation, unnecessary increases in the cost of and delay in the development and commercialization of new biotechnology products. These deficiencies also increase the risk of further unnecessary biotechnology scares, which may cause public overreaction against biotechnology products, preventing the maximization of social welfare. With science and society poised to soar from first-generation biotechnology (focused on crops modified for agricultural benefit), to next-generation developments (including transgenic fish, insects, and livestock, and pharmaceutical-producing and industrial compound-producing plants and animals), it is necessary to establish a comprehensive, efficient, and scientifically rigorous regulatory system. This Article details how to achieve such a result through fixing the deficiencies in, and risks created by, the current regulatory structure. Ignoring many details, the solutions can be summarized in two categories. First, statutory and regulatory gaps that are identified must be closed with new legislation and regulation. Second, regulation of genetically modified products must be shifted from a haphazard model based on statutes not intended to cover biotechnology to a system based upon agency expertise in handling particular types of risks.

Recent regulatory experience of low-Btu coal gasification. Volume III. Supporting case studies

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ackerman, E.; Hart, D.; Lethi, M.

The MITRE Corporation conducted a five-month study for the Office of Resource Applications in the Department of Energy on the regulatory requirements of low-Btu coal gasification. During this study, MITRE interviewed representatives of five current low-Btu coal gasification projects and regulatory agencies in five states. From these interviews, MITRE has sought the experience of current low-Btu coal gasification users in order to recommend actions to improve the regulatory process. This report is the third of three volumes. It contains the results of interviews conducted for each of the case studies. Volume 1 of the report contains the analysis of themore » case studies and recommendations to potential industrial users of low-Btu coal gasification. Volume 2 contains recommendations to regulatory agencies.« less

CURRENT ENVIRONMENT FOR INTRODUCING HEALTH TECHNOLOGY ASSESSMENT IN GREECE.

PubMed

Kani, Chara; Kourafalos, Vasilios; Litsa, Panagiota

2017-01-01

The aim of this study was to describe the current regulatory environment in Greece to evaluate the potential introduction of health technology assessment (HTA) for medicinal products for human use. Data sources consist of national legislation on pricing and reimbursement of health technologies to identify the potential need of establishing HTA and its relevant structure. The pricing procedure regarding medicinal products for human use is based on an external reference pricing mechanism which considers the average of the three lowest Euorpean Union prices. Currently, a formal HTA procedure has not been applied in Greece, and the only prerequisite used for the reimbursement of medicinal products for human use is their inclusion in the Positive Reimbursement List. To restrict pharmaceutical expenditure, a variety of measures-such as clawback mechanisms, rebates, monthly budget caps per physician, generics penetration targeting-have been imposed, aiming mainly to regulate the price level rather than control the introduction of medicinal products for human use in the Greek pharmaceutical market. Greece has the opportunity to rapidly build capacity, implement, and take advantage of the application of HTA mechanisms by clearly defining the goals, scope, systems, context, stakeholders, and methods that will be involved in the local HTA processes, taking into account the country's established e-prescription system and the recently adapted legislative framework.

Evolution of context dependent regulation by expansion of feast/famine regulatory proteins

DOE PAGES

Plaisier, Christopher L.; Lo, Fang -Yin; Ashworth, Justin; ...

2014-11-14

Expansion of transcription factors is believed to have played a crucial role in evolution of all organisms by enabling them to deal with dynamic environments and colonize new environments. We investigated how the expansion of the Feast/Famine Regulatory Protein (FFRP) or Lrp-like proteins into an eight-member family in Halobacterium salinarum NRC-1 has aided in niche-adaptation of this archaeon to a complex and dynamically changing hypersaline environment. We mapped genome-wide binding locations for all eight FFRPs, investigated their preference for binding different effector molecules, and identified the contexts in which they act by analyzing transcriptional responses across 35 growth conditions thatmore » mimic different environmental and nutritional conditions this organism is likely to encounter in the wild. Integrative analysis of these data constructed an FFRP regulatory network with conditionally active states that reveal how interrelated variations in DNA-binding domains, effector-molecule preferences, and binding sites in target gene promoters have tuned the functions of each FFRP to the environments in which they act. We demonstrate how conditional regulation of similar genes by two FFRPs, AsnC (an activator) and VNG1237C (a repressor), have striking environment-specific fitness consequences for oxidative stress management and growth, respectively. This study provides a systems perspective into the evolutionary process by which gene duplication within a transcription factor family contributes to environment-specific adaptation of an organism.« less

Evolution of context dependent regulation by expansion of feast/famine regulatory proteins.

PubMed

Plaisier, Christopher L; Lo, Fang-Yin; Ashworth, Justin; Brooks, Aaron N; Beer, Karlyn D; Kaur, Amardeep; Pan, Min; Reiss, David J; Facciotti, Marc T; Baliga, Nitin S

2014-11-14

Expansion of transcription factors is believed to have played a crucial role in evolution of all organisms by enabling them to deal with dynamic environments and colonize new environments. We investigated how the expansion of the Feast/Famine Regulatory Protein (FFRP) or Lrp-like proteins into an eight-member family in Halobacterium salinarum NRC-1 has aided in niche-adaptation of this archaeon to a complex and dynamically changing hypersaline environment. We mapped genome-wide binding locations for all eight FFRPs, investigated their preference for binding different effector molecules, and identified the contexts in which they act by analyzing transcriptional responses across 35 growth conditions that mimic different environmental and nutritional conditions this organism is likely to encounter in the wild. Integrative analysis of these data constructed an FFRP regulatory network with conditionally active states that reveal how interrelated variations in DNA-binding domains, effector-molecule preferences, and binding sites in target gene promoters have tuned the functions of each FFRP to the environments in which they act. We demonstrate how conditional regulation of similar genes by two FFRPs, AsnC (an activator) and VNG1237C (a repressor), have striking environment-specific fitness consequences for oxidative stress management and growth, respectively. This study provides a systems perspective into the evolutionary process by which gene duplication within a transcription factor family contributes to environment-specific adaptation of an organism.

Moving beyond 'rates, roads and rubbish': How do local governments make choices about healthy public policy to prevent obesity?

PubMed Central

Allender, Steven; Gleeson, Erin; Crammond, Brad; Sacks, Gary; Lawrence, Mark; Peeters, Anna; Loff, Bebe; Swinburn, Boyd

2009-01-01

While the causes of obesity are well known traditional education and treatment strategies do not appear to be making an impact. One solution as part of a broader complimentary set of strategies may be regulatory intervention at local government level to create environments for healthy nutrition and increased physical activity. Semi structured interviews were conducted with representatives of local government in Australia. Factors most likely to facilitate policy change were those supported by external funding, developed from an evidence base and sensitive to community and market forces. Barriers to change included a perceived or real lack of power to make change and the complexity of the legislative framework. The development of a systematic evidence base to provide clear feedback on the size and scope of the obesity epidemic at a local level, coupled with cost benefit analysis for any potential regulatory intervention, are crucial to developing a regulatory environment which creates the physical and social environment required to prevent obesity. PMID:19698170

Working with Policy and Regulatory Factors to Implement Universal Design in the Built Environment: The Australian Experience

PubMed Central

Larkin, Helen; Hitch, Danielle; Watchorn, Valerie; Ang, Susan

2015-01-01

Built environments that are usable by all provide opportunities for engagement in meaningful occupations. However, enabling them in day to day design processes and practice is problematic for relevant professions. The purpose of this phenomenological study was to gain greater understanding of the policy and regulatory influences that promote or hinder the uptake of universal design in built environments, to inform better future design. Focus groups or telephone interviews were undertaken with 28 key building industry and disability stakeholders in Australia. Four themes were identified: the difficulties of definition; the push or pull of regulations and policy; the role of formal standards; and, shifting the focus of design thinking. The findings highlight the complexity of working within policy and regulatory contexts when implementing universal design. Occupational therapists working with colleagues from other professions must be aware of these influences, and develop the skills to work with them for successful practice. PMID:26184278

Regulatory Disruption and Arbitrage in Health-Care Data Protection.

PubMed

Terry, Nicolas P

This article explains how the structure of U.S. health-care data protection (specifically its sectoral and downstream properties) has led to a chronically uneven policy environment for different types of health-care data. It examines claims for health-care data protection exceptionalism and competing demands such as data liquidity. In conclusion, the article takes the position that healthcare- data exceptionalism remains a valid imperative and that even current concerns about data liquidity can be accommodated in an exceptional protective model. However, re-calibrating our protection of health-care data residing outside of the traditional health-care domain is challenging, currently even politically impossible. Notwithstanding, a hybrid model is envisioned with downstream HIPAA model remaining the dominant force within the health-care domain, but being supplemented by targeted upstream and point-of-use protections applying to health-care data in disrupted spaces.

Arousal regulation and affective adaptation to human responsiveness by a robot that explores and learns a novel environment

PubMed Central

Hiolle, Antoine; Lewis, Matthew; Cañamero, Lola

2014-01-01

In the context of our work in developmental robotics regarding robot–human caregiver interactions, in this paper we investigate how a “baby” robot that explores and learns novel environments can adapt its affective regulatory behavior of soliciting help from a “caregiver” to the preferences shown by the caregiver in terms of varying responsiveness. We build on two strands of previous work that assessed independently (a) the differences between two “idealized” robot profiles—a “needy” and an “independent” robot—in terms of their use of a caregiver as a means to regulate the “stress” (arousal) produced by the exploration and learning of a novel environment, and (b) the effects on the robot behaviors of two caregiving profiles varying in their responsiveness—“responsive” and “non-responsive”—to the regulatory requests of the robot. Going beyond previous work, in this paper we (a) assess the effects that the varying regulatory behavior of the two robot profiles has on the exploratory and learning patterns of the robots; (b) bring together the two strands previously investigated in isolation and take a step further by endowing the robot with the capability to adapt its regulatory behavior along the “needy” and “independent” axis as a function of the varying responsiveness of the caregiver; and (c) analyze the effects that the varying regulatory behavior has on the exploratory and learning patterns of the adaptive robot. PMID:24860492

When synthetic chemicals degrade in the environment: What are the absolute fate, effects, and potential risks to humans and the ecosystem?

USGS Publications Warehouse

Boxall, Alistair; Sinclair, C.; Fenner, Kathrin; Kolpin, Dana W.; Maund, S.

2004-01-01

Although some regulatory schemes require information about the impacts of degradates on human and environmental health, that information does not exist for many compounds (25, 26). Pesticides are the exception. In this article, we bring together the available data to address the environmental behavior of degradates and their effects on organisms and discuss how to identify substances of potential concern. In addition, we cite gaps in the current knowledge and make recommendations for future research requirements. While the article focuses on pesticides, we believe these observations can be extended to biologically active compounds and some industrial substances.

Customizing cell signaling using engineered genetic logic circuits.

PubMed

Wang, Baojun; Buck, Martin

2012-08-01

Cells live in an ever-changing environment and continuously sense, process and react to environmental signals using their inherent signaling and gene regulatory networks. Recently, there have been great advances on rewiring the native cell signaling and gene networks to program cells to sense multiple noncognate signals and integrate them in a logical manner before initiating a desired response. Here, we summarize the current state-of-the-art of engineering synthetic genetic logic circuits to customize cellular signaling behaviors, and discuss their promising applications in biocomputing, environmental, biotechnological and biomedical areas as well as the remaining challenges in this growing field. Copyright © 2012 Elsevier Ltd. All rights reserved.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Humphrey, Betty; Bland, Jesse John

This paper documents the history of the TRU program at Sandia, previous and current activities associated with TRU material and waste, interfaces with other TRU waste generator sites and the Waste Isolation Pilot Plan (WIPP), and paths forward for TRU material and waste. This document is a snapshot in time of the TRU program and should be updated as necessary, or when significant changes have occurred in the Sandia TRU program or in the TRU regulatory environment. This paper should serve as a roadmap to capture past TRU work so that efforts are not repeated and ground is not lostmore » due to future inactivity and personnel changes.« less

Marketing Functional Foods: What Have We Learned? An Examination of the Metamucil, Benefit, and Heartwise Introductions as Cholesterol-Reducing Ready-to-Eat Cereals.

PubMed

Childs, N M

1999-01-01

Health claims, U.S. Food and Drug Administration regulatory actions, and marketing practices are examined in the environment precipitating the introduction of the Nutrition and Labeling Education Act (NLEA) in 1990. The introduction of three psyllium-based products in 1989 and 1990, Procter & Gamble's Metamucil wafers, General Mills' Benefit cereal, and Kellogg's Heartwise cereal, are examined for their use of health claims and marketing tactics in a changing regulatory environment. Inconsistent approval of psyllium-based health claims for drug and food products created a confusing environment in the pre- and early post-NLEA era. This was exacerbated by marketing issues regarding consumer communication and product positioning. Suggestions for marketing products with health positionings in the new NLEA environment are proposed.

The air quality and regional climate effects of widespread solar power generation under a changing regulatory environment

NASA Astrophysics Data System (ADS)

Millstein, D.; Zhai, P.; Menon, S.

2011-12-01

Over the past decade significant reductions of NOx and SOx emissions from coal burning power plants in the U.S. have been achieved due to regulatory action and substitution of new generation towards natural gas and wind power. Low natural gas prices, ever decreasing solar generation costs, and proposed regulatory changes, such as to the Cross State Air Pollution Rule, promise further long-run coal power plant emission reductions. Reduced power plant emissions have the potential to affect ozone and particulate air quality and influence regional climate through aerosol cloud interactions and visibility effects. Here we investigate, on a national scale, the effects on future (~2030) air quality and regional climate of power plant emission regulations in contrast to and combination with policies designed to aggressively promote solar electricity generation. A sophisticated, economic and engineering based, hourly power generation dispatch model is developed to explore the integration of significant solar generation resources (>10% on an energy basis) at various regions across the county, providing detailed estimates of substitution of solar generation for fossil fuel generation resources. Future air pollutant emissions from all sectors of the economy are scaled based on the U.S. Environmental Protection Agency's National Emission Inventory to account for activity changes based on population and economic projections derived from county level U.S. Census data and the Energy Information Administration's Annual Energy Outlook. Further adjustments are made for technological and regulatory changes applicable within various sectors, for example, emission intensity adjustments to on-road diesel trucking due to exhaust treatment and improved engine design. The future year 2030 is selected for the emissions scenarios to allow for the development of significant solar generation resources. A regional climate and air quality model (Weather Research and Forecasting, WRF model) is used to investigate the effects of the various solar generation scenarios given emissions projections that account for changing regulatory environment, economic and population growth, and technological change. The results will help to quantify the potential air quality benefits of promotion of solar electricity generation in regions containing high penetration of coal-fired power generation. Note current national solar incentives that are based only on solar generation capacity. Further investigation of changes to regional climate due to emission reductions of aerosols and relevant precursors will provide insight into the environmental effects that may occur if solar power generation becomes widespread.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wellman, Dawn M.; Freshley, Mark D.; Truex, Michael J.

Current requirements for site remediation and closure are standards-based and are often overly conservative, costly, and in some cases, technically impractical to achieve. Use of risk-informed alternate endpoints provide a means to achieve remediation goals that are permitted by regulations and are protective of human health and the environment. Alternate endpoints enable establishing a path for cleanup that may include intermediate remedial milestones and transition points and/or regulatory alternatives to standards-based remediation. A framework is presented that is centered around developing and refining conceptual models in conjunction with assessing risks and potential endpoints as part of a system-based assessment thatmore » integrates site data with scientific understanding of processes that control the distribution and transport of contaminants in the subsurface and pathways to receptors. This system based assessment and subsequent implementation of the remediation strategy with appropriate monitoring are targeted at providing a holistic approach to addressing risks to human health and the environment. This holistic approach also enables effective predictive analysis of contaminant behavior to provide defensible criteria and data for making long-term decisions. Developing and implementing an alternate endpoint-based approach for remediation and waste site closure presents a number of challenges and opportunities. Categories of these challenges include scientific and technical, regulatory, institutional, and budget and resource allocation issues. Opportunities exist for developing and implementing systems-based approaches with respect to supportive characterization, monitoring, predictive modeling, and remediation approaches.« less

[The right to food in obesogenic environments: Reflections on the role of health professionals].

PubMed

Piaggio, Laura Raquel

2016-01-01

Faced with the current obesity epidemic, this article problematizes the way the right to food is often circumscribed to situations of nutritional deficit. It is argued that the right to adequate food is violated in obesogenic environments and that protection of the right requires the establishment of measures to regulate advertising and marketing practices regarding ultra-processed products. The work suggests that the main barriers to the implementation of such measures are the strategies employed by Big Food; among these, strategies that have the scientific community as a target and/or means are highlighted. Certain basic underlying assumptions are identified in the discourse of health professionals that contribute to create a framework of legitimacy regarding the consumption of ultra-processed products. The adoption of an ethical position that is free of conflicts of interest is suggested, so as to advocate for needed regulatory measures of a statutory nature.

Role of adverse outcome pathways in developing computational models for regulatory toxicology

EPA Science Inventory

Regulatory toxicology for both human health and the environment increasingly is moving from a sole reliance on direct observation of apical toxicity outcomes in whole organism toxicity tests, to predictive approaches in which unacceptable outcomes and risk are inferred from mecha...

Cross-Cutting issues in Regulatory Supervision of Spent Fuel Radioactive Waste and Radioactively Contaminated Land in North-West Russia

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sneve, M. K.; Smith, G. M.

2006-07-01

The Norwegian Government is promoting improvements in radiation protection and nuclear safety in North-West Russia. Among priority areas there is the improvement of spent nuclear fuel and radioactive waste management, as well as remediation operations at the Shore Technical Bases operated by Federal Enterprise SevRAO at Andreeva Bay and Gremikha on the Kola Peninsula. The extreme radiological conditions at these sites present novel difficulties for regulatory supervision of operations. The situation at these sites is such that the existing regulations are applicable, and actions to remedy the situation are not permitted under the current regulatory regime. An improved regulatory process,more » including development of special norms and rules, is required to take account of this unusual situation. The Norwegian strategy includes not only support to industrial projects, but also support to Russian Federation regulatory bodies, to ensure that work is carried out in compliance with Russian Federation law, taking account of international recommendations and other national good practice as relevant in the RF. Accordingly, the Norwegian Radiation Protection Authority has set up a programme of cooperation with the Federal Medical-Biological Agency (FMBA), which is the primary radiation protection authority in the RF. The work is carried out with technical input from the Russian Institute of Biophysics and with inputs from western technical support organisations. The overall objective of the work is to promote effective and efficient regulatory supervision of SevRAO activities at Andreeva Bay and Gremikha within the scope of responsibilities of FMBA. This paper describes the results of an initial threat assessment which allows consideration of the cross-cutting issues associated with developing an overall effective site management plan which deals with short- and long-term issues, and protection of workers as well as of the public and the environment, while achieving a timely and effective use of resources in order to solve the problems. (authors)« less

Reflections on bird and mammal risk assessment for plant protection products in the European Union: Past, present, and future.

PubMed

Brooks, Amy C; Fryer, Mike; Lawrence, Alan; Pascual, Juan; Sharp, Rachel

2017-03-01

The use of plant protection products on agricultural crops can result in exposure of birds and mammals to toxic chemicals. In the European Union, the risks from such exposures are assessed under the current (2009) guidance document from the European Food Safety Authority (EFSA), designed to increase the realism of the theoretical risk assessments in comparison to its predecessor (SANCO/4145/2000). Since its adoption over 7 yr ago, many plant protection products have been evaluated successfully using the 2009 EFSA guidance document. However, there are still significant areas of improvement recommended for future revisions of this guidance. The present Focus article discusses experiences to date with the current scheme, including levels of conservatism in input parameters and interpretation by regulatory authorities together with proposals for how the guidance document could be improved when it is revised in the not too distant future. Several areas for which further guidance is recommended have been identified, such as the derivation of ecologically relevant bird and mammal reproductive endpoints and the use of modeling approaches to contextualize risk assessments. Areas where existing databases could be improved were also highlighted, including the collation of relevant focal species across Europe and expansion of the residue database for food items. To produce a realistic and useable guidance document in the future, it is strongly recommended that there is open and constructive communication between industry, regulatory authorities, and the EFSA. Such collaboration would also encourage harmonization between member states, thus reducing workloads for both industry and regulatory authorities. Environ Toxicol Chem 2017;36:565-575. © 2017 SETAC. © 2017 SETAC.

Sharing regulatory data as tools for strengthening health systems in the Region of the Americas.

PubMed

Sousa, Varley Dias; Ramalho, Pedro I; Silveira, Dâmaris

2016-05-01

Regulatory transparency is an imperative characteristic of a reliable National Regulatory Authority. In the region of the Americas, the process of building an open government is still fragile and fragmented across various Health Regulatory Agencies (HRAs) and Regional Reference Authorities (RRAs). This study assessed the transparency status of RRAs, focusing on various medicine life-cycle documents (the Medicine Dossier, Clinical Trial Report, and Inspection Report) as tools for strengthening health systems. Based on a narrative (nonsystematic) review of RRA regulatory transparency, transparency status was classified as one of two types: public disclosure of information (intra-agency data) and data- and work-sharing (inter-agency data). The risks/benefits of public disclosure of medicine-related information were assessed, taking into account 1) the involvement and roles of multiple stakeholders (health care professionals, regulators, industry, community, and academics) and 2) the protection of commercial and personal confidential data. Inter-agency data- and work-sharing was evaluated in the context of harmonization and cooperation projects that focus on regulatory convergence. Technical and practical steps for establishing an openness directive for the pharmaceutical regulatory environment are proposed to improve and strengthen health systems in the Americas. Addressing these challenges requires leadership from entities such as the Pan American Health Organization to steer and support collaborative regional alliances that advance the development and establishment of a trustworthy regulatory environment and a sustainable public health system in the Americas, using international successful initiatives as reference and taking into account the domestic characteristics and experiences of each individual country.

ReNE: A Cytoscape Plugin for Regulatory Network Enhancement

PubMed Central

Politano, Gianfranco; Benso, Alfredo; Savino, Alessandro; Di Carlo, Stefano

2014-01-01

One of the biggest challenges in the study of biological regulatory mechanisms is the integration, americanmodeling, and analysis of the complex interactions which take place in biological networks. Despite post transcriptional regulatory elements (i.e., miRNAs) are widely investigated in current research, their usage and visualization in biological networks is very limited. Regulatory networks are commonly limited to gene entities. To integrate networks with post transcriptional regulatory data, researchers are therefore forced to manually resort to specific third party databases. In this context, we introduce ReNE, a Cytoscape 3.x plugin designed to automatically enrich a standard gene-based regulatory network with more detailed transcriptional, post transcriptional, and translational data, resulting in an enhanced network that more precisely models the actual biological regulatory mechanisms. ReNE can automatically import a network layout from the Reactome or KEGG repositories, or work with custom pathways described using a standard OWL/XML data format that the Cytoscape import procedure accepts. Moreover, ReNE allows researchers to merge multiple pathways coming from different sources. The merged network structure is normalized to guarantee a consistent and uniform description of the network nodes and edges and to enrich all integrated data with additional annotations retrieved from genome-wide databases like NCBI, thus producing a pathway fully manageable through the Cytoscape environment. The normalized network is then analyzed to include missing transcription factors, miRNAs, and proteins. The resulting enhanced network is still a fully functional Cytoscape network where each regulatory element (transcription factor, miRNA, gene, protein) and regulatory mechanism (up-regulation/down-regulation) is clearly visually identifiable, thus enabling a better visual understanding of its role and the effect in the network behavior. The enhanced network produced by ReNE is exportable in multiple formats for further analysis via third party applications. ReNE can be freely installed from the Cytoscape App Store (http://apps.cytoscape.org/apps/rene) and the full source code is freely available for download through a SVN repository accessible at http://www.sysbio.polito.it/tools_svn/BioInformatics/Rene/releases/. ReNE enhances a network by only integrating data from public repositories, without any inference or prediction. The reliability of the introduced interactions only depends on the reliability of the source data, which is out of control of ReNe developers. PMID:25541727

Does the Regulatory Environment for E-Cigarettes Influence the Effectiveness of E-Cigarettes for Smoking Cessation?: Longitudinal Findings From the ITC Four Country Survey.

PubMed

Yong, Hua-Hie; Hitchman, Sara C; Cummings, K Michael; Borland, Ron; Gravely, Shannon M L; McNeill, Ann; Fong, Geoffrey T

2017-11-01

To date, no studies have explored how different regulatory environments may influence the effectiveness of electronic cigarettes (ECs) as a smoking cessation aid. This study compares the real-world effectiveness of adult smokers using ECs for quitting compared with quitting unassisted or quitting with nicotine replacement therapy (NRT) and/or prescription medications in two countries with restrictive policies towards ECs (ie, Canada and Australia) versus two countries with less restrictive policies (ie, United States and United Kingdom). Data were drawn from the International Tobacco Control Four Country surveys, from the United States and Canada (2 waves, n = 318 and 380, respectively), the United Kingdom (3 waves, n = 439) and Australia (4 waves, n = 662), collected 2010-2014. Smokers at baseline wave who reported making a quit attempt at follow-up were included. The primary outcome was self-reported abstinence for at least 30 days regardless of smoking status at follow-up assessment. Data across waves were combined and analyzed using generalized estimating equations. Compared to unassisted quitting (ie, no medications or ECs), smokers who used ECs for quitting from countries with less restrictive EC policy environments were more likely (OR = 1.95, 95%CI = 1.19-3.20, p < .01), whereas smokers who used ECs for quitting from countries with more restrictive EC policies were less likely (OR = 0.36, 95%CI = 0.18-0.72, p < .01), to report sustained abstinence for at least 30 days. Use of ECs in the real world during a quit attempt appears only effective for sustaining smoking abstinence in a less restrictive EC environment suggesting that the benefits of ECs for smoking cessation are likely highly dependent on the regulatory environment. What this study adds: This is the first study to examine the impact of regulatory environment for ECs on their real-world effectiveness for smoking cessation. This study shows that in a less restrictive EC regulatory environment, use of ECs during a quit attempt facilitates, but in a more restrictive environment, it inhibits, short-term sustained abstinence. The findings underscore the need for careful consideration on how best to regulate this emerging product so that EC benefits for smoking cessation are maximized and its risks to public health are minimized. © The Author 2017. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco.

Strengthening health professions regulation in Cambodia: a rapid assessment.

PubMed

Clarke, David; Duke, Jan; Wuliji, Tana; Smith, Alyson; Phuong, Keat; San, Un

2016-03-10

This paper describes a rapid assessment of Cambodia's current system for regulating its health professions. The assessment forms part of a co-design process to set strategic priorities for strengthening health profession regulation to improve the quality and safety of health services. A health system approach for strengthening health professions' regulation is underway and aims to support the Government of Cambodia's plans for scaling up its health workforce, improving health services' safety and quality, and meeting its Association of South East Asian Nations (ASEAN) obligations to facilitate trade in health care services. The assessment used a mixed methods approach including: A desktop review of key laws, plans, reports and other documents relating to the regulation of the health professions in Cambodia (medicine, dentistry, midwifery, nursing and pharmacy); Key informant interviews with stakeholders in Cambodia (The term "stakeholders" refers to government officials, people working on health professional regulation, people working for the various health worker training institutions and health workers at the national and provincial level); Surveys and questionnaires to assess Cambodian stakeholder knowledge of regulation; Self-assessments by members of the five Cambodian regulatory councils regarding key capacities and activities of high-performing regulatory bodies; and A rapid literature review to identify: The key functions of health professional regulation; The key issues affecting the Cambodian health sector (including relevant developments in the wider ASEAN region); and "Smart" health profession regulation practices of possible relevance to Cambodia. We found that the current regulatory system only partially meets Cambodia's needs. A number of key regulatory functions are being performed, but overall, the current system was not designed with Cambodia's specific needs in mind. The existing system is also overly complex, with considerable duplication and overlap between governance and regulatory arrangements for the five regulated professions. There is considerable scope for reform to the current regulatory system to better align the system to Cambodia's: Current needs and circumstances; Health system strategic priorities; and International obligations. Cambodia is also well placed to base its reformed regulatory system on recent developments of "smart regulatory practices" for health professionals.

77 FR 24746 - Constraint on Releases of Airborne Radioactive Materials to the Environment for Licensees Other...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-25

... Materials to the Environment for Licensees Other Than Power Reactors AGENCY: Nuclear Regulatory Commission... Environment for Licensees other than Power Reactors.'' This RG provides guidance on methods acceptable to the... environment. ADDRESSES: Please refer to Docket ID NRC-2010-0158 when contacting the NRC about the availability...

24 CFR 1710.15 - Regulatory exemption-multiple site subdivision-determination required.

Code of Federal Regulations, 2011 CFR

2011-04-01

.... Any development will likely have some impact on the surrounding environment. Development which... 24 Housing and Urban Development 5 2011-04-01 2011-04-01 false Regulatory exemption-multiple site subdivision-determination required. 1710.15 Section 1710.15 Housing and Urban Development Regulations Relating...

24 CFR 1710.15 - Regulatory exemption-multiple site subdivision-determination required.

Code of Federal Regulations, 2014 CFR

2014-04-01

.... Any development will likely have some impact on the surrounding environment. Development which... 24 Housing and Urban Development 5 2014-04-01 2014-04-01 false Regulatory exemption-multiple site subdivision-determination required. 1710.15 Section 1710.15 Housing and Urban Development Regulations Relating...

24 CFR 1710.15 - Regulatory exemption-multiple site subdivision-determination required.

Code of Federal Regulations, 2013 CFR

2013-04-01

.... Any development will likely have some impact on the surrounding environment. Development which... 24 Housing and Urban Development 5 2013-04-01 2013-04-01 false Regulatory exemption-multiple site subdivision-determination required. 1710.15 Section 1710.15 Housing and Urban Development Regulations Relating...

24 CFR 1710.15 - Regulatory exemption-multiple site subdivision-determination required.

Code of Federal Regulations, 2012 CFR

2012-04-01

.... Any development will likely have some impact on the surrounding environment. Development which... 24 Housing and Urban Development 5 2012-04-01 2012-04-01 false Regulatory exemption-multiple site subdivision-determination required. 1710.15 Section 1710.15 Housing and Urban Development Regulations Relating...

Setting monitoring objectives for landscape-size areas

Treesearch

Craig M. Olson; Dean Angelides

2000-01-01

The setting of objectives for monitoring schemes for landscape-size areas should be a complex task in today's regulatory and sociopolitical atmosphere. The technology available today, the regulatory environment, and the sociopolitical considerations require multiresource inventory and monitoring schemes, whether tile ownership is industrial or for preservation....

Mexico's Geothermal Market Assessment Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Flores-Espino, Francisco; Booth, Sarah; Graves, Andrew

This report is intended to help U.S. companies in the geothermal sector understand potential business opportunities created by recent changes in the Mexican energy market and regulatory environment. can also provide a variety of technology products and services for export into the Mexican market. This report will help U.S. companies identify the many public and private sector stakeholders in the United States and Mexico, which can help U.S. companies navigate the new regulatory and permitting environment, build new partnerships, and identify vehicles for financial assistance and risk mitigation.

Clostridium difficile infection: current, forgotten and emerging treatment options.

PubMed

Drekonja, Dimitri M

2014-09-01

Clostridium difficile infection (CDI) has increased in incidence and severity, and is now among the most common nosocomial infections. Several agents are available for the initial treatment of CDI, some of which are rarely used, and none of which is clearly superior for initial clinical cure. Fidaxomicin appears to offer a benefit in terms of preventing recurrent disease, although the cost-benefit ratio is debated. Recurrent CDI is a major challenge, occurring after 15-30% of initial episodes. The treatment of recurrent CDI is difficult, with sparse evidence available to support any particular agent. Fecal microbiota therapy, also known as 'stool transplantation', appears to be highly effective, although availability is currently limited, and the regulatory environment is in flux. Synthetic stool products and an orally available fecal microbiota therapy product are both under investigation, which may address the problem of availability. As with most infectious diseases, an effective vaccine would be a welcome addition to our armamentarium, but none is currently available.

The link between infant regulatory problems, temperament traits, maternal depressive symptoms and children's psychopathological symptoms at age three: a longitudinal study in a German at-risk sample.

PubMed

Sidor, Anna; Fischer, Cristina; Cierpka, Manfred

2017-01-01

Difficult conditions during childhood can limit an individual's development in many ways. Factors such as being raised in an at-risk family, child temperamental traits or maternal traits can potentially influence a child's later behaviour. The present study investigated the extent of regulatory problems in 6-month-old infants and their link to temperamental traits and impact on externalizing and internalizing problems at 36 months. Moderating effects of maternal distress and maternal depressive symptoms were tested as well. In a quasi-experimental, longitudinal study, a sample of 185 mother-infant dyads at psychosocial risk was investigated at 6 months with SFS (infants' regulatory problems) and at 3 years with CBCL (children's behavioural problems), EAS (children's temperament), ADS (maternal depressive symptoms) and PSI-SF (maternal stress). A hierarchical regression analysis yielded a significant association between infants' regulatory problems and both externalizing and internalizing behaviour problems at age 3 (accounting for 16% and 14% variance), with both externalizing and internalizing problems being linked to current maternal depressive symptoms (12 and 9% of the variance). Externalizing and internalizing problems were found to be related also to children's temperamental difficulty (18 and 13% of variance) and their negative emotionality. With temperamental traits having been taken into account, only feeding problems at 6 months contributed near-significant to internalizing problems at 3 years. Our results underscore the crucial role of temperament in the path between early regulatory problems and subsequent behavioural difficulties. Children's unfavourable temperamental predispositions such as negative emotionality and generally "difficult temperament" contributed substantially to both externalizing and internalizing behavioural problems in the high-risk sample. The decreased predictive power of regulatory problems following the inclusion of temperamental variables indicates a mediation effect of temperamental traits in the path between early regulatory problems and subsequent behavioural problems. Our results support the main effects of a child's temperament, and to some degree maternal depressive symptoms, rather than the diathesis stress model of interaction between risky environment and temperamental traits. Trial registration D10025651 (NZFH).

77 FR 12985 - Proposed Revised Habitat for the Spotted Owl: Minimizing Regulatory Burdens

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-05

... protect public health, welfare, safety, and our environment while promoting economic growth, innovation... applicable law and science; (3) develop clear direction, as part of the final rule, for evaluating logging... science and economics, including those comments that suggest potential methods for minimizing regulatory...

Data Disclosure for Chemical Evaluations

PubMed Central

Barrow, Craig; Borgert, Christopher J.; Conrad, James W.; Edwards, Debra; Felsot, Allan

2012-01-01

Background: Public disclosure of scientific data used by the government to make regulatory decisions for chemicals is a practical step that can enhance public confidence in the scientific basis of such decisions. Objectives: We reviewed the U.S. Environmental Protection Agency’s (EPA) current practices regarding disclosure of data underlying regulatory and policy decisions involving chemicals, including pesticides. We sought to identify additional opportunities for the U.S. EPA to disclose data and, more generally, to promote broad access to data it uses, regardless of origin. Discussion: We recommend that when the U.S. EPA proposes a regulatory determination or other policy decision that relies on scientific research, it should provide sufficient underlying raw data and information about methods to enable reanalysis and attempts to independently reproduce the work, including the sensitivity of results to alternative analyses. This recommendation applies regardless of who conducted the work. If the U.S. EPA is unable to provide such transparency, it should state whether it had full access to all underlying data and methods. A timely version of submitted data cleared of information about confidential business matters and personal privacy should fully meet the standards of transparency described below, including public access sufficient for others to undertake an independent reanalysis. Conclusion: Reliable chemical evaluation is essential for protecting public health and the environment and for ensuring availability of useful chemicals under appropriate conditions. Permitting qualified researchers to endeavor to independently reproduce the analyses used in regulatory determinations of pesticides and other chemicals would increase confidence in the scientific basis of such determinations. PMID:23228957

75 FR 73946 - Worker Safety and Health Program: Safety Conscious Work Environment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-30

... DEPARTMENT OF ENERGY 10 CFR Part 851 Worker Safety and Health Program: Safety Conscious Work... Nuclear Regulatory Commission's ``Safety-Conscious Work Environment'' guidelines as a model. DOE published.... Second, not only would instituting a ``Safety-Conscious Work Environment'' by regulation be redundant...

Technologies and Approaches to Elucidate and Model the Virulence Program of Salmonella.

DOE Office of Scientific and Technical Information (OSTI.GOV)

McDermott, Jason E.; Yoon, Hyunjin; Nakayasu, Ernesto S.

Salmonella is a primary cause of enteric diseases in a variety of animals. During its evolution into a pathogenic bacterium, Salmonella acquired an elaborate regulatory network that responds to multiple environmental stimuli within host animals and integrates them resulting in fine regulation of the virulence program. The coordinated action by this regulatory network involves numerous virulence regulators, necessitating genome-wide profiling analysis to assess and combine efforts from multiple regulons. In this review we discuss recent high-throughput analytic approaches to understand the regulatory network of Salmonella that controls virulence processes. Application of high-throughput analyses have generated a large amount of datamore » and driven development of computational approaches required for data integration. Therefore, we also cover computer-aided network analyses to infer regulatory networks, and demonstrate how genome-scale data can be used to construct regulatory and metabolic systems models of Salmonella pathogenesis. Genes that are coordinately controlled by multiple virulence regulators under infectious conditions are more likely to be important for pathogenesis. Thus, reconstructing the global regulatory network during infection or, at the very least, under conditions that mimic the host cellular environment not only provides a bird’s eye view of Salmonella survival strategy in response to hostile host environments but also serves as an efficient means to identify novel virulence factors that are essential for Salmonella to accomplish systemic infection in the host.« less

Developing a strategy and closure criteria for radioactive and mixed waste sites in the ORNL remedial action program: Regulatory interface

DOE Office of Scientific and Technical Information (OSTI.GOV)

Trabalka, J.R.

1987-09-01

Some options for stabilization and treatment of contaminated sites can theoretically provide a once-and-for-all solution (e.g., removal or destruction of contaminants). Most realizable options, however, leave contaminants in place (in situ), potentially isolated by physical or chemical, but more typically, by hydrologic measures. As a result of the dynamic nature of the interactions between contaminants, remedial measures, and the environment, in situ stablization measures are likely to have limited life spans, and maintenance and monitoring of performance become an essential part of the scheme. The length of formal institutional control over the site and related questions about future uses ofmore » the land and waters are of paramount importance. Unique features of the ORNL site and environs appear to be key ingredients in achieving the very long term institutional control necessary for successful financing and implementation of in situ stabilization. Some formal regulatory interface is necessary to ensure that regulatory limitations and new guidance which can affect planning and implementation of the ORNL Remedial Action Program are communicated to ORNL staff and potential technical and financial limitations which can affect schedules or alternatives for achievement of long-term site stabilization and the capability to meet environmental regulations are provided to regulatory bodies as early as possible. Such an interface should allow decisions on closure criteria to be based primarily on technical merit and protection of human health and the environment. A plan for interfacing with federal and state regulatory authorities is described. 93 refs., 1 fig., 4 tabs.« less

Legal and regulatory responses to innovative treatment.

PubMed

Chan, Tracey Evans

2013-01-01

Developments in medical technology, healthcare delivery, and commercial interests in medicine have increased both the potential for conflicts of interest on the part of physicians, and doubts over the sufficiency of patient autonomy as a justification for administering innovative therapy. The legal and regulatory treatment of innovative therapy is therefore an important question, on which there is a current lack of consensus on a number of issues. This paper discusses recent developments in Singapore and uses them as a springboard to flesh out basic regulatory issues that arise from the deployment of innovative treatment: the distinction between innovative treatment and clinical research, the adequacy of the current post hoc scrutiny of innovative therapy under existing legal principles and the need for further specialised regulatory oversight.

Regulating nanomedicine - can the FDA handle it?

PubMed

Bawa, Raj

2011-05-01

There is enormous excitement and expectation surrounding the multidisciplinary field of nanomedicine - the application of nanotechnology to healthcare - which is already influencing the pharmaceutical industry. This is especially true in the design, formulation and delivery of therapeutics. Currently, nanomedicine is poised at a critical stage. However, regulatory guidance in this area is generally lacking and critically needed to provide clarity and legal certainty to manufacturers, policymakers, healthcare providers as well as public. There are hundreds, if not thousands, of nanoproducts on the market for human use but little is known of their health risks, safety data and toxicity profiles. Less is known of nanoproducts that are released into the environment and that come in contact with humans. These nanoproducts, whether they are a drug, device, biologic or combination of any of these, are creating challenges for the Food and Drug Administration (FDA), as regulators struggle to accumulate data and formulate testing criteria to ensure development of safe and efficacious nanoproducts (products incorporating nanoscale technologies). Evidence continues to mount that many nanoproducts inherently posses novel size-based properties and toxicity profiles. Yet, this scientific fact has been generally ignored by the FDA and the agency continues to adopt a precautionary approach to the issue in hopes of countering future potential negative public opinion. As a result, the FDA has simply maintained the status quo with regard to its regulatory policies pertaining to nanomedicine. Therefore, there are no specific laws or mechanisms in place for oversight of nanomedicine and the FDA continues to treat nanoproducts as substantially equivalent ("bioequivalent") to their bulk counterparts. So, for now nanoproducts submitted for FDA review will continue to be subjected to an uncertain regulatory pathway. Such regulatory uncertainty could negatively impact venture funding, stifle nanomedicine research and development (R&D) and erode public acceptance of nanoproducts. The end-result of this could be a delay or loss of commercialized nanoproducts. Whether the FDA eventually creates new regulations, tweaks existing ones or establishes a new regulatory center to handle nanoproducts, for the time being it should at least look at nanoproducts on a case-by-case basis. The FDA should not attempt regulation of nanomedicine by applying existing statutes alone, especially where scientific evidence suggests otherwise. Incorporating nanomedicine regulation into the current regulatory scheme is a poor idea. Regulation of nanomedicine must balance innovation and R&D with the principle of ensuring maximum public health protection and safety.

Innovative farmers and regulatory gatekeepers: Genetically modified crops regulation and adoption in developing countries

PubMed Central

Sinebo, Woldeyesus; Maredia, Karim

2016-01-01

ABSTRACT The regulation of genetically modified (GM) crops is a topical issue in agriculture and environment over the past 2 decades. The objective of this paper is to recount regulatory and adoption practices in some developing countries that have successfully adopted GM crops so that aspiring countries may draw useful lessons and best practices for their biosafatey regulatory regimes. The first 11 mega-GM crops growing countries each with an area of more than one million hectares in 2014 were examined. Only five out of the 11 countries had smooth and orderly adoption of these crops as per the regulatory requirement of each country. In the remaining 6 countries (all developing countries), GM crops were either introduced across borders without official authorization, released prior to regulatory approval or unapproved seeds were sold along with the approved ones in violation to the existing regulations. Rapid expansion of transgenic crops over the past 2 decades in the developing world was a result of an intense desire by farmers to adopt these crops irrespective of regulatory roadblocks. Lack of workable biosafety regulatory system and political will to support GM crops encouraged unauthorized access to GM crop varieties. In certain cases, unregulated access in turn appeared to result in the adoption of substandard or spurious technology which undermined performance and productivity. An optimal interaction among the national agricultural innovation systems, biosafety regulatory bodies, biotech companies and high level policy makers is vital in making a workable regulated progress in the adoption of GM crops. Factoring forgone opportunities to farmers to benefit from GM crops arising from overregulation into biosafety risk analysis and decision making is suggested. Building functional biosafety regulatory systems that balances the needs of farmers to access and utilize the GM technology with the regulatory imperatives to ensure adequate safety to the environment and human health is recommended. PMID:26954893

78 FR 69485 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-19

... in the test environment. The test environment is designed to closely mirror the live trading... Test Environment November 13, 2013. Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934... fees under Rule 7030(d) for use of the NASDAQ Testing Facility (``NTF'') test environment located in...

The Critical Role of Nurturing Environments for Promoting Human Wellbeing

PubMed Central

Biglan, Anthony; Flay, Brian R.; Embry, Dennis D.; Sandler, Irwin N.

2013-01-01

The recent Institute of Medicine report on prevention (National Research Council [NRC] & IOM, 2009) noted the substantial inter-relationship among mental, emotional, and behavioral disorders, and pointed out that, to a great extent, these problems stem from a set of common conditions. However, despite the evidence, current research and practice continues to deal with the prevention of mental, emotional, and behavioral disorders as if they are unrelated and each stem from different conditions. This paper proposes a framework that could accelerate progress in preventing these problems. Environments that foster successful development and prevent the development of psychological and behavioral problems are usefully characterized as nurturing environments. First, these environments minimize biologically and psychologically toxic events. Second, they teach, promote, and richly reinforce prosocial behavior, including self-regulatory behaviors and all of the skills needed to become productive adult members of society. Third, they monitor and limit opportunities for problem behavior. Fourth, they foster psychological flexibility—the ability to be mindful of one's thoughts and feelings and act in the service of one's values, even when one's thoughts and feelings discourage taking valued action. We review evidence to support this synthesis and describe the kind of public health movement that could increase the prevalence of nurturing environments and, thereby, contribute to the prevention of most mental, emotional, and behavioral disorders. PMID:22583340

European Union research in support of environment and health: Building scientific evidence base for policy.

PubMed

Karjalainen, Tuomo; Hoeveler, Arnd; Draghia-Akli, Ruxandra

2017-06-01

Opinion polls show that the European Union citizens are increasingly concerned about the impact of environmental factors on their health. In order to respond and provide solid scientific evidence for the numerous policies related to the protection of human health and the environment managed at the Union level, the European Union made a substantial investment in research and innovation in the past two decades through its Framework Programmes for Research and Technological Development, including the current programme, Horizon 2020, which started in 2014. This policy review paper analysed the portfolio of forty collaborative projects relevant to environment and health, which received a total amount of around 228 million euros from the EU. It gives details on their contents and general scientific trends observed, the profiles of the participating countries and institutions, and the potential policy implications of the results obtained. The increasing knowledge base is needed to make informed policy decisions in Europe and beyond, and should be useful to many stakeholders including the scientific community and regulatory authorities. Copyright © 2017. Published by Elsevier Ltd.

Health Effects of Environmental Exposures, Occupational Hazards and Climate Change in Ethiopia: Synthesis of Situational Analysis, Needs Assessment and the Way Forward.

PubMed

Berhane, Kiros; Kumie, Abera; Samet, Jonathan

2016-01-01

The burden of diseases caused by environmental and occupational health hazards and the effects of global climate change are of growing concerns in Ethiopia. However, no adequate information seems to be available on the current situation. This means there is a critical gap in research, policy framework and implementation in the country. The purpose of this paper was to synthesize evidence from a systematic situational analysis and needs assessment to help establish a hub for research and training on three major themes and their related policy frameworks: air pollution and health, occupational health and safety and climate change and health. The methods used in this work include a systematic review of secondary data from peer-reviewed literature, thesis reports from academia, government and national statistical reports. Limited primary data based on key informant interviews held with major stakeholders were also used as sources of data. Exposures to high levels of indoor and outdoor air pollutants were found to be major sources of public health challenges. Lack of occupational safety and health due to agricultural activities and exposure to industries was found to be substantial. Worse is the growing fear that climate change will pose increasingly significant multidimensional challenges to the environment and public health. Across all three areas of focus, there was a paucity of information on local scientific evidence. There is also very limited trained skilled manpower and physical infrastructure to monitor the environment and enforce regulatory guidelines. Research, policy frameworks and regulatory mechanisms were among the cross-cutting issues that needed urgent attention. Critical gaps were observed in research and training across the three themes. Also, there is a limitation in implementing the link between policy and related regulations in the environment and health.

Perfluoroalkyl and Polyfluoroalkyl Substances in the Environment: Terminology, Classification, and Origins

PubMed Central

Buck, Robert C; Franklin, James; Berger, Urs; Conder, Jason M; Cousins, Ian T; de Voogt, Pim; Jensen, Allan Astrup; Kannan, Kurunthachalam; Mabury, Scott A; van Leeuwen, Stefan PJ

2011-01-01

The primary aim of this article is to provide an overview of perfluoroalkyl and polyfluoroalkyl substances (PFASs) detected in the environment, wildlife, and humans, and recommend clear, specific, and descriptive terminology, names, and acronyms for PFASs. The overarching objective is to unify and harmonize communication on PFASs by offering terminology for use by the global scientific, regulatory, and industrial communities. A particular emphasis is placed on long-chain perfluoroalkyl acids, substances related to the long-chain perfluoroalkyl acids, and substances intended as alternatives to the use of the long-chain perfluoroalkyl acids or their precursors. First, we define PFASs, classify them into various families, and recommend a pragmatic set of common names and acronyms for both the families and their individual members. Terminology related to fluorinated polymers is an important aspect of our classification. Second, we provide a brief description of the 2 main production processes, electrochemical fluorination and telomerization, used for introducing perfluoroalkyl moieties into organic compounds, and we specify the types of byproducts (isomers and homologues) likely to arise in these processes. Third, we show how the principal families of PFASs are interrelated as industrial, environmental, or metabolic precursors or transformation products of one another. We pay particular attention to those PFASs that have the potential to be converted, by abiotic or biotic environmental processes or by human metabolism, into long-chain perfluoroalkyl carboxylic or sulfonic acids, which are currently the focus of regulatory action. The Supplemental Data lists 42 families and subfamilies of PFASs and 268 selected individual compounds, providing recommended names and acronyms, and structural formulas, as well as Chemical Abstracts Service registry numbers. Integr Environ Assess Manag 2011;7:513–541. © 2011 SETAC PMID:21793199

Barriers to investigator-initiated deep brain stimulation and device research

PubMed Central

Malone, Donald; Okun, Michael S.; Booth, Joan; Machado, Andre G.

2014-01-01

The success of device-based research in the clinical neurosciences has overshadowed a critical and emerging problem in the biomedical research environment in the United States. Neuroprosthetic devices, such as deep brain stimulation (DBS), have been shown in humans to be promising technologies for scientific exploration of neural pathways and as powerful treatments. Large device companies have, over the past several decades, funded and developed major research programs. However, both the structure of clinical trial funding and the current regulation of device research threaten investigator-initiated efforts in neurologic disorders. The current atmosphere dissuades clinical investigators from pursuing formal and prospective research with novel devices or novel indications. We review our experience in conducting a federally funded, investigator-initiated, device-based clinical trial that utilized DBS for thalamic pain syndrome. We also explore barriers that clinical investigators face in conducting device-based clinical trials, particularly in early-stage studies or small disease populations. We discuss 5 specific areas for potential reform and integration: (1) alternative pathways for device approval; (2) eliminating right of reference requirements; (3) combining federal grant awards with regulatory approval; (4) consolidation of oversight for human subjects research; and (5) private insurance coverage for clinical trials. Careful reformulation of regulatory policy and funding mechanisms is critical for expanding investigator-initiated device research, which has great potential to benefit science, industry, and, most importantly, patients. PMID:24670888

“AQMEII Status Update” | Science Inventory | US EPA

EPA Pesticide Factsheets

“AQMEII Status Update”This presentation provided an overview and status update of the Air Quality Model Evaluation International Initative (AQMEII) to participants of a workshop of the Task Force on Hemispheric Transport of Air Pollution (TF-HTAP) . In addition, the presentation also outlines the objectives and potential timeline for a possible next phase of AQMEII that would involve a collaboration with the current modeling activities of TF-HTAP. The purpose of the presentation was to provide participants at the HTAP meeting with an overview of current AQMEII activities and timelines and to obtain feedback from HTAP workshop participants regarding HTAP timelines. The National Exposure Research Laboratory (NERL) Atmospheric Modeling and Analysis Division (AMAD) conducts research in support of EPA mission to protect human health and the environment. AMAD research program is engaged in developing and evaluating predictive atmospheric models on all spatial and temporal scales for forecasting the air quality and for assessing changes in air quality and air pollutant exposures, as affected by changes in ecosystem management and regulatory decisions. AMAD is responsible for providing a sound scientific and technical basis for regulatory policies based on air quality models to improve ambient air quality. The models developed by AMAD are being used by EPA, NOAA, and the air pollution community in understanding and forecasting not only the magnitude of the air po

The global threat of antimicrobial resistance: science for intervention

PubMed Central

Roca, I.; Akova, M.; Baquero, F.; Carlet, J.; Cavaleri, M.; Coenen, S.; Cohen, J.; Findlay, D.; Gyssens, I.; Heure, O.E.; Kahlmeter, G.; Kruse, H.; Laxminarayan, R.; Liébana, E.; López-Cerero, L.; MacGowan, A.; Martins, M.; Rodríguez-Baño, J.; Rolain, J.-M.; Segovia, C.; Sigauque, B.; Taconelli, E.; Wellington, E.; Vila, J.

2015-01-01

In the last decade we have witnessed a dramatic increase in the proportion and absolute number of bacterial pathogens resistant to multiple antibacterial agents. Multidrug-resistant bacteria are currently considered as an emergent global disease and a major public health problem. The B-Debate meeting brought together renowned experts representing the main stakeholders (i.e. policy makers, public health authorities, regulatory agencies, pharmaceutical companies and the scientific community at large) to review the global threat of antibiotic resistance and come up with a coordinated set of strategies to fight antimicrobial resistance in a multifaceted approach. We summarize the views of the B-Debate participants regarding the current situation of antimicrobial resistance in animals and the food chain, within the community and the healthcare setting as well as the role of the environment and the development of novel diagnostic and therapeutic strategies, providing expert recommendations to tackle the global threat of antimicrobial resistance. PMID:26029375

Regulatory Technology Development Plan - Sodium Fast Reactor. Mechanistic Source Term - Trial Calculation. Work Plan

DOE Office of Scientific and Technical Information (OSTI.GOV)

Grabaskas, David; Bucknor, Matthew; Jerden, James

2016-02-01

The overall objective of the SFR Regulatory Technology Development Plan (RTDP) effort is to identify and address potential impediments to the SFR regulatory licensing process. In FY14, an analysis by Argonne identified the development of an SFR-specific MST methodology as an existing licensing gap with high regulatory importance and a potentially long lead-time to closure. This work was followed by an initial examination of the current state-of-knowledge regarding SFR source term development (ANLART-3), which reported several potential gaps. Among these were the potential inadequacies of current computational tools to properly model and assess the transport and retention of radionuclides duringmore » a metal fuel pool-type SFR core damage incident. The objective of the current work is to determine the adequacy of existing computational tools, and the associated knowledge database, for the calculation of an SFR MST. To accomplish this task, a trial MST calculation will be performed using available computational tools to establish their limitations with regard to relevant radionuclide release/retention/transport phenomena. The application of existing modeling tools will provide a definitive test to assess their suitability for an SFR MST calculation, while also identifying potential gaps in the current knowledge base and providing insight into open issues regarding regulatory criteria/requirements. The findings of this analysis will assist in determining future research and development needs.« less

Emergent adaptive behaviour of GRN-controlled simulated robots in a changing environment.

PubMed

Yao, Yao; Storme, Veronique; Marchal, Kathleen; Van de Peer, Yves

2016-01-01

We developed a bio-inspired robot controller combining an artificial genome with an agent-based control system. The genome encodes a gene regulatory network (GRN) that is switched on by environmental cues and, following the rules of transcriptional regulation, provides output signals to actuators. Whereas the genome represents the full encoding of the transcriptional network, the agent-based system mimics the active regulatory network and signal transduction system also present in naturally occurring biological systems. Using such a design that separates the static from the conditionally active part of the gene regulatory network contributes to a better general adaptive behaviour. Here, we have explored the potential of our platform with respect to the evolution of adaptive behaviour, such as preying when food becomes scarce, in a complex and changing environment and show through simulations of swarm robots in an A-life environment that evolution of collective behaviour likely can be attributed to bio-inspired evolutionary processes acting at different levels, from the gene and the genome to the individual robot and robot population.

Emergent adaptive behaviour of GRN-controlled simulated robots in a changing environment

PubMed Central

Yao, Yao; Storme, Veronique; Marchal, Kathleen

2016-01-01

We developed a bio-inspired robot controller combining an artificial genome with an agent-based control system. The genome encodes a gene regulatory network (GRN) that is switched on by environmental cues and, following the rules of transcriptional regulation, provides output signals to actuators. Whereas the genome represents the full encoding of the transcriptional network, the agent-based system mimics the active regulatory network and signal transduction system also present in naturally occurring biological systems. Using such a design that separates the static from the conditionally active part of the gene regulatory network contributes to a better general adaptive behaviour. Here, we have explored the potential of our platform with respect to the evolution of adaptive behaviour, such as preying when food becomes scarce, in a complex and changing environment and show through simulations of swarm robots in an A-life environment that evolution of collective behaviour likely can be attributed to bio-inspired evolutionary processes acting at different levels, from the gene and the genome to the individual robot and robot population. PMID:28028477

The oral administration of bacterial extracts prevents asthma via the recruitment of regulatory T cells to the airways.

PubMed

Navarro, S; Cossalter, G; Chiavaroli, C; Kanda, A; Fleury, S; Lazzari, A; Cazareth, J; Sparwasser, T; Dombrowicz, D; Glaichenhaus, N; Julia, V

2011-01-01

The prevalence of asthma has steadily increased during the last decade, probably as the result of changes in the environment, including reduced microbial exposure during infancy. Accordingly, experimental studies have shown that deliberate infections with live pathogens prevent the development of allergic airway diseases in mice. Bacterial extracts are currently used in children suffering from repeated upper respiratory tract infections. In the present study, we have investigated whether bacterial extracts, commercially available as Broncho-Vaxom (BV), could prevent allergic airway disease in mice. Oral treatment with BV suppressed airway inflammation through interleukin-10 (IL-10)-dependent and MyD88 (myeloid differentiation primary response gene (88))-dependent mechanisms and induced the conversion of FoxP3 (forkhead box P3)(-) T cells into FoxP3(+) regulatory T cells. Furthermore, CD4(+) T cells purified from the trachea of BV-treated mice conferred protection against airway inflammation when adoptively transferred into sensitized mice. Therefore, treatment with BV could possibly be a safe and efficient strategy to prevent the development of allergic diseases in children.

Immunosuppression-Independent Role of Regulatory T Cells against Hypertension-Driven Renal Dysfunctions.

PubMed

Fabbiano, Salvatore; Menacho-Márquez, Mauricio; Robles-Valero, Javier; Pericacho, Miguel; Matesanz-Marín, Adela; García-Macías, Carmen; Sevilla, María A; Montero, M J; Alarcón, Balbino; López-Novoa, José M; Martín, Pilar; Bustelo, Xosé R

2015-10-01

Hypertension-associated cardiorenal diseases represent one of the heaviest burdens for current health systems. In addition to hemodynamic damage, recent results have revealed that hematopoietic cells contribute to the development of these diseases by generating proinflammatory and profibrotic environments in the heart and kidney. However, the cell subtypes involved remain poorly characterized. Here we report that CD39(+) regulatory T (TREG) cells utilize an immunosuppression-independent mechanism to counteract renal and possibly cardiac damage during angiotensin II (AngII)-dependent hypertension. This mechanism relies on the direct apoptosis of tissue-resident neutrophils by the ecto-ATP diphosphohydrolase activity of CD39. In agreement with this, experimental and genetic alterations in TREG/TH cell ratios have a direct impact on tissue-resident neutrophil numbers, cardiomyocyte hypertrophy, cardiorenal fibrosis, and, to a lesser extent, arterial pressure elevation during AngII-driven hypertension. These results indicate that TREG cells constitute a first protective barrier against hypertension-driven tissue fibrosis and, in addition, suggest new therapeutic avenues to prevent hypertension-linked cardiorenal diseases. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Arsenic waste management: a critical review of testing and disposal of arsenic-bearing solid wastes generated during arsenic removal from drinking water.

PubMed

Clancy, Tara M; Hayes, Kim F; Raskin, Lutgarde

2013-10-01

Water treatment technologies for arsenic removal from groundwater have been extensively studied due to widespread arsenic contamination of drinking water sources. Central to the successful application of arsenic water treatment systems is the consideration of appropriate disposal methods for arsenic-bearing wastes generated during treatment. However, specific recommendations for arsenic waste disposal are often lacking or mentioned as an area for future research and the proper disposal and stabilization of arsenic-bearing waste remains a barrier to the successful implementation of arsenic removal technologies. This review summarizes current disposal options for arsenic-bearing wastes, including landfilling, stabilization, cow dung mixing, passive aeration, pond disposal, and soil disposal. The findings from studies that simulate these disposal conditions are included and compared to results from shorter, regulatory tests. In many instances, short-term leaching tests do not adequately address the range of conditions encountered in disposal environments. Future research directions are highlighted and include establishing regulatory test conditions that align with actual disposal conditions and evaluating nonlandfill disposal options for developing countries.

Genetic Toxicology in the 21st Century: Reflections and Future Directions

PubMed Central

Mahadevan, Brinda; Snyder, Ronald D.; Waters, Michael D.; Benz, R. Daniel; Kemper, Raymond A.; Tice, Raymond R.; Richard, Ann M.

2011-01-01

A symposium at the 40th anniversary of the Environmental Mutagen Society, held from October 24–28, 2009 in St. Louis, MO, surveyed the current status and future directions of genetic toxicology. This article summarizes the presentations and provides a perspective on the future. An abbreviated history is presented, highlighting the current standard battery of genotoxicity assays and persistent challenges. Application of computational toxicology to safety testing within a regulatory setting is discussed as a means for reducing the need for animal testing and human clinical trials, and current approaches and applications of in silico genotoxicity screening approaches across the pharmaceutical industry were surveyed and are reported here. The expanded use of toxicogenomics to illuminate mechanisms and bridge genotoxicity and carcinogenicity, and new public efforts to use high-throughput screening technologies to address lack of toxicity evaluation for the backlog of thousands of industrial chemicals in the environment are detailed. The Tox21 project involves coordinated efforts of four U.S. Government regulatory/research entities to use new and innovative assays to characterize key steps in toxicity pathways, including genotoxic and nongenotoxic mechanisms for carcinogenesis. Progress to date, highlighting preliminary test results from the National Toxicology Program is summarized. Finally, an overview is presented of ToxCast™, a related research program of the U.S. Environmental Protection Agency, using a broad array of high throughput and high content technologies for toxicity profiling of environmental chemicals, and computational toxicology modeling. Progress and challenges, including the pressing need to incorporate metabolic activation capability, are summarized. PMID:21538556

Data Integrity-A Study of Current Regulatory Thinking and Action.

PubMed

Shafiei, Nader; De Montardy, Regis; Rivera-Martinez, Edwin

2015-01-01

In reaction to breaches of data integrity in the pharmaceutical industry, regulatory authorities have introduced inspection approaches or initiatives with the aim of reducing occurrences of data integrity problems. This review article-based on study of 65 cases of regulatory action from 2002 to 2014-provides an overview of current regulatory thinking and action on breaches of data integrity affecting GxP (health-related regulations) processes supporting non-clinical studies, clinical studies, laboratory controls, and production controls. These case studies largely represent position of the U.S. Food and Drug Administration and the regulatory agencies affiliated with the European Medicines Agency. Also discussed is the role of human factors as a potential source of data integrity problems. The article concludes by recommending some remedial controls that could be established to avoid or reduce occurrences of data integrity problems.Lay Abstract: In fulfilling their mission to protect public health, regulatory agencies (e.g., U.S. Food and Drug Administration, European Medicines Agency) must establish confidence that medical products they approve are fit for their intended use. In so doing they rely on scientific and operational data generated during research, development, manufacturing, sales, marketing, distribution, and post-marketing surveillance activities. The level of confidence they build is directly proportional to the scientific validity and integrity of data presented to them by the sponsors of medical products. In this article we present analysis of 65 case studies that document regulatory action taken by various regulatory agencies on breach of data integrity between 2002 and 2014. The ensuing discussion on current trends largely represents position of the U.S. Food and Drug Administration and European Medicines Agency. The article concludes by proposing some remedial controls that could be established by pharmaceutical companies to avoid or reduce occurrences of data integrity problems. © PDA, Inc. 2015.

Innovative Legal Approaches to Address Obesity

PubMed Central

Pomeranz, Jennifer L; Teret, Stephen P; Sugarman, Stephen D; Rutkow, Lainie; Brownell, Kelly D

2009-01-01

Context: The law is a powerful public health tool with considerable potential to address the obesity issue. Scientific advances, gaps in the current regulatory environment, and new ways of conceptualizing rights and responsibilities offer a foundation for legal innovation. Methods: This article connects developments in public health and nutrition with legal advances to define promising avenues for preventing obesity through the application of the law. Findings: Two sets of approaches are defined: (1) direct application of the law to factors known to contribute to obesity and (2) original and innovative legal solutions that address the weak regulatory stance of government and the ineffectiveness of existing policies used to control obesity. Specific legal strategies are discussed for limiting children's food marketing, confronting the potential addictive properties of food, compelling industry speech, increasing government speech, regulating conduct, using tort litigation, applying nuisance law as a litigation strategy, and considering performance-based regulation as an alternative to typical regulatory actions. Finally, preemption is an overriding issue and can play both a facilitative and a hindering role in obesity policy. Conclusions: Legal solutions are immediately available to the government to address obesity and should be considered at the federal, state, and local levels. New and innovative legal solutions represent opportunities to take the law in creative directions and to link legal, nutrition, and public health communities in constructive ways. PMID:19298420

Reasserting the primacy of human needs to reclaim the 'lost half' of sustainable development.

PubMed

Everard, Mark; Longhurst, James W S

2018-04-15

The concept of sustainable development evolved from growing awareness of the interdependence of social and economic progress with the limits of the supporting natural environment, becoming progressively integrated into global agreements and transposition into local regulatory and implementation frameworks. We argue that transposition of the concept into regulation and supporting tools reduced the focus to minimal environmental and social standards, perceived as imposing constraints rather than opportunities for innovation to meet human needs. The aspirational 'half' of the concept of sustainable development specifically addressing human needs was thus lost in transposing high ideals into regulatory instruments. The Sustainable Development Goals (SDGs) restore focus on interlinked human needs, stimulating innovation of products and processes to satisfy them. Through three case studies - PVC water pipes, river quality management in England, and UK local air quality management - we explore the current operationalisation of the concept in diverse settings, using the SDG framework to highlight the broader societal purposes central to sustainable development. Partnerships involving civil society support evolution of regulatory instruments and their implementation, optimising social and ecological benefits thereby serving more human needs. Restoring the visionary 'lost half' of sustainable development - meeting human needs in sustainable ways - creates incentives for innovation and partnership; an innovation framework rather than a perceived constraint. Copyright © 2017 Elsevier B.V. All rights reserved.

Considering the cumulative risk of mixtures of chemicals – A challenge for policy makers

PubMed Central

2012-01-01

Background The current paradigm for the assessment of the health risk of chemical substances focuses primarily on the effects of individual substances for determining the doses of toxicological concern in order to inform appropriately the regulatory process. These policy instruments place varying requirements on health and safety data of chemicals in the environment. REACH focuses on safety of individual substances; yet all the other facets of public health policy that relate to chemical stressors put emphasis on the effects of combined exposure to mixtures of chemical and physical agents. This emphasis brings about methodological problems linked to the complexity of the respective exposure pathways; the effect (more complex than simple additivity) of mixtures (the so-called 'cocktail effect'); dose extrapolation, i.e. the extrapolation of the validity of dose-response data to dose ranges that extend beyond the levels used for the derivation of the original dose-response relationship; the integrated use of toxicity data across species (including human clinical, epidemiological and biomonitoring data); and variation in inter-individual susceptibility associated with both genetic and environmental factors. Methods In this paper we give an overview of the main methodologies available today to estimate the human health risk of environmental chemical mixtures, ranging from dose addition to independent action, and from ignoring interactions among the mixture constituents to modelling their biological fate taking into account the biochemical interactions affecting both internal exposure and the toxic potency of the mixture. Results We discuss their applicability, possible options available to policy makers and the difficulties and potential pitfalls in implementing these methodologies in the frame of the currently existing policy framework in the European Union. Finally, we suggest a pragmatic solution for policy/regulatory action that would facilitate the evaluation of the health effects of chemical mixtures in the environment and consumer products. Conclusions One universally applicable methodology does not yet exist. Therefore, a pragmatic, tiered approach to regulatory risk assessment of chemical mixtures is suggested, encompassing (a) the use of dose addition to calculate a hazard index that takes into account interactions among mixture components; and (b) the use of the connectivity approach in data-rich situations to integrate mechanistic knowledge at different scales of biological organization. PMID:22759500

Environmental Implementation Plan

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1993-03-15

The purpose of the Environmental Implementation Plan (EIP) is to show the current and future (five years) environmental plans from individual site organizations and divisions, as well as site environmental programs and initiatives which are designed to protect the environment and meet or exceed changing environmental/regulatory requirements. Communicating with site organizations, departments, and committees is essential in making the site`s environmental-planning process work. The EIP gives the site the what, when, how, and why for environmental requirements. Through teamwork and proactive planning, a partnership for environmental excellence is formed to achieve the site vision for SRS to become the recognizedmore » model for Environmental Excellence in the Department of Energy`s Nuclear Weapons Complex.« less

Environmental Implementation Plan

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1993-03-15

The purpose of the Environmental Implementation Plan (EIP) is to show the current and future (five years) environmental plans from individual site organizations and divisions, as well as site environmental programs and initiatives which are designed to protect the environment and meet or exceed changing environmental/regulatory requirements. Communicating with site organizations, departments, and committees is essential in making the site's environmental-planning process work. The EIP gives the site the what, when, how, and why for environmental requirements. Through teamwork and proactive planning, a partnership for environmental excellence is formed to achieve the site vision for SRS to become the recognizedmore » model for Environmental Excellence in the Department of Energy's Nuclear Weapons Complex.« less

In the Eyes of Others: Monitoring for Relational Value Cues

ERIC Educational Resources Information Center

Tyler, James M.

2008-01-01

It was hypothesized that monitoring the social environment for relational value (RV) cues both consumes and depletes self-regulatory resources. Consistent with predictions, the results suggest that regulatory resources are depleted when people monitor for relational cues (Experiments 1 and 2), that the capacity to monitor for complex (vs. simple)…

3 CFR - Proposed Revised Habitat for the Spotted Owl: Minimizing Regulatory Burdens

Code of Federal Regulations, 2013 CFR

2013-01-01

... “regulatory system must protect public health, welfare, safety, and our environment while promoting economic... habitat, consistent with applicable law and science; and (6) to the extent permitted by law, adopt the... habitat for the spotted owl, based on a full evaluation of all key criteria: the relevant science...

Biodiversity maintenance in food webs with regulatory environmental feedbacks.

PubMed

Bagdassarian, Carey K; Dunham, Amy E; Brown, Christopher G; Rauscher, Daniel

2007-04-21

Although the food web is one of the most fundamental and oldest concepts in ecology, elucidating the strategies and structures by which natural communities of species persist remains a challenge to empirical and theoretical ecologists. We show that simple regulatory feedbacks between autotrophs and their environment when embedded within complex and realistic food-web models enhance biodiversity. The food webs are generated through the niche-model algorithm and coupled with predator-prey dynamics, with and without environmental feedbacks at the autotroph level. With high probability and especially at lower, more realistic connectance levels, regulatory environmental feedbacks result in fewer species extinctions, that is, in increased species persistence. These same feedback couplings, however, also sensitize food webs to environmental stresses leading to abrupt collapses in biodiversity with increased forcing. Feedback interactions between species and their material environments anchor food-web persistence, adding another dimension to biodiversity conservation. We suggest that the regulatory features of two natural systems, deep-sea tubeworms with their microbial consortia and a soil ecosystem manifesting adaptive homeostatic changes, can be embedded within niche-model food-web dynamics.

A review of the evidence for endocrine disrupting effects of current-use chemicals on wildlife populations.

PubMed

Matthiessen, Peter; Wheeler, James R; Weltje, Lennart

2018-03-01

This review critically examines the data on claimed endocrine-mediated adverse effects of chemicals on wildlife populations. It focuses on the effects of current-use chemicals, and compares their apparent scale and severity with those of legacy chemicals which have been withdrawn from sale or use, although they may still be present in the environment. The review concludes that the effects on wildlife of many legacy chemicals with endocrine activity are generally greater than those caused by current-use chemicals, with the exception of ethinylestradiol and other estrogens found in sewage effluents, which are causing widespread effects on fish populations. It is considered that current chemical testing regimes and risk assessment procedures, at least those to which pesticides and biocides are subjected, are in part responsible for this improvement. This is noteworthy as most ecotoxicological testing for regulatory purposes is currently focused on characterizing apical adverse effect endpoints rather than identifying the mechanism(s) responsible for any observed effects. Furthermore, a suite of internationally standardized ecotoxicity tests sensitive for potential endocrine-mediated effects is now in place, or under development, which should ensure further characterization of substances with these properties so that they can be adequately regulated.

Going "social" to access experimental and potentially life-saving treatment: an assessment of the policy and online patient advocacy environment for expanded access.

PubMed

Mackey, Tim K; Schoenfeld, Virginia J

2016-02-02

Social media is fundamentally altering how we access health information and make decisions about medical treatment, including for terminally ill patients. This specifically includes the growing phenomenon of patients who use online petitions and social media campaigns in an attempt to gain access to experimental drugs through expanded access pathways. Importantly, controversy surrounding expanded access and "compassionate use" involves several disparate stakeholders, including patients, manufacturers, policymakers, and regulatory agencies-all with competing interests and priorities, leading to confusion, frustration, and ultimately advocacy. In order to explore this issue in detail, this correspondence article first conducts a literature review to describe how the expanded access policy and regulatory environment in the United States has evolved over time and how it currently impacts access to experimental drugs. We then conducted structured web searches to identify patient use of online petitions and social media campaigns aimed at compelling access to experimental drugs. This was carried out in order to characterize the types of communication strategies utilized, the diseases and drugs subject to expanded access petitions, and the prevalent themes associated with this form of "digital" patient advocacy. We find that patients and their families experience mixed results, but still gravitate towards the use of online campaigns out of desperation, lack of reliable information about treatment access options, and in direct response to limitations of the current fragmented structure of expanded access regulation and policy currently in place. In response, we discuss potential policy reforms to improve expanded access processes, including advocating greater transparency for expanded access programs, exploring use of targeted economic incentives for manufacturers, and developing systems to facilitate patient information about existing treatment options. This includes leveraging recent legislative attention to reform expanded access through the CURE Act Provisions contained in the proposed U.S. 21st Century Cures Act. While expanded access may not be the best option for the majority of individuals, terminally ill patients and their families nevertheless deserve better processes, policies, and availability to potentially life-changing information, before they decide to pursue an online campaign in the desperate hope of gaining access to experimental drugs.

Self-Regulation across Time of First-Generation Online Learners

ERIC Educational Resources Information Center

Barnard-Brak, Lucy; Paton, Valerie Osland; Lan, William Y.

2010-01-01

Self-regulatory skills have been associated with positive outcomes for learners. In the current study, we examined the self-regulatory skills of students who are first-generation online learners over the course of their first semester of online instruction. The purpose of this study is to determine whether the online self-regulatory skills of…

17 CFR 400.4 - Information concerning associated persons of financial institutions that are government...

Code of Federal Regulations, 2010 CFR

2010-04-01

... completed and current Form U-4 (promulgated by a self-regulatory organization) or Form MSD-4 (as required... regulatory agency for such financial institution, a statement correcting such information. (c) For the... shall: (1) Promptly obtain and, within 10 days thereafter, file with the appropriate regulatory agency...

77 FR 52977 - Regulatory Capital Rules: Advanced Approaches Risk-Based Capital Rule; Market Risk Capital Rule

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-30

... Corporation 12 CFR Parts 324, 325 Regulatory Capital Rules: Advanced Approaches Risk-Based Capital Rule... 325 RIN 3064-AD97 Regulatory Capital Rules: Advanced Approaches Risk-Based Capital Rule; Market Risk... the agencies' current capital rules. In this NPR (Advanced Approaches and Market Risk NPR) the...

78 FR 27113 - Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Public Hearing; Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-09

.... FDA-2013-N-0402] Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Public... public meeting that will provide an overview of the current status of the regulatory science initiatives... societies, and other interested stakeholders-- as it fulfills its statutory requirement under the Generic...

76 FR 76777 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-08

... fees: (i) For a data set of real-time TRACE disseminated TBA transaction data at the same rates currently in effect for similar real-time TRACE disseminated data sets, and (ii) for a data set of historic TRACE TBA transaction data at the same rates currently in effect for similar Historic TRACE Data sets.\\4...

75 FR 2897 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-19

... of a mutual fund to investors at the fund's current net asset value, plus any applicable sales load... codified as NASD IM-2830-2, that requires members to sell mutual funds at the public offering price not... sell shares of mutual funds to non-member broker-dealers at a price below the current public offering...

Deciphering RNA regulatory elements in trypanosomatids: one piece at a time or genome-wide?

PubMed

Gazestani, Vahid H; Lu, Zhiquan; Salavati, Reza

2014-05-01

Morphological and metabolic changes in the life cycle of Trypanosoma brucei are accomplished by precise regulation of hundreds of genes. In the absence of transcriptional control, RNA-binding proteins (RBPs) shape the structure of gene regulatory maps in this organism, but our knowledge about their target RNAs, binding sites, and mechanisms of action is far from complete. Although recent technological advances have revolutionized the RBP-based approaches, the main framework for the RNA regulatory element (RRE)-based approaches has not changed over the last two decades in T. brucei. In this Opinion, after highlighting the current challenges in RRE inference, we explain some genome-wide solutions that can significantly boost our current understanding about gene regulatory networks in T. brucei. Copyright © 2014 Elsevier Ltd. All rights reserved.

Considerations on photochemical genotoxicity. II: report of the 2009 International Workshop on Genotoxicity Testing Working Group.

PubMed

Lynch, Anthony M; Guzzie, Peggy J; Bauer, Daniel; Gocke, Elmar; Itoh, Satoru; Jacobs, Abby; Krul, Cyrille A M; Schepky, Andreas; Tanaka, Noriho; Kasper, Peter

2011-08-16

A workshop to reappraise the previous IWGT recommendations for photogenotoxicity testing [E. Gocke, L. Muller, P.J. Guzzie, S. Brendler-Schwaab, S. Bulera, C.F. Chignell, L.M. Henderson, A. Jacobs, H. Murli, R.D. Snyder, N. Tanaka, Considerations on photochemical genotoxicity: report of the International Workshop on Genotoxicity Test Procedures working group, Environ. Mol. Mutagen., 35 (2000) 173-184] was recently held as part of the 5th International Workshop on Genotoxicity Testing (IWGT) meeting in Basel, Switzerland (August 17-19, 2009). An Expert Panel was convened from regulatory, academic and industrial scientists (with several members serving on the original panel) and chaired by Dr Peter Kasper (BfArM, Germany). The aim of the workshop was to review progress made in photo(geno)toxicity testing over the past decade; a period which saw the introduction of several regulatory photosafety guidances in particular in Europe and the USA. Based on current regulatory guidelines a substantial proportion of compounds trigger the requirements for photosafety testing. Moreover, there has been growing concern within industry about the performance of the in vitro photosafety tests in the "real world" of compound development. Therefore, the expert group reviewed the status of the current regulatory guidance's and the impact these have had on compound development in the context of the various triggers for photosafety testing. In addition, the performance of photogenotoxicity assays (old and new) was discussed, particularly in view of reports of pseudophotoclastogencity. The Expert Panel finished with an assessment of the positioning of photogenotoxicity testing within a photosafety testing strategy. The most significant conclusion made by the Expert Panel was that photogenotoxicity testing should no longer be recommended as part of the standard photosafety testing strategy. In addition, progress was made on the refinement of triggers for photosafety testing. For example, there was support for harmonisation of methods to determine the Molar Extinction Coefficient (MEC) and a consensus agreement that there should be no requirement for testing of compounds with a MEC<1000Lmol(-1)cm(-1). Copyright © 2011 Elsevier B.V. All rights reserved.

Small RNA profiling in Mycobacterium tuberculosis identifies MrsI as necessary for an anticipatory iron sparing response.

PubMed

Gerrick, Elias R; Barbier, Thibault; Chase, Michael R; Xu, Raylin; François, Josie; Lin, Vincent H; Szucs, Matthew J; Rock, Jeremy M; Ahmad, Rushdy; Tjaden, Brian; Livny, Jonathan; Fortune, Sarah M

2018-06-19

One key to the success of Mycobacterium tuberculosis as a pathogen is its ability to reside in the hostile environment of the human macrophage. Bacteria adapt to stress through a variety of mechanisms, including the use of small regulatory RNAs (sRNAs), which posttranscriptionally regulate bacterial gene expression. However, very little is currently known about mycobacterial sRNA-mediated riboregulation. To date, mycobacterial sRNA discovery has been performed primarily in log-phase growth, and no direct interaction between any mycobacterial sRNA and its targets has been validated. Here, we performed large-scale sRNA discovery and expression profiling in M. tuberculosis during exposure to five pathogenically relevant stresses. From these data, we identified a subset of sRNAs that are highly induced in multiple stress conditions. We focused on one of these sRNAs, ncRv11846, here renamed mycobacterial regulatory sRNA in iron (MrsI). We characterized the regulon of MrsI and showed in mycobacteria that it regulates one of its targets, bfrA , through a direct binding interaction. MrsI mediates an iron-sparing response that is required for optimal survival of M. tuberculosis under iron-limiting conditions. However, MrsI is induced by multiple host-like stressors, which appear to trigger MrsI as part of an anticipatory response to impending iron deprivation in the macrophage environment. Copyright © 2018 the Author(s). Published by PNAS.

The application of UAS towards tornado research and forecasting

NASA Astrophysics Data System (ADS)

Houston, A. L.; Argrow, B. M.; Frew, E.; Weiss, C.

2014-12-01

UAS hold significant potential to advance the understanding of tornadoes and improve tornado warning skill. While the current regulatory environment places limits on the application of UAS towards these ends, demonstrated success targeting tornadic and non-tornadic supercells proves the general feasibility of this work. In this presentation we will summarize the successes using UAS to collect data in the vicinity of supercell thunderstorms and discuss ways that these data, along with additional data collected in future field campaigns, can be used answer basic research questions concerning tornado formation and applied research questions concerning the value of UAS in the tornado warning decision process. The associative relationship between the rear-flank downdraft (RFD) and tornadogenesis has long been recognized. Yet, despite decades of research focused on tornadoes, the causal relationship between the RFD and tornadogenesis remains unresolved. In the presentation, we will describe ways that UAS could be used to test hypotheses posed to explain this causal relationship. We will also present a strategy to quantify the impact of UAS on tornado warning skill. Through controlled forecast experiments conducted using data collected through small field campaigns that leverage prior success targeting supercell thunderstorms with UAS, the value of targeted surveillance of potentially tornadic storms using UAS can be assessed. Significant changes to the existing regulatory environment are likely required for UAS, operated in a targeted surveillance mode, to contribute to improving tornado warning skill, but progress can be made today towards quantifying the impact that UAS could make.

Systems Modeling at Multiple Levels of Regulation: Linking Systems and Genetic Networks to Spatially Explicit Plant Populations

PubMed Central

Kitchen, James L.; Allaby, Robin G.

2013-01-01

Selection and adaptation of individuals to their underlying environments are highly dynamical processes, encompassing interactions between the individual and its seasonally changing environment, synergistic or antagonistic interactions between individuals and interactions amongst the regulatory genes within the individual. Plants are useful organisms to study within systems modeling because their sedentary nature simplifies interactions between individuals and the environment, and many important plant processes such as germination or flowering are dependent on annual cycles which can be disrupted by climate behavior. Sedentism makes plants relevant candidates for spatially explicit modeling that is tied in with dynamical environments. We propose that in order to fully understand the complexities behind plant adaptation, a system that couples aspects from systems biology with population and landscape genetics is required. A suitable system could be represented by spatially explicit individual-based models where the virtual individuals are located within time-variable heterogeneous environments and contain mutable regulatory gene networks. These networks could directly interact with the environment, and should provide a useful approach to studying plant adaptation. PMID:27137364

Strong Ion Regulatory Abilities Enable the Crab Xenograpsus testudinatus to Inhabit Highly Acidified Marine Vent Systems

PubMed Central

Hu, Marian Y.; Guh, Ying-Jey; Shao, Yi-Ta; Kuan, Pou-Long; Chen, Guan-Lin; Lee, Jay-Ron; Jeng, Ming-Shiou; Tseng, Yung-Che

2016-01-01

Hydrothermal vent organisms have evolved physiological adaptations to cope with extreme abiotic conditions including temperature and pH. To date, acid-base regulatory abilities of vent organisms are poorly investigated, although this physiological feature is essential for survival in low pH environments. We report the acid-base regulatory mechanisms of a hydrothermal vent crab, Xenograpsus testudinatus, endemic to highly acidic shallow-water vent habitats with average environment pH-values ranging between 5.4 and 6.6. Within a few hours, X. testudinatus restores extracellular pH (pHe) in response to environmental acidification of pH 6.5 (1.78 kPa pCO2) accompanied by an increase in blood HCO3- levels from 8.8 ± 0.3 to 31 ± 6 mM. Branchial Na+/K+-ATPase (NKA) and V-type H+-ATPase (VHA), the major ion pumps involved in branchial acid-base regulation, showed dynamic increases in response to acidified conditions on the mRNA, protein and activity level. Immunohistochemical analyses demonstrate the presence of NKA in basolateral membranes, whereas the VHA is predominantly localized in cytoplasmic vesicles of branchial epithelial- and pillar-cells. X. testudinatus is closely related to other strong osmo-regulating brachyurans, which is also reflected in the phylogeny of the NKA. Accordingly, our results suggest that the evolution of strong ion regulatory abilities in brachyuran crabs that allowed the occupation of ecological niches in euryhaline, freshwater, and terrestrial habitats are probably also linked to substantial acid-base regulatory abilities. This physiological trait allowed X. testudinatus to successfully inhabit one of the world's most acidic marine environments. PMID:26869933

Regulatory Fit Improves Fitness for People With Low Exercise Experience.

PubMed

Kay, Sophie A; Grimm, Lisa R

2017-04-01

Considering only 20.8% of American adults meet current physical activity recommendations, it is important to examine the psychological processes that affect exercise motivation and behavior. Drawing from regulatory fit theory, this study examined how manipulating regulatory focus and reward structures would affect exercise performance, with a specific interest in investigating whether exercise experience would moderate regulatory fit effects. We predicted that regulatory fit effects would appear only for participants with low exercise experience. One hundred and sixty-five young adults completed strength training exercise tasks (i.e., sit-ups, squats, plank, and wall-sit) in regulatory match or mismatch conditions. Consistent with predictions, only participants low in experience in regulatory match conditions exercised more compared with those in regulatory mismatch conditions. Although this is the first study manipulating regulatory fit in a controlled setting to examine exercise behavior, findings suggest that generating regulatory fit could positively influence those low in exercise experience.

Regulation to Create Environments Conducive to Physical Activity: Understanding the Barriers and Facilitators at the Australian State Government Level

PubMed Central

Shill, Jane; Mavoa, Helen; Crammond, Brad; Loff, Bebe; Peeters, Anna; Lawrence, Mark; Allender, Steven; Sacks, Gary; Swinburn, Boyd A.

2012-01-01

Introduction Policy and regulatory interventions aimed at creating environments more conducive to physical activity (PA) are an important component of strategies to improve population levels of PA. However, many potentially effective policies are not being broadly implemented. This study sought to identify potential policy/regulatory interventions targeting PA environments, and barriers/facilitators to their implementation at the Australian state/territory government level. Methods In-depth interviews were conducted with senior representatives from state/territory governments, statutory authorities and non-government organisations (n = 40) to examine participants': 1) suggestions for regulatory interventions to create environments more conducive to PA; 2) support for preselected regulatory interventions derived from a literature review. Thematic and constant comparative analyses were conducted. Results Policy interventions most commonly suggested by participants fell into two areas: 1) urban planning and provision of infrastructure to promote active travel; 2) discouraging the use of private motorised vehicles. Of the eleven preselected interventions presented to participants, interventions relating to walkability/cycling and PA facilities received greatest support. Interventions involving subsidisation (of public transport, PA-equipment) and the provision of more public transport infrastructure received least support. These were perceived as not economically viable or unlikely to increase PA levels. Dominant barriers were: the powerful ‘road lobby’, weaknesses in the planning system and the cost of potential interventions. Facilitators were: the provision of evidence, collaboration across sectors, and synergies with climate change/environment agendas. Conclusion This study points to how difficult it will be to achieve policy change when there is a powerful ‘road lobby’ and government investment prioritises road infrastructure over PA-promoting infrastructure. It highlights the pivotal role of the planning and transport sectors in implementing PA-promoting policy, however suggests the need for clearer guidelines and responsibilities for state and local government levels in these areas. Health outcomes need to be given more direct consideration and greater priority within non-health sectors. PMID:23028434

Current Regulations and Regulatory Actions

EPA Pesticide Factsheets

This site will provide basic information on clean air permitting under the title V operating permits program, provide access to state and regional permitting programs, and maintain access to proposed and final regulatory requirements.

Online Self-Regulatory Learning Behaviors as a Mediator in the Relationship between Online Course Perceptions with Achievement

ERIC Educational Resources Information Center

Barnard, Lucy; Paton, Valerie; Lan, William

2008-01-01

Positive perceptions of online course communication and collaboration have been associated with better academic outcomes, while self-regulatory learning behaviors have also been linked to academic achievement and other positive learning outcomes. In the current study, we examined whether self-regulatory learning behaviors may be considered as…

Meta-Analysis of Single-Case Design Research on Self-Regulatory Interventions for Academic Performance

ERIC Educational Resources Information Center

Perry, Valerie; Albeg, Loren; Tung, Catherine

2012-01-01

The current study examined the effects of self-regulatory interventions on reading, writing, and math by conducting a meta-analysis of single-case design research. Self-regulatory interventions have promise as an effective approach that is both minimally invasive and involves minimal resources. Effects of the interventions were analyzed by…

Working by the Rules: Early Childhood Professionals' Perceptions of Regulatory Requirements

ERIC Educational Resources Information Center

Fenech, M.; Robertson, G.; Sumsion, J.; Goodfellow, J.

2007-01-01

The regulatory environment in which long daycare centres are required to operate plays a key role in determining what early childhood professionals do and how they go about doing it. This paper reports findings from a state-wide survey undertaken in New South Wales, Australia, which shows how early childhood professionals position themselves on…

Learning by Preparing to Teach: Fostering Self-Regulatory Processes and Achievement during Complex Mathematics Problem Solving

ERIC Educational Resources Information Center

Muis, Krista R.; Psaradellis, Cynthia; Chevrier, Marianne; Di Leo, Ivana; Lajoie, Susanne P.

2016-01-01

We developed an intervention based on the learning by teaching paradigm to foster self-regulatory processes and better learning outcomes during complex mathematics problem solving in a technology-rich learning environment. Seventy-eight elementary students were randomly assigned to 1 of 2 conditions: learning by preparing to teach, or learning for…

Examining the Influence of Self-Efficacy and Self-Regulation in Online Learning

ERIC Educational Resources Information Center

Bradley, Rachel L.; Browne, Blaine L.; Kelley, Heather M.

2017-01-01

This paper examined self-efficacy and self-regulatory skills and their influence on achievement in an online learning environment. This study utilized the Online Academic Success Indicators Scale (OASIS). The results of the scale were compared to previous tests measuring the predictive nature of self-efficacy and self-regulatory skills on academic…

Collaborative Multimedia Learning: Influence of a Social Regulatory Support on Learning Performance and on Collaboration

ERIC Educational Resources Information Center

Acuña, Santiago Roger; López-Aymes, Gabriela

2016-01-01

This paper analyzes the effects of a support aimed at favoring the social regulatory processes in a computer-supported collaborative learning (CSCL) environment, specifically in a comprehension task of a multimedia text about Psychology of Communication. This support, named RIDE (Saab, van Joolingen, & van Hout-Wolters, 2007; 2012), consists…

Human Genome Editing in the Clinic: New Challenges in Regulatory Benefit-Risk Assessment.

PubMed

Abou-El-Enein, Mohamed; Cathomen, Toni; Ivics, Zoltán; June, Carl H; Renner, Matthias; Schneider, Christian K; Bauer, Gerhard

2017-10-05

As genome editing rapidly progresses toward the realization of its clinical promise, assessing the suitability of current tools and processes used for its benefit-risk assessment is critical. Although current regulations may initially provide an adequate regulatory framework, improvements are recommended to overcome several existing technology-based safety and efficacy issues. Copyright © 2017 Elsevier Inc. All rights reserved.

77 FR 7980 - Department Regulatory Agenda; Semiannual Summary

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

...The Regulatory Agenda is a semiannual summary of all current and projected rulemakings, reviews of existing regulations, and completed actions of the Department. The Agenda provides the public with information about the Department of Transportation's regulatory activity. It is expected that this information will enable the public to be more aware of and allow it to more effectively participate in the Department's regulatory activity. The public is also invited to submit comments on any aspect of this Agenda.

75 FR 79811 - Department Regulatory Agenda; Semiannual Summary

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

...The regulatory agenda is a semiannual summary of all current and projected rulemakings, reviews of existing regulations, and completed actions of the Department. The agenda provides the public with information about the Department of Transportation's regulatory activity. It is expected that this information will enable the public to be more aware of and allow it to more effectively participate in the Department's regulatory activity. The public is also invited to submit comments on any aspect of this agenda.

75 FR 21839 - Department Regulatory Agenda; Semiannual Summary

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

...The regulatory agenda is a semiannual summary of all current and projected rulemakings, reviews of existing regulations, and completed actions of the Department. The agenda provides the public with information about the Department of Transportation's regulatory activity. It is expected that this information will enable the public to be more aware of and allow it to more effectively participate in the Department's regulatory activity. The public is also invited to submit comments on any aspect of this agenda.

The Telecommunications Environment and Its Implications for System Design.

ERIC Educational Resources Information Center

Learn, Larry L.; McGill, Michael J.

1984-01-01

Discusses changing telecommunications environment and effect these changes might have on information systems design. Major telecommunications factors and trends reviewed are classified as technical (application of computer technologies to classical telecommunications problems), economic, and regulatory policy related (divestiture of American…

A Paradigm Shift to Protect Environment

EPA Science Inventory

Attempts to protect the environment have primarily been remedial with the intent to move away from environmental problems. Congressional agendas have provided specific acts related to pollution of air, water, and toxic wastes. These acts provide the regulatory powers to move away...

Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles.

PubMed

Goodman, Joanne; Cowen, Simon; Devanarayan, Viswanath; Egging, David; Emrich, Thomas; Golob, Michaela; Kramer, Daniel; McNally, Jim; Munday, James; Nelson, Robert; Pedras-Vasconcelos, João A; Piironen, Timo; Sickert, Denise; Skibeli, Venke; Fjording, Marianne Scheel; Timmerman, Philip

2018-02-01

European Bioanalysis Forum Workshop, Lisbon, Portugal, September 2016: At the recent European Bioanalysis Forum Focus Workshop, 'current analysis of immunogenicity: best practices and regulatory hurdles', several important challenges facing the bioanalytical community in relation to immunogenicity assays were discussed through a mixture of presentations and panel sessions. The main areas of focus were the evolving regulatory landscape, challenges of assay interferences from either drug or target, cut-point setting and whether alternative assays can be used to replace neutralizing antibody assays. This workshop report captures discussions and potential solutions and/or recommendations made by the speakers and delegates.

Thermal pollution impacts on rivers and power supply in the Mississippi River watershed

DOE Office of Scientific and Technical Information (OSTI.GOV)

Miara, Ariel; Vorosmarty, Charles J.; Macknick, Jordan E.

Thermal pollution from power plants degrades riverine ecosystems with ramifications beyond the natural environment as it affects power supply. The transport of thermal effluents along river reaches may lead to plant-to-plant interferences by elevating condenser inlet temperatures at downstream locations, which lower thermal efficiencies and trigger regulatory-forced power curtailments. We evaluate thermal pollution impacts on rivers and power supply across 128 plants with once-through cooling technologies in the Mississippi River watershed. By leveraging river network topologies with higher resolutions (0.05 degrees) than previous studies, we reveal the need to address the issue in a more spatially resolved manner, capable ofmore » uncovering diverse impacts across individual plants, river reaches and sub-basins. Results show that the use of coarse river network resolutions may lead to substantial overestimations in magnitude and length of impaired river reaches. Overall, there is a modest limitation on power production due to thermal pollution, given existing infrastructure, regulatory and climate conditions. However, tradeoffs between thermal pollution and electricity generation show important implications for the role of alternative cooling technologies and environmental regulation under current and future climates. Recirculating cooling technologies may nearly eliminate thermal pollution and improve power system reliability under stressed climate-water conditions. Regulatory limits also reduce thermal pollution, but at the expense of significant reductions in electricity generation capacity. However, results show several instances when power production capacity rises at individual plants when regulatory limits reduce upstream thermal pollution. Furthermore, these dynamics across energy-water systems highlight the need for high-resolution simulations and the value of coherent planning and optimization across infrastructure with mutual dependencies on natural resources to overcome climate-water constraints on productivity and bring to fruition energy and environmental win-win opportunities.« less

Thermal pollution impacts on rivers and power supply in the Mississippi River watershed

DOE PAGES

Miara, Ariel; Vorosmarty, Charles J.; Macknick, Jordan E.; ...

2018-03-08

Thermal pollution from power plants degrades riverine ecosystems with ramifications beyond the natural environment as it affects power supply. The transport of thermal effluents along river reaches may lead to plant-to-plant interferences by elevating condenser inlet temperatures at downstream locations, which lower thermal efficiencies and trigger regulatory-forced power curtailments. We evaluate thermal pollution impacts on rivers and power supply across 128 plants with once-through cooling technologies in the Mississippi River watershed. By leveraging river network topologies with higher resolutions (0.05 degrees) than previous studies, we reveal the need to address the issue in a more spatially resolved manner, capable ofmore » uncovering diverse impacts across individual plants, river reaches and sub-basins. Results show that the use of coarse river network resolutions may lead to substantial overestimations in magnitude and length of impaired river reaches. Overall, there is a modest limitation on power production due to thermal pollution, given existing infrastructure, regulatory and climate conditions. However, tradeoffs between thermal pollution and electricity generation show important implications for the role of alternative cooling technologies and environmental regulation under current and future climates. Recirculating cooling technologies may nearly eliminate thermal pollution and improve power system reliability under stressed climate-water conditions. Regulatory limits also reduce thermal pollution, but at the expense of significant reductions in electricity generation capacity. However, results show several instances when power production capacity rises at individual plants when regulatory limits reduce upstream thermal pollution. Furthermore, these dynamics across energy-water systems highlight the need for high-resolution simulations and the value of coherent planning and optimization across infrastructure with mutual dependencies on natural resources to overcome climate-water constraints on productivity and bring to fruition energy and environmental win-win opportunities.« less

Thermal pollution impacts on rivers and power supply in the Mississippi River watershed

NASA Astrophysics Data System (ADS)

Miara, Ariel; Vörösmarty, Charles J.; Macknick, Jordan E.; Tidwell, Vincent C.; Fekete, Balazs; Corsi, Fabio; Newmark, Robin

2018-03-01

Thermal pollution from power plants degrades riverine ecosystems with ramifications beyond the natural environment as it affects power supply. The transport of thermal effluents along river reaches may lead to plant-to-plant interferences by elevating condenser inlet temperatures at downstream locations, which lower thermal efficiencies and trigger regulatory-forced power curtailments. We evaluate thermal pollution impacts on rivers and power supply across 128 plants with once-through cooling technologies in the Mississippi River watershed. By leveraging river network topologies with higher resolutions (0.05°) than previous studies, we reveal the need to address the issue in a more spatially resolved manner, capable of uncovering diverse impacts across individual plants, river reaches and sub-basins. Results show that the use of coarse river network resolutions may lead to substantial overestimations in magnitude and length of impaired river reaches. Overall, there is a modest limitation on power production due to thermal pollution, given existing infrastructure, regulatory and climate conditions. However, tradeoffs between thermal pollution and electricity generation show important implications for the role of alternative cooling technologies and environmental regulation under current and future climates. Recirculating cooling technologies may nearly eliminate thermal pollution and improve power system reliability under stressed climate-water conditions. Regulatory limits also reduce thermal pollution, but at the expense of significant reductions in electricity generation capacity. However, results show several instances when power production capacity rises at individual plants when regulatory limits reduce upstream thermal pollution. These dynamics across energy-water systems highlight the need for high-resolution simulations and the value of coherent planning and optimization across infrastructure with mutual dependencies on natural resources to overcome climate-water constraints on productivity and bring to fruition energy and environmental win-win opportunities.

Establishment of apoptotic regulatory network for genetic markers of colorectal cancer and optimal selection of traditional Chinese medicine target.

PubMed

Tian, Tongde; Chen, Chuanliang; Yang, Feng; Tang, Jingwen; Pei, Junwen; Shi, Bian; Zhang, Ning; Zhang, Jianhua

2017-03-01

The paper aimed to screen out genetic markers applicable to early diagnosis for colorectal cancer and establish apoptotic regulatory network model for colorectal cancer, and to analyze the current situation of traditional Chinese medicine (TCM) target, thereby providing theoretical evidence for early diagnosis and targeted therapy of colorectal cancer. Taking databases including CNKI, VIP, Wanfang data, Pub Med, and MEDLINE as main sources of literature retrieval, literatures associated with genetic markers that are applied to early diagnosis of colorectal cancer were searched and performed comprehensive and quantitative analysis by Meta analysis, hence screening genetic markers used in early diagnosis of colorectal cancer. KEGG analysis was employed to establish apoptotic regulatory network model based on screened genetic markers, and optimization was conducted on TCM targets. Through Meta analysis, seven genetic markers were screened out, including WWOX, K-ras, COX-2, P53, APC, DCC and PTEN, among which DCC has the highest diagnostic efficiency. Apoptotic regulatory network was built by KEGG analysis. Currently, it was reported that TCM has regulatory function on gene locus in apoptotic regulatory network. The apoptotic regulatory model of colorectal cancer established in this study provides theoretical evidence for early diagnosis and TCM targeted therapy of colorectal cancer in clinic.

GIS-assisted spatial analysis for urban regulatory detailed planning: designer's dimension in the Chinese code system

NASA Astrophysics Data System (ADS)

Yu, Yang; Zeng, Zheng

2009-10-01

By discussing the causes behind the high amendments ratio in the implementation of urban regulatory detailed plans in China despite its law-ensured status, the study aims to reconcile conflict between the legal authority of regulatory detailed planning and the insufficient scientific support in its decision-making and compilation by introducing into the process spatial analysis based on GIS technology and 3D modeling thus present a more scientific and flexible approach to regulatory detailed planning in China. The study first points out that the current compilation process of urban regulatory detailed plan in China employs mainly an empirical approach which renders it constantly subjected to amendments; the study then discusses the need and current utilization of GIS in the Chinese system and proposes the framework of a GIS-assisted 3D spatial analysis process from the designer's perspective which can be regarded as an alternating processes between the descriptive codes and physical design in the compilation of regulatory detailed planning. With a case study of the processes and results from the application of the framework, the paper concludes that the proposed framework can be an effective instrument which provides more rationality, flexibility and thus more efficiency to the compilation and decision-making process of urban regulatory detailed plan in China.

Novel GM animal technologies and their governance.

PubMed

Bruce, Ann; Castle, David; Gibbs, Corrina; Tait, Joyce; Whitelaw, C Bruce A

2013-08-01

Scientific advances in methods of producing genetically modified (GM) animals continue, yet few such animals have reached commercial production. Existing regulations designed for early techniques of genetic modification pose formidable barriers to commercial applications. Radically improved techniques for producing GM animals invite a re-examination of current regulatory regimes. We critically examine current GM animal regulations, with a particular focus on the European Union, through a framework that recognises the importance of interactions among regulatory regimes, innovation outcomes and industry sectors. The current focus on the regulation of risk is necessary but is unable to discriminate among applications and tends to close down broad areas of application rather than facilitate innovation and positive industry interactions. Furthermore, the fields of innovative animal biosciences appear to lack networks of organisations with co-ordinated future oriented actions. Such networks could drive coherent programmes of innovation towards particular visions and contribute actively to the development of regulatory systems for GM animals. The analysis presented makes the case for regulatory consideration of each animal bioscience related innovation on the basis of the nature of the product itself and not the process by which it was developed.

78 FR 76344 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-17

... environment and on which they may test their automated systems that integrate with the Exchange. For example... Establish Fees Under Rule 7030(d) for Use of the Carteret Testing Facility Test Environment December 11... the Testing Facility (``NTF'') test environment located in Carteret, New Jersey, which will provide a...

78 FR 76350 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC.; Notice of Filing and Immediate Effectiveness...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-17

... switch port in the test environment. The test environment is designed to closely mirror the live equity... Change To Establish Fees Under the PHLX Pricing Schedule for Use of the Carteret Testing Facility Test... establish fees under the Pricing Schedule for use of the Testing Facility (``NTF'') test environment located...

Engineering hydrogels as extracellular matrix mimics

PubMed Central

Geckil, Hikmet; Xu, Feng; Zhang, Xiaohui; Moon, SangJun

2010-01-01

Extracellular matrix (ECM) is a complex cellular environment consisting of proteins, proteoglycans, and other soluble molecules. ECM provides structural support to mammalian cells and a regulatory milieu with a variety of important cell functions, including assembling cells into various tissues and organs, regulating growth and cell–cell communication. Developing a tailored in vitro cell culture environment that mimics the intricate and organized nanoscale meshwork of native ECM is desirable. Recent studies have shown the potential of hydrogels to mimic native ECM. Such an engineered native-like ECM is more likely to provide cells with rational cues for diagnostic and therapeutic studies. The research for novel biomaterials has led to an extension of the scope and techniques used to fabricate biomimetic hydrogel scaffolds for tissue engineering and regenerative medicine applications. In this article, we detail the progress of the current state-of-the-art engineering methods to create cell-encapsulating hydrogel tissue constructs as well as their applications in in vitro models in biomedicine. PMID:20394538

Current challenges in tobacco control.

PubMed

Slama, K

2004-10-01

Tobacco is the world's biggest preventable killer, but the circumstances of its history, the power and influence of its commerce and the nature of addiction make it a very difficult public health issue. Determinants of smoking are both individual and environmental. Genetics and environment influence to varying degrees all of the steps in a smoker's career. Persistence of use, degree of addiction to nicotine and difficulty in stopping are influenced by inherited traits and nicotine susceptibility, whereas the social environment and the individual's cognitions are the key factors in starting smoking and successfully stopping smoking. The tools available to tobacco control include influencing the social and cultural norms concerning tobacco; legislative and regulatory measures to protect the population and to limit tobacco industry marketing tactics, now encapsulated in the Framework Convention on Tobacco Control; and programmes to enhance the chance of not starting and successfully stopping. Strategies for tobacco control must work at both societal and individual levels, and directions are being taken that include genetic, pharmacological, behavioural, socio-cultural and international approaches.

What exactly is an exact copy? And why it matters when trying to ban human reproductive cloning in Australia.

PubMed

Gogarty, B

2003-04-01

This paper examines the current Australian regulatory response to human reproductive cloning. The central consideration is the capacity of the current regulatory regime to effectively deter human cloning efforts. A legislative prohibition on human cloning must be both effective and clear enough to allow researchers to know what practices are acceptable. This paper asks whether the current Australian regime evinces these qualities and suggests that Australia should follow the example set in the UK by the enactment of the Human Reproductive Cloning Act 2001.

Land Development and Subdivision Regulations that Support Access Management

DOT National Transportation Integrated Search

1993-01-01

This report examines the role of the comprehensive plan in developing an access : management program, aspects of current regulatory practice that contribute to : access problems, and regulatory techniques that support access management : principles. ...

How do health care education and training professionals learn about the environment?

PubMed

Glazer, H R; Stein, D S; Schafer, D S

1993-01-01

Preparing for the health care system of the future includes the ability to abstract information from relevant sectors of the environment. This study looked at the way health care educators scan the environment and the relationship of scanning behavior to management style. Results indicate that education and training professionals focus on the regulatory and customer sectors of the environment more than the technological and sociopolitical sectors.

How the American, Degree-Granting For-Profit Higher Education Sector Manages the Regulatory Environment: An Intrinsic Case Study

ERIC Educational Resources Information Center

Barron, Caulyne Nichole

2013-01-01

This intrinsic case study examined the context of the American, degree-granting for-profit higher education sector between 2009 and 2012, applying institutional theory and resource dependency theory to develop an understanding of how the degree-granting for-profit sector of American higher education manages regulatory pressures. The study examines…

Creating an effort tracking tool to improve therapeutic cancer clinical trials workload management and budgeting.

PubMed

James, Pam; Bebee, Patty; Beekman, Linda; Browning, David; Innes, Mathew; Kain, Jeannie; Royce-Westcott, Theresa; Waldinger, Marcy

2011-11-01

Quantifying data management and regulatory workload for clinical research is a difficult task that would benefit from a robust tool to assess and allocate effort. As in most clinical research environments, The University of Michigan Comprehensive Cancer Center (UMCCC) Clinical Trials Office (CTO) struggled to effectively allocate data management and regulatory time with frequently inaccurate estimates of how much time was required to complete the specific tasks performed by each role. In a dynamic clinical research environment in which volume and intensity of work ebbs and flows, determining requisite effort to meet study objectives was challenging. In addition, a data-driven understanding of how much staff time was required to complete a clinical trial was desired to ensure accurate trial budget development and effective cost recovery. Accordingly, the UMCCC CTO developed and implemented a Web-based effort-tracking application with the goal of determining the true costs of data management and regulatory staff effort in clinical trials. This tool was developed, implemented, and refined over a 3-year period. This article describes the process improvement and subsequent leveling of workload within data management and regulatory that enhanced the efficiency of UMCCC's clinical trials operation.

Development and use of microbial-based cleaning products (MBCPs): Current issues and knowledge gaps.

PubMed

Arvanitakis, George; Temmerman, Robin; Spök, Armin

2018-06-01

Cleaning products containing microbes as active ingredients are becoming increasingly prevalent as an alternative to chemical-based cleaning products. These microbial-based cleaning products (MBCPs) are being used in domestic and commercial settings (i.e., households and businesses) and institutional settings (e.g., hospitals, schools, etc.), in a variety of cleaning activities (hard surface cleaning, odour control, degreasing, septic tank treatments, etc.). They are typically described as "environmentally friendly" and "non-toxic". Publicly available information sources (scientific literature, patent databases, commercial websites) were searched for information on microbial species contained in MBCPs, their mode of action, cleaning applications in which they are used, and their potential impacts on human health and the environment. Although information was found providing a broad indication of microbial genera/species used, information on specific species/strains and quantities produced and sold is generally lacking. This makes it difficult to conduct a meaningful examination of any risks to human health and the environment from the production and use of MBCPs and to determine how effective current policies and regulatory frameworks are in addressing these issues. These and other challenges were addressed at an international workshop in Ottawa, Canada in June 2013 by a number of stakeholders, including industry, government, academic and non-governmental organizations. Copyright © 2017. Published by Elsevier Ltd.

The challenges of nutrition policymaking.

PubMed

Slavin, Joanne L

2015-02-07

In my over three decades of work in the field of food and nutrition, I have participated in many efforts that seek new policy initiatives in the hopes that these programs can curb rates of obesity and chronic disease and help consumers make healthier dietary choices. Because of the profound effect that many of these policies have on consumers, the food environment, federal nutrition assistance programs and subsequent policy and regulatory recommendations, it is imperative that only the strongest, best available evidence is used to set policy. This review evaluates methods by which current nutrition policies use scientific research as well as provides recommendations for how best to ensure future nutrition policies are truly science-based and likely to have a meaningful impact on public health. Specifically, this review will: Describe the current food and nutrition policy environment in the US Examine how science is used in federal food and nutrition policymaking efforts, using the Dietary Guidelines for Americans (DGA) as an example Describe strong versus weak science as well as what types of studies are most appropriate for use in policymaking Discuss the potential effects and consequences of making policy recommendations in the absence of scientific consensus or agreement Make recommendations to support the present and ongoing development of science-based policy likely to positively impact public health.

From little white lies to filthy liars: the evolution of honesty and deception in young children.

PubMed

Talwar, Victoria; Crossman, Angela

2011-01-01

Though it is frequently condemned, lie-telling is a common and frequent activity in interpersonal interactions, with apparent social risks and benefits. The current review examines the development of deception among children. It is argued that early lying is normative, reflecting children's emerging cognitive and social development. Children lie to preserve self-interests as well as for the benefit of others. With age, children learn about the social norms that promote honesty while encouraging occasional prosocial lie-telling. Yet, lying can become a problem behavior with frequent or inappropriate use over time. Chronic lie-telling of any sort risks social consequences, such as the loss of credibility and damage to relationships. By middle childhood, chronic reliance on lying may be related to poor development of conscience, weak self-regulatory control, and antisocial behavior, and it could be indicative of maladjustment and put the individual in conflict with the environment. The goal of the current chapter is to capture the complexity of lying and build a preliminary understanding of how children's social experiences with their environments, their own dispositions, and their developing cognitive maturity interact, over time, to predict their lying behavior and, for some, their chronic and problem lying. Implications for fostering honesty in young children are discussed.

Reassessment of Planetary Protection Requirements for Mars Sample Return Missions

NASA Astrophysics Data System (ADS)

Smith, David; Race, Margaret; Farmer, Jack

In 2008, NASA asked the US National Research Council (NRC) to review the findings of the report, Mars Sample Return: Issues and Recommendations (National Academy Press, 1997), and to update its recommendations in the light of both current understanding of Mars's biolog-ical potential and ongoing improvements in biological, chemical, and physical sample-analysis capabilities and technologies. The committee established to address this request was tasked to pay particular attention to five topics. First, the likelihood that living entities may be included in samples returned from Mars. Second, scientific investigations that should be conducted to reduce uncertainty in the assessment of Mars' biological potential. Third, the possibility of large-scale effects on Earth's environment if any returned entity is released into the environment. Fourth, the status of technological measures that could be taken on a mission to prevent the inadvertent release of a returned sample into Earth's biosphere. Fifth, criteria for intentional sample release, taking note of current and anticipated regulatory frameworks. The paper outlines the recommendations contained in the committee's final report, Planetary Protection Requirements for Mars Sample Return Missions (The National Academies Press, 2009), with particular emphasis placed on the scientific, technical and policy changes since 1997 and indications as to how these changes modify the recommendations contained in the 1997 report.

Prevalence and Correlates of the Belief That Electronic Cigarettes are a Lot Less Harmful Than Conventional Cigarettes Under the Different Regulatory Environments of Australia and the United Kingdom

PubMed Central

Borland, Ron; Balmford, James; Hitchman, Sara C.; Cummings, K. Michael; Driezen, Pete; Thompson, Mary E.

2017-01-01

Introduction: The rapid rise in electronic cigarettes (ECs) globally has stimulated much debate about the relative risk and public health impact of this new emerging product category as compared to conventional cigarettes. The sale and marketing of ECs containing nicotine are banned in many countries (eg, Australia) but are allowed in others (eg, United Kingdom). This study examined prevalence and correlates of the belief that ECs are a lot less harmful than conventional cigarettes under the different regulatory environments in Australia (ie, more restrictive) and the United Kingdom (ie, less restrictive). Methods: Australian and UK data from the 2013 survey of the International Tobacco Control Four-Country project were analyzed. Results: More UK than Australian respondents (58.5% vs. 35.2%) believed that ECs are a lot less harmful than conventional cigarettes but more respondents in Australia than in the United Kingdom selected “Don’t Know” (36.5% vs. 17.1%). The proportion that responded “A little less, equally or more harmful” did not differ between countries. Correlates of the belief that ECs are “A lot less harmful” differed between countries, while correlates of “Don’t Know” response did not differ. Conclusions: Consistent with the less restrictive regulatory environment affecting the sale and marketing of ECs, smokers and recent ex-smokers in the United Kingdom were more likely to believe ECs were less harmful relative to conventional cigarettes compared to those in Australia. Implications: What this study adds: Among smokers and ex-smokers, this study found that the belief that ECs are (a lot) less harmful than conventional cigarettes was considerably higher in the United Kingdom than in Australia in 2013. The finding is consistent with the less restrictive regulatory environment for ECs in the United Kingdom, suggesting that the regulatory framework for ECs adopted by a country can affect smokers’ perceptions about the relative harmfulness of ECs, the group that stands to gain the most from having an accurate belief about the relative harms of ECs. PMID:27190403

Prevalence and Correlates of the Belief That Electronic Cigarettes are a Lot Less Harmful Than Conventional Cigarettes Under the Different Regulatory Environments of Australia and the United Kingdom.

PubMed

Yong, Hua-Hie; Borland, Ron; Balmford, James; Hitchman, Sara C; Cummings, K Michael; Driezen, Pete; Thompson, Mary E

2017-02-01

The rapid rise in electronic cigarettes (ECs) globally has stimulated much debate about the relative risk and public health impact of this new emerging product category as compared to conventional cigarettes. The sale and marketing of ECs containing nicotine are banned in many countries (eg, Australia) but are allowed in others (eg, United Kingdom). This study examined prevalence and correlates of the belief that ECs are a lot less harmful than conventional cigarettes under the different regulatory environments in Australia (ie, more restrictive) and the United Kingdom (ie, less restrictive). Australian and UK data from the 2013 survey of the International Tobacco Control Four-Country project were analyzed. More UK than Australian respondents (58.5% vs. 35.2%) believed that ECs are a lot less harmful than conventional cigarettes but more respondents in Australia than in the United Kingdom selected "Don't Know" (36.5% vs. 17.1%). The proportion that responded "A little less, equally or more harmful" did not differ between countries. Correlates of the belief that ECs are "A lot less harmful" differed between countries, while correlates of "Don't Know" response did not differ. Consistent with the less restrictive regulatory environment affecting the sale and marketing of ECs, smokers and recent ex-smokers in the United Kingdom were more likely to believe ECs were less harmful relative to conventional cigarettes compared to those in Australia. What this study adds: Among smokers and ex-smokers, this study found that the belief that ECs are (a lot) less harmful than conventional cigarettes was considerably higher in the United Kingdom than in Australia in 2013. The finding is consistent with the less restrictive regulatory environment for ECs in the United Kingdom, suggesting that the regulatory framework for ECs adopted by a country can affect smokers' perceptions about the relative harmfulness of ECs, the group that stands to gain the most from having an accurate belief about the relative harms of ECs. © The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco.

Technology's Impact on Production

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rachel Amann; Ellis Deweese; Deborah Shipman

2009-06-30

As part of a cooperative agreement with the United States Department of Energy (DOE) - entitled Technology's Impact on Production: Developing Environmental Solutions at the State and National Level - the Interstate Oil and Gas Compact Commission (IOGCC) has been tasked with assisting state governments in the effective, efficient, and environmentally sound regulation of the exploration and production of natural gas and crude oil, specifically in relation to orphaned and abandoned wells and wells nearing the end of productive life. Project goals include: (1) Developing (a) a model framework for prioritization and ranking of orphaned or abandoned well sites; (b)more » a model framework for disbursement of Energy Policy Act of 2005 funding; and (c) a research study regarding the current status of orphaned wells in the nation. (2) Researching the impact of new technologies on environmental protection from a regulatory perspective. Research will identify and document (a) state reactions to changing technology and knowledge; (b) how those reactions support state environmental conservation and public health; and (c) the impact of those reactions on oil and natural gas production. (3) Assessing emergent technology issues associated with wells nearing the end of productive life. Including: (a) location of orphaned and abandoned well sites; (b) well site remediation; (c) plugging materials; (d) plug placement; (e) the current regulatory environment; and (f) the identification of emergent technologies affecting end of life wells. New Energy Technologies - Regulating Change, is the result of research performed for Tasks 2 and 3.« less

Toll-like receptors in inflammatory bowel diseases: a decade later.

PubMed

Cario, Elke

2010-09-01

Differential alteration of Toll-like receptor (TLR) expression in inflammatory bowel disease (IBD) was first described 10 years ago. Since then, studies from many groups have led to the current concept that TLRs represent key mediators of innate host defense in the intestine, involved in maintaining mucosal as well as commensal homeostasis. Recent findings in diverse murine models of colitis have helped to reveal the mechanistic importance of TLR dysfunction in IBD pathogenesis. It has become evident that environment, genetics, and host immunity form a multidimensional and highly interactive regulatory triad that controls TLR function in the intestinal mucosa. Imbalanced relationships within this triad may promote aberrant TLR signaling, critically contributing to acute and chronic intestinal inflammatory processes in IBD colitis and associated cancer.

Energy Facility Siting by Means of Environmental Modelling with LANDSAT, Thematic Mapper and Geographic Information System (GIS) Data

NASA Technical Reports Server (NTRS)

1982-01-01

Currently based on ground and aerial surveys, the land cover data base of the Pennsylvania Power and Light Company is routinely used for modelling the effects of alternative generating plant and transmission line sites on the local and regional environment. The development of a satellite-based geographic information system would facilitate both the preparation of environmental impact statements by power companies and assessment of the data by the Nuclear Regulatory Commission. A cooperative project is planned to demonstrate the methodology for integrating satellite data into an existing geographic information system, d to further evaluate the ability of satellite data in modeling environmental conditions that would be applied in the preparation and assessment of environmental impact statements.

Connecting Metabolic Pathways: Sigma Factors in Streptomyces spp.

PubMed Central

Sun, Di; Liu, Cong; Zhu, Jingrong; Liu, Weijie

2017-01-01

The gram-positive filamentous bacterium Streptomyces is one of the largest resources for bioactive metabolites, particularly antibiotics. Antibiotic production and other metabolic processes are tightly regulated at the transcriptional level. Sigma (σ) factors are components of bacterial RNA polymerases that determine promoter specificity. In Streptomyces, σ factors also play essential roles in signal transduction and in regulatory networks, thereby assisting in their survival in complex environments. However, our current understanding of σ factors in Streptomyces is still limited. In this mini-review, we demonstrate the roles of Streptomyces σ factors, illustrating that these serve as linkers of different metabolic pathways. Further investigations on σ factors may improve our knowledge of Streptomyces physiology and benefit exploitation of Streptomyces resources. PMID:29312231

Flowering time control and applications in plant breeding.

PubMed

Jung, Christian; Müller, Andreas E

2009-10-01

Shifting the seasonal timing of reproduction is a major goal of plant breeding efforts to produce novel varieties that are better adapted to local environments and changing climatic conditions. The key regulators of floral transition have been studied extensively in model species, and in recent years a growing number of related genes have been identified in crop species, with some notable exceptions. These sequences and variants thereof, as well as several major genes which were only identified in crop species, can now be used by breeders as molecular markers and for targeted genetic modification of flowering time. This article reviews the major floral regulatory pathways and discusses current and novel strategies for altering bolting and flowering behavior in crop plants.

Riboregulators: Fine-Tuning Virulence in Shigella.

PubMed

Fris, Megan E; Murphy, Erin R

2016-01-01

Within the past several years, RNA-mediated regulation (ribo-regulation) has become increasingly recognized for its importance in controlling critical bacterial processes. Regulatory RNA molecules, or riboregulators, are perpetually responsive to changes within the micro-environment of a bacterium. Notably, several characterized riboregulators control virulence in pathogenic bacteria, as is the case for each riboregulator characterized to date in Shigella. The timing of virulence gene expression and the ability of the pathogen to adapt to rapidly changing environmental conditions is critical to the establishment and progression of infection by Shigella species; ribo-regulators mediate each of these important processes. This mini review will present the current state of knowledge regarding RNA-mediated regulation in Shigella by detailing the characterization and function of each identified riboregulator in these pathogens.

75 FR 40000 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-13

... has proposed this rule change in order to preserve FINRA's current quorum requirements in anticipation.... Sec. 19 (2010). In anticipation of the foregoing amendment to the General Corporation Law, FINRA has...

Development of drugs for celiac disease: review of endpoints for Phase 2 and 3 trials

PubMed Central

Gottlieb, Klaus; Dawson, Jill; Hussain, Fez; Murray, Joseph A.

2015-01-01

Celiac disease is a lifelong disorder for which there is currently only one known, effective treatment: a gluten-free diet. New treatment approaches have recently emerged; several drugs are in Phase 2 trials and results appear promising; however, discussion around regulatory endpoints is in its infancy. We will briefly discuss the drugs that are under development and then shift our attention to potential trial endpoints, such as patient-reported outcomes, histology, serology, gene expression analysis and other tests. We will outline the differing requirements for proof-of-concept Phase 2 trials and Phase 3 registration trials, with a particular emphasis on current thinking in regulatory agencies. We conclude our paper with recommendations and a glossary of regulatory terms, to enable readers who are less familiar with regulatory language to take maximum advantage of this review. PMID:25725041

40 CFR 52.480 - Photochemical Assessment Monitoring Stations (PAMS) Program.

Code of Federal Regulations, 2010 CFR

2010-07-01

... of Columbia's Department of Consumer and Regulatory Affairs submitted a plan for the establishment... 40 Protection of Environment 3 2010-07-01 2010-07-01 false Photochemical Assessment Monitoring Stations (PAMS) Program. 52.480 Section 52.480 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY...

Foraging environment determines the genetic architecture and evolutionary potential of trophic morphology in cichlid fishes.

PubMed

Parsons, Kevin J; Concannon, Moira; Navon, Dina; Wang, Jason; Ea, Ilene; Groveas, Kiran; Campbell, Calum; Albertson, R Craig

2016-12-01

Phenotypic plasticity allows organisms to change their phenotype in response to shifts in the environment. While a central topic in current discussions of evolutionary potential, a comprehensive understanding of the genetic underpinnings of plasticity is lacking in systems undergoing adaptive diversification. Here, we investigate the genetic basis of phenotypic plasticity in a textbook adaptive radiation, Lake Malawi cichlid fishes. Specifically, we crossed two divergent species to generate an F 3 hybrid mapping population. At early juvenile stages, hybrid families were split and reared in alternate foraging environments that mimicked benthic/scraping or limnetic/sucking modes of feeding. These alternate treatments produced a variation in morphology that was broadly similar to the major axis of divergence among Malawi cichlids, providing support for the flexible stem theory of adaptive radiation. Next, we found that the genetic architecture of several morphological traits was highly sensitive to the environment. In particular, of 22 significant quantitative trait loci (QTL), only one was shared between the environments. In addition, we identified QTL acting across environments with alternate alleles being differentially sensitive to the environment. Thus, our data suggest that while plasticity is largely determined by loci specific to a given environment, it may also be influenced by loci operating across environments. Finally, our mapping data provide evidence for the evolution of plasticity via genetic assimilation at an important regulatory locus, ptch1. In all, our data address long-standing discussions about the genetic basis and evolution of plasticity. They also underscore the importance of the environment in affecting developmental outcomes, genetic architectures, morphological diversity and evolutionary potential. © 2016 John Wiley & Sons Ltd.

Nanofiber Scaffold-Based Tissue-Engineered Retinal Pigment Epithelium to Treat Degenerative Eye Diseases

PubMed Central

Khristov, Vladimir; Wan, Qin; Sharma, Ruchi; Jha, Balendu Shekhar; Lotfi, Mostafa; Maminishkis, Arvydas; Simon, Carl G.

2016-01-01

Abstract Clinical-grade manufacturing of a functional retinal pigment epithelium (RPE) monolayer requires reproducing, as closely as possible, the natural environment in which RPE grows. In vitro, this can be achieved by a tissue engineering approach, in which the RPE is grown on a nanofibrous biological or synthetic scaffold. Recent research has shown that nanofiber scaffolds perform better for cell growth and transplantability compared with their membrane counterparts and that the success of the scaffold in promoting cell growth/function is not heavily material dependent. With these strides, the field has advanced enough to begin to consider implementation of one, or a combination, of the tissue engineering strategies discussed herein. In this study, we review the current state of tissue engineering research for in vitro culture of RPE/scaffolds and the parameters for optimal scaffold design that have been uncovered during this research. Next, we discuss production methods and manufacturers that are capable of producing the nanofiber scaffolds in such a way that would be biologically, regulatory, clinically, and commercially viable. Then, a discussion of how the scaffolds could be characterized, both morphologically and mechanically, to develop a testing process that is viable for regulatory screening is performed. Finally, an example of a tissue-engineered RPE/scaffold construct is given to provide the reader a framework for understanding how these pieces could fit together to develop a tissue-engineered RPE/scaffold construct that could pass regulatory scrutiny and can be commercially successful. PMID:27110730

Bacterial Adaptation of Respiration from Oxic to Microoxic and Anoxic Conditions: Redox Control

PubMed Central

Bueno, Emilio; Mesa, Socorro; Bedmar, Eulogio J.; Richardson, David J.

2012-01-01

Abstract Under a shortage of oxygen, bacterial growth can be faced mainly by two ATP-generating mechanisms: (i) by synthesis of specific high-affinity terminal oxidases that allow bacteria to use traces of oxygen or (ii) by utilizing other substrates as final electron acceptors such as nitrate, which can be reduced to dinitrogen gas through denitrification or to ammonium. This bacterial respiratory shift from oxic to microoxic and anoxic conditions requires a regulatory strategy which ensures that cells can sense and respond to changes in oxygen tension and to the availability of other electron acceptors. Bacteria can sense oxygen by direct interaction of this molecule with a membrane protein receptor (e.g., FixL) or by interaction with a cytoplasmic transcriptional factor (e.g., Fnr). A third type of oxygen perception is based on sensing changes in redox state of molecules within the cell. Redox-responsive regulatory systems (e.g., ArcBA, RegBA/PrrBA, RoxSR, RegSR, ActSR, ResDE, and Rex) integrate the response to multiple signals (e.g., ubiquinone, menaquinone, redox active cysteine, electron transport to terminal oxidases, and NAD/NADH) and activate or repress target genes to coordinate the adaptation of bacterial respiration from oxic to anoxic conditions. Here, we provide a compilation of the current knowledge about proteins and regulatory networks involved in the redox control of the respiratory adaptation of different bacterial species to microxic and anoxic environments. Antioxid. Redox Signal. 16, 819–852. PMID:22098259

A multi-agent system for coordinating international shipping

DOE Office of Scientific and Technical Information (OSTI.GOV)

Goldsmith, S.Y.; Phillips, L.R.; Spires, S.V.

1998-05-01

Moving commercial cargo across the US-Mexico border is currently a complex, paper-based, error-prone process that incurs expensive inspections and delays at several ports of entry in the Southwestern US. Improved information handling will dramatically reduce border dwell time, variation in delivery time, and inventories, and will give better control of the shipment process. The Border Trade Facilitation System (BTFS) is an agent-based collaborative work environment that assists geographically distributed commercial and government users with transshipment of goods across the US-Mexico border. Software agents mediate the creation, validation and secure sharing of shipment information and regulatory documentation over the Internet, usingmore » the World Wide Web to interface with human actors. Agents are organized into Agencies. Each agency represents a commercial or government agency. Agents perform four specific functions on behalf of their user organizations: (1) agents with domain knowledge elicit commercial and regulatory information from human specialists through forms presented via web browsers; (2) agents mediate information from forms with diverse otologies, copying invariant data from one form to another thereby eliminating the need for duplicate data entry; (3) cohorts of distributed agents coordinate the work flow among the various information providers and they monitor overall progress of the documentation and the location of the shipment to ensure that all regulatory requirements are met prior to arrival at the border; (4) agents provide status information to human actors and attempt to influence them when problems are predicted.« less

Should the scope of human mixture risk assessment span legislative/regulatory silos for chemicals?

PubMed

Evans, Richard M; Martin, Olwenn V; Faust, Michael; Kortenkamp, Andreas

2016-02-01

Current chemicals regulation operates almost exclusively on a chemical-by-chemical basis, however there is concern that this approach may not be sufficiently protective if two or more chemicals have the same toxic effect. Humans are indisputably exposed to more than one chemical at a time, for example to the multiple chemicals found in food, air and drinking water, and in household and consumer products, and in cosmetics. Assessment of cumulative risk to human health and/or the environment from multiple chemicals and routes can be done in a mixture risk assessment (MRA). Whilst there is a broad consensus on the basic science of mixture toxicology, the path to regulatory implementation of MRA within chemical risk assessment is less clear. In this discussion piece we pose an open question: should the scope of human MRA cross legislative remits or 'silos'? We define silos as, for instance, legislation that defines risk assessment practice for a subset of chemicals, usually on the basis of substance/product, media or process orientation. Currently any form of legal mandate for human MRA in the EU is limited to only a few pieces of legislation. We describe two lines of evidence, illustrated with selected examples, that are particularly pertinent to this question: 1) evidence that mixture effects have been shown for chemicals regulated in different silos and 2) evidence that humans are co-exposed to chemicals from different silos. We substantiate the position that, because there is no reason why chemicals allocated to specific regulatory silos would have non-overlapping risk profiles, then there is also no reason to expect that MRA limited only to chemicals within one silo can fully capture the risk that may be present to human consumers. Finally, we discuss possible options for implementation of MRA and we hope to prompt wider discussion of this issue. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

Final Report: Risk assessment for produced water discharges to Louisiana open bays

DOE Office of Scientific and Technical Information (OSTI.GOV)

Meinhold, A.F.; DePhillips, M.P.; Holtzman, S.

1996-03-01

Potential human health and environmental impacts from discharges of produced water to the Gulf of Mexico are of concern to regulators at the State and Federal levels, the public, environmental interest groups and industry. Current and proposed regulations require a zero discharge limit for coastal facilities, based primarily on studies in low energy, poorly flushed environments. However, produced water discharges in coastal Louisiana include a number of open bay sites, where potential human health and environmental impacts are likely to be smaller than those demonstrated for low energy canal environments, but greater than the minimal impacts associated with offshore discharges.more » Additional data and assessments are needed to support risk managers at the State and Federal levels in the development of regulations that protect human health and the environment without unnecessary cost to the economic welfare of the region and the nation. This project supports the Natural Gas and Oil Initiative objectives to: (1) improve coordination on environmental research; (2) streamline State and Federal regulation; (3) enhance State, and Federal regulatory decision making capability; (4) enhance dialogue through industry/government/public partnerships; and (5) work with States and Native American Tribes.« less

Challenges posed to the European pharmaceutical regulatory system by highly personalized medicines.

PubMed

Johnston, John D; Feldschreiber, Peter

2014-03-01

The European pharmaceutical regulatory system has not yet been challenged by issues related to highly personalized medicines such as those to be found with active substances that affect RNA biochemistry. We review the current status of RNA-based pharmacology and present three possible case histories. The implications for the European pharmaceutical regulatory system are discussed. © 2013 The British Pharmacological Society.

EPA office of solid waste (OSW) report to Congress

DOE Office of Scientific and Technical Information (OSTI.GOV)

Derkics, D.

1996-12-31

An EPA Office of Solid Waste Report to Congress is presented in outline form. The following topics are discussed: special waste chronology; statutory hazardous waste exemption; 1988 report to Congress findings; 1993 regulatory determination; current (1996), regulatory status of fossil fuel combustion wastes; co-management study; Electric Power Research Institute (EPRI) activities; EPRI coal ash field study sites; oil ash total combustion; fossil fuel combustion; current EPA activities; and Federal Register Notice.

Pharmaceutical liposomal drug delivery: a review of new delivery systems and a look at the regulatory landscape.

PubMed

Zylberberg, Claudia; Matosevic, Sandro

2016-11-01

Liposomes were the first nanoscale drug to be approved for clinical use in 1995. Since then, the technology has grown considerably, and pioneering recent work in liposome-based delivery systems has brought about remarkable developments with significant clinical implications. This includes long-circulating liposomes, stimuli-responsive liposomes, nebulized liposomes, elastic liposomes for topical, oral and transdermal delivery and covalent lipid-drug complexes for improved drug plasma membrane crossing and targeting to specific organelles. While the regulatory bodies' opinion on liposomes is well-documented, current guidance that address new delivery systems are not. This review describes, in depth, the current state-of-the-art of these new liposomal delivery systems and provides a critical overview of the current regulatory landscape surrounding commercialization efforts of higher-level complexity systems, the expected requirements and the hurdles faced by companies seeking to bring novel liposome-based systems for clinical use to market.

Polybrominated diphenyl ethers (PBDEs) in China: policies and recommendations for sound management of plastics from electronic wastes.

PubMed

Ni, Kun; Lu, Yonglong; Wang, Tieyu; Shi, Yajuan; Kannan, Kurunthachalam; Xu, Li; Li, Qiushuang; Liu, Shijie

2013-01-30

Polybrominated diphenyl ethers (PBDEs), used as flame retardants (BFRs), are incorporated in plastics of most electronic equipment. Among BFR mixtures, deca-BDE is the most widely used commercial additive in the polymer industry and the use of deca-BDE is currently not subject to any restrictions in China. However, debate over environmental and health risks associated with deca-BDE still remains. Regulatory agencies in developed countries have adopted and/or established environmentally sound strategies for the management of potential threat posed by PBDEs to the environment and human health. No regulations or management policies for PBDEs currently exist in China at either central or provincial government levels. Large amounts of plastics containing PBDEs are still in use and must be disposed of after their lifetimes, creating outdoor reservoirs for the future dispersal of PBDEs into the environment. Concerted action is needed not only to regulate the production and use of PBDEs but also to find ways to effectively manage waste electrical and electronic products that contain PBDEs. This article is the first to investigate the policy issues and current problems related to the use of PBDEs in China. In addition, we estimate the mass flows of PBDEs contained in Waste Electrical and Electronic Equipment (WEEE) in China. We suggest alternatives to PBDEs and sound management of plastics used in electrical and electronic equipment (EEE) that contain PBDEs. Copyright © 2012 Elsevier Ltd. All rights reserved.

Study of the regulatory issues affecting truck freight movement in the Midwest.

DOT National Transportation Integrated Search

2014-12-01

This project investigated regulatory issues that may affect or limit freight movement in Iowa and other Midwest states: Illinois, Kansas, : Minnesota, Missouri, Nebraska, South Dakota, and Wisconsin. Current state regulations for the following are re...

ER Consolidated Qtrly Rpt_July-September 2015_January 2016

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cochran, John R.

2016-01-01

This Environmental Restoration Operations (ER) Consolidated Quarterly Report (ER Quarterly Report) provides the status of ongoing corrective action activities being implemented by Sandia National Laboratories, New Mexico (SNL/NM) for the July, August, and September 2015 quarterly reporting period. The Solid Waste Management Units (SWMUs) and Areas of Concern (AOCs) identified for corrective action at SNL/NM are listed in Table I-1. The work completed during this quarter is reported below in Sections I.2.1 and I.2.2. Section I.2.1 summarizes the quarterly activities at sites undergoing corrective action field activities (SWMUs 8 and 58, 68, 149, 154, and 502, and three groundwater AOCs).more » Section I.2.2 summarizes quarterly activities at sites where the New Mexico Environment Department (NMED) has issued a certificate of completion and the site is in the corrective action complete (CAC) regulatory process. Currently, the Mixed Waste Landfill (MWL, SWMU 76) is the only site in the CAC regulatory process. Corrective action activities have been deferred at the Long Sled Track (SWMU 83), the Gun Facilities (SWMU 84), and the Short Sled Track (SWMU 240) because these are active mission facilities.« less

Environmentally induced epigenetic toxicity: potential public health concerns

PubMed Central

Marczylo, Emma L.; Jacobs, Miriam N.; Gant, Timothy W.

2016-01-01

Abstract Throughout our lives, epigenetic processes shape our development and enable us to adapt to a constantly changing environment. Identifying and understanding environmentally induced epigenetic change(s) that may lead to adverse outcomes is vital for protecting public health. This review, therefore, examines the present understanding of epigenetic mechanisms involved in the mammalian life cycle, evaluates the current evidence for environmentally induced epigenetic toxicity in human cohorts and rodent models and highlights the research considerations and implications of this emerging knowledge for public health and regulatory toxicology. Many hundreds of studies have investigated such toxicity, yet relatively few have demonstrated a mechanistic association among specific environmental exposures, epigenetic changes and adverse health outcomes in human epidemiological cohorts and/or rodent models. While this small body of evidence is largely composed of exploratory in vivo high-dose range studies, it does set a precedent for the existence of environmentally induced epigenetic toxicity. Consequently, there is worldwide recognition of this phenomenon, and discussion on how to both guide further scientific research towards a greater mechanistic understanding of environmentally induced epigenetic toxicity in humans, and translate relevant research outcomes into appropriate regulatory policies for effective public health protection. PMID:27278298

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cochran, John R.

This Environmental Restoration Operations (ER) Consolidated Quarterly Report (ER Quarterly Report) provides the status of ongoing corrective action activities being implemented at Sandia National Laboratories, New Mexico (SNL/NM) during the July, August, and September 2016 quarterly reporting period. The Solid Waste Management Units (SWMUs) and Areas of Concern (AOCs) identified for corrective action at SNL/NM are listed in Table I-1. Sections I.2.1 and I.2.2 summarize the work completed during this quarter. Section I.2.1 summarizes the quarterly activities at sites undergoing corrective action field activities. Field activities are conducted at the three groundwater AOCs (Burn Site Groundwater [BSG AOC], Technical Areamore » [TA]-V Groundwater [TAVG AOC], and Tijeras Arroyo Groundwater [TAG AOC]). Section I.2.2 summarizes quarterly activities at sites where the New Mexico Environment Department (NMED) issued a certificate of completion and the sites are in the corrective action complete (CAC) regulatory process. Currently, SWMUs 8 and 58, 68, 149, 154, and 502 are in the CAC regulatory process. Corrective action activities are deferred at the Long Sled Track (SWMU 83), the Gun Facilities (SWMU 84), and the Short Sled Track (SWMU 240) because these three sites are active mission facilities. These three active sites are located in TA-III.« less

Fc-dependent depletion of tumor-infiltrating regulatory T cells co-defines the efficacy of anti–CTLA-4 therapy against melanoma

PubMed Central

Simpson, Tyler R.; Li, Fubin; Montalvo-Ortiz, Welby; Sepulveda, Manuel A.; Bergerhoff, Katharina; Arce, Frederick; Roddie, Claire; Henry, Jake Y.; Yagita, Hideo; Wolchok, Jedd D.; Peggs, Karl S.; Ravetch, Jeffrey V.

2013-01-01

Treatment with monoclonal antibody specific for cytotoxic T lymphocyte–associated antigen 4 (CTLA-4), an inhibitory receptor expressed by T lymphocytes, has emerged as an effective therapy for the treatment of metastatic melanoma. Although subject to debate, current models favor a mechanism of activity involving blockade of the inhibitory activity of CTLA-4 on both effector (T eff) and regulatory (T reg) T cells, resulting in enhanced antitumor effector T cell activity capable of inducing tumor regression. We demonstrate, however, that the activity of anti–CTLA-4 antibody on the T reg cell compartment is mediated via selective depletion of T reg cells within tumor lesions. Importantly, T reg cell depletion is dependent on the presence of Fcγ receptor–expressing macrophages within the tumor microenvironment, indicating that T reg cells are depleted in trans in a context-dependent manner. Our results reveal further mechanistic insight into the activity of anti-CTLA-4–based cancer immunotherapy, and illustrate the importance of specific features of the local tumor environment on the final outcome of antibody-based immunomodulatory therapies. PMID:23897981

Environmentally induced epigenetic toxicity: potential public health concerns.

PubMed

Marczylo, Emma L; Jacobs, Miriam N; Gant, Timothy W

2016-09-01

Throughout our lives, epigenetic processes shape our development and enable us to adapt to a constantly changing environment. Identifying and understanding environmentally induced epigenetic change(s) that may lead to adverse outcomes is vital for protecting public health. This review, therefore, examines the present understanding of epigenetic mechanisms involved in the mammalian life cycle, evaluates the current evidence for environmentally induced epigenetic toxicity in human cohorts and rodent models and highlights the research considerations and implications of this emerging knowledge for public health and regulatory toxicology. Many hundreds of studies have investigated such toxicity, yet relatively few have demonstrated a mechanistic association among specific environmental exposures, epigenetic changes and adverse health outcomes in human epidemiological cohorts and/or rodent models. While this small body of evidence is largely composed of exploratory in vivo high-dose range studies, it does set a precedent for the existence of environmentally induced epigenetic toxicity. Consequently, there is worldwide recognition of this phenomenon, and discussion on how to both guide further scientific research towards a greater mechanistic understanding of environmentally induced epigenetic toxicity in humans, and translate relevant research outcomes into appropriate regulatory policies for effective public health protection.

Sodium and phosphorus-based food additives: persistent but surmountable hurdles in the management of nutrition in chronic kidney disease

PubMed Central

Gutiérrez, Orlando M.

2012-01-01

Sodium and phosphorus-based food additives are among the most commonly consumed nutrients in the world. This is because both have diverse applications in processed food manufacturing, leading to their widespread utilization by the food industry. Since most foods are naturally low in salt, sodium additives almost completely account for the excessive consumption of sodium throughout the world. Similarly, phosphorus additives represent a major and “hidden” phosphorus load in modern diets. These factors pose a major barrier to successfully lowering sodium or phosphorus intake in patients with chronic kidney disease. As such, any serious effort to reduce sodium or phosphorus consumption will require reductions in the use of these additives by the food industry. The current regulatory environment governing the use of food additives does not favor this goal, however, in large part because these additives have historically been classified as generally safe for public consumption. To overcome these barriers, coordinated efforts will be needed to demonstrate that high intakes of these additives are not safe for public consumption and as such, should be subject to greater regulatory scrutiny. PMID:23439374

Resilience of Cyber Systems with Over- and Underregulation.

PubMed

Gisladottir, Viktoria; Ganin, Alexander A; Keisler, Jeffrey M; Kepner, Jeremy; Linkov, Igor

2017-09-01

Recent cyber attacks provide evidence of increased threats to our critical systems and infrastructure. A common reaction to a new threat is to harden the system by adding new rules and regulations. As federal and state governments request new procedures to follow, each of their organizations implements their own cyber defense strategies. This unintentionally increases time and effort that employees spend on training and policy implementation and decreases the time and latitude to perform critical job functions, thus raising overall levels of stress. People's performance under stress, coupled with an overabundance of information, results in even more vulnerabilities for adversaries to exploit. In this article, we embed a simple regulatory model that accounts for cybersecurity human factors and an organization's regulatory environment in a model of a corporate cyber network under attack. The resulting model demonstrates the effect of under- and overregulation on an organization's resilience with respect to insider threats. Currently, there is a tendency to use ad-hoc approaches to account for human factors rather than to incorporate them into cyber resilience modeling. It is clear that using a systematic approach utilizing behavioral science, which already exists in cyber resilience assessment, would provide a more holistic view for decisionmakers. © 2016 Society for Risk Analysis.

From cradle-to-grave at the nanoscale: gaps in U.S. regulatory oversight along the nanomaterial life cycle.

PubMed

Beaudrie, Christian E H; Kandlikar, Milind; Satterfield, Terre

2013-06-04

Engineered nanomaterials (ENMs) promise great benefits for society, yet our knowledge of potential risks and best practices for regulation are still in their infancy. Toward the end of better practices, this paper analyzes U.S. federal environmental, health, and safety (EHS) regulations using a life cycle framework. It evaluates their adequacy as applied to ENMs to identify gaps through which emerging nanomaterials may escape regulation from initial production to end-of-life. High scientific uncertainty, a lack of EHS and product data, inappropriately designed exemptions and thresholds, and limited agency resources are a challenge to both the applicability and adequacy of current regulations. The result is that some forms of engineered nanomaterials may escape federal oversight and rigorous risk review at one or more stages along their life cycle, with the largest gaps occurring at the postmarket stages, and at points of ENM release to the environment. Oversight can be improved through pending regulatory reforms, increased research and development for the monitoring, control, and analysis of environmental and end-of-life releases, introduction of periodic re-evaluation of ENM risks, and fostering a "bottom-up" stewardship approach to the responsible management of risks from engineered nanomaterials.

Sodium- and phosphorus-based food additives: persistent but surmountable hurdles in the management of nutrition in chronic kidney disease.

PubMed

Gutiérrez, Orlando M

2013-03-01

Sodium- and phosphorus-based food additives are among the most commonly consumed nutrients in the world. This is because both have diverse applications in processed food manufacturing, leading to their widespread use by the food industry. Since most foods are naturally low in salt, sodium additives almost completely account for the excessive consumption of sodium throughout the world. Similarly, phosphorus additives represent a major and "hidden" phosphorus load in modern diets. These factors pose a major barrier to successfully lowering sodium or phosphorus intake in patients with CKD. As such, any serious effort to reduce sodium or phosphorus consumption will require reductions in the use of these additives by the food industry. The current regulatory environment governing the use of food additives does not favor this goal, however, in large part because these additives have historically been classified as generally safe for public consumption. To overcome these barriers, coordinated efforts will be needed to demonstrate that high intake of these additives is not safe for public consumption and as such should be subject to greater regulatory scrutiny. Copyright © 2013 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Food Crises and Food Safety Incidents in European Union, United States, and Maghreb Area: Current Risk Communication Strategies and New Approaches.

PubMed

Chammem, Nadia; Issaoui, Manel; De Almeida, Ana Isabel Dâmaso; Delgado, Amélia Martins

2018-03-22

Globalization has created a dynamic market, which has dramatically intensified interchanges of goods and information as well as the flow of people among nations. This international phenomenon offers the consumer a choice between a wide variety of foods from diverse locations. However, there are challenges to improving food security and safety on a global scale; the major question is how food safety can be guaranteed while increasing the complexity of food supply chains. A food produced in a certain location usually contains ingredients, additives, and preservatives from different and distant origins. Although countries take several food control measures, their institutional and regulatory frameworks diverge widely, as do the definitions of food crisis, food incidents, and risk management approaches. The present review discusses some past food safety issues and lessons learned. Convergences and differences in the regulatory framework of food control agencies in different regions of the world are herein revealed. Emerging risks are also discussed, particularly the spread of antibiotic resistance in the food chain and the environment, as well as the rise of new antibiotic-resistant pathogenic strains with broader tolerance to environmental factors.

The context of discrimination: workplace conditions, institutional environments, and sex and race discrimination charges.

PubMed

Hirsh, C Elizabeth; Kornrich, Sabino

2008-03-01

This article explores the organizational conditions under which discrimination charges occur. Drawing on structural and organizational theories of the workplace, the authors demonstrate how organizational conditions affect workers' and regulatory agents' understandings of unlawful discrimination. Using a national sample of work establishments, matched to discrimination-charge data obtained from the Equal Employment Opportunity Commission (EEOC), the authors examine how characteristics of the workplace and institutional environment affect variation in the incidence of workers' charges of sex and race discrimination and in the subset of discrimination claims that are verified by EEOC investigators. The findings indicate that workplace conditions, including size, composition, and minority management, affect workers' charges as well as verified claims; the latter are also affected by institutional factors, such as affirmative action requirements, subsidiary status, and industrial sector. These results suggest that internal workplace conditions affect both workers' and regulatory agents' interpretations of potentially discriminatory experiences, while institutional conditions matter only for regulatory agents' interpretations of those events.

An Exploration of the Legal and Regulatory Environment of Privacy and Security through Active Research, Guided Study, Blog Creation, and Discussion

ERIC Educational Resources Information Center

Peslak, Alan R.

2010-01-01

One of the most important topics for today's information technology professional is the study of legal and regulatory issues as they relate to privacy and security of personal and business data and identification. This manuscript describes the topics and approach taken by the instructors that focuses on independent research of source documents and…

A Minimal Regulatory Network of Extrinsic and Intrinsic Factors Recovers Observed Patterns of CD4+ T Cell Differentiation and Plasticity

PubMed Central

Martinez-Sanchez, Mariana Esther; Mendoza, Luis; Villarreal, Carlos; Alvarez-Buylla, Elena R.

2015-01-01

CD4+ T cells orchestrate the adaptive immune response in vertebrates. While both experimental and modeling work has been conducted to understand the molecular genetic mechanisms involved in CD4+ T cell responses and fate attainment, the dynamic role of intrinsic (produced by CD4+ T lymphocytes) versus extrinsic (produced by other cells) components remains unclear, and the mechanistic and dynamic understanding of the plastic responses of these cells remains incomplete. In this work, we studied a regulatory network for the core transcription factors involved in CD4+ T cell-fate attainment. We first show that this core is not sufficient to recover common CD4+ T phenotypes. We thus postulate a minimal Boolean regulatory network model derived from a larger and more comprehensive network that is based on experimental data. The minimal network integrates transcriptional regulation, signaling pathways and the micro-environment. This network model recovers reported configurations of most of the characterized cell types (Th0, Th1, Th2, Th17, Tfh, Th9, iTreg, and Foxp3-independent T regulatory cells). This transcriptional-signaling regulatory network is robust and recovers mutant configurations that have been reported experimentally. Additionally, this model recovers many of the plasticity patterns documented for different T CD4+ cell types, as summarized in a cell-fate map. We tested the effects of various micro-environments and transient perturbations on such transitions among CD4+ T cell types. Interestingly, most cell-fate transitions were induced by transient activations, with the opposite behavior associated with transient inhibitions. Finally, we used a novel methodology was used to establish that T-bet, TGF-β and suppressors of cytokine signaling proteins are keys to recovering observed CD4+ T cell plastic responses. In conclusion, the observed CD4+ T cell-types and transition patterns emerge from the feedback between the intrinsic or intracellular regulatory core and the micro-environment. We discuss the broader use of this approach for other plastic systems and possible therapeutic interventions. PMID:26090929

Regulatory issues in accreditation of toxicology laboratories.

PubMed

Bissell, Michael G

2012-09-01

Clinical toxicology laboratories and forensic toxicology laboratories operate in a highly regulated environment. This article outlines major US legal/regulatory issues and requirements relevant to accreditation of toxicology laboratories (state and local regulations are not covered in any depth). The most fundamental regulatory distinction involves the purposes for which the laboratory operates: clinical versus nonclinical. The applicable regulations and the requirements and options for operations depend most basically on this consideration, with clinical toxicology laboratories being directly subject to federal law including mandated options for accreditation and forensic toxicology laboratories being subject to degrees of voluntary or state government–required accreditation.

Regulatory RNA in Mycobacterium tuberculosis, back to basics.

PubMed

Schwenk, Stefan; Arnvig, Kristine B

2018-06-01

Since the turn of the millenium, RNA-based control of gene expression has added an extra dimension to the central dogma of molecular biology. Still, the roles of Mycobacterium tuberculosis regulatory RNAs and the proteins that facilitate their functions remain elusive, although there can be no doubt that RNA biology plays a central role in the baterium's adaptation to its many host environments. In this review, we have presented examples from model organisms and from M. tuberculosis to showcase the abundance and versatility of regulatory RNA, in order to emphasise the importance of these 'fine-tuners' of gene expression.

Reverse Engineering of Genome-wide Gene Regulatory Networks from Gene Expression Data

PubMed Central

Liu, Zhi-Ping

2015-01-01

Transcriptional regulation plays vital roles in many fundamental biological processes. Reverse engineering of genome-wide regulatory networks from high-throughput transcriptomic data provides a promising way to characterize the global scenario of regulatory relationships between regulators and their targets. In this review, we summarize and categorize the main frameworks and methods currently available for inferring transcriptional regulatory networks from microarray gene expression profiling data. We overview each of strategies and introduce representative methods respectively. Their assumptions, advantages, shortcomings, and possible improvements and extensions are also clarified and commented. PMID:25937810

Regulatory sequence analysis tools.

PubMed

van Helden, Jacques

2003-07-01

The web resource Regulatory Sequence Analysis Tools (RSAT) (http://rsat.ulb.ac.be/rsat) offers a collection of software tools dedicated to the prediction of regulatory sites in non-coding DNA sequences. These tools include sequence retrieval, pattern discovery, pattern matching, genome-scale pattern matching, feature-map drawing, random sequence generation and other utilities. Alternative formats are supported for the representation of regulatory motifs (strings or position-specific scoring matrices) and several algorithms are proposed for pattern discovery. RSAT currently holds >100 fully sequenced genomes and these data are regularly updated from GenBank.

What exactly is an exact copy? And why it matters when trying to ban human reproductive cloning in Australia

PubMed Central

Gogarty, B

2003-01-01

This paper examines the current Australian regulatory response to human reproductive cloning. The central consideration is the capacity of the current regulatory regime to effectively deter human cloning efforts. A legislative prohibition on human cloning must be both effective and clear enough to allow researchers to know what practices are acceptable. This paper asks whether the current Australian regime evinces these qualities and suggests that Australia should follow the example set in the UK by the enactment of the Human Reproductive Cloning Act 2001. PMID:12672887

Strategies of bringing drug product marketing applications to meet current regulatory standards.

PubMed

Wu, Yan; Freed, Anita; Lavrich, David; Raghavachari, Ramesh; Huynh-Ba, Kim; Shah, Ketan; Alasandro, Mark

2015-08-01

In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards. It also discusses stability and method designs to meet process validation and global development efforts.

Current NRC Perspectives Concerning Primary Water Stress Corrosion Cracking

NASA Astrophysics Data System (ADS)

Alley, David; Dunn, Darrell

Materials currently used in nuclear power plants are reliable and are generally resistant to environmental degradation. However, occurrences of environmental degradation have been observed as the current fleet of reactors ages. Primary water stress corrosion cracking (PWSCC) is of particular interest to the US Nuclear Regulatory Commission (NRC). This paper provides a historical assessment of operating experience associated with PWSCC and welding issues associated with PWSCC resistant materials. The paper also considers the regulatory issues associated with PWSCC, especially those associated with gaps in the understanding of the behavior of PWSCC resistant material under actual reactor conditions.

Regulatory T cells in the control of host-microorganism interactions (*).

PubMed

Belkaid, Yasmine; Tarbell, Kristin

2009-01-01

Each microenvironment requires a specific set of regulatory elements that are finely and constantly tuned to maintain local homeostasis. Various populations of regulatory T cells contribute to the maintenance of this equilibrium and establishment of controlled immune responses. In particular, regulatory T cells limit the magnitude of effector responses, which may result in failure to adequately control infection. However, regulatory T cells also help limit collateral tissue damage caused by vigorous antimicrobial immune responses against pathogenic microbes as well as commensals. In this review, we describe various situations in which the balance between regulatory T cells and effector immune functions influence the outcome of host-microorganism coexistence and discuss current hypotheses and points of polemic associated with the origin, target, and antigen specificity of both endogenous and induced regulatory T cells during these interactions.

Using virtual reality to explore self-regulation in high-risk settings.

PubMed

Kniffin, Tracey C; Carlson, Charles R; Ellzey, Antonio; Eisenlohr-Moul, Tory; Beck, Kelly Battle; McDonald, Renee; Jouriles, Ernest N

2014-10-01

Virtual reality (VR) models allow investigators to explore high-risk situations carefully in the laboratory using physiological assessment strategies and controlled conditions not available in field settings. This article introduces the use of a virtual experience to examine the influence of self-regulatory skills training on female participants' reactions to a high-risk encounter with an aggressive male. Sixty-three female participants were recruited for the study. Demographic data indicated that 54% of the participants were not currently in a relationship, 36.5% were in a committed relationship, and 9.5% were occasionally dating. After obtaining informed consent, participants were assigned randomly to either a diaphragmatic breathing training condition or an attention control condition. Results indicated that both groups rated the virtual environment as equally realistic; the aggressive advances of the male were also perceived as equally real across the two experimental groups. Physiological data indicated that there were no differences between the groups on respiration or cardiovascular measures during baseline or during the VR task. After the VR experience, however, the participants in the breathing training condition had lower respiration rates and higher heart rate variability measures than those in the control condition. The results suggest that VR platforms provide a realistic and challenging environment to examine how self-regulation procedures may influence behavioral outcomes. Real-time dynamic engagement in a virtual setting affords investigators with an opportunity to evaluate the utility of self-regulatory skills training for improving safety in situations where there are uncertain and risky outcomes. © The Author(s) 2014.

Regulatory challenges associated with conducting multicountry clinical trials in resource-limited settings.

PubMed

Ndebele, Paul; Blanchard-Horan, Christina; Shahkolahi, Akbar; Sanne, Ian

2014-01-01

International public health and infectious diseases research has expanded to become a global enterprise transcending national and continental borders in organized networks addressing high-impact diseases. In conducting multicountry clinical trials, sponsors and investigators have to ensure that they meet regulatory requirements in all countries in which the clinical trials will be conducted. Some of these requirements include review and approval by national drug regulatory authorities and recognized research ethics committees. A limiting factor to the efficient conduct of multicountry clinical trials is the regulatory environment in each collaborating country, with significant differences determined by various factors including the laws and the procedures used in each country. The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.

RNAi technologies in agricultural biotechnology: The Toxicology Forum 40th Annual Summer Meeting.

PubMed

Sherman, James H; Munyikwa, Tichafa; Chan, Stephen Y; Petrick, Jay S; Witwer, Kenneth W; Choudhuri, Supratim

2015-11-01

During the 40th Annual Meeting of The Toxicology Forum, the current and potential future science, regulations, and politics of agricultural biotechnology were presented and discussed. The meeting session described herein focused on the technology of RNA interference (RNAi) in agriculture. The general process by which RNAi works, currently registered RNAi-based plant traits, example RNAi-based traits in development, potential use of double stranded RNA (dsRNA) as topically applied pesticide active ingredients, research related to the safety of RNAi, biological barriers to ingested dsRNA, recent regulatory RNAi science reviews, and regulatory considerations related to the use of RNAi in agriculture were discussed. Participants generally agreed that the current regulatory framework is robust and appropriate for evaluating the safety of RNAi employed in agricultural biotechnology and were also supportive of the use of RNAi to develop improved crop traits. However, as with any emerging technology, the potential range of future products, potential future regulatory frameworks, and public acceptance of the technology will continue to evolve. As such, continuing dialogue was encouraged to promote education of consumers and science-based regulations. Copyright © 2015 Elsevier Inc. All rights reserved.

Associations between national gambling policies and disordered gambling prevalence rates within Europe.

PubMed

Planzer, Simon; Gray, Heather M; Shaffer, Howard J

2014-01-01

Policymakers and other interested stakeholders currently are seeking information about the comparative effectiveness of different regulatory approaches to minimising gambling-related harm. This study responds to this research gap by exploring associations between gambling policies and disordered gambling prevalence rates. We gathered information about gambling policies for thirty European jurisdictions and past-year prevalence rates for disordered gambling for twelve of these jurisdictions. We present policy trends and prevalence rates and then describe the level of association between policy and prevalence. We observe one statistically significant association between policy and prevalence: rates of sub-clinical (i.e., Level 2) disordered gambling were higher within environments that mandated less strict regulation of advertising for online gambling. Finally, we discuss the implications of our research in the context of the current process regarding the pan-European regulation of gambling. Our findings do not offer evidence for certain assumptions made in the past by the European judiciary. Copyright © 2013 Elsevier Ltd. All rights reserved.

Why do patients engage in medical tourism?

PubMed

Runnels, Vivien; Carrera, P M

2012-12-01

Medical tourism is commonly perceived and popularly depicted as an economic issue, both at the system and individual levels. The decision to engage in medical tourism, however, is more complex, driven by patients' unmet need, the nature of services sought and the manner by which treatment is accessed. In order to beneficially employ the opportunities medical tourism offers, and address and contain possible threats and harms, an informed decision is crucial. This paper aims to enhance the current knowledge on medical tourism by isolating the focal content of the decisions that patients make. Based on the existing literature, it proposes a sequential decision-making process in opting for or against medical care abroad, and engaging in medical tourism, including considerations of the required treatments, location of treatment, and quality and safety issues attendant to seeking care. Accordingly, it comments on the imperative of access to health information and the current regulatory environment which impact on this increasingly popular and complex form of accessing and providing medical care. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Pheromone-Based Pest Management in China: Past, Present, and Future Prospects.

PubMed

Cui, Gen Zhong; Zhu, Junwei Jerry

2016-07-01

Semiochemical-based pest management technology has been widely used to monitor and control insect pests in agricultural, forestry, and public health sectors in the western world. It became a popular tool in the early 1970s with tremendous efforts in developing environment-friendly control technologies for the integrated pest management. However, in China, similar research lagged 15 to 20 years and was not initiated until the late 1980s. In this review, we present the early history of pheromone research that has led to the current practical applications in China, particularly in the development of pheromone-based pest management products. We also provide information regarding the current status of pheromone-based product manufacturing, marketing, and regulatory issues related to local semiochemical industries, which may be useful to other international companies interested in pursuing business in China. In addition, we share some research topics that represent new directions of the present pheromone research to explore novel tools for advancing semiochemical-based pest management in China.

Water Systems Project 1: Current Systems and Regulatory Support

EPA Science Inventory

Water Systems Project 1 objectives: 1) Supply research results to support federal regulations and guidance; 2) provide strategies to regions, states, and communities for improved regulatory compliance, and 3) provide rapid and effective emergency response where appropriate (e.g. ...

Research on Current Water Systems and Regulatory Support

EPA Science Inventory

This project will supply research results to support federal regulations and guidance. It will also provide strategies to regions, states, and communities for improved regulatory compliance and rapid and effective emergency response where appropriate (e.g. harmful algal bloom out...

A New Regulatory Policy for FTTx-Based Next-Generation Access Networks

NASA Astrophysics Data System (ADS)

Makarovič, Boštjan

2013-07-01

This article critically assesses the latest European Commission policies in relation to next-generation access investment that put focus on regulated prices and relaxing of wholesale access obligations. Pointing at the vital socio-legal and economic arguments, it further challenges the assumptions of the current EU regulatory framework and calls for a more contractual utility-based model of regulation instead of the current system that overly relies on market-driven infrastructure-based competition.

Regulation of stem cell-based therapies in Canada: current issues and concerns.

PubMed

von Tigerstrom, Barbara; Nguyen, Thu Minh; Knoppers, Bartha Maria

2012-09-01

Stem cell therapies offer enormous potential for the treatment of a wide range of diseases and conditions. Despite the excitement over such advances, regulators are faced with the challenge of determining criteria to ensure stem cells and their products are safe and effective for human use. However, stem cell-based products and therapies present unique regulatory challenges because standard drug development models do not wholly apply given the complexity and diversity of these products and therapies. As a result, regulatory requirements are often unclear and ambiguous creating unnecessary barriers for research. In order to better understand the barriers that might affect Canadian stem cell researchers, we sought feedback from stakeholders regarding areas of uncertainty or concern about existing regulatory oversight of cell therapies. A selection of Canadian researchers and clinicians working in the area of stem cell research were interviewed to assess certain key questions: 1) whether current regulatory requirements are easily accessible and well understood; 2) whether regulatory requirements create important challenges or barriers; and 3) whether there is a need for further guidance on the issue. The results of this survey are summarized and compared to issues and concerns experienced in other countries, as reported in the literature, to identify challenges which may be on the horizon and to provide possible solutions for regulatory reform.

Interplay of Dysphoria and Anxiety Sensitivity in Relation to Emotion Regulatory Cognitions of Smoking Among Treatment-seeking Smokers

PubMed Central

Garey, Lorra; Bakhshaie, Jafar; Brandt, Charles P.; Langdon, Kirsten J.; Kauffman, Brooke Y.; Schmidt, Norman B.; Leventhal, Adam M.; Zvolensky, Michael J.

2017-01-01

Background and Objectives There is evidence that anxiety sensitivity (AS) plays a role in the maintenance of smoking, yet there is little understanding of how AS interplays with other affective symptomatology variables that are also related to smoking, such as dysphoria. Therefore, the current cross-sectional study evaluated the interactive effects of AS and dysphoria on emotion regulatory cognitions, including smoking negative affect reduction expectancies, perceived barriers for cessation, and smoking-specific experiential avoidance. Method A total of 448 adult treatment-seeking daily smokers, who responded to study advertisements, were recruited to participate in a smoking cessation treatment trial (47.8% female; Mage = 37.2, SD =13.5). The current study utilized self-report baseline data from trial participants. Results After accounting for covariates, simple slope analyses revealed that AS was positively related to negative affect reduction expectancies (β = .03, p =.01), perceived barriers to cessation (β =.22, p = .002), and smoking avoidance and inflexibility (β =.07, p = .04), among smokers with lower (versus higher) levels of dysphoria. Conclusions The current findings suggest that higher levels of dysphoria may mitigate the relation between AS and emotion regulatory cognitions of smoking. Scientific Significance The current findings highlight the unique and additive clinical relevance of AS and dysphoria regarding emotion regulatory smoking cognitions that may impede quit success. PMID:27122303

40 CFR 60.4805 - What is a siting analysis?

Code of Federal Regulations, 2011 CFR

2011-07-01

... impacts that are prepared to comply with state, local, or other Federal regulatory requirements may be... 40 Protection of Environment 6 2011-07-01 2011-07-01 false What is a siting analysis? 60.4805 Section 60.4805 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS...

PREFACE TO: "PHARMACEUTICALS AND PERSONAL CARE PRODUCTS IN THE ENVIRONMENT: SCIENTIFIC AND REGULATORY ISSUES"

EPA Science Inventory

Often overlooked in our daily lives are the inescapable, intimate, and immediate connections between our personal activities and the environment in which we live. This is especially true with regard to the use and disposal of consumer chemicals. A significant aspect of our global...

Exploring Online Graduate Students' Responses to Online Self-Regulation Training

ERIC Educational Resources Information Center

Dunn, Karee E.; Rakes, Glenda C.

2015-01-01

In this study, online graduate students participated in four brief online self-regulatory trainings for self-efficacy, achievement goal orientation, learning strategies, and attributional thinking. These variables are critical to success in learning environments, but perhaps even more so in the online academic environment (Rakes, Dunn, &…

Surface Disposal of Waste Water Treatment Plant Biosludge – an Important Source of Perfluorinated Compound Contamination in the Environment?

EPA Science Inventory

With more than a decade of intensive scientific research and increasing regulatory pressure worldwide, the sources of perfluoroalkyl acids (PFAA) in the environment and routes of human exposure still need to be fully characterized. Several studies have documented PFAA contaminat...

Passive Sampling in Regulatory Chemical Monitoring of Nonpolar Organic Compounds in the Aquatic Environment

EPA Science Inventory

We reviewed compliance monitoring requirements in the European Union (EU), the United States(USA), and the Oslo-Paris Convention for the protection of the marine environment of the North-East Atlantic (OSPAR), and evaluated if these are met by passive sampling methods for nonpola...

Prescriptive or Interpretive Regulation at the Frontlines of Care Work in the “Three Worlds” of Canada, Germany and Norway

PubMed Central

Daly, Tamara; Struthers, Jim; Müller, Beatrice; Taylor, Deanne; Goldmann, Monika; Doupe, Malcolm; Jacobsen, Frode F.

2018-01-01

This paper examines the tension between macro level regulation and the rule breaking and rule following that happens at the workplace level. Using a comparative study of Canada, Norway, and Germany, the paper documents how long-term residential care work is regulated and organized differently depending on country, regional, and organizational contexts. We ask where each jurisdiction’s staffing regulations fall on a prescription-interpretation continuum; we define prescription as a regulatory tendency to identify what to do and when and how to do it, and interpretation as a tendency to delineate what to do but not when and how to do it. In examining frontline care workers’ strategies for accomplishing everyday social, health, and dining care tasks we explore how a policy-level prescriptive or interpretive regulatory approach affects the potential for promising practices to emerge on the frontlines of care work. Overall, we note the following associations: prescriptive regulatory environments tend to be accompanied by a lower ratio of professional to non-professional staff, a higher concentration of for-profit providers, a lower ratio of staff to residents and a sharper division of labour. Interpretive regulatory environments tend to have higher numbers of professionals relative to non-professionals, more limited for-profit provision, a higher ratio of staff to residents, and a more relational division of labour that enables the work to be more fluid and responsive. The implication of a prescriptive environment, such as is found in Ontario, Canada, is that frontline care workers possess less autonomy to be creative in meeting residents’ needs, a tendency towards more task-oriented care and less job autonomy. The paper reveals that what matters is the type of regulation as well as the regulatory tendency towards controlling frontline care workers decision-making and decision-latitude. PMID:29467547

Disparate Fluorescence Properties of 2-[4′-(Iodoacetamido)anilino]-Naphthalene-6-Sulfonic Acid Attached to Cys-84 and Cys-35 of Troponin C in Cardiac Muscle Troponin

PubMed Central

Dong, Wen-Ji; Wang, Chien-Kao; Gordon, Albert M.; Cheung, Herbert C.

1997-01-01

Two monocysteine mutants of cardiac muscle troponin C, cTnC(C35S) and cTnC(C84S), were genetically generated and labeled with the fluorescent probe 2-[4′-(iodoacetamido)anilino]naphthalene-6-sulfonic acid (IAANS) at Cys-84 and Cys-35, respectively. Cys-84 is located on helix D in the regulatory N-domain, and Cys-35 is at the -y position of the inactive 12-residue loop of site I. These labeled mutants were studied by a variety of steady-state and time-resolved fluorescence methods. In the absence of divalent cation, the fluorescence of the attached IAANS indicated an exposed environment at Cys-35 and a relatively less-exposed environment at Cys-84. The binding of Ca2+ to the single regulatory site elicited a large enhancement of the emission of IAANS attached to Cys-84, but only marginal fluorescence changes of the probe at Cys-35. Upon reconstitution of the labeled cTnC mutants with troponin I and troponin T to form the three-subunit troponin, the fluorescence of IAANS-Cys-84 in apo-troponin was spectrally similar to that observed with the Ca2+-loaded uncomplexed cTnC mutant. Only very moderate changes in the fluorescence of IAANS-Cys-84 were observed when the regulatory site in reconstituted troponin was saturated. The exposed Cys-35 environment of the uncomplexed cTnC mutant became considerably less exposed and less polar when the mutant was incorporated into apo-troponin. In contrast to the Cys-84 site, saturation of the regulatory site II by Ca2+ in reconstituted troponin resulted in a reversal of the environment of the Cys-35 site toward a more exposed and more polar environment. These results indicated involvement of the inactive loop I in the Ca2+ trigger mechanism in cardiac muscle. The fluorescence of IAANS at both Cys-84 and Cys-35 was sensitive to phosphorylation of cTnI in reconstituted troponin, and the sensitivity was observed with both apo-troponin and Ca2+-loaded troponin. PMID:9017210

Regulatory Impact Analysis (RIA) for the Proposed Revisions to the Sulfur Dioxide National Ambient Air Quality Standards (NAAQS)

EPA Pesticide Factsheets

This Regulatory Impact Analysis (RIA) provides estimates of the incremental costs and monetized human health benefits of attaining a revised short‐term Sulfur Dioxide (SO2) NAAQS within the current monitoring network.

Best Practices for Use of Historical Control Data of Proliferative Rodent Lesions.

EPA Science Inventory

The Historical Control Data Working Group under the direction of the Scientific and Regulatory Policy Committee (SRPC) of the Society of Toxicologic Pathology (STP) was tasked with reviewing the current scientific practices, regulatory guidance and relevant literature pertaining ...

Current limitations and recommendations to improve testing for the environmental assessment of endocrine active substances

EPA Science Inventory

In this paper existing regulatory frameworks and test systems for assessing potential endocrine-active chemicals are described, and associated challenges discussed, along with proposed approaches to address these challenges. Regulatory frameworks vary somewhat across organizatio...

Germline Stem Cells: Origin and Destiny

PubMed Central

Lehmann, Ruth

2012-01-01

Germline stem cells are key to genome transmission to future generations. Over recent years, there have been numerous insights into the regulatory mechanisms that govern both germ cell specification and the maintenance of the germline in adults. Complex regulatory interactions with both the niche and the environment modulate germline stem cell function. This perspective highlights some examples of this regulation to illustrate the diversity and complexity of the mechanisms involved. PMID:22704513

Computational modeling identifies key gene regulatory interactions underlying phenobarbital-mediated tumor promotion

PubMed Central

Luisier, Raphaëlle; Unterberger, Elif B.; Goodman, Jay I.; Schwarz, Michael; Moggs, Jonathan; Terranova, Rémi; van Nimwegen, Erik

2014-01-01

Gene regulatory interactions underlying the early stages of non-genotoxic carcinogenesis are poorly understood. Here, we have identified key candidate regulators of phenobarbital (PB)-mediated mouse liver tumorigenesis, a well-characterized model of non-genotoxic carcinogenesis, by applying a new computational modeling approach to a comprehensive collection of in vivo gene expression studies. We have combined our previously developed motif activity response analysis (MARA), which models gene expression patterns in terms of computationally predicted transcription factor binding sites with singular value decomposition (SVD) of the inferred motif activities, to disentangle the roles that different transcriptional regulators play in specific biological pathways of tumor promotion. Furthermore, transgenic mouse models enabled us to identify which of these regulatory activities was downstream of constitutive androstane receptor and β-catenin signaling, both crucial components of PB-mediated liver tumorigenesis. We propose novel roles for E2F and ZFP161 in PB-mediated hepatocyte proliferation and suggest that PB-mediated suppression of ESR1 activity contributes to the development of a tumor-prone environment. Our study shows that combining MARA with SVD allows for automated identification of independent transcription regulatory programs within a complex in vivo tissue environment and provides novel mechanistic insights into PB-mediated hepatocarcinogenesis. PMID:24464994

Regulating and Litigating in the Public Interest

PubMed Central

Hawkes, Corinna

2007-01-01

The pressure to regulate the marketing of high-energy, nutrient-poor foods to young people has been mounting in light of concern about rising worldwide levels of overweight and obesity. In 2004, the World Health Organization called on governments, industry, and civil society to act to reduce unhealthy marketing messages. Since then, important changes have taken place in the global regulatory environment regarding the marketing of food to young people. Industry has developed self-regulatory approaches, civil society has campaigned for statutory restrictions, and governments have dealt with a range of regulatory proposals. Still, there have been few new regulations that restrict food marketing to young people. Despite calls for evidence-based policy, new regulatory developments appear to have been driven less by evidence than by ethics. PMID:17901436

The forecast for RAC extrapolation: mostly cloudy.

PubMed

Goldman, Elizabeth; Jacobs, Robert; Scott, Ellen; Scott, Bonnie

2011-09-01

The current statutory and regulatory guidance for recovery audit contractor (RAC) extrapolation leaves providers with minimal protection against the process and a limited ability to challenge overpayment demands. Providers not only should understand the statutory and regulatory basis for extrapolation forecast, but also should be able to assess their extrapolation risk and their recourse through regulatory safeguards against contractor error. Providers also should aggressively appeal all incorrect RAC denials to minimize the potential impact of extrapolation.

[Chemical risk in operating rooms and technical progress: the obligations and responsibilities of law].

PubMed

Oddo, Antonio

2013-01-01

We are going to consider the specific applications of the new legal system and of the most recent body of laws to those work environments of particular risk, such as healthcare facilities and in particular operating rooms. In such environments, volatile chemicals classified as "dangerous" are used with consequent exposure to "chemical risk", both of those persons professionally involved, depending on the type of activity, and of the patients to whom such activities are addressed in the same environment. Once the chemical risk is framed in the existing regulatory system, it must be specifically evaluated the application of the same principle to the particular chemical risk arising from the use of anesthetic agents in the operating room, for example sevoflurane and desflurane, being careful to test wether and how much this risk can be eliminated or reduced to minimum in relation to the new achievements of the technical progress. So, as soon as the quality of "dangerous chemical agent" of the "volatile chemicals" and of the "volatile liquid anesthetic" (sevoflurane and desflurane) as well--which are characterized by a lower degree of toxicity and for this reason are mostly used in current chemical practice, preferable to some anesthetic gases such as nitrous oxide--is legally verified, it is necessary to relate the scientific and technical data which result from the current "state of art" also to the other binding regulations that are imposed for the "prevention and protection from chemical agents", according to the relative Title IX of the TUSL (Unique text for Safety and Health at Work).

Bottom-up GGM algorithm for constructing multiple layered hierarchical gene regulatory networks

USDA-ARS?s Scientific Manuscript database

Multilayered hierarchical gene regulatory networks (ML-hGRNs) are very important for understanding genetics regulation of biological pathways. However, there are currently no computational algorithms available for directly building ML-hGRNs that regulate biological pathways. A bottom-up graphic Gaus...

76 FR 11395 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-02

... identify specific current regulations that may be outdated, ineffective, or excessively burdensome. The purpose of this regulatory review is to make the Department's regulations more effective and less... review existing significant regulations to determine if they are outmoded, ineffective, insufficient or...

Validation of an entirely in vitro approach for rapid prototyping of DNA regulatory elements for synthetic biology

PubMed Central

Chappell, James; Jensen, Kirsten; Freemont, Paul S.

2013-01-01

A bottleneck in our capacity to rationally and predictably engineer biological systems is the limited number of well-characterized genetic elements from which to build. Current characterization methods are tied to measurements in living systems, the transformation and culturing of which are inherently time-consuming. To address this, we have validated a completely in vitro approach for the characterization of DNA regulatory elements using Escherichia coli extract cell-free systems. Importantly, we demonstrate that characterization in cell-free systems correlates and is reflective of performance in vivo for the most frequently used DNA regulatory elements. Moreover, we devise a rapid and completely in vitro method to generate DNA templates for cell-free systems, bypassing the need for DNA template generation and amplification from living cells. This in vitro approach is significantly quicker than current characterization methods and is amenable to high-throughput techniques, providing a valuable tool for rapidly prototyping libraries of DNA regulatory elements for synthetic biology. PMID:23371936

Rationale for Selection of Pesticides, Herbicides, and Related Compounds from the Hanford SST/DST Waste Considered for Analysis in Support of the Regulatory DQO (Privatization)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wiemers, K.D.; Daling, P.; Meier, K.

1999-01-04

Regulated pesticides, herbicides, miticides, and fungicides were evaluated for their potential past and current use at the Hanford Site. The starting list of these compounds is based on regulatory analyte input lists discussed in the Regulatory DQO. Twelve pesticide, herbicide, miticide, and fungicide compounds are identified for analysis in the Hanford SST and DST waste in support of the Regulatory DQO. The compounds considered for additional analyses are non-detected, considered stable in the tank waste matrix, and of higher toxicity/carcinogenicity.

RCRA, superfund and EPCRA hotline training module. Introduction to: RCRA corrective action updated July 1996

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1996-07-01

The module discusses the regulatory and statutory requirements and authorities governing the Resource Conservation and Recovery Act (RCRA) corrective action process. There are minimal regulatory requirements at present, but the Agency has issued a proposed rule (55 FR 30798; July 27, 1990) that would establish a comprehensive regulatory framework for implementing the corrective action program. This proposed rule and other guidance developed pursuant to statutory authorities are used to structure corrective action requirements in facility permits and orders. This module describes the current statutory and regulatory structure and discusses the future of the proposed rule.

Drug evaluation in children 10years after the European pediatric regulation current challenges and perspectives.

PubMed

Élie, Valery; Leroux, Stéphanie; Kaguelidou, Florentia; Jacqz-Aigrain, Evelyne

2018-04-01

The European pediatric regulation, that entered into force in June 2007 with the objectives to improve the health of children in Europe, dramatically changed the regulatory environment of paediatric drug evaluation in Europe. The recent 10years European medicines agency (EMA) report showed that the number of paediatric trials increased and that 238 new medicines and indications for use in children were authorised in the EU. However, results remain constrated and futur developments require european collaborations beween all experts in developmental pharmacology, drug evaluation and trial conduct, training, all aspects already considered in different EU paediatric programs. Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Toll-like receptors in inflammatory bowel diseases: A decade later

PubMed Central

Cario, Elke

2010-01-01

Differential alteration of Toll-like receptor (TLR) expression in inflammatory bowel disease (IBD) was first described 10 years ago. Since then, studies from many groups have led to the current concept that TLRs represent key mediators of innate host defense in the intestine, involved in maintaining mucosal as well as commensal homeostasis. Recent findings in diverse murine models of colitis have helped to reveal the mechanistic importance of TLR dysfunction in IBD pathogenesis. It has become evident that environment, genetics, and host immunity form a multidimensional and highly interactive regulatory triad that controls TLR function in the intestinal mucosa. Imbalanced relationships within this triad may promote aberrant TLR signaling, critically contributing to acute and chronic intestinal inflammatory processes in IBD colitis and associated cancer. (Inflamm Bowel Dis 2010) PMID:20803699

A variational approach to niche construction.

PubMed

Constant, Axel; Ramstead, Maxwell J D; Veissière, Samuel P L; Campbell, John O; Friston, Karl J

2018-04-01

In evolutionary biology, niche construction is sometimes described as a genuine evolutionary process whereby organisms, through their activities and regulatory mechanisms, modify their environment such as to steer their own evolutionary trajectory, and that of other species. There is ongoing debate, however, on the extent to which niche construction ought to be considered a bona fide evolutionary force, on a par with natural selection. Recent formulations of the variational free-energy principle as applied to the life sciences describe the properties of living systems, and their selection in evolution, in terms of variational inference. We argue that niche construction can be described using a variational approach. We propose new arguments to support the niche construction perspective, and to extend the variational approach to niche construction to current perspectives in various scientific fields. © 2018 The Authors.

Modern banking, collection, compatibility testing and storage of blood and blood components.

PubMed

Green, L; Allard, S; Cardigan, R

2015-01-01

The clinical practice of blood transfusion has changed considerably over the last few decades. The potential risk of transfusion transmissible diseases has directed efforts towards the production of safe and high quality blood. All transfusion services now operate in an environment of ever-increasing regulatory controls encompassing all aspects of blood collection, processing and storage. Stringent donor selection, identification of pathogens that can be transmitted through blood, and development of technologies that can enhance the quality of blood, have all led to a substantial reduction in potential risks and complications associated with blood transfusion. In this article, we will discuss the current standards required for the manufacture of blood, starting from blood collection, through processing and on to storage. © 2014 The Association of Anaesthetists of Great Britain and Ireland.

A variational approach to niche construction

PubMed Central

Ramstead, Maxwell J. D.; Veissière, Samuel P. L.; Campbell, John O.; Friston, Karl J.

2018-01-01

In evolutionary biology, niche construction is sometimes described as a genuine evolutionary process whereby organisms, through their activities and regulatory mechanisms, modify their environment such as to steer their own evolutionary trajectory, and that of other species. There is ongoing debate, however, on the extent to which niche construction ought to be considered a bona fide evolutionary force, on a par with natural selection. Recent formulations of the variational free-energy principle as applied to the life sciences describe the properties of living systems, and their selection in evolution, in terms of variational inference. We argue that niche construction can be described using a variational approach. We propose new arguments to support the niche construction perspective, and to extend the variational approach to niche construction to current perspectives in various scientific fields. PMID:29643221

Health claims on food products in Southeast Asia: regulatory frameworks, barriers, and opportunities.

PubMed

Tan, Karin Y M; van der Beek, Eline M; Chan, M Y; Zhao, Xuejun; Stevenson, Leo

2015-09-01

The Association of Southeast Asian Nations aims to act as a single market and allow free movement of goods, services, and manpower. The purpose of this article is to present an overview of the current regulatory framework for health claims in Southeast Asia and to highlight the current barriers and opportunities in the regulatory frameworks in the Association of Southeast Asian Nations. To date, 5 countries in Southeast Asia, i.e., Indonesia, Malaysia, the Philippines, Singapore, and Thailand, have regulations and guidelines to permit the use of health claims on food products. There are inconsistencies in the regulations and the types of evidence required for health claim applications in these countries. A clear understanding of the regulatory frameworks in these countries may help to increase trade in this fast-growing region and to provide direction for the food industry and the regulatory community to develop and market food products with better nutritional quality tailored to the needs of Southeast Asian consumers. © The Author(s) 2015. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

The regulatory battleground: A briefing for commanders

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wirick, D.

1995-12-31

This imperfect analogy likens the history and current status of public utility regulation to a military campaign. Clearly, the relationship between regulators and utilities has not always been combative, but intermittent conflict has necessarily characterized the relationship. Nonetheless, this military analogy describes some of the elements of the history of regulation and may have implications for regulatory policy in the near term. The scene is a battlefield headquarters not far from the heat of the conflict. The commanders of regulatory units are gathered. In the distance, the low rumble of troop movements can be heard. Ladies and gentlemen, please takemore » your seats. As you are aware, recent developments have placed regulatory forces in extreme jeopardy. Our forces are under stress, and though they continue to fight, the confusion of the current situation is beginning to take its toll. In most cases, reinforcements have been denied and our lines of logistical support have been weakened. Without effective and rapid action on our part, the regulatory battle will be lost and we will be driven from the field. Until consumers are well-enough armed to protect themselves, a process that is certainly suspect and potentially time-consuming, they will be powerless and undoubtedly victimized.« less

Trajectories of regulatory behaviors in early infancy: Determinants of infant self-distraction and self-comforting.

PubMed

Planalp, Elizabeth M; Braungart-Rieker, Julia M

2015-03-01

The ability to effectively regulate emotions is an important marker for early socioemotional development. The uses of self-comforting behaviors and self-distraction have been empirically supported as effective regulatory strategies for infants, though research on determinants of such behaviors is scarce. Thus, a more thorough examination of the development of regulatory behaviors is needed. For the current study, 135 mothers, fathers, and their infants participated in laboratory visits at 3-, 5-, and 7-months of age where parent sensitivity and infant regulatory strategies were coded from the Still Face Paradigm. Parents also filled out questionnaires about infant temperament and parental involvement. Using multi-level modeling to examine levels and trajectories of self-comforting and self-distraction, the current study found: 1) infants higher in temperamental surgency used more self-distraction and self-comforting, 2) infants lower in surgency with highly involved parents increased in self-distraction at a faster rate, particularly with highly involved fathers, and 3) infants used self-comforting more than average with fathers when the infant was also lower in temperamental regulation. In addition, we examined trajectories of parent involvement and temperament in relation to infant regulatory strategy.

Environmental impacts and regulatory policy implications of spray disposal of dredged material in Louisiana wetlands

USGS Publications Warehouse

Cahoon, D.R.; Cowan, J.H.

1988-01-01

The capabilities of a new wetland dredging technology were assessed along with associated newly developed state and federal regulatory policies to determine if policy expectations realistically match the technological achievement. Current regulatory practices require amelioration of spoil bank impacts upon abandonment of an oil/gas well, but this may not occur for many years or decades, if at all. Recently, a dreding method (high-pressure spray spoil disposal) was developed that does not create a spoil bank in the traditional sense. Its potential for reducing environmental impacts was recognized immediately by regulatory agencies for whom minimizing spoil bank impacts is a major concern. The use of high-pressure spray disposal as a suitable alternative to traditional dreding technology has been adopted as policy even though its value as a management tool has never been tested or verified. A qualitative evaluation at two spoil disposal sites in saline marsh indicates that high-pressure spray disposal may indeed have great potential to minimize impacts, but most of this potential remains unverified. Also, some aspects of current regulatory policy may be based on unrealistic expectations as to the ability of this new technology to minimize or eliminate spoil bank impacts.

Remedial Action Assessment System (RAAS): Evaluation of selected feasibility studies of CERCLA (Comprehensive Environmental Response, Compensation, and Liability Act) hazardous waste sites

DOE Office of Scientific and Technical Information (OSTI.GOV)

Whelan, G.; Hartz, K.E.; Hilliard, N.D.

1990-04-01

Congress and the public have mandated much closer scrutiny of the management of chemically hazardous and radioactive mixed wastes. Legislative language, regulatory intent, and prudent technical judgment, call for using scientifically based studies to assess current conditions and to evaluate and select costeffective strategies for mitigating unacceptable situations. The NCP requires that a Remedial Investigation (RI) and a Feasibility Study (FS) be conducted at each site targeted for remedial response action. The goal of the RI is to obtain the site data needed so that the potential impacts on public health or welfare or on the environment can be evaluatedmore » and so that the remedial alternatives can be identified and selected. The goal of the FS is to identify and evaluate alternative remedial actions (including a no-action alternative) in terms of their cost, effectiveness, and engineering feasibility. The NCP also requires the analysis of impacts on public health and welfare and on the environment; this analysis is the endangerment assessment (EA). In summary, the RI, EA, and FS processes require assessment of the contamination at a site, of the potential impacts in public health or the environment from that contamination, and of alternative RAs that could address potential impacts to the environment. 35 refs., 7 figs., 1 tab.« less

75 FR 81316 - Detroit Edison Company; FERMI 2; Environmental Assessment and Finding of No Significant Impact

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-27

... Department of Natural Resources and Environment regarding the environmental impact of the proposed action... the human environment. Accordingly, the NRC has determined not to prepare an environmental impact... Assessment and Finding of No Significant Impact The U.S. Nuclear Regulatory Commission (NRC) is considering...

The Legal Environment for Hardwood Lands in California

Treesearch

Sam Doak; Kass Green; Sally K. Fairfax; Sharon G. Johnson

1991-01-01

Intensified use of California's hardwood lands is evolving rapidly. With these changes come clashes over the appropriateness of various land uses and, in some cases, regulatory efforts to control some of these activities. The legal environment facing hardwood landowners is a confusing mix of state, Federal, and local measures. This paper first describes and...

78 FR 16177 - Safety Zone; M/V XIANG YUN KOU and MODU NOBLE DISCOVERER; Resurrection Bay, Seward, AK

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-14

... and comment. Immediate action is needed to protect human life, property, and the environment from... regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small... voluntary consensus standards. 14. Environment We have analyzed this rule under Department of Homeland...

Using Economic Experiments to Test Electricity Policy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kiesling, Lynne

2005-11-01

The industry's history of central generation, coordination, and regulation breeds a natural suspicion of whether or not decentralized coordination and a more market-based, decentralized regulatory approach can work. To see how people will behave in a decentralized environment with decentralized institutions, one must test the environment and institutions experimentally, with real people.

The Design of Technology-Rich Learning Environments as Metacognitive Tools in History Education

ERIC Educational Resources Information Center

Poitras, Eric; Lajoie, Susanne; Hong, Yuan-Jin

2012-01-01

Research has shown that learners do not always engage in appropriate metacognitive and self-regulatory processes while learning complex historical topics. However, little research exists to guide the design of technology-rich learning environments as metacognitive tools in history education. In order to address this issue, we designed a…

The Personal Learning Environment and the Human Condition: From Theory to Teaching Practice

ERIC Educational Resources Information Center

Johnson, Mark; Liber, Oleg

2008-01-01

We present the Personal Learning Environment (PLE) as a practical intervention concerning the organization of technology in education. We explain this by proposing a cybernetic model of the "Personal Learner" using Beer's Viable System Model (VSM). Using the VSM, we identify different regulatory mechanisms that maintain viability for learners, and…

POLLUTION FROM PERSONAL ACTIONS, ACTIVITIES, AND BEHAVIORS: PHARMACEUTICALS AND PERSONAL CARE PRODUCTS IN THE ENVIRONMENT MULTIDIMENSIONAL SCIENCE ISSUES RELEVANT TO REGULATORY CONSIDERATIONS

EPA Science Inventory

Perhaps more so than with any other class of anthropogenic chemicals, the occurrence of pharmaceuticals and personal care products (PPCPS) in the environment highlights the immediate, intimate, and inseparable connection between the personal activities of individual citizens and ...

The CLIA-Model: A Framework for Designing Powerful Learning Environments for Thinking and Problem Solving

ERIC Educational Resources Information Center

De Corte, Erik; Verschaffel, Lieven; Masui, Chris

2004-01-01

A major challenge for education and educational research is to build on our present understanding of learning for designing environments for education that are conducive to fostering in students self-regulatory and cooperative learning skills, transferable knowledge, and a disposition toward competent thinking and problem solving. Taking into…

Effects of Four Different Regulatory Mechanisms on the Dynamics of Gene Regulatory Cascades

NASA Astrophysics Data System (ADS)

Hansen, Sabine; Krishna, Sandeep; Semsey, Szabolcs; Lo Svenningsen, Sine

2015-07-01

Gene regulatory cascades (GRCs) are common motifs in cellular molecular networks. A given logical function in these cascades, such as the repression of the activity of a transcription factor, can be implemented by a number of different regulatory mechanisms. The potential consequences for the dynamic performance of the GRC of choosing one mechanism over another have not been analysed systematically. Here, we report the construction of a synthetic GRC in Escherichia coli, which allows us for the first time to directly compare and contrast the dynamics of four different regulatory mechanisms, affecting the transcription, translation, stability, or activity of a transcriptional repressor. We developed a biologically motivated mathematical model which is sufficient to reproduce the response dynamics determined by experimental measurements. Using the model, we explored the potential response dynamics that the constructed GRC can perform. We conclude that dynamic differences between regulatory mechanisms at an individual step in a GRC are often concealed in the overall performance of the GRC, and suggest that the presence of a given regulatory mechanism in a certain network environment does not necessarily mean that it represents a single optimal evolutionary solution.

RegPrecise 3.0--a resource for genome-scale exploration of transcriptional regulation in bacteria.

PubMed

Novichkov, Pavel S; Kazakov, Alexey E; Ravcheev, Dmitry A; Leyn, Semen A; Kovaleva, Galina Y; Sutormin, Roman A; Kazanov, Marat D; Riehl, William; Arkin, Adam P; Dubchak, Inna; Rodionov, Dmitry A

2013-11-01

Genome-scale prediction of gene regulation and reconstruction of transcriptional regulatory networks in prokaryotes is one of the critical tasks of modern genomics. Bacteria from different taxonomic groups, whose lifestyles and natural environments are substantially different, possess highly diverged transcriptional regulatory networks. The comparative genomics approaches are useful for in silico reconstruction of bacterial regulons and networks operated by both transcription factors (TFs) and RNA regulatory elements (riboswitches). RegPrecise (http://regprecise.lbl.gov) is a web resource for collection, visualization and analysis of transcriptional regulons reconstructed by comparative genomics. We significantly expanded a reference collection of manually curated regulons we introduced earlier. RegPrecise 3.0 provides access to inferred regulatory interactions organized by phylogenetic, structural and functional properties. Taxonomy-specific collections include 781 TF regulogs inferred in more than 160 genomes representing 14 taxonomic groups of Bacteria. TF-specific collections include regulogs for a selected subset of 40 TFs reconstructed across more than 30 taxonomic lineages. Novel collections of regulons operated by RNA regulatory elements (riboswitches) include near 400 regulogs inferred in 24 bacterial lineages. RegPrecise 3.0 provides four classifications of the reference regulons implemented as controlled vocabularies: 55 TF protein families; 43 RNA motif families; ~150 biological processes or metabolic pathways; and ~200 effectors or environmental signals. Genome-wide visualization of regulatory networks and metabolic pathways covered by the reference regulons are available for all studied genomes. A separate section of RegPrecise 3.0 contains draft regulatory networks in 640 genomes obtained by an conservative propagation of the reference regulons to closely related genomes. RegPrecise 3.0 gives access to the transcriptional regulons reconstructed in bacterial genomes. Analytical capabilities include exploration of: regulon content, structure and function; TF binding site motifs; conservation and variations in genome-wide regulatory networks across all taxonomic groups of Bacteria. RegPrecise 3.0 was selected as a core resource on transcriptional regulation of the Department of Energy Systems Biology Knowledgebase, an emerging software and data environment designed to enable researchers to collaboratively generate, test and share new hypotheses about gene and protein functions, perform large-scale analyses, and model interactions in microbes, plants, and their communities.

Mapping cis-Regulatory Domains in the Human Genome UsingMulti-Species Conservation of Synteny

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ahituv, Nadav; Prabhakar, Shyam; Poulin, Francis

2005-06-13

Our inability to associate distant regulatory elements with the genes that they regulate has largely precluded their examination for sequence alterations contributing to human disease. One major obstacle is the large genomic space surrounding targeted genes in which such elements could potentially reside. In order to delineate gene regulatory boundaries we used whole-genome human-mouse-chicken (HMC) and human-mouse-frog (HMF) multiple alignments to compile conserved blocks of synteny (CBS), under the hypothesis that these blocks have been kept intact throughout evolution at least in part by the requirement of regulatory elements to stay linked to the genes that they regulate. A totalmore » of 2,116 and 1,942 CBS>200 kb were assembled for HMC and HMF respectively, encompassing 1.53 and 0.86 Gb of human sequence. To support the existence of complex long-range regulatory domains within these CBS we analyzed the prevalence and distribution of chromosomal aberrations leading to position effects (disruption of a genes regulatory environment), observing a clear bias not only for mapping onto CBS but also for longer CBS size. Our results provide a genome wide data set characterizing the regulatory domains of genes and the conserved regulatory elements within them.« less

EGRINs (Environmental Gene Regulatory Influence Networks) in Rice That Function in the Response to Water Deficit, High Temperature, and Agricultural Environments[OPEN

PubMed Central

Hafemeister, Christoph; Nicotra, Adrienne B.; Jagadish, S.V. Krishna; Bonneau, Richard; Purugganan, Michael

2016-01-01

Environmental gene regulatory influence networks (EGRINs) coordinate the timing and rate of gene expression in response to environmental signals. EGRINs encompass many layers of regulation, which culminate in changes in accumulated transcript levels. Here, we inferred EGRINs for the response of five tropical Asian rice (Oryza sativa) cultivars to high temperatures, water deficit, and agricultural field conditions by systematically integrating time-series transcriptome data, patterns of nucleosome-free chromatin, and the occurrence of known cis-regulatory elements. First, we identified 5447 putative target genes for 445 transcription factors (TFs) by connecting TFs with genes harboring known cis-regulatory motifs in nucleosome-free regions proximal to their transcriptional start sites. We then used network component analysis to estimate the regulatory activity for each TF based on the expression of its putative target genes. Finally, we inferred an EGRIN using the estimated transcription factor activity (TFA) as the regulator. The EGRINs include regulatory interactions between 4052 target genes regulated by 113 TFs. We resolved distinct regulatory roles for members of the heat shock factor family, including a putative regulatory connection between abiotic stress and the circadian clock. TFA estimation using network component analysis is an effective way of incorporating multiple genome-scale measurements into network inference. PMID:27655842

Low-income minority fathers' control strategies and children's regulatory skills

PubMed Central

Malin, Jenessa L.; Cabrera, Natasha J.; Karberg, Elizabeth; Aldoney, Daniela; Rowe, Meredith

2015-01-01

The current study explored the bidirectional association of children's individual characteristics, fathers' control strategies at 24-months and children's regulatory skills at pre-kindergarten (pre-K). Using a sample of low-income minority families with 2-year-olds from the Early Head Start Evaluation Research Program (n = 71) we assessed the association between child gender and vocabulary skills, fathers' control strategies at 24-months (e.g., regulatory behavior and regulatory language), and children's sustained attention and emotion regulation at pre-kindergarten. There were three main findings. First, fathers' overwhelmingly use commands (e.g., do that) to promote compliance in their 24-month old children. Second, children's vocabulary skills predict fathers' regulatory behaviors during a father-child interaction, whereas children's gender predicts fathers' regulatory language during an interaction. Third, controlling for maternal supportiveness, fathers' regulatory behaviors at 24-months predict children's sustained attention at pre-kindergarten whereas fathers' regulatory language at 24-months predicts children's emotion regulation at pre-kindergarten. Our findings highlight the importance of examining paternal contributions to children's regulatory skills. PMID:25798496

Low-income, minority fathers' control strategies and their children's regulatory skills.

PubMed

Malin, Jenessa L; Cabrera, Natasha J; Karberg, Elizabeth; Aldoney, Daniela; Rowe, Meredith L

2014-01-01

The current study explored the bidirectional association of children's individual characteristics, fathers' control strategies at 24 months, and children's regulatory skills at prekindergarten (pre-K). Using a sample of low-income, minority families with 2-year-olds from the Early Head Start Research and Evaluation Project (n = 71), we assessed the association between child gender and vocabulary skills, fathers' control strategies at 24 months (e.g., regulatory behavior and regulatory language), and children's sustained attention and emotion regulation at prekindergarten. There were three main findings. First, fathers overwhelmingly used commands (e.g., "Do that.") to promote compliance in their 24-month-old children. Second, children's vocabulary skills predicted fathers' regulatory behaviors during a father-child interaction whereas children's gender predicted fathers' regulatory language during an interaction. Third, controlling for maternal supportiveness, fathers' regulatory behaviors at 24 months predicted children's sustained attention at pre-K whereas fathers' regulatory language at 24 months predicted children's emotion regulation at pre-K. Our findings highlight the importance of examining paternal contributions to children's regulatory skills. © 2014 Michigan Association for Infant Mental Health.

COUNCIL FOR REGULATORY ENVIRONMENTAL MODELING (CREM) PILOT WATER QUALITY MODEL SELECTION TOOL

EPA Science Inventory

EPA's Council for Regulatory Environmental Modeling (CREM) is currently supporting the development of a pilot model selection tool that is intended to help the states and the regions implement the total maximum daily load (TMDL) program. This tool will be implemented within the ...

77 FR 26768 - Food and Drug Administration/International Society for Pharmaceutical Engineering Cosponsorship...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-07

... year, FDA speakers provide updates on current efforts affecting the development of global regulatory strategies, while industry professionals from some of today's leading pharmaceutical companies present case... hear directly from FDA experts and representatives of global regulatory authorities on best practices...

Issues in mass spectrometry between bench chemists and regulatory laboratory managers

USDA-ARS?s Scientific Manuscript database

At the 123rd AOAC Annual Meeting in Philadelphia, 45 residue chemists gathered for a roundtable discussion of mass spectrometry (MS) for regulatory purposes involving chemical residues analysis. The session was conceived to address current technical and communication issues about MS between “bench ...

The road to pharmacist prescribing in Alberta Health Services.

PubMed

Gray, Margaret; Mysak, Tania

2016-09-15

The implementation of policy within a health organization to support a new legislative and regulatory framework of pharmacist prescribing in the Canadian province of Alberta is described. The evolution of pharmacists' practice activities to encompass medication management through independent prescribing authority has occurred in many jurisdictions around the world. In 2007, Alberta pharmacists were granted the most progressive scope of practice in all of North America. Pursuant to a series of legislative and regulatory initiatives enacted since 2000, the provincial health authority, Alberta Health Services (AHS), has worked to (1) establish a policy framework that supports pharmacist prescribing, (2) provide opportunities for pharmacist prescribing in both inpatient and ambulatory care practice environments, and (3) provide motivation and resources for AHS pharmacists to acquire "additional prescribing authorization" (APA) that enables them to independently prescribe and manage patients' ongoing drug therapy. Pharmacists with APA currently are permitted to prescribe all medications requiring a prescription, with the exception of opiates and other controlled substances; efforts to expand pharmacist prescribing to include those medications are ongoing. Currently, nearly half of all AHS pharmacists have APA. The health authority plans to make APA a standard expectation for all clinical pharmacists working in collaborative practice settings. Opportunities provided to Alberta pharmacists by legislation have been embraced by the provincial health authority. The AHS leadership remains committed to ensuring that its pharmacists practice to the full extent of their scope of practice and actively encourages and supports them in their efforts to provide optimal patient care. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Contemporary Obstetric Triage.

PubMed

Sandy, Edward Allen; Kaminski, Robert; Simhan, Hygriv; Beigi, Richard

2016-03-01

The role of obstetric triage in the care of pregnant women has expanded significantly. Factors driving this change include the Emergency Medical Treatment and Active Labor Act, improved methods of testing for fetal well-being, increasing litigation risk, and changes in resident duty hour guidelines. The contemporary obstetric triage facility must have processes in place to provide a medical screening examination that complies with regulatory statues while considering both the facility's maternal level of care and available resources. This review examines the history of the development of obstetric triage, current considerations in a contemporary obstetric triage paradigm, and future areas for consideration. An example of a contemporary obstetric triage program at an academic medical center is presented. A successful contemporary obstetric triage paradigm is one that addresses the questions of "sick or not sick" and "labor or no labor," for every obstetric patient that presents for care. Failure to do so risks poor patient outcome, poor patient satisfaction, adverse litigation outcome, regulatory scrutiny, and exclusion from federal payment programs. Understanding the role of contemporary obstetric triage in the current health care environment is important for both providers and health care leadership. This study is for obstetricians and gynecologists as well as family physicians. After completing this activity, the learner should be better able to understand the scope of a medical screening examination within the context of contemporary obstetric triage; understand how a facility's level of maternal care influences clinical decision making in a contemporary obstetric triage setting; and understand the considerations necessary for the systematic evaluation of the 2 basic contemporary obstetric questions, "sick or not sick?" and "labor or no labor?"

Ethinyl estradiol and other human pharmaceutical estrogens in the aquatic environment: a review of recent risk assessment data.

PubMed

Laurenson, James P; Bloom, Raanan A; Page, Stephen; Sadrieh, Nakissa

2014-03-01

Interest in pharmaceuticals in the environment has increased substantially in recent years. Several studies in particular have assessed human and ecological risks from human pharmaceutical estrogens, such as 17α-ethinyl estradiol (EE2). Regulatory action also has increased, with the USA and other countries developing rules to address estrogens and other pharmaceuticals in the environment. Accordingly, the Center for Drug Evaluation and Research at the US Food and Drug Administration has conducted a review and analysis of current data on the long-term ecological exposure and effects of EE2 and other estrogens. The results indicate that mean-flow long-term predicted environmental concentrations (PECs) of EE2 in approximately 99% or more of US surface water segments downstream of wastewater treatment plants are lower than a predicted no-effect concentration (PNEC) for aquatic chronic toxicity of 0.1 ng/L. Exceedances are expected to be primarily in localized, effluent-dominated water segments. The median mean-flow PEC is more than two orders of magnitude lower than this PNEC. Similar results exist for other pharmaceutical estrogens. Data also suggest that the contribution of EE2 more broadly to total estrogenic load in the environment from all sources (including other human pharmaceutical estrogens, endogenous estrogens, natural environmental estrogens, and industrial chemicals), while highly uncertain and variable, appears to be relatively low overall. Additional data and a more comprehensive approach for data collection and analysis for estrogenic substances in the environment, especially in effluent-dominated water segments in sensitive environments, would more fully characterize the risks.

The past, present, and future of the U.S. electric power sector: Examining regulatory changes using multivariate time series approaches

NASA Astrophysics Data System (ADS)

Binder, Kyle Edwin

The U.S. energy sector has undergone continuous change in the regulatory, technological, and market environments. These developments show no signs of slowing. Accordingly, it is imperative that energy market regulators and participants develop a strong comprehension of market dynamics and the potential implications of their actions. This dissertation contributes to a better understanding of the past, present, and future of U.S. energy market dynamics and interactions with policy. Advancements in multivariate time series analysis are employed in three related studies of the electric power sector. Overall, results suggest that regulatory changes have had and will continue to have important implications for the electric power sector. The sector, however, has exhibited adaptability to past regulatory changes and is projected to remain resilient in the future. Tests for constancy of the long run parameters in a vector error correction model are applied to determine whether relationships among coal inventories in the electric power sector, input prices, output prices, and opportunity costs have remained constant over the past 38 years. Two periods of instability are found, the first following railroad deregulation in the U.S. and the second corresponding to a number of major regulatory changes in the electric power and natural gas sectors. Relationships among Renewable Energy Credit prices, electricity prices, and natural gas prices are estimated using a vector error correction model. Results suggest that Renewable Energy Credit prices do not completely behave as previously theorized in the literature. Potential reasons for the divergence between theory and empirical evidence are the relative immaturity of current markets and continuous institutional intervention. Potential impacts of future CO2 emissions reductions under the Clean Power Plan on economic and energy sector activity are estimated. Conditional forecasts based on an outlined path for CO2 emissions are developed from a factor-augmented vector autoregressive model for a large dataset. Unconditional and conditional forecasts are compared for U.S. industrial production, real personal income, and estimated factors. Results suggest that economic growth will be slower under the Clean Power Plan than it would otherwise; however, CO2 emissions reductions and economic growth can be achieved simultaneously.

Timing is everything :

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kobos, Peter Holmes; Walker, La Tonya Nicole; Malczynski, Leonard A.

People save for retirement throughout their career because it is virtually impossible to save all youll need in retirement the year before you retire. Similarly, without installing incremental amounts of clean fossil, renewable or transformative energy technologies throughout the coming decades, a radical and immediate change will be near impossible the year before a policy goal is set to be in place. Therefore, our research question is, To meet our desired technical and policy goals, what are the factors that affect the rate we must install technology to achieve these goals in the coming decades? Existing models do not includemore » full regulatory constraints due to their often complex, and inflexible approaches to solve for optimal engineering instead of robust and multidisciplinary solutions. This project outlines the theory and then develops an applied software tool to model the laboratory-to-market transition using the traditional technology readiness level (TRL) framework, but develops subsequent and a novel regulatory readiness level (RRL) and market readiness level (MRL). This tool uses the ideally-suited system dynamics framework to incorporate feedbacks and time delays. Future energy-economic-environment models, regardless of their programming platform, may adapt this software model component framework or module to further vet the likelihood of new or innovative technology moving through the laboratory, regulatory and market space. The prototype analytical framework and tool, called the Technology, Regulatory and Market Readiness Level simulation model (TRMsim) illustrates the interaction between technology research, application, policy and market dynamics as they relate to a new or innovative technology moving from the theoretical stage to full market deployment. The initial results that illustrate the models capabilities indicate for a hypothetical technology, that increasing the key driver behind each of the TRL, RRL and MRL components individually decreases the time required for the technology to progress through each component by 63, 68 and 64%, respectively. Therefore, under the current working assumptions, to decrease the time it may take for a technology to move from the conceptual stage to full scale market adoption one might consider expending additional effort to secure regulatory approval and reducing the uncertainty of the technologys demand in the marketplace.« less

[Regulatory requirements regarding cell-based medicinal products for human and veterinary use - a comparison].

PubMed

Kuhlmann-Gottke, Johanna; Duchow, Karin

2015-11-01

At present, there is no separate regulatory framework for cell-based medicinal products (CBMP) for veterinary use at the European or German level. Current European and national regulations exclusively apply to the corresponding medicinal products for human use. An increasing number of requests for the regulatory classification of CBMP for veterinary use, such as allogeneic stem cell preparations and dendritic cell-based autologous tumour vaccines, and a rise in scientific advice for companies developing these products, illustrate the need for adequate legislation. Currently, advice is given and decisions are made on a case-by-case basis regarding the regulatory classification and authorisation requirements.Since some of the CBMP - in particular in the area of stem-cell products - are developed in parallel for human and veterinary use, there is an urgent need to create specific legal definitions, regulations, and guidelines for these complex innovative products in the veterinary sector as well. Otherwise, there is a risk that that the current legal grey area regarding veterinary medicinal products will impede therapeutic innovations in the long run. A harmonised EU-wide approach is desirable. Currently the European legislation on veterinary medicinal products is under revision. In this context, veterinary therapeutics based on allogeneic cells and tissues will be defined and regulated. Certainly, the legal framework does not have to be as comprehensive as for human CBMP; a leaner solution is conceivable, similar to the special provisions for advanced-therapy medicinal products laid down in the German Medicines Act.

An electronic regulatory document management system for a clinical trial network.

PubMed

Zhao, Wenle; Durkalski, Valerie; Pauls, Keith; Dillon, Catherine; Kim, Jaemyung; Kolk, Deneil; Silbergleit, Robert; Stevenson, Valerie; Palesch, Yuko

2010-01-01

A computerized regulatory document management system has been developed as a module in a comprehensive Clinical Trial Management System (CTMS) designed for an NIH-funded clinical trial network in order to more efficiently manage and track regulatory compliance. Within the network, several institutions and investigators are involved in multiple trials, and each trial has regulatory document requirements. Some of these documents are trial specific while others apply across multiple trials. The latter causes a possible redundancy in document collection and management. To address these and other related challenges, a central regulatory document management system was designed. This manuscript shares the design of the system as well as examples of it use in current studies. Copyright (c) 2009 Elsevier Inc. All rights reserved.

In Vitro, In Vivo and Post Explantation Testing of Glucose-Detecting Biosensors: Current Methods and Recommendations

PubMed Central

Koschwanez, Heidi E.; Reichert, W. Monty

2007-01-01

To date, there have been a number of cases where glucose sensors have performed well over long periods of implantation; however, it remains difficult to predict whether a given sensor will perform reliably, will exhibit gradual degradation of performance, or will fail outright soon after implantation. Typically, the literature emphasizes the sensor that performed well, while only briefly (if at all) mentioning the failed devices. This leaves open the question of whether current sensor designs are adequate for the hostile in vivo environment, and whether these sensors have been assessed by the proper regimen of testing protocols. This paper reviews the current in vitro and in vivo testing procedures used to evaluate the functionality and biocompatibility of implantable glucose sensors. An overview of the standards and regulatory bodies that govern biomaterials and end-product device testing precedes a discussion of up-to-date invasive and non-invasive technologies for diabetes management. Analysis of current in vitro, in vivo, and then post implantation testing is presented. Given the underlying assumption that the success of the sensor in vivo foreshadows the long-term reliability of the sensor in the human body, the relative merits of these testing methods are evaluated with respect to how representative they are of human models. PMID:17524479

America's "undiscovered" laboratory for health services research.

PubMed

Gimbel, Ronald W; Pangaro, Louis; Barbour, Galen

2010-08-01

Debate over reforming the nation's healthcare system has stimulated a need for health services research (HSR) models that are nationally applicable. Toward this end, the authors identify the Military Health System (MHS) as America's "undiscovered" laboratory for HSR. Although many may confuse the MHS with the Department of Veterans Affairs (VA), the 2 systems vary dramatically with respect to their beneficiary populations, access to care, and other important attributes. In this article, the authors describe key characteristics of the MHS including its large beneficiary base, its direct care operating environment, its dedicated medical school and graduate education programs, and its fully operational integrated health information system. Although a few health systems (eg, Kaiser Permanente, Partners Healthcare, and Department of Veterans Affairs) possess some characteristics, no other has all of these components in place. This article sets the stage for contemporary HSR studies with broad applicability to current issues in American healthcare that could be performed within the MHS. Inclusion of the MHS environment in HSR studies of health services delivery modalities, adoption of health information technology, access to care, relationship of medical education to effective safe care delivery, health disparities, child health, and behavioral health would provide strong underpinnings for proposed changes in American healthcare delivery. Finally, the article highlights current regulatory barriers to research within the MHS whereas suggesting steps to minimize their impact in conducting HSR.

Nurse leaders' perceptions of what compromises successful leadership in today's acute inpatient environment.

PubMed

Upenieks, Valda

2003-01-01

The purpose of this study was to gain an understanding of nurse leaders' perceptions of both the value of their roles in today's health care setting and their beliefs about how power and gender interface with role worth. Support for the theoretical significance of this research stemmed from Kanter's Structural Theory of Organizational Behavior. Four leaders were recruited at the executive level and 12 at the director/managerial level. The results of the deductive analysis supported Kanter's theory. Eighty-three percent of the nurse leaders validated that access to power, opportunity, information, and resources created an empowered environment, producing a climate that fostered leadership success and enhanced levels of job satisfaction among nurses. This study provided groundwork on the kinds of leadership traits that foster nursing satisfaction and on whether or not gender influences leadership effectiveness. The findings of this study are both timely and relevant for nurse leaders faced with the effects of the current supply-and-demand nursing shortage and with fiscal restraints mandated by managed care and regulatory agencies.

Biomarkers and their dependence on well-reported antibodies.

PubMed

Voskuil, Jan

2015-11-01

Jan Voskuil is the Chief Scientific Officer at antibody manufacturer Everest Biotech in Oxfordshire, UK. After specializing in prokaryotic cell biology through his PhD program in Amsterdam, The Netherlands and a postdoctorate position at Stanford (CA, USA), he switched to the science of neurodegenerative diseases at Oxford, UK through postdoctorate positions at Dunn School of Pathology and at MRC and through a leading position at the Alzheimer drug discovery company Synaptica. He subsequently gained experience in a Good Laboratory Practice-regulatory environment in contract research organization companies both in Oxfordshire and Cambridgeshire, validating assays in Flow Cytometry and ELISA platforms and writing standard operating procedures. His extensive experience with generating and characterizing monoclonal and polyclonal antibodies in combination with accrued knowledge on most immunoassays in academic and commercial environments made him the ideal candidate to take charge in putting Everest Biotech on the global map by ever raising the quality and size of its catalog and by delivery of adequate technical support. As a result, Everest antibodies are currently part of most globally well-known catalogs, and its products are increasingly recognized as useful alternatives to unfit monoclonal antibodies.

["Get it while you can!" attitude: late industrialization and implications for work, environment, and health in Ceará State, Brazil].

PubMed

Rigotto, Raquel Maria

2007-01-01

The present study focuses on the characteristics of late industrialization in a city in Ceará State (in the semiarid region of Northeast Brazil) and its implications for work, environment, and health in the context of industrial mobility and advanced capitalism. Using direct observation of work processes, interviews (with production managers, company presidents, workers, local authorities, and community leaders), institutional visits and secondary data analysis, eight recently built factories that manufacture chemicals, shoes, electric appliances, clothing, mechanical parts, and packaging were analyzed as to relocation, technology, organization, work relations, worker profile, environmental and occupational risks, and the impact of these factors on health and regulatory mechanisms. The lack of adequate criteria for attracting and accepting new investments, leading to a "get it while you can" attitude, the poor quality of jobs and environmental conditions, and the scale of new changes and risks in the area, like the difficulties of the public sector and society in dealing with these challenges, raise the issue of sustainability in the current development processes.

Environmental Implementation Plan

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1994-02-01

The Environmental Implementation Plan (EIP) is a dynamic long-range environmental-protection plan for SRS. The EIP communicates the current and future (five year) environmental plans from individual organizations and divisions as well as site environmental initiatives which are designed to protect the environment and meet or exceed compliance with changing environmental/ regulatory requirements. Communication with all site organizations is essential for making the site environmental planning process work. Demonstrating environmental excellence is a high priority embodied in DOE and WSRC policy. Because of your support and participation in the three EIP initiatives; Reflections, Sectional Revision, and Integrated Planning, improvements are beingmore » made to the EIP and SRS environmental protection programs. I appreciate the ``Partnership in Environmental Excellence`` formed by the environmental coordinators and professionals who work daily toward our goal of compliance and environmental excellence. I look forward to seeing continued success and improvement in our environmental protection programs through combined efforts of all site organizations to protect our employees, the public health, and the environment. Together, we will achieve our site vision for SRS to be the recognized model for Environmental Excellence in the DOE Nuclear Weapons Complex.« less

Helminth–host immunological interactions: prevention and control of immune-mediated diseases

PubMed Central

Elliott, David E.; Weinstock, Joel V.

2013-01-01

Exposure to commensal and pathogenic organisms strongly influences our immune system. Exposure to helminths was frequent before humans constructed their current highly hygienic environment. Today, in highly industrialized countries, contact between humans and helminths is rare. Congruent with the decline in helminth infections is an increase in the prevalence of autoimmune and inflammatory disease. It is possible that exclusion of helminths from the environment has permitted the emergence of immune-mediated disease. We review the protective effects of helminths on expression of inflammatory bowel disease, multiple sclerosis, and animal models of these and other inflammatory diseases. We also review the immune pathways altered by helminths that may afford protection from these illnesses. Helminth exposure tends to inhibit IFN-γ and IL-17 production, promote IL-4, IL-10, and TGF-β release, induce CD4+ T cell Foxp3 expression, and generate regulatory macrophages, dendritic cells, and B cells. Helminths enable protective pathways that may vary by specific species and disease model. Helminths or their products likely have therapeutic potential to control or prevent immune-mediated illness. PMID:22239614

Laser Communication Demonstration System (LCDS) and future mobile satellite services

NASA Technical Reports Server (NTRS)

Chen, Chien-Chung; Wilhelm, Michael D.; Lesh, James R.

1995-01-01

The Laser Communications Demonstration System (LCDS) is a proposed in-orbit demonstration of high data rate laser communications technology conceived jointly by NASA and U.S. industry. The program objectives are to stimulate industry development and to demonstrate the readiness of high data rate optical communications in Earth orbit. For future global satellite communication systems using intersatellite links, laser communications technology can offer reduced mass and power requirements and higher channel bandwidths without regulatory constraints. As currently envisioned, LCDS will consist of one or two orbiting laser communications terminals capable of demonstrating high data rate (greater than 750Mbps) transmission in a dynamic space environment. Two study teams led by Motorola and Ball Aerospace are currently in the process of conducting a Phase A/B mission definition study of LCDS under contracts with JPL/NASA. The studies consist of future application survey, concept and requirements definition, and a point design of the laser communications flight demonstration. It is planned that a single demonstration system will be developed based on the study results. The Phase A/B study is expected to be completed by the coming June, and the current results of the study are presented in this paper.

Guidelines to Avoid Biocontamination of Antarctic Subglacial Aquatic Environments: Forward Contamination Concerns, Environmental Management and Scientific Stewardship of Icy analogue environments

NASA Astrophysics Data System (ADS)

Race, M. S.; Hobbie, J.; et al.

2007-12-01

For more than a decade, scientists and space mission planners have recognized the importance of collaborative information exchange with the Antarctic research community to address their many shared exploration challenges, from drilling methods, remote sample collection, and data interpretation, to concerns about cross contamination that could adversely impact both the environment and interpretation of scientific data. Another shared concern exists in the regulatory realm; both the Antarctic and outer space environments are subject to separate international treaties that impose regulatory controls and oversight with serious implications for exploration planning. In recent years, both communities have faced the need to adjust their regulatory controls in light of fast-paced advances in scientific understanding of extreme environments, particularly related to potential microbial life. Both communities have sought and received advice from the National Research Council (NRC) through studies that suggested ways to update their respective oversight and regulatory systems while allowing for continued scientific exploration. A recently completed NRC study "Exploration of Antarctic Subglacial Aquatic Environments: Environmental and Scientific Stewardship" provided a suite of recommendations to address1) 'cleanliness' levels necessary for equipment and devices used in exploration of subglacial aquatic environments, as well as 2) the scientific basis for contamination standards, and 3) the steps for defining an overall exploration strategy conducive to sound environmental management and scientific stewardship. This talk will present the findings of the recent multinational NRC study, which is likely to translate into useful information for analogue studies that proceed to test techniques and capabilities for exploring an Europan ocean, other icy celestial locations, and related science targets on Earth. As the science and exploration of subglacial environments grows beyond its infancy, the initial methodologies and protocols will undoubtedly continue to need further development and regular revision - making continued collaboration and communication between the polar and space communities mutually beneficial and advisable. NRC Study Committee members: 1 John E. Hobbie (Chair), Marine Biological Laboratory, Woods Hole, Massachusetts; 2 Amy Baker, Technical Administrative Services, Littleton, Colorado; 3 Garry Clarke, The University of British Columbia, Vancouver, Canada; 4 Peter T. Doran, University of Illinois at Chicago, Earth and Environmental Sciences; 5 David Karl, University of Hawaii at Manoa, School of Ocean and Earth Science, Honolulu; 6 Barbara Methé, The Institute for Genomic Research, Rockville, Maryland; 7 Heinz Miller, Alfred-Wegener-Institute for Polar and Marine Research, Germany; 8 Samuel B. Mukasa, University of Michigan, Ann Arbor; 9 Margaret Race, SETI Institute, Mountain View, California; 10 Warwick Vincent, Département de Biologie, Université Laval, Québec, Canada; 11 David Walton, British Antarctic Survey, Cambridge, United Kingdom; 12 James White, University of Colorado, Boulder, 13 Maria Uhle (Study Director), National Research Council.

Exploring REACH as a potential data source for characterizing ecotoxicity in life cycle assessment.

PubMed

Müller, Nienke; de Zwart, Dick; Hauschild, Michael; Kijko, Gaël; Fantke, Peter

2017-02-01

Toxicity models in life cycle impact assessment (LCIA) currently only characterize a small fraction of marketed substances, mostly because of limitations in the underlying ecotoxicity data. One approach to improve the current data situation in LCIA is to identify new data sources, such as the European Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) database. The present study explored REACH as a potential data source for LCIA based on matching reported ecotoxicity data for substances that are currently also included in the United Nations Environment Programme/Society for Environmental Toxicology and Chemistry (UNEP/SETAC) scientific consensus model USEtox for characterizing toxicity impacts. Data are evaluated with respect to number of data points, reported reliability, and test duration, and are compared with data listed in USEtox at the level of hazardous concentration for 50% of the covered species per substance. The results emphasize differences between data available via REACH and in USEtox. The comparison of ecotoxicity data from REACH and USEtox shows potential for using REACH ecotoxicity data in LCIA toxicity characterization, but also highlights issues related to compliance of submitted data with REACH requirements as well as different assumptions underlying regulatory risk assessment under REACH versus data needed for LCIA. Thus, further research is required to address data quality, pre-processing, and applicability, before considering data submitted under REACH as a data source for use in LCIA, and also to explore additionally available data sources, published studies, and reports. Environ Toxicol Chem 2017;36:492-500. © 2016 SETAC. © 2016 SETAC.

Identification, assessment and management of "endocrine disruptors" in wildlife in the EU substance legislation--discussion paper from the German Federal Environment Agency (UBA).

PubMed

Frische, Tobias; Bachmann, Jean; Frein, Daniel; Juffernholz, Tanja; Kehrer, Anja; Klein, Anita; Maack, Gerd; Stock, Frauke; Stolzenberg, Hans-Christian; Thierbach, Claudia; Walter-Rohde, Susanne

2013-12-16

A discussion paper was developed by a panel of experts of the German Federal Environment Agency (UBA) contributing to the on-going debate on the identification, assessment and management of endocrine disruptors with a view to protect wildlife according to the EU substance legislation (plant protection products, biocides, industrial chemicals). Based on a critical synthesis of the state-of-the-art regarding regulatory requirements, testing methods, assessment schemes, decision-making criteria and risk management options, we advise an appropriate and consistent implementation of this important subject into existing chemicals legislation in Europe. Our proposal for a balanced risk management of endocrine disruptors essentially advocates transparent regulatory decision making based on a scientifically robust weight of evidence approach and an adequate risk management consistent across different legislations. With respect to the latter, a more explicit consideration of the principle of proportionality of regulatory decision making and socio-economic benefits in the on-going debate is further encouraged. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Non-animal models of epithelial barriers (skin, intestine and lung) in research, industrial applications and regulatory toxicology.

PubMed

Gordon, Sarah; Daneshian, Mardas; Bouwstra, Joke; Caloni, Francesca; Constant, Samuel; Davies, Donna E; Dandekar, Gudrun; Guzman, Carlos A; Fabian, Eric; Haltner, Eleonore; Hartung, Thomas; Hasiwa, Nina; Hayden, Patrick; Kandarova, Helena; Khare, Sangeeta; Krug, Harald F; Kneuer, Carsten; Leist, Marcel; Lian, Guoping; Marx, Uwe; Metzger, Marco; Ott, Katharina; Prieto, Pilar; Roberts, Michael S; Roggen, Erwin L; Tralau, Tewes; van den Braak, Claudia; Walles, Heike; Lehr, Claus-Michael

2015-01-01

Models of the outer epithelia of the human body - namely the skin, the intestine and the lung - have found valid applications in both research and industrial settings as attractive alternatives to animal testing. A variety of approaches to model these barriers are currently employed in such fields, ranging from the utilization of ex vivo tissue to reconstructed in vitro models, and further to chip-based technologies, synthetic membrane systems and, of increasing current interest, in silico modeling approaches. An international group of experts in the field of epithelial barriers was convened from academia, industry and regulatory bodies to present both the current state of the art of non-animal models of the skin, intestinal and pulmonary barriers in their various fields of application, and to discuss research-based, industry-driven and regulatory-relevant future directions for both the development of new models and the refinement of existing test methods. Issues of model relevance and preference, validation and standardization, acceptance, and the need for simplicity versus complexity were focal themes of the discussions. The outcomes of workshop presentations and discussions, in relation to both current status and future directions in the utilization and development of epithelial barrier models, are presented by the attending experts in the current report.

Research in space commercialization, technology transfer, and communications, volume 2

NASA Technical Reports Server (NTRS)

Dunn, D. A.; Agnew, C. E.

1983-01-01

Spectrum management, models for evaluating communication systems, the communications regulatory environment, expert prediction and consensus, remote sensing, and manned space operations research are discussed.

Environmental Protection Agency, Protecting Children's Environmental Health

MedlinePlus

... Indicators of children's health - "America's Children and the Environment" report Scientific journal articles Standards and Regulations Regulations Regulatory development tracker Guidelines for Considering Children's Health in Economic ...

Regulating and litigating in the public interest: regulating food marketing to young people worldwide: trends and policy drivers.

PubMed

Hawkes, Corinna

2007-11-01

The pressure to regulate the marketing of high-energy, nutrient-poor foods to young people has been mounting in light of concern about rising worldwide levels of overweight and obesity. In 2004, the World Health Organization called on governments, industry, and civil society to act to reduce unhealthy marketing messages. Since then, important changes have taken place in the global regulatory environment regarding the marketing of food to young people. Industry has developed self-regulatory approaches, civil society has campaigned for statutory restrictions, and governments have dealt with a range of regulatory proposals. Still, there have been few new regulations that restrict food marketing to young people. Despite calls for evidence-based policy, new regulatory developments appear to have been driven less by evidence than by ethics.

Receptors rather than signals change in expression in four physiological regulatory networks during evolutionary divergence in threespine stickleback.

PubMed

Di Poi, Carole; Bélanger, Dominic; Amyot, Marc; Rogers, Sean; Aubin-Horth, Nadia

2016-07-01

The molecular mechanisms underlying behavioural evolution following colonization of novel environments are largely unknown. Molecules that interact to control equilibrium within an organism form physiological regulatory networks. It is essential to determine whether particular components of physiological regulatory networks evolve or if the network as a whole is affected in populations diverging in behavioural responses, as this may affect the nature, amplitude and number of impacted traits. We studied the regulation of four physiological regulatory networks in freshwater and marine populations of threespine stickleback raised in a common environment, which were previously characterized as showing evolutionary divergence in behaviour and stress reactivity. We measured nineteen components of these networks (ligands and receptors) using mRNA and monoamine levels in the brain, pituitary and interrenal gland, as well as hormone levels. Freshwater fish showed higher expression in the brain of adrenergic (adrb2a), serotonergic (htr2a) and dopaminergic (DRD2) receptors, but lower expression of the htr2b receptor. Freshwater fish also showed higher expression of the mc2r receptor of the glucocorticoid axis in the interrenals. Collectively, our results suggest that the inheritance of the regulation of these networks may be implicated in the evolution of behaviour and stress reactivity in association with population divergence. Our results also suggest that evolutionary change in freshwater threespine stickleback may be more associated with the expression of specific receptors rather than with global changes of all the measured constituents of the physiological regulatory networks. © 2016 John Wiley & Sons Ltd.

77 FR 7613 - Dow Chemical Company; Dow Chemical TRIGA Research Reactor; Facility Operating License No. R-108

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

... NUCLEAR REGULATORY COMMISSION [Docket No. 50-264; NRC-2012-0026] Dow Chemical Company; Dow Chemical TRIGA Research Reactor; Facility Operating License No. R-108 AGENCY: Nuclear Regulatory Commission... Facility Operating License No. R-108 (``Application''), which currently authorizes the Dow Chemical Company...

78 FR 49563 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-14

... futures on all of the volatility indexes that underlie volatility index options trading on CBOE. Currently, volatility index (security) futures expirations correspond to each volatility index options expiration months...-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Proposed Rule To Amend Rule...

76 FR 30605 - Assessment and Collection of Regulatory Fees For Fiscal Year 2011

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-26

... the Wireless Telecommunications Bureau's Numbering Resource Utilization Forecast and Annual CMRS... compute their fee payment using the standard methodology \\32\\ that is currently in place for CMRS Wireless... Commission, Regulatory Fees Fact Sheet: What You Owe--Commercial Wireless Services for FY 2010 at 1 (released...

75 FR 39603 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-09

..., Commission, from Liz Heese, Managing Director, Issuer Services, Pink OTC Markets, Inc. (``Pink OTC''), dated January 20, 2010 (``Pink OTC Letter''), and Letter to Elizabeth M. Murphy, Secretary, Commission, from...'') market. FINRA currently operates the OTC Bulletin Board (``OTCBB''), which provides a mechanism for FINRA...

75 FR 41262 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-15

... striking and ranking the arbitrators on the lists. Currently, FINRA sends the parties lists of available... arbitrators from the parties' ranking lists. However, after each side exercises its strikes, typically only... arbitrators during the ranking and striking stage of the arbitrator appointment process. In instances where...

Regulatory Enhancements, Infrastructure Modernization, and Connecticut's Interactive, Distance Learning Network.

ERIC Educational Resources Information Center

Pietras, Jesse John

This paper presents an overview of the regulatory, technological, and economic status of interactive distance learning in Connecticut as it relates to the current and future provisioning of services by the telecommunications and cable television industries. The review is predicated upon the following questions: (1) What obligations should the…

76 FR 31271 - Public Meeting: Preliminary Regulatory Determinations for the Third Contaminant Candidate List...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-31

... Regulatory Determinations for the Third Contaminant Candidate List (CCL 3) AGENCY: Environmental Protection... require the EPA to determine every five years, whether to regulate at least five contaminants from the current Contaminant Candidate List (CCL) with a national primary drinking water regulation. The process of...

A Review of International Telecommunications Industry Issues, Structure, and Regulatory Problems.

ERIC Educational Resources Information Center

Cole, Jack E.; And Others

Industry structure studies prior to 1968 are briefly reviewed, and an overview of industrial and technological developments up to the present is provided through synopses of more recent studies. Areas covered include overseas telephone and record carriers; the creation of the Communications Satellite Corporation; the current regulatory and…

Pharma Opportunities and Risks Multiply as Regulatory Reform Remakes APAC: Expanded Accelerated Pathways Challenge Developer Value Story, Evidence Collection, and Market Access Strategies.

PubMed

Grignolo, Alberto; Mingping, Zhang

2018-01-01

Sweeping reforms in the largest markets of the Asia-Pacific region are transforming the regulatory and commercial landscape for foreign pharmaceutical companies. Japan, South Korea, and China are leading the charge, establishing mechanisms and infrastructure that both reflect and help drive international regulatory convergence and accelerate delivery of needed, innovative products to patients. In this rapidly evolving regulatory and commercial environment, drug developers can benefit from reforms and proliferating accelerated pathway (AP) frameworks, but only with regulatory and evidence-generation strategies tailored to the region. Otherwise, they will confront significant pricing and reimbursement headwinds. Although APAC economies are at different stages of development, they share a common imperative: to balance pharmaceutical innovation with affordability. Despite the complexity of meeting these sometimes conflicting demands, companies that focus on demonstrating and delivering value for money, and that price new treatments reasonably and sustainably, can succeed both for their shareholders and the region's patient population.

[Neuropsychological evaluation of the executive functions by means of virtual reality].

PubMed

Climent-Martínez, Gema; Luna-Lario, Pilar; Bombín-González, Igor; Cifuentes-Rodríguez, Alicia; Tirapu-Ustárroz, Javier; Díaz-Orueta, Unai

2014-05-16

Executive functions include a wide range of self regulatory functions that allow control, organization and coordination of other cognitive functions, emotional responses and behaviours. The traditional approach to evaluate these functions, by means of paper and pencil neuropsychological tests, shows a greater than expected performance within the normal range for patients whose daily life difficulties would predict an inferior performance. These discrepancies suggest that classical neuropsychological tests may not adequately reproduce the complexity and dynamic nature of real life situations. Latest developments in the field of virtual reality offer interesting options for the neuropsychological assessment of many cognitive processes. Virtual reality reproduces three-dimensional environments with which the patient interacts in a dynamic way, with a sense of immersion in the environment similar to the presence and exposure to a real environment. Furthermore, the presentation of these stimuli, as well as distractors and other variables, may be controlled in a systematic way. Moreover, more consistent and precise answers may be obtained, and an in-depth analysis of them is possible. The present review shows current problems in neuropsychological evaluation of executive functions and latest advances in the consecution of higher preciseness and validity of the evaluation by means of new technologies and virtual reality, with special mention to some developments performed in Spain.

Mapping care processes within a hospital: from theory to a web-based proposal merging enterprise modelling and ISO normative principles.

PubMed

Staccini, Pascal; Joubert, Michel; Quaranta, Jean-François; Fieschi, Marius

2005-03-01

Today, the economic and regulatory environment, involving activity-based and prospective payment systems, healthcare quality and risk analysis, traceability of the acts performed and evaluation of care practices, accounts for the current interest in clinical and hospital information systems. The structured gathering of information relative to users' needs and system requirements is fundamental when installing such systems. This stage takes time and is generally misconstrued by caregivers and is of limited efficacy to analysts. We used a modelling technique designed for manufacturing processes (IDEF0/SADT). We enhanced the basic model of an activity with descriptors extracted from the Ishikawa cause-and-effect diagram (methods, men, materials, machines, and environment). We proposed an object data model of a process and its components, and programmed a web-based tool in an object-oriented environment. This tool makes it possible to extract the data dictionary of a given process from the description of its elements and to locate documents (procedures, recommendations, instructions) according to each activity or role. Aimed at structuring needs and storing information provided by directly involved teams regarding the workings of an institution (or at least part of it), the process-mapping approach has an important contribution to make in the analysis of clinical information systems.

Current challenges in bioequivalence, quality, and novel assessment technologies for topical products.

PubMed

Yacobi, Avraham; Shah, Vinod P; Bashaw, Edward D; Benfeldt, Eva; Davit, Barbara; Ganes, Derek; Ghosh, Tapash; Kanfer, Isadore; Kasting, Gerald B; Katz, Lindsey; Lionberger, Robert; Lu, Guang Wei; Maibach, Howard I; Pershing, Lynn K; Rackley, Russell J; Raw, Andre; Shukla, Chinmay G; Thakker, Kailas; Wagner, Nathalie; Zovko, Elizabeta; Lane, Majella E

2014-04-01

This paper summarises the proceedings of a recent workshop which brought together pharmaceutical scientists and dermatologists from academia, industry and regulatory agencies to discuss current regulatory issues and industry practices for establishing therapeutic bioequivalence (BE) of dermatologic topical products. The methods currently available for assessment of BE were reviewed as well as alternatives and the advantages and disadvantages of each method were considered. Guidance on quality and performance of topical products was reviewed and a framework to categorise existing and alternative methods for evaluation of BE was discussed. The outcome of the workshop emphasized both a need for greater attention to quality, possibly, via a Quality-By-Design (QBD) approach and a need to develop a "whole toolkit" approach towards the problem of determination of rate and extent in the assessment of topical bioavailability. The discussion on the BE and clinical equivalence of topical products revealed considerable concerns about the variability present in the current methodologies utilized by the industry and regulatory agencies. It was proposed that academicians, researchers, the pharmaceutical industry and regulators work together to evaluate and validate alternative methods that are based on both the underlying science and are adapted to the drug product itself instead of single "universal" method.

Progress Cleaning the Air: Voluntary Partnership Program Accomplishments

EPA Pesticide Factsheets

EPA voluntary clean air partnership programs work in tandem with regulatory programs to protect public health and the environment. This page highlights accomplishments of selected partnership programs.

Perfluoroalkyl and polyfluoroalkyl substances in the environment: terminology, classification, and origins.

PubMed

Buck, Robert C; Franklin, James; Berger, Urs; Conder, Jason M; Cousins, Ian T; de Voogt, Pim; Jensen, Allan Astrup; Kannan, Kurunthachalam; Mabury, Scott A; van Leeuwen, Stefan P J

2011-10-01

The primary aim of this article is to provide an overview of perfluoroalkyl and polyfluoroalkyl substances (PFASs) detected in the environment, wildlife, and humans, and recommend clear, specific, and descriptive terminology, names, and acronyms for PFASs. The overarching objective is to unify and harmonize communication on PFASs by offering terminology for use by the global scientific, regulatory, and industrial communities. A particular emphasis is placed on long-chain perfluoroalkyl acids, substances related to the long-chain perfluoroalkyl acids, and substances intended as alternatives to the use of the long-chain perfluoroalkyl acids or their precursors. First, we define PFASs, classify them into various families, and recommend a pragmatic set of common names and acronyms for both the families and their individual members. Terminology related to fluorinated polymers is an important aspect of our classification. Second, we provide a brief description of the 2 main production processes, electrochemical fluorination and telomerization, used for introducing perfluoroalkyl moieties into organic compounds, and we specify the types of byproducts (isomers and homologues) likely to arise in these processes. Third, we show how the principal families of PFASs are interrelated as industrial, environmental, or metabolic precursors or transformation products of one another. We pay particular attention to those PFASs that have the potential to be converted, by abiotic or biotic environmental processes or by human metabolism, into long-chain perfluoroalkyl carboxylic or sulfonic acids, which are currently the focus of regulatory action. The Supplemental Data lists 42 families and subfamilies of PFASs and 268 selected individual compounds, providing recommended names and acronyms, and structural formulas, as well as Chemical Abstracts Service registry numbers. Copyright © 2011 SETAC.

Improving food environments and tackling obesity: A realist systematic review of the policy success of regulatory interventions targeting population nutrition

PubMed Central

Sisnowski, Jana; Merlin, Tracy

2017-01-01

Background This systematic review (PROSPERO: CRD42015025276) employs a realist approach to investigate the effect of “real-world” policies targeting different aspects of the food environment that shape individual and collective nutrition. Objectives We were interested in assessing intermediate outcomes along the assumed causal pathway to “policy success”, in addition to the final outcome of changed consumption patterns. Data sources We performed a search of 16 databases through October 2015, with no initial restriction by language. Study eligibility criteria We included all publications that reported the effect of statutory provisions aimed at reducing the consumption of energy-dense foods and beverages in the general population. We allowed all methodological approaches that contained some measure of comparison, including studies of implementation progress. Study appraisal and synthesis methods We reviewed included studies using the appraisal tools for pre-post and observational studies developed by the National Heart, Lung, and Blood Institute. Given the considerable heterogeneity in interventions assessed, study designs employed, and outcome measures reported, we opted for a narrative synthesis of results. Results and implications Results drawn from 36 peer-reviewed articles and grey literature reports demonstrated that isolated regulatory interventions can improve intermediate outcomes, but fail to affect consumption at clinically significant levels. The included literature covered six different types of interventions, with 19 studies reporting on calorie posting on chain restaurant menus. The large majority of the identified interventions were conducted in the US. Early results from recent taxation measures were published after the review cut-off date but these suggested more favorable effects on consumption levels. Nevertheless, the evidence assessed in this review suggests that current policies are generally falling short of anticipated health impacts. PMID:28783757

Summary report of PQRI Workshop on Nanomaterial in Drug Products: current experience and management of potential risks.

PubMed

Bartlett, Jeremy A; Brewster, Marcus; Brown, Paul; Cabral-Lilly, Donna; Cruz, Celia N; David, Raymond; Eickhoff, W Mark; Haubenreisser, Sabine; Jacobs, Abigail; Malinoski, Frank; Morefield, Elaine; Nalubola, Ritu; Prud'homme, Robert K; Sadrieh, Nakissa; Sayes, Christie M; Shahbazian, Hripsime; Subbarao, Nanda; Tamarkin, Lawrence; Tyner, Katherine; Uppoor, Rajendra; Whittaker-Caulk, Margaret; Zamboni, William

2015-01-01

At the Product Quality Research Institute (PQRI) Workshop held last January 14-15, 2014, participants from academia, industry, and governmental agencies involved in the development and regulation of nanomedicines discussed the current state of characterization, formulation development, manufacturing, and nonclinical safety evaluation of nanomaterial-containing drug products for human use. The workshop discussions identified areas where additional understanding of material attributes, absorption, biodistribution, cellular and tissue uptake, and disposition of nanosized particles would continue to inform their safe use in drug products. Analytical techniques and methods used for in vitro characterization and stability testing of formulations containing nanomaterials were discussed, along with their advantages and limitations. Areas where additional regulatory guidance and material characterization standards would help in the development and approval of nanomedicines were explored. Representatives from the US Food and Drug Administration (USFDA), Health Canada, and European Medicines Agency (EMA) presented information about the diversity of nanomaterials in approved and newly developed drug products. USFDA, Health Canada, and EMA regulators discussed the applicability of current regulatory policies in presentations and open discussion. Information contained in several of the recent EMA reflection papers was discussed in detail, along with their scope and intent to enhance scientific understanding about disposition, efficacy, and safety of nanomaterials introduced in vivo and regulatory requirements for testing and market authorization. Opportunities for interaction with regulatory agencies during the lifecycle of nanomedicines were also addressed at the meeting. This is a summary of the workshop presentations and discussions, including considerations for future regulatory guidance on drug products containing nanomaterials.

Optimizing the European regulatory framework for sustainable bacteriophage therapy in human medicine.

PubMed

Verbeken, Gilbert; Pirnay, Jean-Paul; De Vos, Daniel; Jennes, Serge; Zizi, Martin; Lavigne, Rob; Casteels, Minne; Huys, Isabelle

2012-06-01

For practitioners at hospitals seeking to use natural (not genetically modified, as appearing in nature) bacteriophages for treatment of antibiotic-resistant bacterial infections (bacteriophage therapy), Europe's current regulatory framework for medicinal products hinders more than it facilitates. Although many experts consider bacteriophage therapy to be a promising complementary (or alternative) treatment to antibiotic therapy, no bacteriophage-specific framework for documentation exists to date. Decades worth of historical clinical data on bacteriophage therapy (from Eastern Europe, particularly Poland, and the former Soviet republics, particularly Georgia and Russia, as well as from today's 27 EU member states and the US) have not been taken into account by European regulators because these data have not been validated under current Western regulatory standards. Consequently, applicants carrying out standard clinical trials on bacteriophages in Europe are obliged to initiate clinical work from scratch. This paper argues for a reduced documentation threshold for Phase 1 clinical trials of bacteriophages and maintains that bacteriophages should not be categorized as classical medicinal products for at least two reasons: (1) such a categorization is scientifically inappropriate for this specific therapy and (2) such a categorization limits the marketing authorization process to industry, the only stakeholder with sufficient financial resources to prepare a complete dossier for the competent authorities. This paper reflects on the current regulatory framework for medicines in Europe and assesses possible regulatory pathways for the (re-)introduction of bacteriophage therapy in a way that maintains its effectiveness and safety as well as its inherent characteristics of sustainability and in situ self-amplification and limitation.

Management of solid waste

NASA Astrophysics Data System (ADS)

Thompson, W. T.; Stinton, L. H.

1980-04-01

Compliance with the latest regulatory requirements addressing disposal of radioactive, hazardous, and sanitary solid waste criteria in the selection, design, and operation of solid waste management facilities. Due to the state of flux of these regulatory requirements from EPA and NRC, several waste management options were of solid waste. The current regulatory constraints and the design and operational requirements for construction of both storage and disposal facilities for use in management of DOE-ORO solid waste are highlighted. Capital operational costs are included for both disposal and storage options.

30 CFR 817.106 - Backfilling and grading: Previously mined areas.

Code of Federal Regulations, 2013 CFR

2013-07-01

... increase the hazard to the public health and safety or to the environment. [48 FR 41735, Sept. 16, 1983, as.... (3) Any highwall remnant shall be stable and not pose a hazard to the public health and safety or to the environment. The operator shall demonstrate, to the satisfaction of the regulatory authority, that...

30 CFR 816.106 - Backfilling and grading: Previously mined areas.

Code of Federal Regulations, 2013 CFR

2013-07-01

... increase the hazard to the public health and safety or to the environment. [48 FR 41734, Sept. 16, 1983, as.... (3) Any highwall remnant shall be stable and not pose a hazard to the public health and safety or to the environment. The operator shall demonstrate, to the satisfaction of the regulatory authority, that...

Effects of Self-Regulatory Status and Practice Type on Student Performance in the Mobile Learning Environment

ERIC Educational Resources Information Center

Tutty, Jeremy Ian

2013-01-01

The next generation of computer-based learning environments has arrived. This generation of technology is characterized by mobile and portable devices such as smartphones and tablet computers with wireless broadband access. With these devices comes the promise of extending the online learning revolution. The purpose of this study was to…

The Self-Regulation of a Child with Cochlear Implants within a School Environment

ERIC Educational Resources Information Center

Patton, Kristin L.

2013-01-01

The purpose of this qualitative research, which utilized a narrative design strategy, was to describe the process of self-regulation of a child who has bilateral cochlear implants within the social environment of school. The study investigated the use of self-regulatory strategies by the cochlear implant recipient. It also examined how the child…

Regulatory considerations for pluripotent stem cell therapies.

PubMed

Carpenter, Melissa K

2017-01-01

The development of pluripotent stem cell (PSC) therapies is rapidly advancing, and a number of PSC-derived cell products are currently being tested in clinical trials. The biological complexity of these therapies results in specific challenges in complying with regulatory guidelines. This includes the choice of starting material, reproducible and consistent manufacturing, and preclinical safety and efficacy assessment of the PSC-derived product. This review discusses current US cell therapy regulations and strategies for compliance with these regulations when developing PSC-derived products. © 2017 Elsevier B.V. All rights reserved.

Administration and Regulation of a Military Retirement System Funded by Private Sector Investments

DTIC Science & Technology

1990-03-01

private sector , as opposed to the current method of investing the funds within the Government, between 1985 and 1989, under assumptions of administrative and regulatory constraints; the timeframe was selected because in 1985 the Government began setting aside funds for future military retirement costs versus the pay-as-you-go method in previous years. The study had three objectives: (1) identify administrative factors that result from modifying the current MRS to an MRS funded by private sector investments; (2) identify regulatory constraints that

The environmental fate of polybrominated diphenyl ethers in the Great Lakes Basin

NASA Astrophysics Data System (ADS)

Gouin, Todd William

Semi-volatile organic compounds, such as the polybrominated diphenyl ethers (PBDEs) have the potential to undergo long-range atmospheric transport (LRAT) to remote locations, which can increase the exposure of sensitive ecosystems to potentially harmful substances. Regulatory instruments, such as the Stockholm Convention on persistent organic pollutants (POPs), have been implemented to limit and/or prevent this exposure. Through the acquisition of scientific data, knowledge can be gained about the environmental fate and human exposure of chemical substances, and the risks associated with using those substances assessed. PBDEs are a class of flame retardants that are used in a wide range of commercial products. In response to growing concern over the detection of PBDEs in remote regions, a number of regulatory bodies have implemented measures to restrict the use of PBDEs. Using a suite of environmental fate models it is shown that PBDEs will most likely partition to organic carbon in soil and sediment, and that their persistence in the environment will be strongly influenced by their reactivity in those compartments. The transport potential of the PBDEs is investigated using the transport and persistence level III model TaPL3, using model environments with and without vegetation. It is suggested that the LRAT potential of the PBDEs is likely to be greater for the more volatile lower brominated congeners than for the higher brominated congeners, and that the LRAT may be sensitive to seasonal changes in the environment, such as temperature, vegetation and changes in precipitation. Furthermore, model results suggest that the PBDEs may be subject to a "spring pulse" effect, whereby concentrations are elevated in air during the early spring. Field studies support the theory of a "spring pulse" effect, where concentrations were observed to be five times greater during the period between snowmelt and bud burst than the average concentration before and after, but conclude that this phenomenon is likely to be important only during the period of a few days. Passive air samplers (PAS) deployed on a seasonal basis suggest that the "spring pulse" effect is not likely to dominate the seasonal trend, but do indicate that areas with high population densities, such as large urban areas, are likely sources of PBDEs to the atmosphere. PAS are thus useful in qualitatively identifying spatial and temporal trends of PBDEs, investigating source-receptor relationships, and may help to assess the effectiveness of regulatory restrictions in the future by monitoring the temporal trend of PBDEs in air. The PBDE congener profile in air is shown to be dominated by decaBDE, which is currently exempt from regulatory restrictions. The presence of decaBDE in air is shown to be almost entirely associated with particles. It is concluded that improving our understanding of particle-bound transport is necessary to better assess the environmental fate of decaBDE.

Environmental statistics and optimal regulation

NASA Astrophysics Data System (ADS)

Sivak, David; Thomson, Matt

2015-03-01

The precision with which an organism can detect its environment, and the timescale for and statistics of environmental change, will affect the suitability of different strategies for regulating protein levels in response to environmental inputs. We propose a general framework--here applied to the enzymatic regulation of metabolism in response to changing nutrient concentrations--to predict the optimal regulatory strategy given the statistics of fluctuations in the environment and measurement apparatus, and the costs associated with enzyme production. We find: (i) relative convexity of enzyme expression cost and benefit influences the fitness of thresholding or graded responses; (ii) intermediate levels of measurement uncertainty call for a sophisticated Bayesian decision rule; and (iii) in dynamic contexts, intermediate levels of uncertainty call for retaining memory of the past. Statistical properties of the environment, such as variability and correlation times, set optimal biochemical parameters, such as thresholds and decay rates in signaling pathways. Our framework provides a theoretical basis for interpreting molecular signal processing algorithms and a classification scheme that organizes known regulatory strategies and may help conceptualize heretofore unknown ones.

An update of the federal drinking water regs

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pontius, F.W.

1995-02-01

Previous reviews have summarized the regulations promulgated for volatile organic chemicals (VOCs), fluoride, surface water treatment, total coliform bacteria, lead and copper, and Phase 2 and Phase 5 synthetic organic contaminants (SOCs) and inorganic contaminants (IOCs). Current developments related to these rules and anticipated new rules are reviewed in this article. Current numerical drinking water standards and best available technology (BAT) are summarized. The status of all current, proposed, and anticipated regulations is also summarized. Dates for anticipated agency actions are based on the US Environmental Protection Agency's (USEPA's) published regulatory agenda and on information released by the agency throughmore » December 1994; these dates can change as the agency reconsiders its regulatory policies.« less

Health and safety implications of occupational exposure to engineered nanomaterials.

PubMed

Stebounova, Larissa V; Morgan, Hallie; Grassian, Vicki H; Brenner, Sara

2012-01-01

The rapid growth and commercialization of nanotechnology are currently outpacing health and safety recommendations for engineered nanomaterials. As the production and use of nanomaterials increase, so does the possibility that there will be exposure of workers and the public to these materials. This review provides a summary of current research and regulatory efforts related to occupational exposure and medical surveillance for the nanotechnology workforce, focusing on the most prevalent industrial nanomaterials currently moving through the research, development, and manufacturing pipelines. Their applications and usage precedes a discussion of occupational health and safety efforts, including exposure assessment, occupational health surveillance, and regulatory considerations for these nanomaterials. Copyright © 2011 Wiley Periodicals, Inc.

Regulative recovery in the sea urchin embryo and the stabilizing role of fail-safe gene network wiring

PubMed Central

Smith, Joel; Davidson, Eric H.

2009-01-01

Design features that ensure reproducible and invariant embryonic processes are major characteristics of current gene regulatory network models. New cis-regulatory studies on a gene regulatory network subcircuit activated early in the development of the sea urchin embryo reveal a sequence of encoded “fail-safe” regulatory devices. These ensure the maintenance of fate separation between skeletogenic and nonskeletogenic mesoderm lineages. An unexpected consequence of the network design revealed in the course of these experiments is that it enables the embryo to “recover” from regulatory interference that has catastrophic effects if this feature is disarmed. A reengineered regulatory system inserted into the embryo was used to prove how this system operates in vivo. Genomically encoded backup control circuitry thus provides the mechanism underlying a specific example of the regulative development for which the sea urchin embryo has long been famous. PMID:19822764

Biotechnology; Managing the Risks of Field Testing Genetically Engineered Organisms

DTIC Science & Technology

1988-06-01

jurisdictional lines. The agencies’ principal regulatory tool for managing the risks of field testing genetically engineered organisms is the authority to...Regulatory authority has been established in numerous federal statutes designed to prevent the occurrence of harm to the environment and public health...would not be reviewed or regulated at all. According to the Insti- tute, "there are numerous organisms outside the confines of t he plant ST~( Iflt l l l

Regulatory T cells in human disease and their potential for therapeutic manipulation

PubMed Central

Taams, Leonie S; Palmer, Donald B; Akbar, Arne N; Robinson, Douglas S; Brown, Zarin; Hawrylowicz, Catherine M

2006-01-01

Regulatory T cells are proposed to play a central role in the maintenance of immunological tolerance in the periphery, and studies in many animal models demonstrate their capacity to inhibit inflammatory pathologies in vivo. At a recent meeting [Clinical Application of Regulatory T Cells, 7–8 April 2005, Horsham, UK, organized by the authors of this review, in collaboration with the British Society for Immunology and Novartis] evidence was discussed that certain human autoimmune, infectious and allergic diseases are associated with impaired regulatory T-cell function. In contrast, evidence from several human cancer studies and some infections indicates that regulatory T cells may impair the development of protective immunity. Importantly, certain therapies, both those that act non-specifically to reduce inflammation and antigen-specific immunotherapies, may induce or enhance regulatory T-cell function. The purpose of this review was to summarize current knowledge on regulatory T-cell function in human disease, and to assess critically how this can be tailored to suit the therapeutic manipulation of immunity. PMID:16630018

Regulatory challenges for GM crops in developing economies: the African experience.

PubMed

Nang'ayo, Francis; Simiyu-Wafukho, Stella; Oikeh, Sylvester O

2014-12-01

Globally, transgenic or genetically modified (GM) crops are considered regulated products that are subject to regulatory oversight during trans-boundary movement, testing and environmental release. In Africa, regulations for transgenic crops are based on the outcomes of the historic Earth Summit Conference held in Rio, Brazil two decades ago, namely, the adoption of the Convention on Biological Diversity (CBD) and the subsequent adoption of the Cartagena Protocol on Biosafety. To exploit the potential benefits of transgenic crops while safeguarding the potential risks on human health and environment, most African countries have signed and ratified the CBD and the Cartagena Protocol on Biosafety. Consequently, these countries are required to take appropriate legal, administrative and other measures to ensure that the handling and utilization of living modified organisms are undertaken in a manner that reduces the risks to humans and the environment. These countries are also expected to provide regulatory oversight on transgenic crops through functional national biosafety frameworks (NBFs). While in principle this approach is ideal, NBFs in most African countries are steeped in a host of policy, legal and operational challenges that appear to be at cross-purposes with the noble efforts of seeking to access, test and deliver promising GM crops for use by resource-limited farmers in Africa. In this paper we discuss the regulatory challenges faced during the development and commercialization of GM crops based on experiences from countries in Sub-Saharan Africa.

Considerations on the EU definition of a nanomaterial: science to support policy making.

PubMed

Bleeker, Eric A J; de Jong, Wim H; Geertsma, Robert E; Groenewold, Monique; Heugens, Evelyn H W; Koers-Jacquemijns, Marjorie; van de Meent, Dik; Popma, Jan R; Rietveld, Anton G; Wijnhoven, Susan W P; Cassee, Flemming R; Oomen, Agnes G

2013-02-01

In recent years, an increasing number of applications and products containing or using nanomaterials have become available. This has raised concerns that some of these materials may introduce new risks for humans or the environment. A clear definition to discriminate nanomaterials from other materials is prerequisite to include provisions for nanomaterials in legislation. In October 2011 the European Commission published the 'Recommendation on the definition of a nanomaterial', primarily intended to provide unambiguous criteria to identify materials for which special regulatory provisions might apply, but also to promote consistency on the interpretation of the term 'nanomaterial'. In this paper, the current status of various regulatory frameworks of the European Union with regard to nanomaterials is described, and major issues relevant for regulation of nanomaterials are discussed. This will contribute to better understanding the implications of the choices policy makers have to make in further regulation of nanomaterials. Potential issues that need to be addressed and areas of research in which science can contribute are indicated. These issues include awareness on situations in which nano-related risks may occur for materials that fall outside the definition, guidance and further development of measurement techniques, and dealing with changes during the life cycle. Copyright © 2012 Elsevier Inc. All rights reserved.

Assessment of possible allergenicity of hypothetical ORFs in common food crops using current bioinformatic guidelines and its implications for the safety assessment of GM crops.

PubMed

Young, Gregory J; Zhang, Shiping; Mirsky, Henry P; Cressman, Robert F; Cong, Bin; Ladics, Gregory S; Zhong, Cathy X

2012-10-01

Before a genetically modified (GM) crop can be commercialized it must pass through a rigorous regulatory process to verify that it is safe for human and animal consumption, and to the environment. One particular area of focus is the potential introduction of a known or cross-reactive allergen not previously present within the crop. The assessment of possible allergenicity uses the guidelines outlined by the Food and Agriculture Organization (FAO) and World Health Organization's (WHO) Codex Alimentarius Commission (Codex) to evaluate all newly expressed proteins. Some regulatory authorities have broadened the scope of the assessment to include all DNA reading frames between stop codons across the insert and spanning the insert/genomic DNA junctions. To investigate the utility of this bioinformatic assessment, all naturally occurring stop-to-stop frames in the non-transgenic genomes of maize, rice, and soybean, as well as the human genome, were compared against the AllergenOnline (www.allergenonline.org) database using the Codex criteria. We discovered thousands of frames that exceeded the Codex defined threshold for potential cross-reactivity suggesting that evaluating hypothetical ORFs (stop-to-stop frames) has questionable value for making decisions on the safety of GM crops. Copyright © 2012 Elsevier Ltd. All rights reserved.

The regulation of agricultural biotechnology: science shows a better way.

PubMed

Miller, Henry I

2010-11-30

National and international regulation of recombinant DNA-modified, or 'genetically engineered' (also referred to as 'genetically modified' or GM), organisms is unscientific and illogical, a lamentable illustration of the maxim that bad science makes bad law. Instead of regulatory scrutiny that is proportional to risk, the degree of oversight is actually inversely proportional to risk. The current approach to regulation, which captures for case-by-case review organisms to be field tested or commercialized according to the techniques used to construct them rather than their properties, flies in the face of scientific consensus. This approach has been costly in terms of economic losses and human suffering. The poorest of the poor have suffered the most because of hugely inflated development costs of genetically engineered plants and food. A model for regulation of field trials known as the 'Stanford Model' is designed to assess risks of new agricultural introductions - whether or not the organisms are genetically engineered, and independent of the genetic modification techniques employed. It offers a scientific, rational, risk-based basis for field trial regulations. Using this sort of model for regulatory review would not only better protect human health and the environment, but would also permit more expeditious development and more widespread use of new plants and seeds. Copyright © 2010 Elsevier B.V. All rights reserved.

Environmental Restoration (ER) Consolidated Quarterly Report_April to June 2017_ October 2017

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cochran, John R.

2017-10-01

This Environmental Restoration Operations (ER) Consolidated Quarterly Report (ER Quarterly Report) provides the status of ongoing corrective action activities being implemented at Sandia National Laboratories, New Mexico (SNL/NM) during the April, May, and June 2017 quarterly reporting period. Table I-1 lists the Solid Waste Management Units (SWMUs) and Areas of Concern (AOCs) identified for corrective action at SNL/NM. Sections I.2.1 and I.2.2 summarize the work completed during this quarter. Section I.2.1 summarizes the quarterly activities at sites undergoing corrective action field activities. Field activities are conducted at the three groundwater AOCs (Burn Site Groundwater [BSG AOC], Technical Area [TA]-V Groundwatermore » [TAVG AOC], and Tijeras Arroyo Groundwater [TAG AOC]). Section I.2.2 summarizes quarterly activities at sites where the New Mexico Environment Department (NMED) Hazardous Waste Bureau (HWB) issued a certificate of completion and the sites are in the corrective action complete (CAC) regulatory process. Currently, SWMUs 8 and 58, 68, 149, 154, and 502 are in the CAC regulatory process. Corrective action activities are deferred at the Long Sled Track (SWMU 83), the Gun Facilities (SWMU 84), and the Short Sled Track (SWMU 240) because these three sites are active mission facilities. These three active mission sites are located in TA-III.« less

"If a woman has even one daughter, I refuse to perform the abortion": Sex determination and safe abortion in India.

PubMed

Potdar, Pritam; Barua, Alka; Dalvie, Suchitra; Pawar, Anand

2015-05-01

In India, safe abortion services are sought mainly in the private sector for reasons of privacy, confidentiality, and the absence of delays and coercion to use contraception. In recent years, the declining sex ratio has received much attention, and implementation of the Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act (2003) has become stringent. However, rather than targeting sex determination, many inspection visits target abortion services. This has led to many private medical practitioners facing negative media publicity, defamation and criminal charges. As a result, they have started turning women away not only in the second trimester but also in the first. Samyak, a Pune-based, non-governmental organization, came across a number of cases of refusal of abortion services during its work and decided to explore the experiences of private medical practitioners with the regulatory mechanisms and what happened to the women. The study showed that as a fallout from the manner of implementation of the PCPNDT Act, safe abortion services were either difficult for women to access or outright denied to them. There is an urgent need to recognize this impact of the current regulatory environment, which is forcing women towards illegal and unsafe abortions. Copyright © 2015. Published by Elsevier Ltd.

A mixed incoherent feed-forward loop contributes to the regulation of bacterial photosynthesis genes.

PubMed

Mank, Nils N; Berghoff, Bork A; Klug, Gabriele

2013-03-01

Living cells use a variety of regulatory network motifs for accurate gene expression in response to changes in their environment or during differentiation processes. In Rhodobacter sphaeroides, a complex regulatory network controls expression of photosynthesis genes to guarantee optimal energy supply on one hand and to avoid photooxidative stress on the other hand. Recently, we identified a mixed incoherent feed-forward loop comprising the transcription factor PrrA, the sRNA PcrZ and photosynthesis target genes as part of this regulatory network. This point-of-view provides a comparison to other described feed-forward loops and discusses the physiological relevance of PcrZ in more detail.

A mixed incoherent feed-forward loop contributes to the regulation of bacterial photosynthesis genes

PubMed Central

Mank, Nils N.; Berghoff, Bork A.; Klug, Gabriele

2013-01-01

Living cells use a variety of regulatory network motifs for accurate gene expression in response to changes in their environment or during differentiation processes. In Rhodobacter sphaeroides, a complex regulatory network controls expression of photosynthesis genes to guarantee optimal energy supply on one hand and to avoid photooxidative stress on the other hand. Recently, we identified a mixed incoherent feed-forward loop comprising the transcription factor PrrA, the sRNA PcrZ and photosynthesis target genes as part of this regulatory network. This point-of-view provides a comparison to other described feed-forward loops and discusses the physiological relevance of PcrZ in more detail. PMID:23392242

75 FR 27768 - Current Connection, LLC; Notice of Preliminary Permit Application Accepted for Filing and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-18

..., Motions To Intervene, and Competing Applications May 11, 2010. On March 30, 2010, Current Connection, LLC.... Applicant Contact: Timothy D. Smith, CEO, Current Connection, LLC, 1300 Rankin Drive, Troy, MI 48083; phone... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13694-000] Current...

Scientific misconduct, the pharmaceutical industry, and the tragedy of institutions.

PubMed

Cohen-Kohler, Jillian Clare; Esmail, Laura C

2007-09-01

This paper examines how current legislative and regulatory models do not adequately govern the pharmaceutical industry towards ethical scientific conduct. In the context of a highly profit-driven industry, governments need to ensure ethical and legal standards are not only in place for companies but that they are enforceable. We demonstrate with examples from both industrialized and developing countries how without sufficient controls, there is a risk that corporate behaviour will transgress ethical boundaries. We submit that there is a critical need for urgent drug regulatory reform. There must be robust regulatory structures in place which enforce corporate governance mechanisms to ensure that pharmaceutical companies maintain ethical standards in drug research and development and the marketing of pharmaceuticals. What is also needed is for the pharmaceutical industry to adopt authentic "corporate social responsibility" policies as current policies and practices are insufficient.

78 FR 51664 - Vessel Traffic Service Updates, Including Establishment of Vessel Traffic Service Requirements...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-21

... requirements. The changes made by this rule will align regulations with the current operating procedures of the... History V. Discussion of Comments and Changes VI. Regulatory Analyses A. Regulatory Planning and Review B... Waterways Safety System PWSA Ports and Waterways Safety Act SOLAS International Convention for the Safety of...

Process Mining Techniques for Analysing Patterns and Strategies in Students' Self-Regulated Learning

ERIC Educational Resources Information Center

Bannert, Maria; Reimann, Peter; Sonnenberg, Christoph

2014-01-01

Referring to current research on self-regulated learning, we analyse individual regulation in terms of a set of specific sequences of regulatory activities. Successful students perform regulatory activities such as analysing, planning, monitoring and evaluating cognitive and motivational aspects during learning not only with a higher frequency…

Computational challenges in modeling gene regulatory events.

PubMed

Pataskar, Abhijeet; Tiwari, Vijay K

2016-10-19

Cellular transcriptional programs driven by genetic and epigenetic mechanisms could be better understood by integrating "omics" data and subsequently modeling the gene-regulatory events. Toward this end, computational biology should keep pace with evolving experimental procedures and data availability. This article gives an exemplified account of the current computational challenges in molecular biology.

76 FR 46340 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-02

... information.\\18\\ FINRA, however, disagrees with the notion that customer account statements have little or... proposed rule change will provide customers with critical information regarding their accounts and will... access to current information on their accounts via the Internet and by telephone. FINRA believes the...

78 FR 13130 - Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change, as...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-26

... already the case for single-name CDS). Recognizing the highly correlated relationship between long-short...' proprietary positions. ICE Clear Europe does not currently clear CDS positions of customers of its Clearing Members, but it plans to introduce customer clearing for CDS upon receipt of applicable regulatory...

78 FR 51101 - Regulatory Capital Rules: Regulatory Capital, Enhanced Supplementary Leverage Ratio Standards for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-20

... every $100 of current generally applicable leverage exposure based on a group of advanced approaches... approaches adopted by the agencies in July, 2013 (2013 revised capital approaches), the agencies established... organizations subject to the advanced approaches risk-based capital rules. In this notice of proposed rulemaking...

78 FR 71695 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-29

... inquiries and investigations. The current approach of requiring members to report the reference time instead... proposing amendments to the equity trade reporting rules relating to reporting (i) an additional time field for specified trades, (ii) execution time in milliseconds, (iii) reversals, (iv) trades executed on...

76 FR 29808 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-23

... beneficial interest: (A) If the company is currently an investment banking services client of the member or the member has received compensation from the company for investment banking services in the past 12... investment banking services. \\7\\ NYSE/NASD IPO Advisory Committee Report and Recommendations (May 2003). http...

76 FR 24076 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-29

... beneficial interest: (A) If the company is currently an investment banking services client of the member or the member has received compensation from the company for investment banking services in the past 12... investment banking services. \\5\\ NYSE/NASD IPO Advisory Committee Report and Recommendations (May 2003). http...