Guidance Documents (guidance + document)

Distribution by Scientific Domains

Selected Abstracts

Approaches for derivation of environmental quality criteria for substances applied in risk assessment of discharges from offshore drilling operations

Dag Altin
Abstract In order to achieve the offshore petroleum industries "zero harm" goal to the environment, the environmental impact factor for drilling discharges was developed as a tool to identify and quantify the environmental risks associated with disposal of drilling discharges to the marine environment. As an initial step in this work the main categories of substances associated with drilling discharges and assumed to contribute to toxic or nontoxic stress were identified and evaluated for inclusion in the risk assessment. The selection were based on the known toxicological properties of the substances, or the total amount discharged together with their potential for accumulation in the water column or sediments to levels that could be expected to cause toxic or nontoxic stress to the biota. Based on these criteria 3 categories of chemicals were identified for risk assessment the water column and sediments: Natural organic substances, metals, and drilling fluid chemicals. Several approaches for deriving the environmentally safe threshold concentrations as predicted no effect concentrations were evaluated in the process. For the water column consensus were reached for using the species sensitivity distribution approach for metals and the assessment factor approach for natural organic substances and added drilling chemicals. For the sediments the equilibrium partitioning approach was selected for all three categories of chemicals. The theoretically derived sediment quality criteria were compared to field-derived threshold effect values based on statistical approaches applied on sediment monitoring data from the Norwegian Continental Shelf. The basis for derivation of predicted no effect concentration values for drilling discharges should be consistent with the principles of environmental risk assessment as described in the Technical Guidance Document on Risk Assessment issued by the European Union. [source]

Evidence-Based Strategies for Reading Instruction of Older Students with Learning Disabilities

Greg Roberts
Over a quarter of 8th-grade students and more than one-third of 4th graders do not read well enough to understand important concepts and acquire new knowledge from grade-level text. For students with learning disabilities, the numbers are more troubling. This article describes features of evidence-based instruction for students who continue to struggle with reading in late elementary, middle, and high school. Recommendations are organized into 5 areas that are critical to the reading improvement of older struggling readers: (1) word study, (2) fluency, (3) vocabulary, (4) comprehension, and (5) motivation. Much of the content in this article reflects our efforts with the Special Education and Reading Strands at the National Center on Instruction, funded by the Office of Special Education Programs and the Office of Elementary and Secondary Education. Two reports, both available at, have particular relevance,Interventions for Adolescent Struggling Readers: A Meta-Analysis with Implications for Practice and Academic Literacy Instruction for Adolescents: A Guidance Document from the Center on Instruction. [source]

Remediation process optimization: A status report

REMEDIATION, Issue 3 2007
Sriram Madabhushi
There are hundreds of contaminated sites with remediation systems that require evaluation and modification to accomplish cleanup goals. These systems are operating well past projected cleanup schedules, cost more than projected to operate, and may not be as protective of human health and the environment as planned. Remediation process optimization (RPO) is an effective method to assess the progress of a system toward achieving cleanup goals within desired time frames and to make the necessary changes in order to reach those goals. Eight main components to the RPO process are evaluated during a review and an implementation plan of recommended changes to the system is developed. Follow-up and tracking are essential to successful RPO programs. In this article, the authors present a summary of a recent Technical and Regulatory (TechReg) Guidance Document (Interstate Technology and Regulatory Council [ITRC], 2004) and related Technology Overview Series on Advanced Topics in RPO (ITRC, 2006) in a distilled form. © 2007 Wiley Periodicals, Inc. [source]

Impact of baseline ECG collection on the planning, analysis and interpretation of ,thorough' QT trials

Venkat Sethuraman
Abstract The current guidelines, ICH E14, for the evaluation of non-antiarrhythmic compounds require a ,thorough' QT study (TQT) conducted during clinical development (ICH Guidance for Industry E14, 2005). Owing to the regulatory choice of margin (10,ms), the TQT studies must be conducted to rigorous standards to ensure that variability is minimized. Some of the key sources of variation can be controlled by use of randomization, crossover design, standardization of electrocardiogram (ECG) recording conditions and collection of replicate ECGs at each time point. However, one of the key factors in these studies is the baseline measurement, which if not controlled and consistent across studies could lead to significant misinterpretation. In this article, we examine three types of baseline methods widely used in the TQT studies to derive a change from baseline in QTc (time-matched, time-averaged and pre-dose-averaged baseline). We discuss the impact of the baseline values on the guidance-recommended ,largest time-matched' analyses. Using simulation we have shown the impact of these baseline approaches on the type I error and power for both crossover and parallel group designs. In this article, we show that the power of study decreases as the number of time points tested in TQT study increases. A time-matched baseline method is recommended by several authors (Drug Saf. 2005; 28(2):115,125, Health Canada guidance document: guide for the analysis and review of QT/QTc interval data, 2006) due to the existence of the circadian rhythm in QT. However, the impact of the time-matched baseline method on statistical inference and sample size should be considered carefully during the design of TQT study. The time-averaged baseline had the highest power in comparison with other baseline approaches. Copyright © 2008 John Wiley & Sons, Ltd. [source]

Guidance on Novel Influenza A/H1N1 in Solid Organ Transplant Recipients,

Officially endorsed by the American Society of Transplantation (AST), The Transplantation Society (TTS), the Canadian Society of Transplantation (CST)
Novel influenza A/H1N1 virus has caused significant illness worldwide. In response to this global crisis, the American Society of Transplantation (AST) Infectious Diseases Community of Practice and the Transplant Infectious Diseases section of The Transplantation Society (TTS) developed a guidance document for novel H1N1. In this paper, we discuss current guidance for H1N1 as it relates to solid organ transplantation. We include discussion around clinical presentation, diagnosis, therapy and prevention specifically addressing areas such as chemoprophylaxis, immunization and donor-derived infection. Although this document addresses conditions specific to novel H1N1, many principles could be applied to future pandemics. As new information emerges about novel H1N1, updates will be made to the electronic version of the document posted on the websites of the AST and TTS. [source]

Audit of local performance compared with standards recommended by the national guidelines for aetiologic investigation of permanent childhood hearing impairment

S. Yoong
Abstract Background National guidelines for aetiologic investigation of childhood deafness were developed as the Newborn Hearing Screening Program (NHSP) was being implemented in the United Kingdom. This guidance document was expected to be incorporated into the operational procedure of the NHSP. Method This criterion-based audit compared local care set against developed guidelines that can be used to assess the appropriateness of specific investigations, services and outcomes. Data on children diagnosed to have sensorineural deafness from March 2002,2004 were extracted from an established computerized database for analysis. Results Forty-seven children were included; 17 have bilateral severe to profound hearing loss, 25 have bilateral mild to moderate loss and 5 with unilateral loss. A high proportion of Pakistani children were from consanguineous marriages with a family history of deafness. Total 29.8% of children were diagnosed through newborn screening and 70.2% detected through hearing surveillance programmes. For children with bilateral severe to profound deafness, 53.0% accepted, 5.9% declined and 41.2% were not offered imaging of their inner ears. A total of 47.1% accepted and 52.9% declined electrocardiograph (ECG) evaluation. Total 70.6% accepted and 29.4% declined connexin mutations testing. Parental requests were required for those with lesser degree of hearing loss. Total 24% accepted, 28% declined and 48% were not offered connexin testing. None were offered ECG and imaging. Testing for congenital infections was inappropriate for children over 1 year old. Ten subjects accepted and five declined this investigation. In the total group, 63.8% accepted, 17.0% declined and 19.1% were not offered referral to the ophthalmic service. Total 46.8% accepted, 44.7% declined and 8.5% were not offered referral to genetics service. Investigations resulted in two connexin-positive children with moderate loss. Conclusion Our study identified key areas where guidelines were not followed. These were related to lack of funding and parental choice. This sample has a higher connexin ,hit' rate for lesser degree deafness. [source]

Experiences with integrated impact assessment , empirical evidence from a survey in three European member states

Martin Achtnicht
Abstract The paper contributes to the discussion on the use of methods and quantification in regulatory impact assessment. We investigate whether there are differences between the three dimensions of sustainable development in terms of the methodical efforts to assess potential impacts. Based on a survey in Germany, the Netherlands and the UK, we provide some evidence regarding these questions. We find that regulatory impact assessment is still biased towards assessing intended and mainly economic costs. There is a gap between the recommended use of methods in official guidance documents and the practice in member states. The reason for this gap can be seen in the existence of operational problems in practice such as lack of data or lack of tools. However, we find that the degree of sophistication of conducted IAs can be improved if responsible desk officers receive training or make use of guidance documents and receive support from co-ordination units. Copyright © 2009 John Wiley & Sons, Ltd and ERP Environment. [source]

From Boundary Drawing to Transitions: the Creation of Normativity under the EU Directive on Integrated Pollution Prevention and Control

Bettina Lange
This article aims to make a contribution to debates about how to conceptualise normativity. It argues that normativity can not be just understood through defining it and in particular through identifying conceptual boundaries around the normative and the non-normative. Instead the article suggests that it is important to explore how transitions between the non-normative and the normative occur in practice. This argument is developed through a critical examination of literature on legal pluralism and an analysis of qualitative empirical data on the drafting of technical guidance documents under the European Union Directive on Integrated Pollution Prevention and Control (96/61/EC). [source]

Interaction equations for multiaxial fatigue assessment of welded structures

ABSTRACT Multiaxial fatigue data from 233 welded test specimens taken from eight different studies have been evaluated based on three published interaction equations for normal and shear stress. The interaction equations were obtained from SFS 2378, Eurocode 3 and International Institute of Welding (IIW) recommendations. Fatigue classes for normal and shear stress were obtained directly from the design guidance documents. Additionally, mean fatigue strengths were determined by regression analysis of bending only and torsion only data for different specimen types. In some cases, the S,N slopes assumed by the different standards were not appropriate for the test data. Specimens that showed significantly different cracking locations or cracking mode between bending and torsion were not easily correlated by the interaction equations. Interaction equations work best in cases where both the normal stress and the shear stress tend to produce crack initiation and growth in the same location and in the same direction. The use of a damage summation of 0.5 for non-proportional loading as recommended by IIW was consistent with experimental observations for tube-to-plate specimens. Other codes used a damage sum of unity. [source]

A Case Study of Soil-Gas Sampling in Silt and Clay-Rich (Low-Permeability) Soils

Todd A. McAlary
Soil-gas sampling and analysis is a common tool used in vapor intrusion assessments; however, sample collection becomes more difficult in fine-grained, low-permeability soils because of limitations on the flow rate that can be sustained during purging and sampling. This affects the time required to extract sufficient volume to satisfy purging and sampling requirements. The soil-gas probe tubing or pipe and sandpack around the probe screen should generally be purged prior to sampling. After purging, additional soil gas must be extracted for chemical analysis, which may include field screening, laboratory analysis, occasional duplicate samples, or analysis for more than one analytical method (e.g., volatile organic compounds and semivolatile organic compounds). At present, most regulatory guidance documents do not distinguish between soil-gas sampling methods that are appropriate for high- or low-permeability soils. This paper discusses permeability influences on soil-gas sample collection and reports data from a case study involving soil-gas sampling from silt and clay-rich soils with moderate to extremely low gas permeability to identify a sampling approach that yields reproducible samples with data quality appropriate for vapor intrusion investigations for a wide range of gas-permeability conditions. [source]

Aquatic risks of pesticides, ecological protection goals, and common aims in european union legislation

Theo CM Brock
Abstract This discussion paper presents a framework for spatiotemporal differentiation in ecological protection goals to assess the risks of pesticides in surface waters. It also provides a proposal to harmonize the different scientific approaches for ecotoxicological effect assessment adopted in guidance documents that support different legislative directives in the European Union (Water Framework Directive and Uniform Principles). Decision schemes to derive maximum permissible concentrations in surface water are presented. These schemes are based on approaches recommended in regulatory guidance documents and are scientifically underpinned by critical review papers concerning the impact of pesticides on freshwater organisms and communities. Special attention is given to the approaches based on standard test species, species sensitivity distribution curves, and model ecosystem experiments. The decision schemes presented here may play a role in the "acceptability" debate and can be used as options in the process of communication between risk assessors and risk managers as well as between these risk experts and other stakeholders. [source]

The european union risk assessment on zinc and zinc compounds: The process and the facts

Charles W.M. Bodar
Abstract A risk assessment on zinc and zinc compounds was carried out within the framework of Council Regulation 793/93/EEC on Existing Chemicals. This risk assessment basically followed the European Union (EU) technical guidance documents (TGDs). These TGDs are built on the current knowledge on quantitative risk assessments, mainly for organic chemicals. This article describes the tailor-made approach for the zinc risk assessment. This work lasted almost a decade and involved the contributions of all EU member states and industry, who discussed the risk assessment during technical meetings. The risk assessment is initially based on scientific findings but is interrelated with pragmatic considerations. It follows a comprehensive approach, covering both environmental and human health. In the environmental part, new methodologies were developed to deal with the natural background of zinc, essentiality, speciation, and the use of species sensitivity distributions. The major results and the process of drawing conclusions of the risk assessment are outlined: potential environmental risks of zinc and zinc compounds may occur at local and regional scales in surfacewater, sediment, and soil. No potential health risks were identified for consumers and man indirectly exposed via the environment. For workers, potential health risks were identified only for zinc oxide and zinc chloride. [source]

Assessing the impact of ICH E9

David Brown
Abstract The ICH harmonized tripartite guideline ,Statistical Principles for Clinical Trials', more commonly referred to as ICH E9, was adopted by the regulatory bodies of the European Union, Japan and the USA in 1998. This document united related guidance documents on statistical methodology from each of the three ICH regions, and meant that for the first time clear consistent guidance on statistical principles was available to those conducting and reviewing clinical trials. At the 10th anniversary of the guideline's adoption, this paper discusses the influence of ICH E9 by presenting a perspective on how approaches to some aspects of clinical trial design, conduct and analysis have changed in that time in the context of regulatory submissions in the European Union. Copyright © 2008 John Wiley & Sons, Ltd. [source]

Japanese Guidance for Ventricular Assist Devices/Total Artificial Hearts

Takashi Yamane
Abstract To facilitate research and development (R&D) and to expedite the review processes of medical devices, the Ministry of Health, Labor and Welfare (MHLW) and the Ministry of Economy, Trade and Industry (METI) founded a joint committee to establish guidance for newly emerging technology. From 2005 to 2007, two working groups held discussions on ventricular assist devices and total artificial hearts, including out-of-hospital programs, based on previous guidance documents and standards. Based on this discussion, the METI published the R&D Guidelines for innovative artificial hearts in 2007, and in 2008 the MHLW published a Notification by Director regarding the evaluation criteria for emerging technology. [source]

The interface between the child welfare and criminal justice systems in England

Jenny Gray
Abstract The development of government guidance can seem a mysterious process to those outside government. This paper, which draws on the author's experience, is intended to give some insight into how guidance in two areas,child witnesses and children involved in prostitution,was developed within the existing legal framework. Since that time, the Sexual Offences Act 2003 has come into force in England and Wales and the Children Bill is currently before Parliament. The paper begins by setting out the key legislation, regulations and guidance that underpinned the child welfare and criminal justice systems as they related to child protection at the time the guidance was being developed. It then describes how the different guidance documents relate to each other and the implications for practice. The development of speci,c guidance is drawn upon to illustrate some of the tensions that had to be resolved during the drafting and the processes by which they were ,nalized for approval by the Government. A key area requiring careful consideration was the differences between the family and criminal justice systems. In the former, the welfare of the child is paramount when making decisions and in the latter, the court has a duty to ensure the defendant has a fair trial. Copyright © 2004 John Wiley & Sons, Ltd. [source]