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Hazard Identification (hazard + identification)
Selected AbstractsImmune Function Tests for Hazard Identification: A Paradigm Shift in Drug DevelopmentBASIC AND CLINICAL PHARMACOLOGY & TOXICOLOGY, Issue 4 2006Elizabeth R. Gore The purpose of the more stringent approach to immunotoxicology testing was to better identify unintended immunosuppression; however, the requirement was met with much discussion and debate. At the center of the discussion was an attempt to reconcile opposing regulatory directives from agencies outside of Europe that adhere to a more selective, weight-of-evidence approach to functional evaluations. Uncertainty over the predictive value of the recommended immune function tests relative to conventional toxicology parameters prompted an investigation by the International Committee on Harmonization (ICH). The results of a preliminary, industry-wide survey indicated that only a low percentage of pharmaceuticals adversely affect immune function without alterations to standard toxicology parameters. Expected ICH guidelines will ultimately determine to what extent and for what purpose immune function tests will be conducted. In the meantime, optimization of the recommended immune function tests is ongoing. The T-cell dependent antibody response (TDAR) by either conventional Sheep Red Blood Cell (SRBC) plaque assay or by the modified ELISA method using either SRBC or keyhole limpet hemocyanin (KLH) as antigen is being extensively evaluated to determine best practices and procedures for preclinical immunotoxicity evaluations. This review addresses some aspects of the debate concerning the appropriateness of immune function tests for hazard identification, along with recommendations for optimizing TDAR methodology to ensure adequate sensitivity and predictability in risk assessments for immunotoxicity. [source] Microbial Hazard Identification in Fresh Fruits and Vegetables.BIOTECHNOLOGY JOURNAL, Issue 3 2007By Jennylynd James (Editor). No abstract is available for this article. [source] Principles of risk assessment for determining the safety of chemicals: Recent assessment of residual solvents in drugs and di(2-ethylhexyl) phthalateCONGENITAL ANOMALIES, Issue 2 2004Ryuichi Hasegawa ABSTRACT Risk assessment of chemicals is essential for the estimation of chemical safety, and animal toxicity data are typically used in the evaluation process, which consists of hazard identification, dose,response assessment, exposure assessment, and risk characterization. Hazard identification entails the collection of all available toxicity data and assessment of toxicity endpoints based on findings for repeated dose toxicity, carcinogenicity or genotoxicity and species-specificity. Once a review is compiled, the allowable lifetime exposure level of a chemical is estimated from a dose,response assessment based on several measures. For non-carcinogens and non-genotoxic carcinogens, the no-observed-adverse-effect-level (NOAEL) is divided by uncertainty factors (e.g. with environmental pollutants) or safety factors (e.g. with food additives) to derive a tolerable daily intake (TDI) or acceptable daily intake (ADI), respectively. These factors include interspecies and individual differences, duration of exposure, quality of data, and nature of toxicity such as carcinogenicity or neurotoxicity. For genotoxic carcinogens, low dose extrapolation is accomplished with mathematical modeling (e.g. linearized multistage model) from the point of departure to obtain exposure levels that will be associated with an excess lifetime cancer risk of a certain level. Data for levels of chemicals in food, water and air, are routinely used for exposure assessment. Finally, risk characterization is performed to ensure that the established ,safe' level of exposure exceeds the estimated level of actual exposure. These principles have led to the evaluation of several existing chemicals. To establish a guideline for residual solvents in medicine, the permitted daily exposure (PDE), equivalent to TDI, of N,N-dimethylformamide was derived on the basis of developmental toxicity (malformation) and of N-methylpyrrolidone on the basis of the developmental neurotoxicity. A TDI for di(2-ethylhexyl)phthalate was derived from assessment of testicular toxicity. [source] Cytotoxic Bacillus spp. belonging to the B. cereus and B. subtilis groups in Norwegian surface watersJOURNAL OF APPLIED MICROBIOLOGY, Issue 5 2004Ø. Østensvik Abstract Aims:, To investigate the presence and numbers of Bacillus spp. spores in surface waters and examine isolates belonging to the B. cereus and B. subtilis groups for cytotoxicity, and to discuss the presence of cytotoxic Bacillus spp. in surface water as hazard identification in a risk assessment approach in the food industry. Methods and Results:, Samples from eight different rivers with variable degree of faecal pollution, and two drinking water sources, were heat shocked and examined for the presence of Bacillus spp. spores using membrane filtration followed by cultivation on bovine blood agar plates. Bacillus spp. was present in all samples. The numbers varied from 15 to 1400 CFU 100 ml,1. Pure cultures of 86 Bacillus spp. isolates representing all sampling sites were characterized using colony morphology, atmospheric requirements, spore and sporangium morphology, and API 50 CHB and API 20E. Bacillus spp. representing the B. cereus and B. subtilis groups were isolated from all samples. Twenty-one isolates belonging to the B. cereus and B. subtilis groups, representing eight samples, were screened for cytotoxicity. Nine strains of B. cereus and five strains belonging to the B. subtilis group were cytotoxic. Conclusions:, The presence of cytotoxic Bacillus spp. in surface water represents a possible source for food contamination. Filtration and chlorination of surface water, the most common drinking water treatment in Norway, do not remove Bacillus spores efficiently. This was confirmed by isolation of spores from tap water samples. Significance and Impact of the Study:, Contamination of food with water containing low numbers of Bacillus spores implies a risk for bacterial growth in foods. Consequently, high numbers of Bacillus spp. may occur after growth in some products. High numbers of cytotoxic Bacillus spp. in foods may represent a risk for food poisoning. [source] Incorporation of inherent safety principles in process safety managementPROCESS SAFETY PROGRESS, Issue 4 2007Paul R. Amyotte Abstract Process safety management (PSM) deals with the identification, understanding, and control of process hazards to prevent process-related injuries and incidents. Explicit incorporation of the principles of inherent safety in the basic definition and functional operation of the various PSM elements can help to improve the quality of the safety management effort. Numerous inherent safety examples, both technical and nontechnical, are given in this paper. Existing qualitative and quantitative tools that already include, or could incorporate, inherent safety are described. Recently developed inherent safety tools for quantitative hazard identification and assessment are identified from either the literature or the current authors' work. Qualitative protocols for incorporating inherent safety into PSM elements are also presented. The language of inherent safety, although largely unused in PSM documentation, has a key role to play in enhancing the effectiveness of PSM. © 2007 American Institute of Chemical Engineers Process Saf Prog 2007 [source] Disease risk analysis: a tool for primate conservation planning and decision makingAMERICAN JOURNAL OF PRIMATOLOGY, Issue 9 2006D.A. Travis Abstract Concern about emerging and re-emerging diseases plays an increasing role in conservation and management of both captive and free-ranging nonhuman primates (NHPs). Managers and policy makers must formulate conservation plans in an arena plagued by uncertainty, complexity, emotion, and politics. The risk analysis paradigm provides a framework that brings together scientists and policy experts to make better decisions for both people and animals. Risk analysis is a multidisciplinary, science-based process that provides an organized and logical approach for incorporating scientific information into policy development in the real world. By blending four specific goal-oriented stages,hazard identification, risk assessment, risk management, and risk communication,one can logically assess the probability that an adverse event, such as the introduction of an emerging disease into a naïve population, will occur. The following is a review of this process as it pertains to NHP conservation and risks associated with infectious diseases. Am. J. Primatol. 68:855,867, 2006. © 2006 Wiley-Liss, Inc. [source] Immune Function Tests for Hazard Identification: A Paradigm Shift in Drug DevelopmentBASIC AND CLINICAL PHARMACOLOGY & TOXICOLOGY, Issue 4 2006Elizabeth R. Gore The purpose of the more stringent approach to immunotoxicology testing was to better identify unintended immunosuppression; however, the requirement was met with much discussion and debate. At the center of the discussion was an attempt to reconcile opposing regulatory directives from agencies outside of Europe that adhere to a more selective, weight-of-evidence approach to functional evaluations. Uncertainty over the predictive value of the recommended immune function tests relative to conventional toxicology parameters prompted an investigation by the International Committee on Harmonization (ICH). The results of a preliminary, industry-wide survey indicated that only a low percentage of pharmaceuticals adversely affect immune function without alterations to standard toxicology parameters. Expected ICH guidelines will ultimately determine to what extent and for what purpose immune function tests will be conducted. In the meantime, optimization of the recommended immune function tests is ongoing. The T-cell dependent antibody response (TDAR) by either conventional Sheep Red Blood Cell (SRBC) plaque assay or by the modified ELISA method using either SRBC or keyhole limpet hemocyanin (KLH) as antigen is being extensively evaluated to determine best practices and procedures for preclinical immunotoxicity evaluations. This review addresses some aspects of the debate concerning the appropriateness of immune function tests for hazard identification, along with recommendations for optimizing TDAR methodology to ensure adequate sensitivity and predictability in risk assessments for immunotoxicity. [source] | ||||||||||