URL: http://www.foodrisk.umd.edu/risk_analysis/RA/risk_char.cfm

Risk Characterization

Risk Characterization is defined in the Codex Alimentarius Commission Procedural Manual, Fourteenth Edition (2004) as “The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment.”

The Joint FAO/WHO Expert Consultation defines risk characterization as the "integration of hazard identification, hazard characterization and exposure assessment into an estimation of the adverse effects likely to occur in a given population, including attendant uncertainties"

Format	Author(s)	Title / Description	Date added	Details
	World Health Organization	Toxicological and Health Aspects of Melamine and Cyanuric acid: report of a WHO expert meeting in collaboration with FAO, supported by Health Canada This Expert Meeting report provides a range of recommendations for further information and new studies to better understand the risk to human health posed by melamine and its analogues. Topics include methods for analysis of melamine, occurrence, exposure estimates, epidemiological and toxicological data, and risk assessment. (more) Publication Year: 2009	May 26, 2009
	Orlandi, PA; Chu, DT; Bier, JW; Jackson, GJ	Parasites and the Food Supply This Scientific Status Summary, prepared for the Institute of Food Technologists’ Expert Panel on Food Safety and Nutrition, discusses the sources and incidence of human infection by foodborne parasites and the new technologies that are being developed for their prevention, detection, and inactivation. (more) Publication Month: April 2002	Feb 26, 2009
	Bureau of Chemical Safety Food Directorate Health Products and Food Branch/Health Canada	Survey and Health Risk Assessment of Background Levels of Melamine in Infant Formula Allowed for Sale in Canada This report describes a study conducted in response to the reports of melamine contamination from infant formula foods and milk and milk-derived foods imported from China. Included in this report is a survey in which samples of 80 different infant formula products were analyzed for melamine, using a method with a detection limit of 4 ng/g of melamine. The results of this survey were used to estimate dietary intakes of melamine for infants of different ages in Canada. (more) Publication Month: November 2008	Feb 5, 2009
	European Food Safety Authority	Statement of EFSA on risks for public health due to the presences of melamine in infant milk and other milk products in China This statement was published in response to a request from the European Commission, and includes scientific advice on the risks to human health due to the possible presence of melamine in composite food products imported from China into the European Union (EU). Included in this report are exposure scenarios and guidelines and recommendations by EFSA in responding to the potential threat of melamine contamination in composite foods and in milk powder across the European Union. (more) Publication Date: Wednesday, September 24, 2008	Feb 5, 2009
	Environmental Protection Agency	Microbial Risk Assessment Thesaurus Federal and international agencies, private sector organizations, and academics use terms and definitions differently in their microbial risk assessments. This Thesaurus is a compendium of risk assessment terms found in frameworks, methodologies, and assessments. It provides insight into how various entities use specific microbial risk assessment terms in their activities and helps those responsible for such assessments both conduct and communicate about them more effectively. This Thesaurus was developed by the USEPA, Office of Water. (more) Publication Month: September 2007	Feb 4, 2009
	Tuttle, J; Gomez, T; Doyle, MP; Wells, TG; Zhao, T; Tauxe, RV; Griffin, PM	Lessons from a Large Outbreak of Escherichia coli O157:H7 Infections: Insights into the Infectious Dose and Method of Widespread Contamination of Hamburger Patties In this report, data from a meat traceback done to investigate the possible sources of contamination of hamburger patties with E. coli 0157:H7 is presented. In addition, the paper estimates the dose required for infection and analyzes the ability of current standard microbiological tests to predict the presence of E. coli 0157:H7 in beef. (more) Publication Date: Tuesday, February 3, 1998	Jan 23, 2009
	Food and Agriculture Organization of the United Nations/World Health Organization	Hazard Characterization for Pathogens in Food and Water - Guidelines This report provides guidelines to conducting successful hazard characterizations pertaining to pathogens in water. Included are discussions on the process of hazard characterization, data collection and evaluation, descriptive characterization, and dose-response modeling. (more) Publication Year: 2003	Jan 23, 2009
	Food and Agriculture Organization of the United Nations/World Health Organization	Risk Management and Food Safety This report describes how both the identification of the standards of acceptable risk appropriate to different types of food hazards, and the establishment of procedures to ensure that the risks are kept within the limits set by those standards play a crucial role in developing food safety for all countries. Included in this report are guidelines for building a risk management framework, general principles of risk management, and current risk management practices provided by the Codex. In addition, conclusions and recommendations and a structural diagram of risk analysis in general are included in the annexes. (more) Publication Date: Friday, January 31, 1997	Jan 23, 2009
	Food and Agriculture Organization of the United Nations/World Health Organization	Risk characterization of Salmonella Spp. in eggs and broiler chickens and Listeria monocytogenes in ready-to-eat foods This report describes risk assessments of Salmonella spp. in broiler chickens and eggs and Listeria monocytogenes in ready-to-eat foods. The purpose of this report is to present a summary of the risk characterizations reviewed during the expert consultation regarding Salmonella and L. monocytogenes, preliminary answers to the questions posed by the Codex Committee on Food Hygiene (CCFH), and recommendations for the adaptation of these risk assessments by member countries. Also included are responses to risk management questions. (more) Publication Date: Friday, May 4, 2001	Jan 23, 2009
	Hitchins, AD; Whiting, RC	Food-borne Listeria monocytogenes risk assessment This report details a risk assessment of Listeria monocytogenes in causing illness to humans upon consumption. Specifically, this report models the potential growth of L. monocytogenes between retail point-of-sale and consumption. Included in this report are the Hazard Identification, Exposure Assessment, Hazard Characterization, and Risk Characterization. (more) Publication Month: December 2001	Jan 23, 2009
	Payment, P; Richardson, L; Siemiatycki, J; Dewar, R; Edwardes, M; Franco, E	A randomized trial to evaluate the risk of gastrointestinal disease due to consumption of drinking water meeting current microbiological standards This report describes a study in which a random sample was evaluated for gastrointestinal disease due to consumption of drinking tap water. The study suggests inadequacy of current standards of drinking water in preventing water-borne endemic gastrointestinal disease. (more) Publication Month: June 1991	Jan 22, 2009
	Jaykus, LA	The Application of Quantitative Risk Assessment to Microbial Food Safety Risks This report describes the process of a quantitative risk assessment and how it can be used to analyze the health risks of microbial foodborne pathogens. Each step of the quantitative risk assessment, i.e. hazard identification, exposure assessment, dose-response assessment, and risk characterization, are discussed in full detail. (more) Publication Month: January 1996	Jan 22, 2009
	Wong, D.M.A. LF; Van Boven, M; Busani, L; Clough, H; Kasbohrer, A; Kosmider, R; Little, C; Pires, SM; Pund, R; Snary, EL; Stellbrink, E	Model pathways and data requirements for microbial risk assessment of major animal production types in Europe This report provides an overview of the major food production types in Europe for which pre-harvest risk assessment have been, or are needed to be, made. A single model pathway has been described for broiler production, table-egg production, turkey production, ducks and geese production, pig production, dairy cattle production, beef cattle production, sheep production, and fish production. In addition to the selected model pathway, this report also provides Data Requirements and Conclusions and Recommendations for each production line. (more) Publication Date: Tuesday, February 28, 2006	Jan 16, 2009
	Cohen, Joshua T.	Harvard Risk Assessment of Bovine Spongiform Encephalopathy: Post-public Comment Model and Supplemental Simulation Results This report describes the further analysis contracted by FSIS using the Harvard BSE simulation model conducted in response to public comments on the model originally assessed in October 2005 and subsequently released in July 2006. Included in this report are addendums to Appendix 2 A and C and Appendix 3, as well as the Post-Public Comment Model, Data File Documentation, and Response to Public Comments. (more) Publication Date: Tuesday, December 26, 2006	Jan 13, 2009
	Bauer, Nathan et. al	Draft Interagency Risk Assessment for the Public Health Impact of Highly Pathogenic Avian Influenza Virus (HPAIV) in Poultry, Shell Eggs, and Egg Products Quantitative risk assessment using mathematical modeling to evaluate the effectiveness of interventions to reduce or prevent foodborne illness from HPAIV in the United States. Data from the report indicates there is a 3.5 or 6 day window during which potentially HPAIV-positive poultry or shell eggs, respectively, could escape detection. In addition, the model predicts that consumption of HPAIV-contaminated poultry and shell eggs poses a negligible risk if properly cooked. Included in the report are the Executive Summary, Response to Peer Review Comments, Shell Eggs Model, Poultry Model, and Federal Register Notice (Docket No. FSIS-2007-0001). (more) Publication Month: November 2008	Jan 12, 2009
	Cohen, Joshua T.; Gray, George M.	2005 Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update Quantitative risk assessment using the simulation model developed by the Harvard Center for Risk Analysis (HCRA) to evaluate the risk of BSE spreading among cattle in the United States, and the potential for humans to be exposed to contaminated tissues. The model simulates the response of the U.S. agricultural system for 20 years following the import of BSE-infected cattle. Predictive variables include the number of additional new cases of BSE that develop, the amount of BSE infective agent potentially available in human food, and the epidemic's basic reproduction rate. Also included in the report:      Executive Summary      Appendix 1, Base Case Parameter File Changes from Earlier Analysis      Appendix 2, Detailed Simulation Output: A, B, C      Appendix 3, Numerical Stability of Simulation Output      Appendix 4, Response to Peer Review Comments      Peer Reviewers      Pre-Public Comment Model. (more) Publication Month: October 2005	Jan 12, 2009
	European Food Safety Authority	Calcium fluoride as a source of fluoride added for nutritional purposes to food supplements A scientific opinion provided by the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) on the safety of calcium fluoride added for nutritional purposes as a source of fluoride in food supplements and on the bioavailability of fluoride from this source. The Panel concludes that the use of calcium fluoride as food supplement would be of no safety concern provided that fluoride upper tolerable intake level values established in Europe are not exceeded by the combined exposure from food supplements and the diet. (more) Publication Date: Thursday, November 27, 2008	Jan 9, 2009
	European Food Safety Authority	Mixture of chromium di- and tri-nicotinate as a source of chromium added for nutritional purposes to food supplements A scientific opinion provided by the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) on the safety of a mixture of di- and tri-nicotinate added for nutritional purposes as a source of chromium in food supplements and on the bioavailability of chromium from this source. The Panel concludes that chromium bioavailability from chromium nicotinate is low and comparable to the bioavailability of trivalent chromium from other sources. The Panel also concludes that there is insufficient human data to establish a safe Upper Limit for soluble trivalent chromium salts. (more) Publication Date: Wednesday, November 26, 2008	Jan 9, 2009
	European Food Safety Authority	Magnesium aspartate, potassium aspartate, magnesium potassium aspartate, calcium aspartate, zinc aspartate, and copper aspartate as sources for magnesium, potassium, calcium, zinc, and copper added for nutritional purposes to food supplements A scientific opinion provided by the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) on the safety of magnesium aspartate, potassium aspartate, magnesium potassium aspartate, calcium aspartate, zinc aspartate, and copper aspartate added for nutritional purposes as sources of magnesium, potassium, calcium, zinc and copper added for nutritional purposes in food supplements and on the bioavailability of magnesium, potassium, calcium, zinc, and copper from these sources. The Panel considers that the individual or combined use of zinc and copper aspartates as sources of zinc and copper, at the proposed use levels, are not of safety concern. However, the individual use of calcium, magnesium and potassium aspartates as food supplements, at the proposed use levels, could be of safety concern because the margins of safety towards a no observable adverse effect level (NOAEL) from a 90-day rat study are considered too low. (more) Publication Date: Thursday, November 27, 2008	Jan 9, 2009
	European Food Safety Authority	Reasoned Opinion of EFSA: Setting of an import tolerance for azoxystrobin in passion fruit Application report from COLEACP/PIP to set an import tolerance for azoxystrobin on passion fruit from Kenya. The toxicological profile of azoxystrobin was investigated in the peer review and the data were sufficient to conclude on an Acceptable Daily Intake (ADI) value of 0.1 mg/kg bw/d. (more) Publication Date: Friday, December 12, 2008	Jan 9, 2009
	U.S. Environment Protection Agency	Risk characterization handbook Publication Month: December 2000	Nov 20, 2008
	Food and Agricultural Organization of the United Nations (FAO)/World Health Organization(WHO)/World Organisation for Animal Health	Antimicrobial Use in Aquaculture and Antimicrobial Resistance Consultation to evaluate usage patterns, and the public health impact of the use of antimicrobials, to develop strategies to minimize any risk. (more) Publication Year: 2007	May 30, 2008
	Food Safety and Inspection Service, U.S. Department of Agriculture	Avian Influenza Training This course provides the information and resources needed to recognize clinical signs and gross lesions that could be suggestive of Avian Influenza. Click here to launch the course in a separate browser window. (more) Publication Year: 2007	Mar 11, 2008
	Food and Agriculture Organization of the United Nations/World Health Organization	Animal Feed Impact on Food Safety Report of a Joint FAO/WHO Expert Meeting on Animal Feed Impact on Food Safety which was held at FAO Headquarters in Rome from 8 to 12 October 2007. The meeting concluded that ensuring safe feed is an important component of efforts to reduce and prevent food safety hazards and indicated several potential measures to ensure safe feed. Agenda of the meeting, list of participants, experts' resumes and list of documents are included as appendices. The report is being translated in French and Spanish. Printed copies may be requested from: Daniela.Battaglia@fao.org. (more) Publication Year: 2008	Feb 26, 2008
	Food and Agriculture Organization of the United Nations/World Health Organization	Microbiological Hazards in Fresh Fruits and Vegetables Report of the Expert Meeting FAO and WHO convened on 19–21 October 2007 to consider how to adequately address the extensive request for scientific advice received from the 38th Session of the Codex Committee on Food Hygiene (CCFH) on the microbiological hazards associated with fresh produce. (more) Publication Year: 2008	Feb 22, 2008
	Committee to Assess the Health Implications of Perchlorate Ingestion, National Research Council	Health Implications of Perchlorate Ingestion Study performed by National Research Council, by request of the EPA, the Department of Defense (DOD), the Department of Energy (DOE), and the National Aeronautics and Space Administration (NASA), to evaluate available data on the health effects of perchlorate. Appendices include "Sensitivity of Perchlorate-Induced Iodide Uptake Inhibition to Serum Iodide" and "Physiologically Based Pharmacokinetic Modeling". Full text of final version of report may require purchase, when available. (more) Publication Year: 2005	Feb 16, 2005
	Food and Agriculture Organization of the United Nations/World Health Organization	Enterobacter sakazakii and Other Microorganisms in Powdered Infant Formula Report of a meeting convened by the FAO & WHO on 2-5 Feb. 2004. Includes executive summary and three appendices: List of Background Papers, Data Received in Response to Call for Data, and notes on strategies used in the risk assessment. (more) Publication Year: 2004	Feb 1, 2005
	Joint FAO/WHO Expert Committee on Food Additives	Polychlorinated Dibenzodioxins, Polychlorinated Dibenzofurans, and Coplanar Polychlorinated Biphenyls Safety assessment of dioxins and dioxin-like PCBs. Sections include "Explanation," "Biological Data," "Analytical Methods," "Effects of Processing," "Levels and Patterns of Contamination of Food Commodities," "Estimated Dietary Intake," "Prevention and Control," "Dose-Response Analysis and Estimation of Risk," "Comments," "Evaluation," and "References". (more) Publication Year: 2002	Jan 27, 2004
	Toxicology Excellence for Risk Assessment	Health Risk Assessment/Characterization of the Drinking Water Disinfection Byproduct Chloroform This document, prepared under the direction of the Health and Ecological Criteria Division, Office of Science and Technology, Office of Water, Environmental Protection Agency, presents a risk characterization of the health risks from chronic oral exposure to chloroform. Includes discussion of hazard characterization, dose response, and exposure. (more) Publication Date: Wednesday, November 4, 1998	May 29, 2003
	Harvard School of Public Health, Harvard University	Study Shows Acrylamide in Baked and Fried Foods Does Not Increase Risk of Certain Cancers in Humans This press release describes a study conducted by researchers from the Harvard School of Public Health and the Karolinska Institute in Stockholm, Sweden that found no association between acrylamide in foods and an increased risk of bladder, large bowel, or kidney cancer. The release provides a brief overview of study methods and results. The study results were published in the January 28, 2003 issue of the British Journal of Cancer. (more) Publication Date: Tuesday, January 28, 2003	Jan 29, 2003
	Mucci, L.A., P.W. Dickman, G. Steineck, H.-O. Adami, and K. Augustsson	Dietary Acrylamide and Cancer of the Large Bowel, Kidney, and Bladder: Absence of an Association in a Population-Based Study in Sweden Abstract and report of a study on the link between consumption of acrylamide in foods and the risk of bladder, kidney, or large bowel cancers. Includes a description of study methods and results, and data is provided in tables. (more) Publication Date: Monday, January 13, 2003	Jan 29, 2003
	Risk Assessment Program, Toxicology and Risk Analysis Section, Life Sciences Division, Oak Ridge National Laboratory, Department of Energy	Human Health Risk Exposure Model This tool uses exposure concentrations to calculate doses and risks. The equations for performing this analysis are also available for different exposure scenarios. Exposure through consumption of fish can be found in the RECREATIONAL LAND USE; Exposure to Contaminants in Water section, and exposure through the consumption of homegrown produce can be found in the RESIDENTIAL LAND USE; Exposure to Contaminants in Water section. (more)	Aug 30, 2002
	Sara Fein	FDA Food Safety Surveys This presentation was given at the 1st International Conference on Microbiological Risk Assessment: Foodborne Hazards, held in Adelphi, MD on July 24-26, 2002. It describes FDA food safety surveys, including types of information available, methods, data weights, use in exposure assessment, relevance to children, use in risk characterization, strengths of the data, how to access the data, and the ease of collecting this type of data. The pdf version of this presentation is available here. (more) Publication Date: Thursday, July 25, 2002	Aug 19, 2002
	Chalk, Peter	Terrorism, Infrastructure Protection, and the U.S. Food and Agricultural Sector Testimony before the Senate Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia, which discusses the potential risks from bioterrorism to the food supply. (more) Publication Month: October 2001	Jun 11, 2002
	Sielken and Associates Consulting, Inc.	DistGEN DISTribution GENerator. A tool for Monte Carlo simulation. Applications include exposure and dose analysis, as well as aggregate and cumulative risk characterization. (more)	Jun 3, 2002
	Agency for Toxic Substances and Disease Registry, U.S. Department of Health and Human Services	HazDat Database Database with information on the release of hazardous substances and the effects on human health. Includes contaminants found, contaminant media and maximum concentration levels, impact on population, community health concerns, ATSDR public health threat categorization, and exposure routes. (more)	May 29, 2002
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Important Message for Pregnant Women and Women of Childbearing Age Who May Become Pregnant About the Risks of Mercury in Fish Consumer advisory about the risks of methylmercury in fish to unborn children. Publication Month: March 2001	May 29, 2002
	Fazil, Aamir M.	Hazard and Risk Characterization of Salmonella Presentation on hazard and risk characterization of Salmonella, including use of outbreak data and dose-response models. Publication Date: Tuesday, August 7, 2001	May 15, 2002
	Buchanan, Robert L.	Hazard and Risk Characterizations for Listeria monocytogenes in Ready-to-Eat Foods This presentation includes discussion of dose-response models for hazard and risk characterization, including dose-response relations for specific subpopulations. (more) Publication Date: Tuesday, August 7, 2001	May 15, 2002

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