Hazard Characterization

Hazard Characterization is defined in the Codex Alimentarius Commission Procedural Manual, Fourteenth Edition (2004) as “The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food. For chemical agents, a dose-response assessment should be performed. For biological or physical agents, a dose-response assessment should be performed if the data are obtainable.”

• About Hazard Characterization



• Studies and Data



• Microbiological Hazards
• General Biological Hazards
• Bacteria
• Salmonella
• Listeria
• Other Bacteria
• Fungal Organisms and Toxins
• Parasites
• Viruses
• Prions



• Chemical Hazards
• General Chemical Hazards
• Contaminants
• Acrylamide
• Dioxin/PCB
• Other Contaminants
• Pesticide Residues
• Food and Color Additives
• Veterinary Drug Residues

About Hazard Characterization

Format	Author(s)	Title / Description	Date added	Details
	National Center for Environmental Assessment, Office of Research and Development, Environmental Protection Agency	Approaches for the Application of Physiologically Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment (External Review Draft 2005) Draft report on the evaluation and use of PBPK models in human health risk assessment. Appendices include "Algorithms for predicting chemical-specific parameters for PBPK models," "List of publications relevant to PBPK modeling of environmental chemicals and its use," and "Partition coefficients and metabolic rate constants for PBPK modeling of environmental." Comments are requested. The public comment period has been extended in 70 FR 48950. (more) Deadline: Friday, October 14, 2005 Publication Month: June 2005	Aug 17, 2005
	BELLE	BELLE: Biological Effects of Low Level Exposures Collaborative program that promotes the understanding of low-dose responses. The website includes information about BELLE-sponsored conferences and newsletters. (more)	Feb 19, 2003
	Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (non-food)/Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment/Committee on Carcinogenicity of Chemicals in Food, Consumer Products and th	Committees on Toxicity, Mutagenicity and Carcinogenicity of Chemicals in Food, Consumer Products and the Environment (COT, COM, COC): Joint Statement on the Use of Toxicogenomics in Toxicology Statement regarding the use of toxicogenomics in toxicological risk assessment. Publication Month: December 2004	Jan 13, 2005
	Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment/Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment/Committee on Carcinogenicity of Chemicals in Food, Consumer Products and the Environme	Committees on Toxicity, Mutagenicity and Carcinogenicity of Chemicals in Food, Consumer Products and the Environment: Joint Statement on a Symposium Held by the Three Committees on the Use of Genomics and Proteomics in Toxicology Statement describing discussion and conclusions from a symposium on the use of genomics and proteomics in toxicological risk assessment. (more) Event Date: Monday, October 8, 2001 Publication Date: Tuesday, July 16, 2002	Nov 11, 2004
	Allen, Bruce; Zeiger, Errol; Lawrence, Greg; Friedman, Marvin; Shipp, Annette	Dose-Response Modeling of In Vivo Genotoxicity Data for Use in Risk Assessment: Some Approaches Illustrated by an Analysis of Acrylamide Report of a study on dose-response modeling approaches for genotoxicity data using application to acrylamide data. Access to the full text may require subscription or purchase. (more) Publication Month: February 2005	Jan 14, 2005
	Foureman, Gary L.; Kenyon, Elaina M.	Harmonization in Interspecies Extrapolation: Use of BW3/4 as Default Method in Derivation of the Oral RfD (External Review Draft) Draft report on the use of body weight scaling to the 3/4 power as a general default procedure for interspecies extrapolation for the purposes of deriving an oral reference dose when approaches using physiologically based toxicokinetic modeling or some chemical-specific information are not feasible. Appendices include "BW3/4 scaling vs BW1/1 - a comparison," "The Interspecies BW3/4 Oral Dosimetric Adjustment Factor (DAF) BWh-1/4/BWa-1/4," "The Oral DAF and Portal-of-entry Considerations," and "Hierarchy of approaches for interspecies extrapolation for inhalation dosimetry (from USEPA 1994)." The web page also provides access to the peer review charge questions for the report and to a review of related literature. (more) Deadline: Monday, April 17, 2006 Publication Month: February 2006	Feb 17, 2006
	Dybing, E., et al.	Hazard Characterisation of Chemicals in Food and Diet: Dose Response, Mechanisms and Extrapolation Issues This report discusses biologically-based hazard characterization. It addresses the main issues in hazard characterization, and it focuses on low molecular weight chemicals. Topics covered include modes of toxicological action, causes of underlying variability in toxic responses, dose-response considerations, species differences and interspecies extrapolation, and more. Purchase or subscription is required to access full text. (more) Publication Month: February 2002	Jul 23, 2002
	Food and Agriculture Organization of the United Nations/World Health Organization	Hazard Characterization for Pathogens in Food and Water: Guidelines This document presents a framework for the conduct of microbiological hazard characterization for food- and waterborne pathogens. It includes discussion of the process as a whole and such steps as process initiation, data collection and evaluation, descriptive characterization, modeling the dose-response relationship, validation and review, and presentation of results. Appendices include "Outline of information to include in a hazard characterization" and a glossary. (more) Publication Year: 2003	Sep 15, 2003
	Iyaniwura, Timothy T.	Individual and Subpopulation Variations in Response to Toxic Chemicals: Factors of Susceptibility Review of the influence of age, gender, pregnancy status, dietary/nutritional status, disease/health status, and toxicokinetics and toxicodynamics on individual susceptibility and subpopulation responses to toxic chemicals. (more) Publication Date: Thursday, July 1, 2004	Sep 13, 2004
	Edler, L., et al.	Mathematical Modelling and Quantitative Methods This report discusses current mathematical methods and statistical techniques for hazard characterization. It includes a comparison of the methods of JECFA, FDA, EPA, and other organizations, and develops a framework for the development of new quantitative methods. The report also discusses mathematical modelling of the dose-response process and its role in improving the risk assessment process. Subscription is required at access the full text. (more) Publication Month: February 2002	Jul 23, 2002

Studies and Data

Microbiological Hazards

General Biological Hazards

Bacteria

Salmonella

Listeria

Other Bacteria

Format	Author(s)	Title / Description	Date added	Details
	Kasuga, Fumiko	Archiving of Food Samples From Restaurants and Caterers This presentation was given at the 1st International Conference on Microbiological Risk Assessment: Foodborne Hazards. It provides an example of data collection for hazard characterization, including data sources for dose-response analysis. It also discusses analysis of outbreak data from Japan, including how policy requiring large scale cooking facilities to save samples of raw food materials and cooked dishes has helped in the collection of outbreak data, ways that data from many varied sources are combined, and more. The pdf version of this presentation is available here. (more) Publication Date: Thursday, July 25, 2002	Aug 16, 2002
	Huss, H.H.; Ababouch, L.; Gram, L.	Assessment and Management of Seafood Safety and Quality Report on risk assessment and management issues associated with seafood. Includes discussion of world seafood production and consumption, food safety systems, hazard identification and characterization, and risk management strategies such as HACCP, FSOs, microbiological criteria, traceability, and more. Appendices include "Assessment of Food Safety Programmes," "Hazard Analysis Worksheet," "HACCP Plan Form," and "Generic HACCP Plan for the Production and Processing of Oysters". (more) Publication Year: 2003	Nov 18, 2004
	Environmental Protection Agency	Bacillus Pumilus Strain QST 2808; Exemption From the Requirement of a Tolerance Final rule that exempts Bacillus pumilis strain QST 2808 from a residue tolerance requirement when used under certain conditions. Includes discussion of the toxicological profile, aggregate exposures, cumulative effects, and determination of safety. (more) Publication Date: Wednesday, November 3, 2004	Nov 4, 2004
	Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention	Botulism This page provides an overview of botulism, including incidence, symptoms, diagnosis, treatment, prevention, risk groups, surveillance, and more. (more)	Jul 17, 2002
	Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention	Campylobacter Infections Overview of Campylobacter. Includes diagnosis, treatment, exposure pathways, prevention, incidence, risk groups, surveillance, and more. (more)	Jul 17, 2002
	Song, Wenxia; Zao, Shaohua	Campylobacter jejuni-host Interaction on the Intestinal Mucosal Surface Presentation given at the Research Presentation Symposium held November 18, 2004. Deadline: Tuesday, August 9, 2005 Publication Date: Thursday, November 18, 2004	Aug 9, 2005
	Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention	Cholera Overview of cholera. Includes the risk for cholera in the U.S., prevention, treatment, incidence, exposure pathways, risk groups, surveillance, and more. (more)	Jul 17, 2002
	Data Gaps Working Group, Risk Assessment Consortium	Data Gaps for Selected Microbial Risk Assessments This document contains lists of data gaps identified in published microbial risk assessments by the US Food & Drug Administration, US Department of Agriculture's Food Safety & Inspection Service, and the World Health Organization/Food and Agriculture Organization of the United Nations. Each data gap is identified by exposure assessment category, the type of information needed, and a brief explanation of the specific data gap. For discussion of needs and gaps in microbial risk assessment as a whole, see Fazil, Aamir, et al. 2005. Microbial risk assessment as a foundation for informed decision-making: a needs, gaps and opportunities assessment (NGOA) for microbial risk assessment in food and water. Available here. (more) Publication Date: Thursday, December 2, 2004	Apr 6, 2004
	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
	Food and Agricultural Organization of the United Nations/World Health Organization	Enterobacter sakazakii and Salmonella in Powdered Infant Formula Advance pre-publication copy of the report of the Joint FAO/WHO Expert Committee on Microbiological Risk Assessment on E. sakazakii and Salmonella in powdered infant formula. Includes an executive summary and appendices, including List of Background Papers, Data Received in Response to Call for Data, and Review of Risk Assessment Model. (more) Deadline: Thursday, May 11, 2006 Publication Date: Tuesday, May 2, 2006	May 11, 2006

Fungal Organisms and Toxins

Format	Author(s)	Title / Description	Date added	Details
	National Toxicology Program, Public Health Service, U.S. Department of Health and Human Services	Aflatoxins This report discusses carcinogenicity, properties, use, production, exposure, and regulations of aflatoxins. Publication Month: December 2002	Aug 14, 2002
	Huss, H.H.; Ababouch, L.; Gram, L.	Assessment and Management of Seafood Safety and Quality Report on risk assessment and management issues associated with seafood. Includes discussion of world seafood production and consumption, food safety systems, hazard identification and characterization, and risk management strategies such as HACCP, FSOs, microbiological criteria, traceability, and more. Appendices include "Assessment of Food Safety Programmes," "Hazard Analysis Worksheet," "HACCP Plan Form," and "Generic HACCP Plan for the Production and Processing of Oysters". (more) Publication Year: 2003	Nov 18, 2004
	Gong, Y.Y., et al.	Dietary Aflatoxin Exposure and Impaired Growth in Young Children from Benin and Togo: Cross Sectional Study Report of a study that assessed the effects of aflatoxin exposure in young children in Benin and Togo. Publication Date: Saturday, July 6, 2002	Aug 12, 2002
	American Medical Association/American Nurses Association-American Nurses Foundation/Centers for Disease Control and Prevention/Center for Food Safety and Applied Nutrition, Food and Drug Administration/Food Safety and Inspection Service, U.S. Department	Foodborne Illnesses Table: Non-infectious Agents This table gives etiology, incubation period, signs and symptoms, duration of illness, associated foods, laboratory testing, and treatment information for a variety of contaminants, toxins, and residues. (more) Publication Month: February 2004	Jul 19, 2002
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Foodborne Pathogenic Microorganisms and Natural Toxins Handbook: The "Bad Bug Book" Handbook with information on foodborne pathogenic microorganisms and natural toxins, including information on the associated disease, associated foods, target populations, outbreaks, and more. Appendices include "Infective dose," "Epidemiology summary table," "Factors affecting microbial growth in foods," "Foodborne Disease Outbreaks, United States 1988-1992," and "Additional Foodborne Disease Outbreak Articles and Databases". (more) Publication Month: January 1992	Aug 31, 2001
	Food Safety Department, World Health Organization	GEMS/Food Instructions for Electronic Submission of Data on Chemical Contaminants in Food This document provides an introduction to the GEMS/FOOD Programme and Contaminants Database and gives the protocols for electronic submission of data to this database. (more) Publication Month: January 2002	Aug 16, 2002
	National Toxicology Program, National Institute of Environmental Health Sciences, National Institutes of Health	NTP Technical Report on the Toxicology and Carcinogenesis Studies of Fumonisin B1(CAS No. 116355-83-0) In F344/N Rats and B6C3F1 Mice (Feed Studies) Report of studies on the toxicology and carcinogenesis of Fumonisin B1. Publication Month: December 2001	Aug 14, 2002
	Scientific Panel on Contaminants in the Food Chain, European Food Safety Authority	Opinion of the Scientific Panel on Contaminants in the Food Chain on a Request from the Commission Related to Zearalenone as Undesirable Substance in Animal Feed. (Question No EFSA-Q-2003-037) Opinion adopted on July 28, 2004 regarding zearalenone in animal feed. Includes discussion of analytical methods, legislation, occurrence in feeds, toxicological properties, toxicokinetics, residues in foods, and human dietary exposure. (more) Publication Date: Monday, August 9, 2004	Aug 10, 2004
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Processing Parameters Needed to Control Pathogens in Cold Smoked Fish This report discusses hazards derived from the consumption of cold-smoked fish. It describes pathogens that might be found in cold-smoked fish products, including Listeria monocytogenes, Clostridium botulinum type E, biogenic amines, and parasites. It discusses processing parameters that contribute to pathogen growth and options for minimizing the presence of foodborne pathogens in smoked fish products. The report also discusses the safety of fish harvesting and handling practices and the influence of packaging options on pathogen growth and survival. (more) Publication Date: Thursday, March 29, 2001	Jun 25, 2002
	Office of Seafood, Center for Food Safety and Applied Nutrition, Food and Drug Administration	Scombroid Poisoning This document describes scombroid poisoning, where is occurs, how to identify it, symptoms, what to do if you suspect you have scombroid poisoning, and how to avoid it. (more) Publication Year: 1989	Aug 7, 2002

Parasites

Format	Author(s)	Title / Description	Date added	Details
	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
	Huss, H.H.; Ababouch, L.; Gram, L.	Assessment and Management of Seafood Safety and Quality Report on risk assessment and management issues associated with seafood. Includes discussion of world seafood production and consumption, food safety systems, hazard identification and characterization, and risk management strategies such as HACCP, FSOs, microbiological criteria, traceability, and more. Appendices include "Assessment of Food Safety Programmes," "Hazard Analysis Worksheet," "HACCP Plan Form," and "Generic HACCP Plan for the Production and Processing of Oysters". (more) Publication Year: 2003	Nov 18, 2004
	Institute of Food Science and Technology	Cryptosporidium This report provides an overview of Cryptosporidium parvum. It includes a description of cryptosporidiosis, exposure routes, outbreaks, the life cycle, the resistance of oocysts, growth and control measures in food and water, and detection. (more) Publication Month: September 2001	Aug 9, 2002
	Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention	Cyclospora Infection or Cyclosporiasis Description of Cyclospora, how it is spread, who is at risk for infection, the symptoms of infection, and diagnosis, treatment, and prevention information for this illness. (more) Publication Month: March 2004	Jun 17, 2002
	American Medical Association/American Nurses Association-American Nurses Foundation/Centers for Disease Control and Prevention/Center for Food Safety and Applied Nutrition, Food and Drug Administration/Food Safety and Inspection Service, U.S. Department	Foodborne Illnesses Table: Parasitic Agents This table gives etiology, incubation period, signs and symptoms, duration of illness, associated foods, laboratory testing, and treatment information for Angiostrongylus cantonensis, Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia, Toxoplasma gondii, and Trichinella spiralis. (more) Publication Month: February 2004	Jul 19, 2002
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Foodborne Pathogenic Microorganisms and Natural Toxins Handbook: The "Bad Bug Book" Handbook with information on foodborne pathogenic microorganisms and natural toxins, including information on the associated disease, associated foods, target populations, outbreaks, and more. Appendices include "Infective dose," "Epidemiology summary table," "Factors affecting microbial growth in foods," "Foodborne Disease Outbreaks, United States 1988-1992," and "Additional Foodborne Disease Outbreak Articles and Databases". (more) Publication Month: January 1992	Aug 31, 2001
	Chappell, Cynthia L.	Of Mice, Men and Cell Cultures: Cryptosporidium parvum (Genotype 2) Infectivity 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 examines what laboratory models are contributing to the assessment of waterborne exposure to Cryptosporidium oocysts, whether the data from various studies are comparable, and how risk assessment modelers can use this data in a meaningful way. Finally, the results of a study of three C. parvum genotype 2 isolates that were compared using three different model systems are presented. This data includes dose response curves for antibody-negative volunteers and for neonatal mice. The pdf version of this presentation can be accessed here. (more) Publication Date: Friday, July 26, 2002	Aug 16, 2002
	Risk Assessment Consortium	Predicting Human Dose-Response Relationships from Multiple Biological Models: Issues with Cryptosporidium parvum Riverdale, MD: Agenda, presentations, and handout from this meeting on dose-response modeling of foodborne pathogens. Event Date: Thursday, September 28, 2000 Publication Date: Thursday, September 28, 2000	Jun 17, 2003
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Processing Parameters Needed to Control Pathogens in Cold Smoked Fish This report discusses hazards derived from the consumption of cold-smoked fish. It describes pathogens that might be found in cold-smoked fish products, including Listeria monocytogenes, Clostridium botulinum type E, biogenic amines, and parasites. It discusses processing parameters that contribute to pathogen growth and options for minimizing the presence of foodborne pathogens in smoked fish products. The report also discusses the safety of fish harvesting and handling practices and the influence of packaging options on pathogen growth and survival. (more) Publication Date: Thursday, March 29, 2001	Jun 25, 2002
	Teunis, Peter, Cynthia Chappell, and Pablo Okhuysen	Risk Assessment for Pathogenic Protozoa: Cryptosporidium 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 discusses sources of heterogeneity, bimodal description of water treatment, infectivity of Cryptosporidium oocysts, serum IgG and susceptibility to infection, and dynamics of the immune response to Cryptosporidium. Includes a graph showing dose response relations for 4 different oocyst isolates, and presents dose response models for single and multiple isolates. It also covers immune status dependent dose response considerations. (more) Publication Date: Thursday, July 25, 2002	Aug 21, 2002

Viruses

Format	Author(s)	Title / Description	Date added	Details
	Huss, H.H.; Ababouch, L.; Gram, L.	Assessment and Management of Seafood Safety and Quality Report on risk assessment and management issues associated with seafood. Includes discussion of world seafood production and consumption, food safety systems, hazard identification and characterization, and risk management strategies such as HACCP, FSOs, microbiological criteria, traceability, and more. Appendices include "Assessment of Food Safety Programmes," "Hazard Analysis Worksheet," "HACCP Plan Form," and "Generic HACCP Plan for the Production and Processing of Oysters". (more) Publication Year: 2003	Nov 18, 2004
	Data Gaps Working Group, Risk Assessment Consortium	Data Gaps for Selected Microbial Risk Assessments This document contains lists of data gaps identified in published microbial risk assessments by the US Food & Drug Administration, US Department of Agriculture's Food Safety & Inspection Service, and the World Health Organization/Food and Agriculture Organization of the United Nations. Each data gap is identified by exposure assessment category, the type of information needed, and a brief explanation of the specific data gap. For discussion of needs and gaps in microbial risk assessment as a whole, see Fazil, Aamir, et al. 2005. Microbial risk assessment as a foundation for informed decision-making: a needs, gaps and opportunities assessment (NGOA) for microbial risk assessment in food and water. Available here. (more) Publication Date: Thursday, December 2, 2004	Apr 6, 2004
	American Medical Association/American Nurses Association-American Nurses Foundation/Centers for Disease Control and Prevention/Center for Food Safety and Applied Nutrition, Food and Drug Administration/Food Safety and Inspection Service, U.S. Department	Foodborne Illnesses Table: Viral Agents Table gives etiology, incubation period, signs and symptoms, duration of illness, associated foods, laboratory testing, and treatment of Hepatitis A, noroviruses and other caliciviruses, rotavirus, and other viral agents. (more) Publication Month: February 2004	Jul 19, 2002
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Foodborne Pathogenic Microorganisms and Natural Toxins Handbook: The "Bad Bug Book" Handbook with information on foodborne pathogenic microorganisms and natural toxins, including information on the associated disease, associated foods, target populations, outbreaks, and more. Appendices include "Infective dose," "Epidemiology summary table," "Factors affecting microbial growth in foods," "Foodborne Disease Outbreaks, United States 1988-1992," and "Additional Foodborne Disease Outbreak Articles and Databases". (more) Publication Month: January 1992	Aug 31, 2001
	Institute of Food Science and Technology	Foodborne Viral Infections Overview of foodborne viral infections, their sources, detection, survival characteristics, and control. Publication Date: Tuesday, January 23, 2001	Aug 9, 2002

Prions

Format	Author(s)	Title / Description	Date added	Details
	Center for Food Safety and Applied Nutrition, Food and Drug Administration	Foodborne Pathogenic Microorganisms and Natural Toxins Handbook: The "Bad Bug Book" Handbook with information on foodborne pathogenic microorganisms and natural toxins, including information on the associated disease, associated foods, target populations, outbreaks, and more. Appendices include "Infective dose," "Epidemiology summary table," "Factors affecting microbial growth in foods," "Foodborne Disease Outbreaks, United States 1988-1992," and "Additional Foodborne Disease Outbreak Articles and Databases". (more) Publication Month: January 1992	Aug 31, 2001
	Scientific Steering Committee, Health and Consumer Protection Directorate-General, European Commission	Safety of Animal Rennet in Regard to Risks from Animal TSE and BSE in Particular This opinion paper and supporting report discuss the safety of rennet obtained from calves, cattle, small ruminants, and pigs with respect to TSE and BSE. (more) Publication Date: Thursday, May 16, 2002	Aug 2, 2002