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We are the sole and exclusive host to various content for the food safety risk analysis community. Below are the formats we support.

Federal Register Documents

Federal Register Volume 58 Part IV: Department of Health and Human Services
Source: FoodRisk.org/Federal Register Vol. 58 (27 sections / 875 pages in length)
Author: Food and Drug Administration
Summary: We digitally restored the pages of this original Federal Register document. All pages are downloadable in PDF format.
Resource type: document, tables
Date added to FoodRisk.org: April 21, 2004
Publication Date: January 6, 1993

Federal Register Volume 56 (Proposed NLEA): Department of Health and Human Services
Source: FoodRisk.org/Proposed Federal Register (27 sections / 513 pages in length)
Author: Food and Drug Administration
Summary: We scanned this original Proposed Federal Register document. All pages are downloadable in PDF format.
Resource type: document, tables
Date added to FoodRisk.org: November 26, 2008
Publication Date: November 27, 1991

Regulatory Impact Analysis of the Proposed Rules to Amend the Food Labeling Regulations
Source: FoodRisk.org/Federal Register Vol. 56, No. 229, Nov. 27, 1991, 60856-60877
Author: Food and Drug Administration
Summary: The FDA's regulatory impact analysis of proposed rules to amend the food labeling regulations in response to the 1990 amendments to the Federal Food, Drug, and Cosmetic Act. Includes background information, disscussion of the purpose of the regulatory impact analysis, a description of the proposed action, discussion of market failure, an economic impact analysis, discussion of options considered, and a discussion of international impacts. Numerous tables are included with supporting data
Resource type: document, tables
Date added to FoodRisk.org: October 2002
Pub. date from document: November 27, 1991
Citation Help: ProCite Format | Text Format

This file also provides access to Federal Register Vol. 56, No. 229, Nov. 27, 1991, 60877-60878, “Food Labeling; Declaration of Ingredients and Food Labeling; Declaration of Ingredients, Common or Usual Name for Nonstandardized Foods, Diluted Juice Beverages”, issued by the Food and Drug Administration. This document announces a delay in the statutory effective date of the ingredient labeling provisions of the Nutrition Labeling and Education Act of 1990

Databases

Consumer Storage Practices for Refrigerated Ready-to-Eat Foods
RTI International, Tennessee State University, and Kansas State University conducted a national survey of U.S. adults using a Web-enabled panel survey approach. The purpose of the survey was to characterize home storage and refrigeration practices for a variety of refrigerated ready-to-eat (RTE) foods and consumers' knowledge and use of open date statements (e.g., "use by" or "sell by") among pregnant women, seniors, and the remaining population.
Items: Study design, survey questionnaire, data dictionary, respondent data, survey data
Date added to FoodRisk.org: 2007

Animal-Derived Cosmetic Ingredient Database
RTI, under contract with FDA, constructed this database on cosmetic ingredients that could potentially be derived from animals. These ingredients are of interest because of the potential for transmission of Bovine Spongiform Encephalopathy (BSE) or other Transmissible Spongiform Encephalopathies (TSEs). February 2004
Items:Database and final report.
Date added to FoodRisk.org: February 2004
Pub. date from document: April 2002
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Identification of Animal Ingredients in Dietary Supplements Database
RTI, under contract with FDA, constructed this database on dietary supplement products sold on the Internet that contain animal ingredients. These ingredients are of interest because of the possibility of transmission of Bovine Spongiform Encephalopathy (BSE). February 2004
Items:Database and final report.
Date added to FoodRisk.org: February 2004
Pub. date from document: August 15, 2002
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Survey of Manufacturing Practices in the Dietary Supplement Industry
A survey conducted by Research Triangle Institute (RTI) under contract with FDA of 966 dietary supplement establishments. The purpose of this survey was to learn about the current manufacturing practices and what constitutes GMP's in the industry.
Items:Database and final report.
Date added to FoodRisk.org: June 2002
Pub. date from document: May 17, 2000
Acknowledgements: With special thanks to the Economics team in FDA-CFSAN, Office of Scientific Analysis and Support, Division of Market Studies. June 2002.
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Survey of Listeria monocytogenes in Ready to Eat Foods
The National Food Processors Association (NFPA) conducted this study with the purpose of addressing uncertainties in risk assessment regarding the occurrence of L. Monocytogenes in ready to eat foods.

NFPA collected and tested about 31,700 samples in eight different categories of ready to eat foods. Samples were collected and tested over a period of 14 -23 months from retail markets in Maryland and California Food Net sites. The product categories on the access database include fresh soft "Hispanic" style cheeses, bagged salads, blue veined and soft mold ripened cheeses, smoked seafood and seafood salad. The access database includes information on the product, such as location packaged, geographic area, date listed, date of purchase, date of assay, if vacuum packaged, etc. Test information also includes presumptive positives, number of tubes that are turbid at the 1, 10 and 100 dilution, most probable number, presumptive colonies, cfu/g, etc.
Date added to FoodRisk.org: March 2003
Citation Help: ProCite Format | Text Format

Current State of Food Product Open Dates in the U.S.
Eastern Research Group, under contract with FDA, conducted this study of food product open dates. The information in this study was sought through literature reviews, multiple in-store surveys of food products and discussions with industry personnel and trade organizations. The survey universe consists of 149 product categories covering baked, dairy, frozen, refrigerated, shelf-stable, and chilled ready to eat food products.
Items: Manufacturers Survey Database, Food Products Survey Database, and Documentation
Date added to FoodRisk.org: October 2003
Pub. date from document: July 18, 2003
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Dietary Supplement Sales Database (DSPD)
A survey conducted by Research Triangle Institute (RTI) under contract with FDA. The access database contains labeling and catalogue information of approximately 3,000 dietary supplement products sold in the United States. The database includes information such as the product's name, the name and address of the manufacturer or distributor, the product's ingredients, and claims about the product. Claims may be about the health benefits or nutrient content of the product or may be nutritional support statements. Thus, the database provides information on the range of products available for sale in the United States, where these products are sold, what they contain, and what claims are being made about these products. Also available are the final report of the project, which includes information on the procedures used and a description of the database, and a supplement to the final report, which includes detailed records from the data collection process.
Date added to FoodRisk.org: August 2002
Pub. date from document: October 1999
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Food Testing Laboratory Database (FTLD)
A survey conducted by Research Triangle Institute (RTI) under contract with FDA. The access database contains 546 records of private laboratories that test food. It includes the variables needed to support the kinds of analyses FDA expects to undertake-such as location and contact information, economic variables, test capabilities, and Quality Assurance Programs. The FTLD allows users to sort laboratories by location such as state or country, query laboratories owned by one parent company, sort laboratories by capabilities, and sort laboratories that use quality assurance guidelines such as International Organization for Standardization (ISO) standards, and determine laboratories associated with a certain geographic area or FDA district. This page also contains the final report of the project, which describes the selection process used to distinguish food laboratories from other laboratories, the structure of the FTLD, including the variables, tables, and forms that make up the database. It also describes testing capabilities and summarizes a preliminary analysis of the QAP status of private food testing laboratories and presents recommendations for further research.
Date added to FoodRisk.org: August 2002
Pub. date from document: June 2001 (Database updated April 2004)
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Audits/FDA Food Temperature Database
Data on cold and hot foods from the retailer to the home and dinner plate.
Date added to FoodRisk.org: 2000
Pub. date from document: 1999
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Tools

Cost of Reformulating Foods and Cosmetics
Foods and cosmetics are examples of regulated products which are sometimes reformulated in response to changes in the marketplace or regulatory environment. RTI and the Economics Team at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) produced this model to help estimate the costs incurred in reformulation due to changes in regulations. The report provides information on the process of reformulation and a description of the underlying assumptions and calculations used in developing the model. Instructions for using the model are in Section 4 of the report.
Date added to FoodRisk.org: March 2005
Pub. date from document: July 2002
Citation Help: Text Format

The Food Handling Practices Model (FHPM) version 1.5
Updated version to the quantitative model developed by the FDA under contract with ERG Incorporated of the effects of contributing factors on the incidence of foodborne illness.
Date added to FoodRisk.org: March 30, 2009
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The Food Handling Practices Model (FHPM) version 1.0
Each year millions of cases of foodborne illness occur in the United States. Preceding most cases of foodborne illness is contamination by pathogens and failure to destroy or sufficiently control pathogens in retail and foodservice establishments or households. FDA under contract with RTI International developed a quantitative simulation model of the effects of contributing factors on the incidence of foodborne illness. The food handling practices model is a computer simulation model that allows users to estimate how one or more changes in food handling practices at the retail, foodservice, or household level may affect the annual number of food-related illnesses in the US.
Date added to FoodRisk.org: April 27, 2004
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AuvTool
AuvTool is a software tool for statistical analysis of variability and uncertainty associated with fitting parametric probability distributions to data sets. It was developed for the Office of Research and Development(ORD) of U.S. Environmental Protection Agency, Research Triangle, NC.
Date added to FoodRisk.org: January 2003
Pub. date from document: 2002
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FARE Microbial™
Software program for conducting probabilistic microbial risk assessment. The program was developed by Exponent together with the Food and Drug Administration, and consists of a Contamination and Growth Module and an Exposure Module. Data from the U.S. Department of Agriculture's Continuing Survey of Food Intakes by Individuals (CSFII) 1994-96, 98 are included in the program. A users manual, containing both installation and use guidelines, is provided
Date added to FoodRisk.org: November 2002
Pub. date from document: September 2002
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FDA Labeling cost model
FDA contracted with (Research Triangle Institute) RTI to update RTI's 1990 labeling cost model to make the model more relevant for the types of analyses currently conducted by FDA. This report provides background information on the process of changing the labeling information on food packaging, a description of the revised cost estimates used in the model, a description of the underlying assumptions and calculations used in developing the model, and instructions for working with the model to obtain specific cost estimates.
Date added to FoodRisk.org: February 2003
Pub. date from document: January 2003
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Foodborne Disease Outbreak Questionnaire
A telephone questionnaire to be used by departments of public health to gather information that can help establish the relationship between dose of foodborne pathogens and health impacts.
Date added to FoodRisk.org: 2000
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Reports

Analyses of the Relationships between Consumer Health Concerns and Purchase of Food Products
Report of a survey conducted by Research Triangle Institute (RTI) under contract with CFSAN of approximately 24,000 households. The purpose of the study was to analyze the relationships between consumer health concerns and purchases of food products, focusing on fresh bread and refrigerated milk.
Pub. date: April 2006

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
Pub. date: December 2004
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The Role of Quantitative Microbiological Risk Assessment in Risk Management Options Assessment
This document served as a background paper for the Joint FAO/WHO Consultation held in Kiel, Germany on March 18-22, 2002. It discusses the use of quantitative risk assessment in evaluating and comparing options for risk management.
Date added to FoodRisk.org: February 2004
Pub. date from document: March 2002
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Conduct of Quantitative Microbial Risk Assessments by U.S. Food and Drug Administration's Center for Food Safety and Applied Nutrition: Lessons Learned

This document served as a background paper for the Joint FAO/WHO Consultation held in Kiel, Germany on March 18-22, 2002. It discusses FDA's Center for Food Safety and Applied Nutrition (CFSAN)'s approach to microbial risk assessment, outlines CFSAN's measures to involve interested parties in the risk assessment process, and discusses lessons learned by CFSAN regarding "(1) commissioning a risk assessment, (2) interaction between risk managers and risk assessors during the conduct of a risk assessment, (3) acquiring input from interested parties, (4) peer review, and (5) reporting the results."
Date added to FoodRisk.org: February 2004
Pub. date from document: March 2002
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Analysis of Hazard Analysis Critical Control Point (HACCP) Survey Data
A three phase survey conducted by Research Triangle Institute (RTI) under contract with FDA of 17,000 food manufacturing plants under FDA jurisdiction. The purpose of this survey was to determine the current food safety practices in the food processing industry and to estimate the costs of implementing a HACCP plan. Items: 1 report in pdf format. Data in access, xls and ascii format--coming soon.
Date added to FoodRisk.org: June 2002
Pub. date from document: July 2001
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Cost of Restrictions on Gulf Oyster Harvesting for Control of Vibrio vulnificus-Caused Disease
Report of a study conducted by the Research Triangle Institute (RTI) for the Food and Drug Administration (FDA) on the costs of various control plans for Vibrio vulnificus in Gulf of Mexico oysters. It includes an estimate of the compliance costs of the Interstate Shellfish Sanitation Conference (ISSC) interim control plan for Vibrio vulnificus in oysters. Data is provided in tables and charts on oyster harvests, oysters bound for raw consumption, number of harvesters, processing plants, and shippers, baseline prices, and more
Date added to FoodRisk.org: September 2002
Pub. date from document: October 1996
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Presentations

Tools for Prioritizing Food Safety Concerns: An FDA Perspective
http://www.jifsan.umd.edu/tools_2007.htm
Source: Joint Institute for Food Safety and Applied Nutrition
Author: Buchanan, Robert
Summary: This presentation discusses managing food safety risk and risk ranking from FDA perspective. It was presented at the 2007 Tools For Prioritizing Food Safety Concerns Workshop.
Publication Date: July 16, 2007

Tools For Prioritizing Food Safety Concerns Workshop
http://www.jifsan.umd.edu/tools_2007.htm
Source: Joint Institute for Food Safety and Applied Nutrition
Author: FDA/CFSAN/USDA/FSIS/CanTox/EPA/General Mills/Unilever
Summary: The Tools for Prioritizing Food Safety Concerns Workshop was held June 4-6, 2007, in Greenbelt, MD. The goal of the workshop was to bring together different organizations who are working on tools for risk screening, ranking, and prioritization to discuss approaches and develop recommendations for a process to prioritize risks associated with chemical and microbial contaminants in food.
Publication Date: July 16, 2007

Tomato Safety Research Needs Workshop, JIFSAN - UF/IFAS 2007
http://www.jifsan.umd.edu/tomato_wkp2007.htm
Source: Joint Institute for Food Safety and Applied Nutrition
Author: Joint Institute for Food Safety and Applied Nutrition/University of Florida Institute of Food and Agricultural Sciences
Summary: The Tomato Safety Research Needs Workshop, was held February 21-22, 2007 in College Park, Maryland. The two major goals of the workshop were to prioritize research needed to solve the problem of Salmonella and other human pathogens in tomatoes and to begin the process of developing a platform for on-going communication and coordination. Forty scientists representing academia, government, producers and trade groups participated.
Publication Date: July 16, 2007

Food allergies: Issues in establishing thresholds - W7 - Symposium, Society For Risk Analysis Annual Meeting 2006
Up to 6% of children and 4% of the total US population have IgE-mediated food allergies. Accurate and informative food labeling is critical for these allergic consumers because they need to rely on strict avoidance to prevent potentially serious reactions. The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 requires that the label of a food product that is or contains an ingredient that bears or contains a major food allergen declare the presence of the allergen. An important scientific issue associated with the implementation of FALCPA is the existence of threshold levels below which it is unlikely that a food allergic individual would experience an adverse effect. This session will explore the science of food allergies, the application of risk and safety assessments to establishing thresholds, and the identification of data sources that can be used to understand the prevalence of allergies.
Item: Presentations
Date added to FoodRisk.org: February 2007
Pub. date from document: December 2006

RAC Symposium 2004: Data Collection and Utilization in Risk Assessment and Management Decisions
Agenda, abstracts, presentations, and executive summary of the symposium "Data Collection and Utilization in Risk Assessment and Management Decisions," held September 14, 2004 in College Park, MD.
Date added to FoodRisk.org: March 2005
   

RAC Symposium 2003: Peer review of Risk Assessments and Related Activities
Agenda, abstracts, presentations, and speaker bios from the Joint JIFSAN/SRA/RAC Symposium on Peer Review of Risk Assessments and Related Activities, held September 30, 2003 in Riverdale, MD.
 

Presentations from the 1st International Conference on Microbiological Risk Assessment: Foodborne Hazards
Presentations from this conference held July 24-26, 2002 in Adelphi, MD.
 

Predicting human dose-response relationships from multiple biological models:
Issues with Cryptosporidium parvum: Speaker Lists and Presentations
Presentations and speaker bios from this meeting held September 28, 2000 in Riverdale, MD.
 

Food Safety Initiative Technical Workshop: Relating Numbers of Foodborne Pathogens to Human Illness
Abstracts, presentations, and speaker bios from this workshop held August 4, 1998 in College Park, MD.

Risk Communication Tutorials
A series of seven on-line tutorials on various facets of risk communication created by Dr.  Katherine McComas as a FoodRisk.org exclusive.  Presentations are best viewed with Internet Explorer 5 or higher.  Each presentation is also available as a printable text version in pdf and a text-only version in html.
Date added to FoodRisk.org: 2001
 

Risk Assessment Tutorials
The following risk assessment tutorials were prepared by Dr. Charlie Yoe as FoodRisk.org Exclusives.
Date added to FoodRisk.org: 2000
 

Pathogen Performance Standards: Insight from Risk Assessment and Economics - W7 - Symposium, Society For Risk Analysis Annual Meeting 2003
Growth in international food trade and concern about terrorism has propelled food safety to a high position on many policymakers' lists of important policy issues. However, even in the absence of major trade-related outbreaks, foodborne illness is a costly problem. In the United States, for example, there are an estimated 76 million cases of acute foodborne illnesses each year, with outcomes that include death and chronic complications, such as arthritis, kidney failure, paralysis, or mental retardation. The economic costs for five U.S. foodborne pathogens are estimated at $6.9 billion annually in medical costs, productivity losses, and premature death. Countries have developed various methods to assure domestic food safety and safety in trade and the World Trade Organization and CODEX Alimentarius have international standards and committees. This symposium addresses a number of technical and policy challenges in the use of risk assessment to construct and justify risk-based performance standards.
Item: Presentations
Date added to FoodRisk.org: January 2004
Pub. date from document: December 2003