FDA-iRISK® is a Web-based risk-assessment tool developed by the U.S. Food and Drug Administration (FDA). Version 5.0 is now available and includes a number of new features and enhancements. This food-safety modeling tool enables users to compare and rank risks from multiple microbial and chemical hazards and predict effectiveness of prevention and control measures, expressed as public-health metrics. Risk managers and other stakeholders can use FDA-iRISK to inform food-safety policy and management decisions.

The Heavy Metal Screening Tool is "designed to be used by risk assessors/managers to rapidly evaluate potential public health risk when confronted with the detection of select heavy metals in foods and food ingredients."

This tool is a joint initiative of the University of Maryland's Joint Institute for Food Safety and Applied Nutrition (UMD JIFSAN) and the Institute for the Advancement of Nutrition and Food Sciences (IAFNS). The levels calculated by this tool are not regulatory levels or limits under consideration by FDA; nor should this tool be used to determine compliance with any FDA guidance or regulations

The In-Plant Deli Meat Model allows users to evaluate the effectiveness of using growth inhibitors, post-lethality interventions, combinations of these interventions, product testing and diversion, and food contact surface testing and sanitation.

The United States Department of Agriculture (USDA) Food Code Selector simplifies the process of extracting consumption information from What We Eat in America (WWEIA), the dietary component of the National Health and Nutrition Examination Surveys (NHANES). This tool allows filtering of NHANES data via direct selection from 8,000+ foods using a streamlined user-friendly interface. This Microsoft Excel-based tool decreases dependence on 3rd party software and allows for transparency and accessibility with the tool’s traceable decision logic.

We developed an improved simplified Quantitative Microbiological Risk Assessment (QMRA) model and tool with reduced data need, applicable to any pathogen - food product combination and in addition suitable for basic QMRA education. The swift QMRA (sQMRA2) – model follows pathogen numbers through part of the food chain, starting at the retail phase, and ends with the estimated number of human cases of illness.

Welcome to the Produce Point of Origin Database (PPOD). PPOD is a searchable database that provides selected commodity-specific information on the movement of produce in the United States, either domestic or international, based on seasonality data. The information is compiled from the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) Market Reports.

Supplemental Materials for Journal of Food Protection Article

Webinar Recording for FDA-iRISK 1.0

A great variety of fruits and vegetables are available in the United States. These items are produced in various geographic regions by a diverse industry. Produce has been increasingly identified as a vehicle for disease outbreaks. Changes in consumption may explain this increase, but analyses of produce consumption are limited. Comprehensive assessments of the public health risks associated with produce depend on quantitative consumption data, including the population fractions and subgroups of consumers, the quantities consumed by these individuals, and the processing that occurs before consumption. Here, we provide an analysis of nationally representative consumption estimates by estimating consumption frequencies, serving sizes, and processing forms for a variety of produce commodities based on 1999 through 2006 data from ‘‘What We Eat in America,’’ the dietary interview component of the National Health and Nutrition Examination Survey performed by the National Center for Health Statistics

The Interactive online Catalogue on Risk assessment (ICRA) serves as a web tool offering a dynamic model catalogue for existing microbial risk assessments for risk assessors aiming to develop their own models. ICRA allows users to compare and contrast models from the same pathogen and/or commodity

Notational analysis is an observational method in which a food employee’s actions can be recorded quickly and in the sequence that they occur. The notational analysis technique was initially employed to record the behavior of food employees by Clayton and Griffith (2004), who adapted the technique from the field of sports science.

A simplified Quantitative Microbiological Risk Assessment (QMRA) model was especially developed to compare the risk of pathogen-food product combinations. The swift quantitative microbiological risk assessment (sQMRA) tool is implemented in Microsoft Excel. Special attention is given to make the sQMRA tool insightful, for educational purposes.

EcoSure, the food safety & quality assurance division of Ecolab, has updated the 1999 Audits International cold temperature database. In addition to an updated data set, the new data help determine whether changes have occurred in cold temperature storage practices of food both in retail establishments and in consumer homes.

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. The survey was funded through a grant from the National Integrated Food Safety Initiative of the Cooperative State Research, Education, and Extension Service, U.S. Department of Agriculture (Grant No. 2004-51110-02177).

In September of 2007, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) contracted with Eastern Research Group, Inc. (ERG) to update its Food Handling Practices Model (FHPM) originally developed by RTI International. The model allows the FDA to estimate the effects of various retail and household practices on the incidence of foodborne illness (FBI).

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.

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.

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

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.

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.

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).

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.

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, based on the earlier labeling cost 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

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).

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

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:

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.

Research Triangle Institute (RTI), under contract with FDA, conducted studies to estimate the costs of implementing HACCP in food plants under FDA jurisdiction. The purpose of these studies was to determine the state of current food safety practices in the food processing industry and estimate the costs of moving from the pre-HACCP baseline to regulatory compliance

A survey conducted by Research Triangle Institute (RTI) under contract with FDA. The access database contains 593 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.

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.

Listeria monocytogenes is readily found in the environment of retail deli establishments and can occasionally contaminate food handled in these establishments. Here we synthesize the available scientific evidence to derive probability distributions and mathematical models of bacterial transfers between environmental surfaces and foods, including those during slicing of food, and of bacterial removal during cleaning and sanitizing

WWEIA-Food Commodity Intake Database (FCID) 2005-10 was developed by U.S. EPA's Office of Pesticide Programs (OPP) to improve the utility of the WWEIA food consumption survey for pesticide dietary exposure assessment.

A series of seven on-line tutorials on various facets of risk communication created by Dr. Katherine McComas as a FoodRisk.org exclusive. Each presentation is available in PDF and PowerPoint (PPT) format.

The previous Director of Center for Food Safety and Security Systems (CFS3), Dr. Robert Buchanan, has been collecting and indexing relevant articles in the area of microbial food safety for the last 25 years. He is making his personal efforts available to the public through FoodRisk.org.

The Chicago Department of Public Health, with support of the US Food and Drug Administration, has created 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.  The documents below are made available in both html (for viewing) and pdf (for printing).  In addition, the questionnaire, in both English and Spanish, is made available as a downloadable Microsoft Word document for editing so that it may be used by departments of public health in outbreaks they may investigate.

The U.S. Food and Drug Administration is responsible for ensuring the safety of all domestic and imported fresh produce consumed in the United States. Outbreaks of illness due to food-borne pathogens associated with fresh produce have increased in the past decade. Despite some high-profile outbreaks, there has been no systematic means by which to compare the different agent-commodity combinations to determine which present the most significant risks and prioritize them as candidates for interventions that might help prevent contamination or inactivate contaminants when they are present in food.

Research Triangle Institute (RTI) conducted a study for the Food and Drug Administration (FDA) to estimate the costs of a seasonal harvesting restriction on Gulf of Mexico oysters and a seasonal marketing restriction on the sale of Gulf Oysters for raw consumption.

Below you will find Word and PDF versions of the Federal Register Part IV released on January 6, 1993. This volume pertains specifically to the Department of Health and Human Services: Food and Drug Administration. All pages were recreated from the original, including text, charts, images and bibliographical references.

This is a scanned copy of the Federal Register, Vol. 56, No. 229, Wednesday, November 27, 1991, Proposed Rules. It addressed 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. The document includes: background information, discussion 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.

his is the PDF version of the 56 FR No. 229 (1991) (Proposed NLEA) released on November 27, 1991 and preceded the final Federal Register Part IV released on January 6, 1993. This document pertains specifically to the Department of Health and Human Services: Food and Drug Administration. All pages were scanned from the original, including text, charts, images and bibliographical references.

These databases were created by Audits International, an independent food research organization, with support from the US Food and Drug Administration.