Risk Assessment /Safety Assessment

As the nation’s food supply becomes more global and complex, decisions about policies aimed at preventing contamination and illness have become even more important to the public’s health. The Food and Drug Administration (FDA) uses risk analysis, a concept and framework fostered by the World Health Organization, to ensure that regulatory decisions about foods are science-based and transparent.

Read more about how FDA’s Center for Food Safety and Applied Nutrition (CFSAN) applies risk analysis, from conventional methods to new, far-reaching tools that use advanced technology to prioritize risks and calculate optimal interventions at Risk Analysis at FDA: Food Safety

 

 

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Topics:

General Information Allergens BSE/TSE Escherichia coli Gluten Food Additives Food Defense

Hepatitis A Virus Highly Pathogenic Avian Influenza Virus Listeria monocytogenes Melamine  Methylmercury Norovirus Vibrio parahaemolyticus

• Additional Information from Other Agencies and Organizations

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General Information

• Risk Management Framework: Best Practices for Resolving Complex Food Safety Risks (PDF - 140 KB)
  February/March 2006  
• Initiation and Conduct of All ‘Major’ Risk Assessments within a Risk Analysis Framework
  March 2002
• Microbial Risk Assessment: Achievements and Future Challenges (PDF - 100 KB)
  December 2001/January 2002
   

Allergens

• Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food
  March 2006
   

BSE/TSE

• An Evaluation of the Risk of Variant Creutzfeldt-Jakob Disease from Exposure to Cattle-Derived Protein Used in Cosmetics
  July 14, 2001
   

Escherichia coli

• Escherichia coli O157:H7 in Apple Cider: A Quantitative Risk Assessment (PPT - 166 KB)
  July 1999
   

Gluten

• Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten (PDF - 462 KB)
  May 2011
• External Peer Review of the FDA/CFSAN Draft Health Hazard Assessment for Gluten in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten (PDF - 292 KB)
  December 2010
   

Food Additives

• Food and Color Additive Program
   

Food Defense

• Food Defense Programs
   

Hepatitis A Virus

• Peer Review Report - Risk Profile: Hepatitis A Virus Infection Associated with Consumption of Fresh and Fresh-Cut Produce
  August 2008
   

Highly Pathogenic Avian Influenza Virus

• Interagency Risk Assessment for the Public Health Impact of Highly Pathogenic Avian Influenza Virus in Poultry, Shell Eggs, and Egg Products
  May 2010
   

Listeria monocytogenes

• Quantitative Assessment of the Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods
  September 2003
• Listeria monocytogenes Risk Assessment Questions and Answers
  October 21, 2003
• Reducing the Risk of Listeria monocytogenes; FDA/CDC 2003 Update of the Listeria Action Plan
  November 2003
• FDA/Center for Food Safety and Applied Nutrition USDA/Food Safety and Inspection Service Centers for Disease Control and Prevention December 2003 Listeria monocytogenes: Risk Assessment and Risk Management Meeting Agenda & Presentations
  December 4, 2003
• Current FDA Activities Related to the Listeria monocytogenes Action Plan
  February 6, 2008
   

Melamine

• External Peer Review of the FDA/CFSAN Draft Report Interim Safety and Risk Assessment of Melamine and its Analogues in Food for Humans (October 3, 2008) and Update (November 28, 2008)
  November 28, 2008
• Update: Interim Safety and Risk Assessment of Melamine and its Analogues in Food for Humans
  November 28, 2008
• Interim Melamine and Analogues Safety/Risk Assessment
  May 25, 2007
• Peer Review Report
  June 7, 2007
   

Methylmercury

• Report of Quantitative Risk and Benefit Assessment of Commercial Fish, focusing on Fetal Neurodevelopmental Effects (Measured by Verbal Development in Children) and on Coronary Heart Disease and Stroke in the General Population
  January, 2009
• A Pooled Analysis of the Iraqi and Seychelles Methylmercury Studies (PDF - 499 KB) 
  (published in Human and Ecological Risk Assessment: Vol. 6., No. 2, pp. 323-340 (2000))
• An Intervention Analysis for the Reduction of Exposure to Methylmercury from the Consumption of Seafood by Women of Child-bearing Age (PDF - 182 KB)
  (published in Regulatory Toxicology and Pharmacology No. 40 pp. 272-280 (2004))
• An Exposure Assessment for Methylmercury from Seafood for Consumers in the United States (PDF - 265 KB)
  (published in Risk Analysis Vol. 22, No. 4, pp. 689-699 (2002))
   

Norovirus

• Norovirus in Bivalve Molluscan Shellfish (upcoming risk assessment)
• Transmission of Norovirus (risk profile, underway)
   

Vibrio parahaemolyticus

• Quantitative Risk Assessment on the Public Health Impact of Pathogenic Vibrio parahaemolyticus in Raw Oysters
  July 19, 2005