Risk and Safety Assessments (Food)

Fact Sheets

• Risk Analysis at FDA: A science-based approach to policy decisions (for Food Safety and Health Professionals)
• FDA-iRISK® version 4.2 - A Food-Safety Modeling Tool
• A Closer Look at FDA-iRISK® version 4.2
• What Is Risk Assessment, and What Does It Have to Do with My Food?

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 public health. FDA’s human foods program 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.

To read about how FDA’s human foods program 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 of Food at FDA.

Topic specific information can be found below.

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Topics

General Information

• Review of Microbiology Laboratory Capacity, Efficiency and Management February 2016
• Initiation and Conduct of All "Major" Risk Assessments within a Risk Analysis Framework March 2002
• Risk Management Framework: Best Practices for Resolving Complex Food Safety Risks (PDF 140KB) February/March 2006
• Microbial Risk Assessment: Achievements and Future Challenges (PDF 100KB) December 2001/January 2002

Allergens

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

Animal Drug Residues

• Multicriteria-based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products April 2015

Arsenic

• Arsenic in Rice and Rice Products Risk Assessment April 2016
• Draft Quantitative Assessment of Inorganic Arsenic in Apple Juice (PDF 296KB) July 2013
  Note: You may request access to the risk model related to this risk assessment by sending a note to FDAFoodSafetyRiskModel@fda.hhs.gov.
• Peer Review Report on the Assessment of Arsenic in Apple Juice (PDF 292KB) December 2012

BSE/TSE

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

Escherichia coli

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

Food Additives

• Food and Color Additive Program

Food Defense

• Food Defense Programs

FSMA-Related Risk Assessments

• Risk Assessment of Foodborne Illness Associated With Pathogens From Produce Grown in Fields Amended With Untreated Biological Soil Amendments of Animal Origin April 2016
• Qualitative Assessment of Risk to Public Health From On Farm Contamination of Produce (PDF: 986KB) November 2015
• Draft Methodological Approach to Identifying High-Risk Foods under Section 204(d)(2) of the FSMA February 2014
• Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (PDF: 651KB) September 2015
  • Appendix 3 of Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (PDF: 50KB) May 2016
  • Appendix 3 of Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm: Evaluation of Food Manufactured, Processed, Packed, or Held (Outside the Farm Definition) in a Facility Co-Located on a Farm for Risk of Intentional Adulteration: Response to Public Comments (PDF: 100KB) May 2016
  • Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm: Response to Public Comments (PDF: 110KB) September 2015

Gluten

• FDA’s Responses to Comments on the Report Titled ‘Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten (PDF 157KB) December 2012
• Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten (PDF 462KB) 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 292KB) December 2010

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

• Joint FDA / Health Canada Quantitative Assessment of the Risk of Listeriosis from Soft-Ripened Cheese Consumption in the United States and Canada July 2015
• Interagency Risk Assessment: Listeria monocytogenes in Retail Delicatessens Technical Report (PDF 10MB) September 2013
  Note: You may request the model, coded in R, related to this risk assessment by sending a note to FDAFoodSafetyRiskModel@fda.hhs.gov.
  • Interagency Risk Assessment: Listeria monocytogenes in Retail Delicatessens Response to Public Comments (PDF 247KB)
  • Interagency Risk Assessment: Listeria monocytogenes in Retail Delicatessens Interpretive Summary (PDF 541KB)
• Draft Interagency Risk Assessment – Listeria monocytogenes in Retail Delicatessens Technical Report (PDF 2.7MB) May 2013
  Note: You may request the model, coded in R, related to this risk assessment by sending a note to FDAFoodSafetyRiskModel@fda.hhs.gov.
  • Draft Interagency Risk Assessment – Listeria monocytogenes in Retail Delicatessens Interpretative Summary (PDF 480KB)
• Current FDA Activities Related to the Listeria monocytogenes Action Plan February 2008
• 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 2003
• Reducing the Risk of Listeria monocytogenes; FDA/CDC 2003 Update of the Listeria Action Plan November 2003

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 2008
  • Update: Interim Safety and Risk Assessment of Melamine and its Analogues in Food for Humans November 2008
  • Interim Melamine and Analogues Safety/Risk Assessment May 2007
  • Peer Review Report June 2007

Methylmercury

• Quantitative Assessment of the Net Effects on Fetal Neurodevelopment from the Eating Commercial Fish (As Measured by IQ and also by Early Age Verbal Development in Children) June 2014
• A Pooled Analysis of the Iraqi and Seychelles Methylmercury Studies (PDF 499KB)
  (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 486KB)
  (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 
  (published in Risk Analysis Vol. 22, No. 4, pp. 689-699 (2002))

Norovirus

• Quantitative Risk Assessment: Norovirus Transmission in Food Establishments August 2017
• Norovirus in Bivalve Molluscan Shellfish (upcoming risk assessment)

Salmonella

• Risk Assessment: Salmonella on Tree Nuts April 2017
• Risk Profile: Pathogen and Filth in Spices October 2013

Spice

• Risk Profile: Pathogen and Filth in Spices October 2017

Vibrio parahaemolyticus

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

Additional Information

• Agency for Toxic Substances and Disease Registry (ATSDR)
• FoodRisk.org
• Integrated Risk Information System (IRIS)
• International Programme on Chemical Safety (IPCS)
• The Joint FAO/WHO Expert Committee on Food Additives (JECFA)
• National Agricultural Library (NAL)