FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
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April 2006

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Managing Food Safety: A Manual for the Voluntary Use of HACCP Principles for Operators of Food Service and Retail Establishments

Table of Contents

Annex 3 - Hazard Analysis

This Annex provides guidance for determining food safety hazards in foods and/or food preparation processes at retail. Although the hazard analysis has been kept general for the purposes of developing your food safety management systems, it is still recommended that you consult with your regulatory authority or other food safety professional when conducting this procedural step.


The purpose of hazard analysis is to develop a list of food safety hazards that are reasonably likely to cause illness or injury if not effectively controlled. The process of conducting a hazard analysis involves two stages:

  1. Hazard Identification
  2. Hazard Evaluation

Hazard identification can be thought of as a brain storming session. This stage focuses on identifying the food safety hazards that might be present in the food given the food preparation process used, the handling of the food, the facility, and general characteristics of the food itself. During this stage, a review is made of the ingredients used in the product, the activities conducted at each step in the process, the equipment used, the final product and its method of storage and distribution, as well as the intended use and consumers of the product. Based on this review, a list of potential biological, chemical, or physical hazards is made at each stage in the food preparation process.

In stage two, the hazard evaluation, each potential hazard is evaluated based on the severity of the potential hazard and its likely occurrence. The purpose of this stage is to determine which of the potential hazards listed in stage one of the hazard analysis warrant control in the HACCP plan. Severity is the seriousness of the consequences of exposure to the hazard. Considerations made when determining the severity of a hazard include understanding the impact of the medical condition caused by the illness, as well as the magnitude and duration of the illness or injury. Consideration of the likely occurrence is usually based upon a combination of experience, epidemiological data, and information in the technical literature. Hazards that are not reasonably likely to occur are not considered in a HACCP plan. During the evaluation of each potential hazard, the food, its method of preparation, transportation, storage, and persons likely to consume the product should be considered to determine how each of these factors may influence the likely occurrence and severity of the hazard being controlled.

Upon completion of the hazard analysis, a list of significant hazards that must be considered in the HACCP plan is made, along with any measure(s) that can be used to control the hazards. These measures, called control measures, are actions or activities that can be used to prevent, eliminate, or reduce a hazard. Some control measures are not essential to food safety, while others are.

Control measures essential to food safety like proper cooking, cooling, and refrigeration of ready-to-eat, potentially hazardous foods are applied at critical control points (CCPs) in the HACCP plan. The term control measure is used because not all hazards can be prevented, but virtually all can be controlled. More than one control measure may be required for a specific hazard. Likewise, more than one hazard may be addressed by a specific control measure (e.g. proper cooking).

The physical characteristics and composition of the food during and after preparation should be considered when determining the risk of a hazard. This means understanding the intrinsic and extrinsic factors of the food that would allow conditions that support the survival or growth of bacteria. Intrinsic factors are those that are inherent to the food and are not readily controlled by people in a retail establishment, such as water activity, nutrient content, and competitive microorganisms. Extrinsic factors are those that people can readily control, such as temperature, acidity, and availability of air.

Once the significant biological hazards are identified for a food, there are several issues to consider when determining if conditions exist that would support their growth or survival, including:

Several questions that you may ask yourself when assessing the food safety hazards in food include the following:

Hazard identification, in conjunction with risk and severity estimation, provides a rational basis for determining hazards of significance. There may be differences of opinion, even among experts, as to the risk of a hazard and one may need to consult reliable information published in peer-reviewed literature or recognized experts in the field. The hazards must at least include those that are commonly associated with a specific product.

A list of specific food safety hazards found in common products follows. As pointed out in Procedural Step 3, each of these food safety hazards belong to more general categories of hazards that may used as you develop your food safety management system:

Table 1. Selected Biological and Chemical Hazards Found at Retail, Associated Foods, and Control Measures.
Bacteria Bacillus cereus
(intoxication caused by heat stable, preformed emetic toxin or toxicoinfection caused by heat labile, diarrheal toxin)
Meat, poultry, starchy foods (rice, potatoes), puddings, soups, cooked vegetables Cooking, Cooling, Cold Holding, Hot Holding
Campylobacter jejuni Poultry, raw milk Cooking, Handwashing, Prevention of Cross-contamination
Clostridium botulinum
(intoxication caused by preformed heat-labile toxin)
Vacuum-packed foods, reduced oxygen packaged foods, under-processed canned foods, garlic-in-oil mixtures, time/temperature abused baked potatoes/sautéed onions Thermal Processing (Time + Pressure), Cooling, Cold Holding, Hot Holding, Acidification and Drying, etc.
Clostridium perfringens Cooked meat and poultry, Cooked meat and poultry products including casseroles, gravies Cooling, Cold Holding, Reheating, Hot Holding
E. coli O157:H7 (other shiga toxin-producing E. coli) Raw ground beef, raw seed sprouts, raw milk, unpasteurized juice, foods contaminated by infected food workers via fecal-oral route Cooking, No Bare Hand Contact with RTE Foods, Employee Health Policy, Handwashing, Prevention of Cross-contamination, Pasteurization or Treatment of Juice
Listeria monocytogenes Raw meat and poultry, fresh soft cheese, Pate, smoked seafood, deli meats, deli salads Cooking, Date Marking, Cold Holding, Handwashing, Prevention of Cross-contamination
Salmonella spp. Meat and poultry, seafood, eggs, raw seed sprouts, raw vegetables, raw milk, unpasteurized juice Cooking, Use of Pasteurized Eggs, Employee Health Policy, No Bare Hand Contact with RTE foods, Handwashing, Pasteurization or Treatment of Juice
Shigella spp. Raw vegetables and herbs, other foods contaminated by infected workers via fecal-oral route Cooking, No Bare Hand Contact with RTE Foods, Employee Health Policy, Handwashing
Staphylococcus aureus
(intoxication caused by preformed heat-stable toxin)
RTE PHF touched by bare hands after cooking and further time/temperature abused Cooling, Cold Holding, Hot Holding, No Bare Hand Contact with RTE Food, Handwashing
Vibrio spp. Seafood, shellfish Cooking, Approved Source, Prevention of Cross-contamination
Parasites Anisakis simplex Various fish (cod, haddock, fluke, pacific salmon, herring, flounder, monkfish) Cooking, Freezing
Taenia spp. Beef and pork Cooking
Trichinella spiralis Pork, bear and seal meat Cooking
Viruses Hepatitis A and E Shellfish, any food contaminated by infected worker via fecal-oral route Approved Source, No Bare Hand Contact with RTE Food, Minimizing Bare Hand Contact with Foods Not RTE, Employee Health Policy, Handwashing
Other Viruses (Rotaviruses, Noroviruses, Reoviruses) Any food contaminated by infected worker via fecal-oral route No Bare Hand Contact with RTE Food, Minimizing Bare Hand Contact with Foods Not RTE, Employee Health Policy, Handwashing


Table 2. Foods that might be served raw or undercooked.
(Refer also to last page of Annex 2 for parasitic considerations for fish.)
Raw Animal Food Menu Item Hazards
Beef Steak Tartare
Salmonella spp.
Escherichia coli O157:H7
Poultry Duck Salmonella spp.
Campylobacter jejuni
Eggs Quiche, hollandaise sauce, Eggs Benedict, homemade mayonnaise, meringue pie, some puddings and custards, Monte Cristo sandwich, mousse, tiramisu, chicken croquettes, rice balls, stuffing, lasagna, french toast, crab cakes, egg nog, fish stuffing, Caesar salad, ice cream Salmonella Enteritidis
Raw Fish/Finfish Lightly cooked fish, sushi, raw-marinated, cold-smoked fish, ceviche, tuna carpaccio Anisakis simplex
Diphyllobothrium spp.
Pseudoterranova decipiens
Vibrio parahaemolyticus
Reef fish:
(barracuda, amberjack, horse-eye jack, black/jack, other large species of jack, king mackerel, large groupers, large snappers)
Ciguatera toxin
Shellfish Oysters
Vibrio vulnificus
Vibrio spp.
Hepatitis A
Raw Dairy Products Raw or unpasteurized milk, some soft cheeses like Camembert, Brie, etc. Listeria monocytogenes
Salmonella spp.
Campylobacter jejuni
E. coli O157:H7
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