Managing Food Safety: A Regulator's Manual For Applying HACCP Principles to Risk-based Retail and Food Service Inspections and Evaluating Voluntary Food Safety Management Systems

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.

HOW DO YOU CONDUCT A HAZARD ANALYSIS?

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:

• The nature of the food (ground or intact; plant or animal)
• Whether the food is improperly cooled after cooking or improperly hot held, (Clostridium perfringens or Bacillus cereus could grow because their spores survive cooking and germinate)
• Whether the food is improperly cold held (Listeria monocytogenes and Yersinia will be a concern because they grow at refrigeration temperatures)
• Whether foods have a high salt content (Vibrio and Staphylococcus aureus are likely to grow because they are salt-tolerant)
• Whether air is unavailable, such as in the interior of a cooked food or a sealed modified-atmosphere package (Clostridium botulinum and C. perfringens will thrive when air is not present)
• Whether water activity is high (Staphylococcus aureus needs to have nutrients readily available in order to thrive, but it can produce a potent toxin in a food with a water activity that is lower than that needed by other organisms)

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

• Does the food permit survival or multiplication of pathogens and/or toxin formation in the food before or during preparation?
• Will the food permit survival or multiplication of pathogens and/or toxin formation during subsequent steps of preparation?
• What has been the safety record for the product in the marketplace? Is there an epidemiological history associated with this food?
• Is the food served to a highly susceptible population?
• What is known about the time/temperature exposure of the food?
• What is the water activity and pH of the food?
• Have bare hands touched the food, or otherwise cross-contaminated it?
• Is the food from a safe source?
• Do food workers practice good personal hygiene, including frequent and effective handwashing?
• Has the food been exposed to unclean or unsanitized equipment?
• Does the preparation procedure or process include a step that destroys pathogens or their toxins? (Consider both vegetative cells and spores)
• Is the product subject to recontamination after cooking?

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 Recommended 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:

• Salmonella and Campylobacter jejuni in raw poultry
• Salmonella Enteriditis in undercooked eggs
• E. coli O157:H7 in raw ground beef
• Listeria monocytogenes in ready-to-eat foods, such as hot dogs and deli meat
• Bacterial pathogens associated with unpasteurized juice or milk
• Staphylococcus aureus toxin formation in ready-to-eat products that are contaminated and later temperature-abused, such as cooked ham
• Bacillus cereus spore survival and toxin formation in cooked rice
• Clostridium perfringens and B. cereus spore survival and subsequent growth in cooked meat/meat products

 

Table 1. Selected Biological and Chemical Hazards Found at Retail, Associated Foods, and Control Measures.

HAZARD		ASSOCIATED FOODS	CONTROL MEASURES
Bacteria	Bacillus cereus (intoxication caused by heat-stable, preformed emetic toxin or toxioinfection 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 cased 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 PHFs 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.

Raw Animal Food	Menu Items	Hazards
Beef	Steak Tartare Carpaccio	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 Clams	Vibrio vulnificus Vibrio spp. Hepatitis A Norovirus
Raw Dairy Products	Raw or unpasteurized milk, some soft cheeses like Camembert, Brie, etc.	Listeria monocytogenes Salmonella spp. Campylobacter jejuni E. coli O157:H7

 

Table 3. Natural Toxins¹ in Seafood

Natural Toxins	Type of fish (species)	Control
Paralytic Shellfish Poisoning (PSP)	Molluscan Shellfish N.E. and N.W. coastal regions of N. America	NSSP approved waters (tags)2 (FDA ICSSL listing)
Neurotoxic Shellfish Poisoning (NSP)	Molluscan Shellfish harvested along coast of Gulf of Mexico	NSSP approved waters (tags)2 (FDA ICSSL listing)
Diarrhetic Shellfish Poisoning (DSP)	Molluscan Shellfish	NSSP approved waters (tags)2 (FDA ICSSL listing)
Amnesic Shellfish Poisoning (ASP)	Molluscan Shellfish N.E. & N.W. coasts of N. America	NSSP approved waters (tags)2 (FDA ICSSL listing)
Ciguatera Fish Poisoning (CFP)	fin fish from extreme S.E. U.S., Hawaii, Subtropical and Tropical areas: barracuda amberjack horse-eye jack black jack other larger species of jack king mackerel large groupers large snappers	Purchase from approved sources: get fish from areas that are not subject of an adverse advisory, or get fish from a reef area known to be monitored for toxicity and not covered by an adverse advisory.
Gempylotoxin, a strong purgative oil (can cause severe diarrhea)	Escolar	FDA recommendation: Escolar should not be marketed in interstate commerce
Etrodotoxin	Puffer Fish or Fugu, usually from Indo-Pacific ocean, however some noted from Atlantic Ocean, Gulf of Mexico and Gulf of California	Illegal to import or receive (exemption: an agreement with one N.Y. importer)
1 Fish and Fishery Products Hazards and Controls Guide, Third Edition, June 2001 2 The tags must contain a unique state issued "certification number" specific for each certified dealer. If the firm is engaged in interstate commerce, this number appears in FDA's Interstate Certified Shellfish Shippers List.

 

Table 4. Fish Considered to be Scombrotoxin-Forming Species¹

Toxin Formation	Species - Market Names	Control
Scombrotoxin formation as a result of time/temperature abuse	Most scombroid poisonings from tuna, mahi-mahi and bluefish. Other species are: Amberjack or yellowtail Anchovy Bluefish Bonito Escolar or Snake Mackerel Gemfish Herring (not River herring) Jack Jobfish Kahawai Mackerel (not Atka) Mahi-Mahi Marlin Pilchard or Sardine Sardine Saury Shad & roe Shad, Gizzard Snapper (Pristipomoides ssp) Sprat or Bristling Trevally Tuna Wahoo	Buy from approved federally inspected suppliers. They are required to receive, hold, and process using a HACCP system. Check for an adequate quantity of ice or other cooling media. If not, a federally inspected supplier or directly from a fishing boat, check for the following at receipt: an adequate quantity of ice or other cooling media the time the fish were caught (from the vessel or supplier) See * information below
1 Fish and Fishery Products Hazards and Controls Guide, Third Edition, June 2001

* FDA Recommended HACCP Controls for Histamine - Quick reference

Secondary Processor (Controls at receipt) Transport records (< 40 °F throughout transit)

OR

Adequate Ice/cooling media surrounding product at delivery

Processing/ Storage

Fresh (not previously frozen)	Previously frozen
4 hrs @ > 40 °F if any exposure is > 70 °F	12 hrs @ > 40 °F if any exposure is > 70 °F
8 hrs @ > 40 °F if NO exposure is > 70 °F	24 hrs @ > 40 °F if NO exposure is > 70 °F

 

Table 5. Common Parasites in Seafood¹

Parasites2	Type of fish/species likely to be used in menu items that will not be cooked	Control
Nematodes or roundworm Cestodes or tapeworms Trematodes or flukes	Sea bass Capelin & roe Cod Flounder Dab Fluke Grouper Halibut Herring Jack Jobfish Kahawai Mackerel Monkfish Mullet Chilean Sea Bass Ocean Perch Plaice Pollock Rockfish Sablefish Salmon & roe (aquacultured and wild) Seatrout Sole Sprat/Bristling Trout/steelhead/rainbow Tuna, small Turbot Wolfish	Purchase from a processor, require the raw fish to have been: Frozen and stored at -4 °F (-20 °C) or below for 7 days; or Frozen at -31 °F (-35 °C) or below and stored at -31 °F (-35 °C) for 15 hours; or Frozen at -31 °F (-35 °C) or below until solid and stored at -4 °F (-20 °C) for 24 hrs. Freezing can be done in your operation if it is done in accordance with the Food Code, Chapter 3.
1Fish and Fishery Products Hazards and Controls Guide, Third Edition, June 2001 2Some food products that have been implicated in human parasitic infection are: ceviche, salmon roe, green herring, undercooked grilled fish, lomi lomi, sashimi, drunken crabs, poisson cru, sushi, cold smoke fish