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

Glossary

The definitions cited in Chapter 1 of the latest edition of the FDA Food Code should be used to supplement this Glossary. In some cases, this Glossary condenses those definitions for the purposes of this particular document.

ACCEPTABLE LEVEL means the presence of a food safety hazard at levels low enough not to cause an illness or injury.

APPROVED SOURCE means an acceptable supplier to the regulatory authority based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.

ACTIVE MANAGERIAL CONTROL means the purposeful incorporation of specific actions or procedures by industry management into the operation of their business to attain control over foodborne illness risk factors.

BACTERIA means single-cell microorganisms without distinct nuclei or organized cell structures.

CCP means Critical Control Point.

CONTAMINATION means the unintended presence in food of potentially harmful substances, including microorganisms, chemicals, and physical objects.

CONTROL MEASURE means any action or activity that can be used to prevent, eliminate or reduce an identified hazard. Control measures determined to be essential for food safety are applied at critical control points in the flow of food.

CORRECTIVE ACTION means an activity that is taken by a person whenever a critical limit is not met.

CRITICAL CONTROL POINT (CCP) means an operational step in a food preparation process at which control can be applied and is essential to prevent or eliminate a hazard or reduce it to an acceptable level.

CRITICAL LIMIT means one or more prescribed parameters that must be met to ensure that a CCP effectively controls a hazard.

CROSS-CONTAMINATION means the transfer of harmful substances or disease-causing microorganisms to food by hands, food-contact surfaces, sponges, cloth towels and utensils that touch raw food, are not cleaned, and then touch ready-to-eat foods. Cross-contamination can also occur when raw food touches or drips onto cooked or ready-to-eat foods.

DEVIATION means the failure to meet a required critical limit for a critical control point.

DANGER ZONE means the temperature range between 5°C (41°F) and 57°C (135°F) that favors the growth of pathogenic microorganisms.

EXCLUDE means to prevent a person from working as a food employee or entering a food establishment except for those areas open to the general public.

FISH means fresh or saltwater finfish, crustaceans and other forms of aquatic life (including alligator, frog, aquatic turtle, jellyfish, sea cucumber, sea urchin and the roe of such animals) other than birds or mammals, and all mollusks, if such life is intended for human consumption; and includes an edible human food product derived in whole or in part from fish, including fish that have been processed in any manner.

FOOD means raw, cooked, or processed edible substance, ice, beverage, chewing gum, or ingredient used or intended for use or for sale in whole or in part for human consumption.

FOOD ESTABLISHMENT means an operation at the retail or food service level, i.e., that serves or offers food directly to the consumer and that, in some cases, includes a production, storage, or distributing operation that supplies the direct-to-consumer operation. Refer to Chapter 1, Defining Retail Food and Food Service Industries, for examples.

FOOD PREPARATION PROCESS means a series of operational steps conducted to produce a food ready to be consumed.

FOODBORNE ILLNESS means sickness resulting from the consumption of foods or beverages contaminated with disease-causing microorganisms, chemicals, or other harmful substances.

FOODBORNE OUTBREAK means the occurrence of two or more cases of a similar illness resulting from the ingestion of a common food.

HACCP means Hazard Analysis and Critical Control Point.

HACCP PLAN means, for the purposes of this document, a written document that is based on the principles of HACCP and describes the procedures to be followed to ensure the control of a specific process or procedure.

HACCP SYSTEM means the result of implementing the HACCP principles in an operation that has foundational comprehensive, prerequisite programs in place. A HACCP system includes the HACCP plan and all prerequisite programs.

HAZARD means a biological, physical, or chemical property that may cause a food to be unsafe for human consumption.

HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) means a prevention-based food safety system that identifies and monitors specific food safety hazards that can adversely affect the safety of food products.

INTERNAL TEMPERATURE means the temperature of the internal portion of a food product.

MEAT means the flesh of animals used as food including the dressed flesh of cattle, swine, sheep, or goats and other edible animals, except fish, poultry, and wild game animals.

MICROORGANISM means a form of life that can be seen only with a microscope; including bacteria, viruses, yeast, and single-celled animals.

MOLLUSCAN SHELLFISH means any edible species of raw fresh or frozen oysters, clams, mussels, and scallops or edible portions thereof, except when the scallop product consists only of the shucked adductor muscle.

MONITORING means the act of observing and making measurements to help determine if critical limits are being met and maintained.

NATIONAL SHELLFISH SANITATION PROGRAM (NSSP) means the voluntary system by which regulatory authorities for shellfish harvesting waters and shellfish processing and transportation and the shellfish industry implement specified controls to ensure that raw and frozen shellfish are safe for human consumption.

NSSP means National Shellfish Sanitation Program.

OPERATIONAL STEP means an activity or stage in the flow of food through a food establishment, such as receiving, storage, preparation, cooking, etc.

PARASITE means an organism that lives on or in another, usually larger, host organism in a way that harms or is of no advantage to the host.

PATHOGEN means a microorganism (bacteria, parasites, viruses, or fungi) that causes disease in humans.

PERSONAL HYGIENE means individual cleanliness and habits.

pH means the measure of the acidity of a product.

POTENTIALLY HAZARDOUS FOOD: means a food that is natural or synthetic and that requires temperature control because it is capable of supporting:

Includes foods of animal origin that are raw or heat-treated; foods of plant origin that are heat-treated or consists of raw seed sprouts, cut melons, and garlic in oil mixtures that are not acidified or otherwise modified at a processing plant in a way that results in mixtures that do not support growth of pathogenic microorganisms as described above.

PREREQUISITE PROGRAMS means procedures, including Standard Operating Procedures (SOPs), that address basic operational and sanitation conditions in an establishment.

PROCEDURAL STEP means an individual activity in applying this Manual to a food establishment's operations.

PROCESS APPROACH means a method of categorizing food operations into one of three categories:

READY-TO-EAT (RTE) FOOD means:

RECORD means a documentation of monitoring observations and verification activities.

REGULATORY AUTHORITY means a federal, state, local, or tribal enforcement body or authorized representative having jurisdiction over the food establishment.

RESTRICT means to limit the activities of a food employee so that there is no risk of transmitting a disease that is transmissible through food and the food employee does not work with exposed food, clean equipment, utensils, linens, and unwrapped single-service or single-use articles.

RISK means an estimate of the likely occurrence of a hazard.

RISK FACTOR means one of the broad categories of contributing factors to foodborne illness outbreaks, as identified in the Centers for Disease Control and Prevention (CDC) Surveillance Report for 1993-1997, that directly relates to foodborne safety concerns within retail and food service establishments. The factors are Food from Unsafe Sources, Inadequate Cooking Temperatures, Improper Holding Temperatures, Contaminated Equipment, and Poor Personal Hygiene.

SEVERITY means the seriousness of the effect(s) of a hazard.

SOP means Standard Operating Procedure.

SHELLFISH means bivalve molluscan shellfish.

SPORE means a very tough, dormant form of certain bacterial cells that is very resistant to desiccation, heat, and a variety of chemical and radiation treatments that are otherwise lethal to vegetative cells.

SPORE-FORMER means a bacterium capable of producing spores under adverse conditions.

STANDARD OPERATING PROCEDURE (SOP) means a written method of controlling a practice in accordance with predetermined specifications to obtain a desired outcome.

TEMPERATURE MEASURING DEVICE means a thermometer, thermocouple, thermistor, or other device for measuring the temperature of food, air, or water.

TOXIGENIC MICROORGANISMS means pathogenic bacteria that cause foodborne illness in humans due to the ingestion of poisonous toxins produced in food.

VALIDATION means that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan, when properly implemented, will effectively control the hazards.

VEGETATIVE CELL means a bacterial cell which is capable of actively growing.

VERIFICATION means, for the purpose of this document, ensuring that monitoring and other functions of a HACCP plan are being properly implemented.

VIRUS means a submicroscopic parasite consisting of nucleic acid (DNA or RNA) surrounded by a protein coat, and sometimes also encased in a lipid and glycoprotein envelope. Viruses are completely dependent on a living host cell to survive and multiply, and therefore can not multiply in or on food.

WATER ACTIVITY (Aw) means the quotient of the water vapor pressure of the substance, divided by the vapor pressure of pure water at the same temperature. Generally speaking, it is the amount of water available in the product to allow bacteria to live and grow.

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