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Glossary |
As stated in the Purpose and Scope portion of Chapter 1, the Food Code definitions need to be used as a supplement to this Glossary. In some cases, this Glossary condenses those definitions for the purpose of this particular document.
Approved source means acceptable to the regulatory authority based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.
Bacteria means living single-cell organisms. Bacteria can be carried by water, wind, insects, plants, animals, and people and survive well on skin and clothes and in human hair. They also thrive in scabs, scars, the mouth, nose, throat, intestines, and room-temperature foods.
CCP means Critical Control Point.
Contamination means the unintended presence in food of potentially harmful substances, including microorganisms, chemicals, and physical objects.
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.
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 or procedure in a process, production method, or recipe, at which control can be applied to prevent, reduce, or eliminate a food safety hazard.
Critical Limit means a measurable limit at a CCP that can be monitored to control the identified hazard to a safe level in the food.
Fish.
a. means fresh or saltwater finfish, crustaceans and other forms of aquatic life (including alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of such animals) other than birds or mammals, and all mollusks, if such life is intended for human consumption.
b. 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 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, for examples.
Foodborne Illness means sickness resulting from acquiring a disease that is carried or transmitted to humans by food containing harmful substances.
Foodborne outbreak means the occurrence of two or more people experiencing the same illness after eating the same food.
HACCP means Hazard Analysis Critical Control Points.
HACCP plan means a written document which is based on the principles of HACCP and which 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 a foundational, comprehensive, prerequisite program in place. A HACCP system includes the HACCP plan and all SOPs.
Hazard means a biological, physical, or chemical property that may cause a food to be unsafe for human consumption.
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 in a food establishment, such as receiving, storage, preparation, cooking, etc.
Parasite means an organism that grows, feeds, and is sheltered on or in a different organism and contributes to its host.
Pathogen means a microorganism (bacteria, parasites, viruses, or fungi) that is infectious and causes disease.
Personal hygiene means individual cleanliness and habits.
Potentially Hazardous Food.
Potentially hazardous food means a food that is natural or synthetic and that requires temperature control because it is capable of supporting:
a. the rapid and progressive growth of infectious or toxigenic microorganisms,
b. the growth and toxin production of Clostridium botulinum, or
c. in raw shell eggs, the growth of Salmonella Enteritidis.
Potentially hazardous food 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 and 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.
Procedural step means an individual activity in applying this Guide to a food establishment's operations.
Process approach means a method of categorizing food operations into one of three modes:
a. Process number one: Food preparation with no cook step wherein ready-to-eat food is stored, prepared, and served;
b. Process number two: Food preparation for same day service wherein food is stored, prepared, cooked, and served; or
c. Process number three: Complex food preparation wherein food is stored, prepared, cooked, cooled, reheated, hot held, and served.
Ready-to-Eat Food.
Ready-to-eat food means a food that is in a form that is edible without washing, cooking, or additional preparation by the food establishment or consumer and that is reasonably expected to be consumed in that form.
Ready-to-eat food includes potentially hazardous food that has been cooked; raw, washed, cut fruits and vegetables; whole, raw, fruits and vegetables that are presented for consumption without the need for further washing, such as at a buffet; and other food presented for consumption for which further washing or cooking is not required and from which rinds, peels, husks, or shells have been removed.
Record means a documentation of monitoring observation and verification activities.
Regulatory authority means a federal, state, local, or tribal enforcement body or authorized representative having jurisdiction over the food establishment.
Risk means an estimate of the likely occurrence of a hazard.
SOP means Standard Operating Procedure.
Shellfish means bi-valve molluscan shellfish.
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.
Toxin means a poisonous substance that may be found in food.
Verification means the use of methods, procedures, or tests by supervisors, designated personnel, or regulators to determine if the food safety system based on the HACCP principles is working to control identified hazards or if modifications need to be made.
Virus means a protein-wrapped genetic material which is the smallest and simplest life-form known, such as hepatitis A.
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NOTICE:
This is a Draft document to guide operators in voluntarily applying HACCP principles in food establishments in the retail segment. It will be trial tested in a structured FDA pilot. The pilot, Notice of which will appear in the Federal Register, is an open process and as experience is gained from the various phases of that pilot, this Guide will be modified. The Agency recognizes that this document has areas that need to be further clarified and developed with broader input and based on industry's experiences with the practicalities of integrating the HACCP approach in their operations. The Guide will continue to evolve and improve. It is anticipated that the field application of this guidance document will identify additional processes, special food considerations, or other facets of a HACCP program that need to be addressed. It is also expected, as reflected in the Annex, that the listing of commodity-specific hazards will be expanded to further assist operators in developing their HACCP systems. The Agency fully recognizes the diversity of "retail food establishments" and their varying in-house resources to implement HACCP. That recognition is combined with an understanding that the success of such implementation is dependent upon identifying realistic and useful ways of making it happen that are customized to the operation. FDA is open to record keeping applications that minimize the burden of instituting a HACCP system while providing the added consumer protection.
FDA is most interested in receiving comments from parties who may review or use this Guide either within the pilot program or outside of that process. Of particular interest to the Agency are alternative ways of controlling hazards, input regarding special food considerations as described in Annex 2, and specific comments with respect to providing additional practical HACCP guidance for the retail industry. To submit comments, please photocopy the pages of concern, mark them up with your suggested changes, and forward them to: Dr. John E. Kvenberg HACCP Policy Strategic Manager (HFS-10) Office of Policy, Planning and Strategic Initiatives Food and Drug Administration 200 C Street, S. W. Washington, DC 20204 |