Table 1 - HACCP Definitions Side-By-Side

Table 1: HACCP Definitions Side-By-Side

FSIS

FDA

NACMCF

CODEX

9 CFR 417; Food Safety and Inspection Service (FSIS)

21 CFR 123; Food and Drug Administration (FDA).

Adopted August 14, 1997, by the National Advisory Committee
on Microbiological Criteria for Foods (NACMCF) as a revision of their 1992 adopted HACCP System document. From the Journal of Food Protection, Volume 61, Number 9, 1998, pages 1246-1259, and as noted in the article, this article may be reproduced without permission. Tables, figures, appendixes, references, and some introductory text portions are not included in this comparison document.

Adopted June 1997; Codex Alimentarius Commission and the FAO/WHO Food Standards Programme, annex to CAC/RCP 1-1969, Rev. 3.

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NOTE: Order of information is realigned to match, where possible, 9 CFR ? 417.

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NOTE: Order of information is realigned to match, where possible, 9 CFR ? 417.

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NOTE: Order of information is realigned to match, where possible, 9 CFR ? 417.

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? 417.1 Definitions:
For purposes of this part, the
following definitions shall
apply

? 123.3 Definitions:
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) and in part 110 of this chapter are applicable to such terms when used in this part, except where they are herein redefined. The following definitions shall also apply:

Definitions:

CCP decision tree.
A sequence of questions to
assist in determining whether a control point is a CCP.

Definitions:

(a) Certification number
means a unique combination
of letters and numbers assigned by a shellfish control authority to a molluscan shellfish
processor.

Control.
(a) To manage the conditions of an operation to maintain compliance with established criteria.

Control.
(verb) To take all necessary actions to ensure and maintain compliance with criteria established in the HACCP plan.

(b)The state where correct procedures are being followed and criteria are being met.

(noun) The state wherein correct procedures are being followed and criteria are being met.

Control measure.

Any action or activity that can be used to prevent, eliminate or reduce a significant hazard.

Control point.
Any step at which biological, chemical, or physical factors can be controlled.

Control measure.

Any action and activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Corrective action.
Procedures to be followed when a deviation occurs

Corrective action.
Procedures followed when a deviation occurs

Criterion.
A requirement on which a judgement or decision can be based.

Corrective action.
Any action to be taken when the results of monitoring at the CCP indicate a loss of control.

Critical control point.
A point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels.

(b) Critical control point
Means a point, step, or procedure in a food process at which control can be applied, and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.

Critical control point.
A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Critical control point (CCP).
A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Critical limit.
The maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.

(c) Critical limit
Means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.

Critical limit.
A maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard.

Critical limit.
A criterion which separates acceptability from unacceptability.

Deviation.
Failure to meet a critical limit.

(d) Fish
Means fresh or saltwater fin fish, crustaceans, other forms of aquatic animal life (including, but not limited to, alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of such animals) other than birds or mammals, and all mollusks, where such animal life is intended for human consumption.

(e) Fishery product
Means any human food product in which fish is a characterizing ingredient.

Flow diagram.
A systematic representation of the sequence of steps or operations used in the production or manufacture of a particular food item.

Food safety hazard.
Any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.

(f) Food safety hazard
Means any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.

(Realigned from Hazard).
A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

(Realigned from Hazard.)
A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.

HACCP.
A systematic approach to the identification, evaluation, and control of food safety hazards.

HACCP.
A system which identifies, evaluates, and controls hazards which are significant for food safety.

HACCP plan.
The written document which is based upon the principles of HACCP and which delineates the procedures to be followed.

HACCP plan.
A document prepared in accordance with the principles of HACCP to ensure control of hazards which are significant for food safety in the segment of the food chain under consideration.

HACCP system.
The HACCP plan in operation, including the HACCP plan itself.

HACCP system.
The result of the implementation of the HACCP Plan.

HACCP team.
The group of people who are responsible for developing, implementing and maintaining the HACCP system.

Hazard.
SEE Food Safety Hazard.

Hazard.
A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

Hazard.
A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.

Hazard analysis.
The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan.

Hazard analysis.
The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore should be addressed in the HACCP plan.

(g) Importer means either the U.S. owner or consignee at the time of entry into the United States, or the U.S. agent or representative of the foreign owner or consignee at the time of entry into the United States, who is responsible for ensuring that goods being offered for entry into the United States are in compliance with all laws affecting the importation. For the purposes of this definition, ordinarily the importer is not the custom house broker, the freight forwarder, the carrier, or the steamship representative.

(h) Molluscan shellfish means any edible species of fresh or frozen oysters, clams, mussels, or scallops, or edible portions of such species, except when the product consists entirely of the shucked adductor muscle.

Monitor.
To conduct a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification.

Prerequisite programs.
Procedures, including Good Manufacturing Practices, that address operational conditions providing the foundation for the HACCP system.

Monitor.
The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control.

Preventive measure.
Physical, chemical, or other means that can be used to control an identified food safety hazard.

(i) Preventive measure means physical, chemical, or other factors that can be used to control an identified food safety hazard.

Process-monitoring instrument.
An instrument or device used to indicate conditions during processing at a critical control point.

(j) Process-monitoring instrument means an instrument or device used to indicate conditions during processing at a critical control point.

(k)(1) Processing means, with respect to fish or fishery products: Handling, storing, preparing, heading, eviscerating, shucking, freezing, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading, or holding.

(2) The regulations in this part do not apply to:

(i) Harvesting or transporting fish or fishery products, without otherwise engaging in processing.

(ii) Practices such as heading, eviscerating, or freezing intended solely to prepare a fish for holding on board a harvest vessel.

(iii) The operation of a retail establishment.

l) Processor means any person engaged in commercial, custom, or institutional processing of fish or fishery products, either in the United States or in a foreign country. A processing includes any person engaged in the production of foods that are to be used in market or consumer tests.

Responsible establishment official.
The individual with overall authority on-site or a higher level official of the establishment.

(m) Scombroid toxin-forming species means tuna, bluefish, mahi mahi, and other species, whether or not in the family Scombridae, in which significant levels of histamine may be produced in the fish flesh by decarboxylation of free histidine as a result of exposure of the fish after capture to temperatures that permit the growth of mesophilic bacteria.

Severity.
The seriousness of the effect(s) of a hazard.

(n) Shall is used to state mandatory requirements.

(o) Shellfish control authority means a Federal, State, or foreign agency, or sovereign tribal government, legally responsible for the administration of a program that includes activities such as classification of molluscan shellfish growing areas, enforcement of molluscan shellfish harvesting controls, and certification of molluscan shellfish processors.

(p) Shellstock means raw, in-shell molluscan shellfish.

(q) Should is used to state recommended or advisory procedures or to identify recommended equipment.

(r) Shucked shellfish means molluscan shellfish that have one or both shells removed.

(s) Smoked or smoke-flavored fishery products means the finished food prepared by:

(1) Treating fish with salt (sodium chloride), and

(2) Subjecting it to the direct action of smoke from burning wood, sawdust, or similar material and/or imparting to it the flavor of smoke by a means such as immersing it in a solution of wood smoke.

Step.
A point, procedure, operation or stage in the food system from primary production to final consumption.

Step.
A point, procedure, operation or stage in the food chain including raw materials, from primary production to final consumption.

(t) Tag means a record of harvesting information attached to a container of shellstock by the harvester or processor.

Validation.
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.

Validation.
Obtaining evidence that the elements of the HACCP plan are effective.

Verification.
Those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan.

Verification.
The application of methods, procedures, tests and other evaluations, in addition to monitoring to determine compliance with the HACCP plan.

REGULATIONS AND DIRECTIVES DEVELOPMENT