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Electronic Code of Federal Regulations

e-CFR data is current as of January 22, 2020

Title 21Chapter ISubchapter BPart 120Subpart A → §120.8


Title 21: Food and Drugs
PART 120—HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS
Subpart A—General Provisions


§120.8   Hazard Analysis and Critical Control Point (HACCP) plan.

(a) HACCP plan. Each processor shall have and implement a written HACCP plan whenever a hazard analysis reveals one or more food hazards that are reasonably likely to occur during processing, as described in §120.7. The HACCP plan shall be developed by an individual or individuals who have been trained in accordance with §120.13 and shall be subject to the recordkeeping requirements of §120.12. A HACCP plan shall be specific to:

(1) Each location where juice is processed by that processor; and

(2) Each type of juice processed by the processor. The plan may group types of juice products together, or group types of production methods together, if the food hazards, critical control points, critical limits, and procedures required to be identified and performed by paragraph (b) of this section are essentially identical, provided that any required features of the plan that are unique to a specific product or method are clearly delineated in the plan and are observed in practice.

(b) The contents of the HACCP plan. The HACCP plan shall, at a minimum:

(1) List all food hazards that are reasonably likely to occur as identified in accordance with §120.7, and that thus must be controlled for each type of product;

(2) List the critical control points for each of the identified food hazards that is reasonably likely to occur, including as appropriate:

(i) Critical control points designed to control food hazards that are reasonably likely to occur and could be introduced inside the processing plant environment; and

(ii) Critical control points designed to control food hazards introduced outside the processing plant environment, including food hazards that occur before, during, and after harvest;

(3) List the critical limits that shall be met at each of the critical control points;

(4) List the procedures, and the frequency with which they are to be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;

(5) Include any corrective action plans that have been developed in accordance with §120.10(a), and that are to be followed in response to deviations from critical limits at critical control points;

(6) List the validation and verification procedures, and the frequency with which they are to be performed, that the processor will use in accordance with §120.11; and

(7) Provide for a recordkeeping system that documents the monitoring of the critical control points in accordance with §120.12. The records shall contain the actual values and observations obtained during monitoring.

(c) Sanitation. Sanitation controls may be included in the HACCP plan. However, to the extent that they are monitored in accordance with §120.6, they are not required to be included in the HACCP plan.

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