[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.8]
[Page 268-269]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120 HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of
Subpart A General Provisions
Sec. 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
Sec. 120.7. The HACCP plan shall be developed by an individual or
individuals who have been trained in accordance with Sec. 120.13 and
shall be subject to the recordkeeping requirements of Sec. 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
[[Page 269]]
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 Sec. 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 Sec. 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 Sec. 120.11; and
(7) Provide for a recordkeeping system that documents the monitoring
of the critical control points in accordance with Sec. 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
Sec. 120.6, they are not required to be included in the HACCP plan.
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