0354 21cfr123

§ 123.7

21 CFR Ch. I (4–1–06 Edition)

that food safety hazard. A HACCP plan
for such fish and fishery products shall
address any other food safety hazards
that are reasonably likely to occur.
(f) Sanitation. Sanitation controls
may be included in the HACCP plan.
However, to the extent that they are
monitored in accordance with § 123.11(b)
they need not be included in the
HACCP plan, and vice versa.
(g) Legal basis. Failure of a processor
to have and implement a HACCP plan
that complies with this section whenever a HACCP plan is necessary, otherwise operate in accordance with the requirements of this part, shall render
the fish or fishery products of that
processor adulterated under section
402(a)(4) of the act. Whether a processor’s actions are consistent with ensuring the safety of food will be determined through an evaluation of the
processors overall implementation of
its HACCP plan, if one is required.
§ 123.7 Corrective actions.
(a) Whenever a deviation from a critical limit occurs, a processor shall take
corrective action either by:
(1) Following a corrective action plan
that is appropriate for the particular
deviation, or
(2) Following the procedures in paragraph (c) of this section.
(b) Processors may develop written
corrective action plans, which become
part of their HACCP plans in accordance with § 123.6(c)(5), by which they
predetermine the corrective actions
that they will take whenever there is a
deviation from a critical limit. A corrective action plan that is appropriate
for a particular deviation is one that
describes the steps to be taken and assigns responsibility for taking those
steps, to ensure that:
(1) No product enters commerce that
is either injurious to health or is otherwise adulterated as a result of the deviation; and
(2) The cause of the deviation is corrected.
(c) When a deviation from a critical
limit occurs and the processor does not
have a corrective action plan that is
appropriate for that deviation, the
processor shall:
(1) Segregate and hold the affected
product, at least until the require-

ments of paragraphs (c)(2) and (c)(3) of
this section are met;
(2) Perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual or individuals who have adequate training or experience to perform
such a review. Adequate training may
or may not include training in accordance with § 123.10;
(3) Take corrective action, when necessary, with respect to the affected
product to ensure that no product enters commerce that is either injurious
to health or is otherwise adulterated as
a result of the deviation;
(4) Take corrective action, when necessary, to correct the cause of the deviation;
(5) Perform or obtain timely reassessment by an individual or individuals
who have been trained in accordance
with § 123.10, to determine whether the
HACCP plan needs to be modified to reduce the risk of recurrence of the deviation, and modify the HACCP plan as
necessary.
(d) All corrective actions taken in accordance with this section shall be
fully documented in records that are
subject to verification in accordance
with § 123.8(a)(3)(ii) and the recordkeeping requirements of § 123.9.
§ 123.8 Verification.
(a) Overall verification. Every processor shall verify that the HACCP plan
is adequate to control food safety hazards that are reasonably likely to
occur, and that the plan is being effectively implemented. Verification shall
include, at a minimum:
(1) Reassessment of the HACCP plan. A
reassessment of the adequacy of the
HACCP plan whenever any changes
occur that could affect the hazard analysis or alter the HACCP plan in any
way or at least annually. Such changes
may include changes in the following:
Raw materials or source of raw materials, product formulation, processing
methods or systems, finished product
distribution systems, or the intended
use or consumers of the finished product. The reassessment shall be performed by an individual or individuals
who have been trained in accordance
with § 123.10. The HACCP plan shall be

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Food and Drug Administration, HHS

§ 123.9

modified immediately whenever a reassessment reveals that the plan is no
longer adequate to fully meet the requirements of § 123.6(c).
(2) Ongoing verification activities. Ongoing verification activities including:
(i) A review of any consumer complaints that have been received by the
processor to determine whether they
relate to the performance of critical
control points or reveal the existence
of unidentified critical control points;
(ii) The calibration of process-monitoring instruments; and,
(iii) At the option of the processor,
the performing of periodic end-product
or in-process testing.
(3) Records review. A review, including
signing and dating, by an individual
who has been trained in accordance
with § 123.10, of the records that document:
(i) The monitoring of critical control
points. The purpose of this review shall
be, at a minimum, to ensure that the
records are complete and to verify that
they document values that are within
the critical limits. This review shall
occur within 1 week of the day that the
records are made;
(ii) The taking of corrective actions.
The purpose of this review shall be, at
a minimum, to ensure that the records
are complete and to verify that appropriate corrective actions were taken in
accordance with § 123.7. This review
shall occur within 1 week of the day
that the records are made; and
(iii) The calibrating of any process
control instruments used at critical
control points and the performing of
any periodic end-product or in-process
testing that is part of the processor’s
verification activities. The purpose of
these reviews shall be, at a minimum,
to ensure that the records are complete, and that these activities occurred in accordance with the processor’s written procedures. These reviews shall occur within a reasonable
time after the records are made.
(b) Corrective actions. Processors shall
immediately follow the procedures in
§ 123.7 whenever any verification procedure, including the review of a consumer complaint, reveals the need to
take a corrective action.
(c) Reassessment of the hazard analysis.
Whenever a processor does not have a

HACCP plan because a hazard analysis
has revealed no food safety hazards
that are reasonably likely to occur, the
processor shall reassess the adequacy
of that hazard analysis whenever there
are any changes that could reasonably
affect whether a food safety hazard
now exists. Such changes may include,
but are not limited to changes in: Raw
materials or source of raw materials,
product formulation, processing methods or systems, finished product distribution systems, or the intended use
or consumers of the finished product.
The reassessment shall be performed
by an individual or individuals who
have been trained in accordance with
§ 123.10.
(d) Recordkeeping. The calibration of
process-monitoring instruments, and
the performing of any periodic endproduct and in-process testing, in accordance with paragraphs (a)(2)(ii)
through (iii) of this section shall be
documented in records that are subject
to the recordkeeping requirements of
§ 123.9.
§ 123.9 Records.
(a) General requirements. All records
required by this part shall include:
(1) The name and location of the
processor or importer;
(2) The date and time of the activity
that the record reflects;
(3) The signature or initials of the
person performing the operation; and
(4) Where appropriate, the identity of
the product and the production code, if
any. Processing and other information
shall be entered on records at the time
that it is observed.
(b) Record retention. (1) All records required by this part shall be retained at
the processing facility or importer’s
place of business in the United States
for at least 1 year after the date they
were prepared in the case of refrigerated products and for at least 2 years
after the date they were prepared in
the case of frozen, preserved, or shelfstable products.
(2) Records that relate to the general
adequacy of equipment or processes
being used by a processor, including
the results of scientific studies and
evaluations, shall be retained at the
processing facility or the importer’s
place of business in the United States

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