[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: 21CFR123.6]
[Page 276-278]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 123 FISH AND FISHERY PRODUCTS--Table of Contents
Subpart A General Provisions
Sec. 123.6 Hazard analysis and Hazard Analysis Critical Control Point
(HACCP) plan.
(a) Hazard analysis. Every processor shall conduct, or have
conducted for it, a hazard analysis to determine whether there are food
safety hazards that are reasonably likely to occur for each kind of fish
and fishery product processed by that processor and to identify the
preventive measures that the processor can apply to control those
hazards. Such food safety hazards can be introduced both within and
outside the processing plant environment, including food safety hazards
that can occur before, during, and after harvest. A food safety hazard
that is reasonably likely to occur is one for which a prudent processor
would establish controls because experience, illness data, scientific
reports, or other information provide a basis to conclude that there is
a reasonable possibility that it will
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occur in the particular type of fish or fishery product being processed
in the absence of those controls.
(b) The HACCP plan. Every processor shall have and implement a
written HACCP plan whenever a hazard analysis reveals one or more food
safety hazards that are reasonably likely to occur, as described in
paragraph (a) of this section. A HACCP plan shall be specific to:
(1) Each location where fish and fishery products are processed by
that processor; and
(2) Each kind of fish and fishery product processed by the
processor. The plan may group kinds of fish and fishery products
together, or group kinds of production methods together, if the food
safety hazards, critical control points, critical limits, and procedures
required to be identified and performed in paragraph (c) of this section
are identical for all fish and fishery products so grouped or for all
production methods so grouped.
(c) The contents of the HACCP plan. The HACCP plan shall, at a
minimum:
(1) List the food safety hazards that are reasonably likely to
occur, as identified in accordance with paragraph (a) of this section,
and that thus must be controlled for each fish and fishery product.
Consideration should be given to whether any food safety hazards are
reasonably likely to occur as a result of the following:
(i) Natural toxins;
(ii) Microbiological contamination;
(iii) Chemical contamination;
(iv) Pesticides;
(v) Drug residues;
(vi) Decomposition in scombroid toxin-forming species or in any
other species where a food safety hazard has been associated with
decomposition;
(vii) Parasites, where the processor has knowledge or has reason to
know that the parasite-containing fish or fishery product will be
consumed without a process sufficient to kill the parasites, or where
the processor represents, labels, or intends for the product to be so
consumed;
(viii) Unapproved use of direct or indirect food or color additives;
and
(ix) Physical hazards;
(2) List the critical control points for each of the identified food
safety hazards, including as appropriate:
(i) Critical control points designed to control food safety hazards
that could be introduced in the processing plant environment; and
(ii) Critical control points designed to control food safety hazards
introduced outside the processing plant environment, including food
safety hazards that occur before, during, and after harvest;
(3) List the critical limits that must be met at each of the
critical control points;
(4) List the procedures, and frequency thereof, 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. 123.7(b), to be followed in response to deviations
from critical limits at critical control points;
(6) List the verification procedures, and frequency thereof, that
the processor will use in accordance with Sec. 123.8(a);
(7) Provide for a recordkeeping system that documents the monitoring
of the critical control points. The records shall contain the actual
values and observations obtained during monitoring.
(d) Signing and dating the HACCP plan. (1) The HACCP plan shall be
signed and dated, either by the most responsible individual onsite at
the processing facility or by a higher level official of the processor.
This signature shall signify that the HACCP plan has been accepted for
implementation by the firm.
(2) The HACCP plan shall be dated and signed:
(i) Upon initial acceptance;
(ii) Upon any modification; and
(iii) Upon verification of the plan in accordance with Sec.
123.8(a)(1).
(e) Products subject to other regulations. For fish and fishery
products that are subject to the requirements of part 113 or 114 of this
chapter, the HACCP plan need not list the food safety hazard associated
with the formation of Clostridium botulinum toxin in the finished,
hermetically sealed container, nor list the controls to prevent
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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
Sec. 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.
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