0354 21cfr123

§ 123.5

21 CFR Ch. I (4–1–06 Edition)

(i) Preventive measure means physical,
chemical, or other factors that can be
used to control an identified food safety hazard.
(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.
(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.
(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.
(t) Tag means a record of harvesting
information attached to a container of
shellstock by the harvester or processor.
§ 123.5 Current
practice.

good

manufacturing

(a) Part 110 of this chapter applies in
determining whether the facilities,
methods, practices, and controls used
to process fish and fishery products are
safe, and whether these products have
been processed under sanitary conditions.
(b) The purpose of this part is to set
forth requirements specific to the processing of fish and fishery products.
§ 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

270

VerDate Aug<31>2005

01:16 Apr 21, 2006

Jkt 208066

PO 00000

Frm 00280

Fmt 8010

Sfmt 8010

Y:\SGML\208066.XXX

208066

Food and Drug Administration, HHS

§ 123.6

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 § 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
§ 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 § 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

271

VerDate Aug<31>2005

01:16 Apr 21, 2006

Jkt 208066

PO 00000

Frm 00281

Fmt 8010

Sfmt 8010

Y:\SGML\208066.XXX

208066

§ 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

272

VerDate Aug<31>2005

01:16 Apr 21, 2006

Jkt 208066

PO 00000

Frm 00282

Fmt 8010

Sfmt 8010

Y:\SGML\208066.XXX

208066