(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. These food safety hazards include those
that can be introduced both within and outside the processing plant
environment, including food safety hazards that can occur before, during, and
after harvest. Controls shall be established for those food safety hazards that
are reasonably likely to occur.
(B) The HACCP plan.
(1)
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 rule. A HACCP plan shall be
specific to:
(a) Each location where fish and fishery products are
processed by that processor; and
(b) Each kind of fish
and fishery product processed by the processor.
(2)
The
HACCP 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 rule 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 do
all of the following:
(1) List
the food safety hazards that are reasonably likely to occur that must be
controlled for each fish and fishery product including as appropriate:
(a) Natural toxins;
(b) Microbiological contamination;
(c) Chemical contamination;
(d) Pesticides;
(e) Drug residues;
(f) Decomposition in scombroid toxin-forming
species or in any other species where a food safety hazard has been associated
with decomposition;
(g) 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;
(h) Unapproved use of direct or indirect food
or color additives; and
(i)
Physical hazards.
(2) List the critical control points for each
of the identified food safety hazards, including as appropriate:
(a) Critical control points designed to
control food safety hazards that could be introduced in the processing plant
environment; and
(b) 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 paragraph (B)
of rule
901:3-7-03 of the Administrative Code, 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
paragraph (A) of rule
901:3-7-04 of the Administrative Code.
(7) Provide for a record keeping 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:
(a)
Upon initial acceptance;
(b) Upon
any modification; and
(c) Upon
verification of the plan in accordance with paragraph
(A)(1) of rule
901:3-7-04 of the Administrative Code.
(E) Products subject to
other rules.
For fish and fishery products that are subject to the
requirements of Chapter 901:3-3 or
901:3-5 of the Administrative Code, 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
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 that are monitored in accordance with
paragraph (A) of rule
901:3-7-07 of the Administrative Code need not be included
in the HACCP plan.