(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.
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:
(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 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:
(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;
(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 rule 901:3-7-03(B) of the Administrative Code, to be followed in response to deviations from critical limits at critical control points;
(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
(E) Products subject to other rules.
For fish and fishery products that are subject to the requirements of Chapter 901:3-3 of the Administrative Code or Chapter 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.
Sanitation controls that are monitored in accordance with rule 901:3-7-07(A) of the Administrative Code need not be included in the HACCP plan.