| (1) |
(2) |
(3) |
(4) |
(5) |
(6) |
(7) |
(8) |
(9) |
(10) |
| Critical Control Point (CCP) |
Significant Hazard(s) |
Critical Limits for each Preventive Measure |
Monitoring |
Corrective Action(s) |
Records |
Verification |
| What |
How |
Frequency |
Who |
| Brining |
C. botulinum toxin formation in finished
product |
Minimum brining time 6 hours |
Length of brining process |
Visual |
Start and end of brining process |
Brine room employee |
Extend brining process |
Production record |
Documentation of brining/drying process establishment |
| Minimum salt concentration of brine at start of brining
60° salinometer |
Salt concentration of brine |
Salinometer |
Start of brining process |
Brine room employee |
Add salt |
Production record |
Review monitoring, corrective action, and verification
records within one week of preparation |
| Minimum ratio of brine:fish 2:1 |
Weight of brine (as determined by volume)
Weight of fish |
Visual to mark on tank
Scale
|
Start of brining process
Each batch |
Brine room employee
Brine room employee |
Add brine
Remove some fish and reweigh |
Production record
Production record |
Monthly calibration of scale |
| Maximum fish thickness 1 1/2"
(Note: Above CLs are designed to produce a minimum water
phase salt level in the loin muscle of 3.5%) |
Fish thickness |
Caliper |
Each batch (10 fish) |
Brine room employee |
Hold and evaluate based on finished product water phase
salt analysis |
Production record |
Quarterly water phase salt analysis |
| Smoking/ drying/ heating |
C. botulinum toxin formation in finished
product |
Minimum time open vent 2 hours |
Time of open vent |
Visual |
Each batch |
Smoker employee |
Extend drying process, and
Hold and evaluate |
Production record |
Documentation of brining/drying process establishment
Review monitoring, corrective action, and verification
records within one week of preparation
Daily calibration of data logger
Quarterly water phase salt analysis |
| Internal temperature of fish held at or above 145°F
for at least 30 minutes |
Internal temperature of fish and time at that temperature |
Digital data logger with probes in 3 of thickest fish in
cold spot of oven |
Continuous with visual at end of batch |
Smoker employee |
Extend heating process, and
Make repairs or adjustments to the smoking chamber, and
Hold and evaluate |
Data logger printout Smoking log |
| Cooling after hot smoking |
C. botulinum toxin formation |
No more than 4 hours between end of smoking process and
placement of racks under refrigeration |
Length of time between end of smoking process and placement
of racks under refrigeration |
Visual observation of end of smoking process and time
of placement in cooler |
Each batch |
Smoker employee |
Place product in cooler, and
Hold and evaluate based on time/temperature of exposure |
Production record |
Review monitoring and corrective action records within
one week of preparation |
| Finished product storage |
C. botulinum toxin formation during finished product
storage |
Maximum cooler temperature 40°F (based on growth of
vegetative pathogens) |
Cooler air temperature |
Digital data logger |
Continuous, with visual once per day |
Production employee |
Adjust or repair cooler, and
Hold and evaluate based on time/temperature of exposure |
Digital logger printout |
Review monitoring and corrective action, and verification
records within one week of preparation
Daily check of data logger accuracy |
FDA. 1998. Clostridium botulinum Toxin Formation (A Biological
Hazard). Ch. 13, In Fish and Fishery Products Hazards & Controls
Guide: Second Edition. 151-173. Department of Health and Human Services,
Public Health Service, Food and Drug Administration, Center for Food Safety
and Applied Nutrition, Office of Seafood, Washington, DC.