Inspections, Compliance, Enforcement, and Criminal Investigations
Big O' Smokehouse, Inc. 4/16/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place, Suite 5900
Detroit, MI 48207
- You must implement the monitoring and recordkeeping procedures listed in your HACCP Plan for Smoked fish to comply with 21 CFR 123.6(b). Specifically, you are not recording/documenting the fish thickness on the production report when whole fish or steaks are vacuum-packed. This is evidenced by our review of the records dated 12/14/11, 12/18/11, 12/22/11, and 1/24/11. Additionally, the storage critical control point is not documented by “downloading daily or at least every 3 days”. The cooling critical limit is not monitored on production reports dated 12/18/11, 12/22/11, 1/23/12, and 1/24/12.
- You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c) (1). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s HACCP Plan for smoked fish does not identify the food safety hazards of pathogen growth and toxin formation, specifically Staphylococcus aureus during the “Brining” critical control point, and undeclared allergenic substances at the “Packing/Labeling” critical control point.
- With regard to the hazard of Staphylococcus aureus, due to its high salt tolerance, FDA recommends that temperatures be controlled at or below 50°F to prevent toxin formation. Alternatively, FDA recommends controlling time to less than 3 hours, when temperatures are not controlled and are expected to be 70°F at any point during the process.
- With regard to the hazard of undeclared allergens, FDA recommends that firms include a critical control point to monitor each batch of labels to ensure that labels declare the allergenic substances. In addition, FALPCA and seafood HACCP also require that finfish species be identified by the correct common and usual name. Adding the “contains fish” statement to all labels does not ensure that each species of your fish are correctly identified.
- Furthermore, your HACCP plan for your smoked fish spread fails to include the food safety hazard of undeclared allergens.
- You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6 (a) and (c) (2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s HACCP plan for smoked fish does not list the critical control point of “Thawing” for controlling the food safety hazard of pathogen growth, including the potential for Clostridium botulinum growth and toxin formation. Specifically, we note that your firm thaws the fish while tightly wrapped in plastic bags. This situation creates an anaerobic environment conducive to Clostridium botulinum toxin formation. Consequently, FDA recommends that temperatures continuously be maintained at or below 38° F during thawing of the sealed packages of raw fish. In your response, you state, “Germination, growth, and toxin formation by C-Bot maximum exposure time is (b)(4) days at (b)(4)F. It seems that frozen fish that is put into the 40°F cooler for 24 hours and is in a plastic food bag does not pose much risk.” We acknowledge your reference to Table A-2 in Appendix 4 of the 4th Edition of the Fish and Fishery Product Hazards and Controls Guidance. However, acceptable exposure times vary with exposure temperatures. In the absence of temperature controls, Clostridium. botulinum growth and toxin formation is likely to occur in the sealed plastic (i.e., due to the potential for an anaerobic environment over time). Therefore a critical control point must be in place at this step to control the thawing temperatures. The values in Table A-2 may be used as guidance for taking a corrective action when the critical limit of 38ºF has been exceeded.
- You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c) (3). A critical limit is defined in 21 CFR 123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for smoked fish and your HACCP plan for smoked salmon spread, do not list critical limits that are adequate to control pathogen growth. Specifically,
- For your smoked salmon spread HACCP plan, your critical limit of “(b)(4) is only adequate in conjunction to monitoring ambient temperature to control pathogen growth and toxin formation. Please refer to Chapter 12 pages 234-236 of the Fish and Fishery Products Hazards and Controls Guidance for more detail. Alternatively if you choose to solely rely on time, FDA recommends that your ready-to-eat products are exposed to unrefrigerated ambient temperature for no more than 1 hour.
- For your smoked fish HACCP plan,
- You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for smoked fish lists a monitoring frequency at the “Smoking Drying Heating” critical control point that is not adequate to control pathogen survival and Clostridium botulinum in your vacuum packaged finished product. Specifically, your monitoring frequency of “every batch” is not adequate. FDA recommends continuous monitoring and recording of both time and temperature with a continuous recorder, in addition to a daily visual check of the recorded data.
- Since you chose to include corrective actions in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan listed in your smoked fish HACCP plan at your “Cooling” critical control point fails to ensure affected products do no enter commerce.
- You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110 and to comply with 21 CFR 123.11(b). However, your firm did not monitor the condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, monitoring the maintenance of handwashing, proper storage of toxic chemicals, and monitoring the control of employee health as evidenced by: