Inspections, Compliance, Enforcement, and Criminal Investigations
The Santa Barbara Smokehouse, Inc. 9/12/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part123. If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act, 21 U.S.C. §342(a)(4).
- 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 Salmon” does not list the food safety hazards of parasites or undeclared allergens in the finished product.
- 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 Salmon” does not list the critical control point of “Thawing” (i.e. under refrigeration) for your cold smoked salmon (b)(4), to control the food safety hazard of Clostridium botulinum growth and toxin formation.
- 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 revised HACCP plan for “Smoked Salmon” provided with your response lists a critical limit of “Product Core temperature (b)(4), at the (b)(4) (CCP4A) critical control point that is not adequate to control the hazard of “Growth of pathogenic organisms and toxins (Clostridium botulinum, Listeria sp.)”. This critical limit is inadequate to control the hazard of Clostridium botulinum growth and toxin formation. If you intend for this product to be hot smoked you should follow the guidance in Chapter 13 of the Fish and Fishery Products Hazards and Controls Guidance (FFPHG) Fourth Edition for the appropriate control strategy (i.e. hot smoking at or above 145ºF /62.8ºC throughout the fish (internal temperature) for at least 30 minutes). If you do not intend for this product to be hot smoked you should follow the guidance in the FFPHG for cold smoking (i.e. temperature not to exceed 90ºF/32.2ºC).
- Your firm’s revised HACCP plan for “Smoked Salmon” provided with your response lists a critical limit of “Internal core temperature of fish on arrival to factory (Fresh (b)(4)) (Frozen (b)(4))” at the “Fish Receiving” (CCP 1) critical control point that is not adequate to control the hazard of “Growth of pathogenic organisms and toxins (Clostridium botulinum, Listeria sp.)”. Your response states that you added the monitoring of “gel ice (b)(4)”, however this is not an adequate control strategy for the products you receive that have a transit time equal to or greater than 4 hours. A more appropriate control strategy is to monitor the internal product or ambient air temperature during transit using a continuous temperature-recording device; or for products held under chemical cooling media, such as gel packs, make visual observations of the adequacy and frozen state of the cooling media in a representative number of containers from throughout the shipment at delivery AND determine internal product temperatures in a representative number of product containers from throughout the shipment at delivery. Please refer to Chapter 12 of the FFPHG for guidance on an appropriate control strategy.
- You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring of “Water phase salt (b)(4) at the “Salting/Curing” (CCP3) critical control point for your vacuum packed cold smoked “Sushi Style Smoked Salmon” listed in your “Smoked Salmon” HACCP plan to control the food safety hazard of Clostridium botulinum growth and toxin formation.
- Because you chose to include a corrective action plan 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 Salmon” HACCP plan dated May 11, 2012 provided with your response, at the “Fish Receiving” (CCP1), critical control point to control the hazard of “Growth of pathogenic organisms and toxins (Clostridium botulinum, Listeria sp.)” is not appropriate. Your corrective action plan does not address the cause of the deviation (i.e. discontinue supplier until evidence is obtained that transportation handling practices have been improved).
- 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, to comply with 21 CFR 123.11(b). However, your firm did not monitor the safety of the water that comes into contact with food or food contact surfaces, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, and protection of food from adulteration with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
- Hoses used for cleaning equipment and other food contact surfaces throughout the facility and used to dispense chlorine dioxide lack backflow prevention devices.
- Chlorine based sanitizer used for spraying food contact surfaces was measured to be at over 400 PPM by the FDA Investigator. The container was labeled as 200 PPM.
- A table in the de-boxing area of the “low-care” room was observed to have pieces of raw salmon after it had been identified as clean and sanitized.
- The process for washing loins (b)(4). Spray from the hose was observed splashing on the floor and coming into contact with raw, in-process loins (b)(4). The same process is used for washing loins after curing.
- The captive boots worn by employees in the “low-care” area were observed to have an accumulation of residue in the threads.
- An employee was observed picking up a napkin from the floor and then touching cold smoked salmon before vacuum packing prior to washing their hands.
- Approximately (b)(4) filled with racks of raw salmon loins in the “low-care” area were placed under a cooler unit in the de-boxing area which was observed to be dripping onto the raw salmon loins. (b)(4) were placed under the cooler unit in the thawing room which had an accumulation of drip in the lower surface.
- You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR § 123.12 (a)(2)(ii). However, your firm did not perform an affirmative step for “fresh” (refrigerated) (b)(4) you imported from (b)(4).
- Due to the number of critical control points listed in your plan and the fact that not all the CCPs apply to all products, we suggest you develop a separate HACCP plan for each product type with the corresponding CCPs (i.e. cold smoked, hot smoked, refrigerated, frozen, etc.)
- The frequency of “Commencement of Trading with Supplier and (b)(4) there on after” listed in your “Smoked Salmon” HACCP plan, at the “Fish Receiving” (CCP1) critical control point to control the hazard of “Presence of unapproved aquaculture drugs” for the salmon you receive from growers may not be appropriate. A more appropriate monitoring frequency is lot by lot monitoring and rejection of lots lacking a compliance letter. In addition, the compliance letter should include information specific to your supplier’s use of aquaculture drugs.
- Although you provided evidence of the installation of temperature chart recorders for the continuous monitoring of your finished product storage cooler near your dry goods storage, you did not provide evidence that you are monitoring your “Finished Product Storage” (CCP8) critical control point.