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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Big O' Smokehouse, Inc. 4/16/12


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
Detroit District
Central  Region
300 River Place, Suite 5900
Detroit, MI 48207
Telephone:    313-393-8100
FAX:    313-393-8139 


April 16, 2012
Mr. Keith A. Osterhaven, President/Owner
Big O’ Smokehouse,  Inc.
9740 Cherry Valley Avenue, SE
Caledonia, MI 49316-9521
Dear Mr. Osterhaven:
We inspected your food and seafood processing facility located at 9740 Cherry Valley Avenue Street, S.E., Caledonia, Michigan, on January 23-27, 2012. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123 renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your vacuum-packed and air packed smoked fish products and smoked fish spread are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance 4th Edition through links in FDA's home page at www.fda.gov.
Your significant violations are as follows:
  1. 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.
  2. 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.
    1. 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.
    2. 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.
    3. Furthermore, your HACCP plan for your smoked fish spread fails to include the food safety hazard of undeclared allergens.
  1. 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. 
  1. 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,
    1. 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.
    2. For your smoked fish HACCP plan,
i.      at the “Cooling” critical control point your firm does not list adequate critical limits to control Clostridium botulinum or pathogen growth. Specifically, your plan lists that your firm cools the products to (b)(4)°F within (b)(4) hours. FDA recommends that cooked seafood products be cooled to from 135°F to below 70°F within 2 hours and further chilled to below 40F within the subsequent 4 hours.
ii.      at the “Brining” critical control point your firm does not list adequate critical limits to control Clostridium botulinum. Specifically, your plan does not include a temperature critical limit. As discussed above, FDA recommends temperature controls at or below 50°F, particularly because your brining times are (b)(4) or (b)(4) hours (depending on fish size).
Your response noted that for the critical control point of brining for your smoked fish HACCP Plan, the actual refrigeration temperature readings are taken in addition to the refrigeration temperature loggers. You insist that the product temperature will not reach 40°F. Your firm noted that the (b)(4) refrigeration systems reduce the air temperature spikes and the water phase salt (b)(4) tests and brine ratio are also conducted to control the hazard of Clostridium botulinum. Despite that you are monitoring/recording the refrigerated air temperatures (b)(4) a day and using a temperature data logger, your data loggers were not available for all production days and the temperatures documented were only (b)(4) a day.
In addition, your response stated your objection to this observation regarding fish thawing when fish are thawed in brine solutions because all brines containing thawed and fresh fish are held in refrigerated conditions. In the absence of temperature controls, pathogen growth and toxin formation, as mentioned above in this letter, specifically Staphylococcus aureus toxin formation may cause the product to be unsafe for consumption. This toxin is heat stable and not destroyed during the cooking process, therefore a critical control point is necessary at the brining step. We acknowledge your response where you state that your study has determined that the brine temperature will not exceed 50°F in less than 18 hours if your room temperature does not exceed 70°F. These may be used as the basis for your critical limits at this step and Chapter 12, Control Strategy Example 4 (pg. 234 – 239), can help you determine the appropriate controls to include in your plan
  1. 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.
  2. 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.
  3. 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:
a.       The metal wire racks that you use to hold fish and fishery products on rolling carts in the smokers were observed with a heavy accumulation of dark brownish-black sticky material and pieces of fish debris from previous batches.
b.      On 1/24/12 you were observed to be handling paperwork in the office, the door of  Smoker (b)(4), the rack in the smoker, and the digital probe used to monitor cooling. You then handled several fillets of fish and then Whitefish Sausage after removal of lot 1-0242 from Smoker (b)(4). You did not wash or sanitize your hands prior to making direct contact with food.
c.       On 1/14/12, an employee was observed with gloved hands moving uncovered plastic tubs containing ready-to-eat (RTE) hot smoked Whitefish steaks and Trout steaks from Cooler (b)(4) to Cooler (b)(4). In moving each of the uncovered bins, the investigator observed the employee walking within a few feet of an employee in the raw processing area where the employee was spraying the metal wire fish rinsing grate and causing deflecting aerosolized water droplets to spread throughout the room. After passing through, the employee then opened an overhead door using a heavily soiled rope, open the door to Cooler (b)(4) by using the handle with yellowish-brown residue all it, and then to push the uncovered bin though clear plastic strip curtains that line the entryway to Cooler (b)(4). These curtains were observed to come into direct contact with the plastic bin liner and fish inside the bin.
The same employee was then observed to be picking up RTE hot smoked Whitefish Steaks and Trout Steaks from lot 1-0232, and placing them into plastic lined cardboard boxes. Throughout processing, the employee was seen opening the soiled door to Cooler (b)(4) and caring open plastic tubs containing additional steaks to be packaged through the plastic curtains, and then continuing to directly handle product without washing and sanitizing his hands or changing gloves. Furthermore, similar bins were observed to be placed directly on the packing room floor while another employee emptied Salmon portions.
d.      On 1/23/12 and 1/24/12, the repeated use of high pressure hoses within approximately four feet of the ware washing 2-compartment sink and adjacent handwashing sink. The hoses were used to rinse the perforated bins, fish draining grate, floor drain, plastic grate that is placed on top of floor drain, the floor, cutting board surface, an employee's apron, employees' gloved hands, and fish. Deflected water from these uneven surfaces was aerosolized throughout the area, including onto handles of the handwash sink, onto employees' clothing, and onto utensils that were stored and ready to use without further cleaning or sanitation.
e.       There was no hand sanitizer in your facility other than a 6.75 oz. bottle that was 1/4 way full in the employee restroom that expired in 07/08.
f.       The use of sodium hypochlorite was not being monitored as evidenced by the lack of sanitation concentration checks by test strips, colorimetric kit or other methodology. Several spray bottles containing sanitizer that were used to sanitize packaging room tabletops, cutting boards, and temperature probes.
g.      An employee was observed changing his/her apron, unfolding and touching it with his/her hands without washing and sanitizing his/her hands after handling a computer keyboard, pen, paperwork, and other insanitary objects. The employee then wore the apron while removing hot smoked ready-to-eat salmon pieces from the smoker trays and placing them in lined bins.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123), and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)).
For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility.   The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as an updated HACCP plan, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations. We may take further action if you do not promptly correct these violations. For instance, we may seize your product(s) and/or enjoin your firm from operating.
Please send your written reply to the Food and Drug Administration, Attention: Kelli Wilkinson, Compliance Officer, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions regarding this letter, please contact Ms. Wilkinson at (313) 393-8120.                                                
Glenn T. Bass
District Director
Detroit District Office