Inspections, Compliance, Enforcement, and Criminal Investigations
Dockside Fish Market 8/11/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
August 11, 2011
RETURN RECEIPT REQUESTED
Refer to MIN 11 - 43
Harley C. Toftey
Shele J. Toftey
Dockside Fish Market
418 W. Highway 61, P.O. Box 921
Grand Marais, Minnesota 55604
Dear Mr. and Ms. Toftey:
We inspected your seafood processing facility located at 418 W. Highway 61, Grand Marais, Minnesota, on May 3-5, 2011. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 and 110). 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 smoked fish 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 through links on FDA’s home page at www.fda.gov.
Your significant violations were as follows:
- 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 list the food safety hazard of histamine associated with the smoked herring and undeclared allergens associated with all finfish products.
- 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:
- Fails to list time and temperature controls as critical limits at the brining critical control point. Specifically, your firm only references “(b)(4)” as critical limits at this critical control point (CCP). However, pathogen growth (specifically, Staphylococcus aureus growth) and toxin formation is a reasonably likely hazard in the absence of time and temperature controls, (b)(4).
- Lists an inadequate critical limit for the brining process. Your plan lists “(b)(4)” but does not provide a value (recipe) for that ratio. In addition, you list that you will monitor with a (b)(4), but do not provide what minimum (b)(4) you must achieve.
- You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency 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 procedure and frequency at the smoking and cooling critical control points that are not adequate to control pathogen growth and toxin formation:
- For your smoking critical control point, your listed monitoring procedures of “(b)(4)” for your “how” and “(b)(4)” for frequency are inadequate. FDA recommends continuously monitoring temperatures with the use of a continuous recording device, and performing a visual check of the recorded data at least once per batch.
- For your cooling critical control point, your listed frequency of “(b)(4)” is inadequate for the length of time your product is exposed to ambient temperature. For this cooling process, you should monitor the temperature at least every two hours.
- 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 procedures of cooling the smoked fish to (b)(4)°F within (b)(4) hours and to (b)(4)°F within (b)(4) hours at the cooling critical control point to control pathogen growth and toxin formation as listed in your HACCP plan for smoked fish. Specifically,
- Your plan calls for the cooling of the smoked fish to (b)(4)°F within (b)(4) hours and to (b)(4)°F within (b)(4) hours. In practice, your firm (b)(4)°F and then transfers them to a cooler. We monitored the cooling rate for several of your smoked fish on one day of our inspection and found that the smoked salmon chunks were still above (b)(4)°F (b)(4) hours after they began cooling. Smoked whitefish was at (b)(4)°F (b)(4) hours after they began cooling, and smoked lake trout was at (b)(4)°F (b)(4) hours after they began cooling.
- 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 for smoked fish at the brining, smoking and cooling critical control points is not appropriate. The corrective actions of “(b)(4)” at the Brining CCP, “(b)(4)” at the Smoking CCP, and “(b)(4)” at the Cooling CCP do not address the cause of the deviations.
- 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 finished product storage for controlling the food safety hazards of pathogen growth and toxin formation.
- 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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However your firm does not have a HACCP plan for fresh and frozen raw herring, whitefish and lake trout to control the food safety hazards of histamine in herring and undeclared allergens in finfish.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
You should respond in writing within 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 HACCP and verification records, 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.
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 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the above address. If you have questions regarding any issues in this letter, please contact Ms. Wisecup at (612) 758-7114.
Gerald J. Berg