|Company:||Bull Frog Fish Farm, Llc.dba Bullfrog Fish Farm Eat My Fish|
|Subject:||Seafood HACCP/CGMP for Foods/Adulterated|
|Issuer:||Minneapolis District Office|
|Issued:||Jan. 19, 2011||Closed:||Dec. 20, 2011|
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Minneapolis District Office
January 19, 2011
RETURN RECEIPT REQUESTED
Refer to MIN 11 - 11
Herbert H. Radmann
Bullfrog Fish Farm, LLC
dba Bullfrog Fish Farm Eat My Fish
N1321 556th Street
Menomonie, Wisconsin 54751
Dear Mr. Radmann:
We inspected your seafood processing facility located at N1321 556th Street, Menomonie, Wisconsin, on August 11, 16-17, 30, September 7 and 14, 2010. 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 trout products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. In addition, our review of your product labels reveals that your Smoked Trout and Smoked Trout Spread products are misbranded within the meaning of section 403(k) of the Act, 21 U.S.C. § 343(k), and the implementing regulations contained within 21 CFR 101. You may find the Act, the CFR, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links on FDA’s home page at
Your significant violations were as follows:
1. 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 Trout Spread does not list the food safety hazard of undeclared allergens.
2. 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 Trout Spread lists a monitoring procedure/frequency at the storage critical control point that is inadequate to control pathogen growth. Your HACCP plan lists a monitoring frequency of (b)(4) per day which is not adequate to control the hazard of pathogen growth and toxin formation.
3. You must have a HACCP plan that provides for a record keeping system that documents the monitoring of the critical control points to comply with 21 CFR 123.6(c)(7). However, your HACCP plan for Smoked Trout Spread and your HACCP plan for Smoked Trout do not provide a record keeping system.
4. You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.8(a). However, your firm did not calibrate your continuous monitoring device to comply with 21 CFR 123.8(2)(ii) as evidenced by your smoking temperature recording logs dated July 19, July 22, July 27, and August 10, 2010, which did not match the temperatures recorded by your tracer logs.
5. 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 smoking records dated March 22 through July 13, 2010, document that you did not follow the monitoring frequency of (b)(4) at the smoking critical control point as required by your HACCP plan.
6. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110 to comply with 21 CFR 123.11(b). However, your firm did not monitor:
a. The safety of water that comes into contact with food or food contact surfaces as evidenced by operating hoses in the production area that did not have back siphonage protection.
b. Prevention of cross-contamination from insanitary objects; protection of food, food packaging material as evidenced by an employee wearing rings and another wearing a bandage that came into direct contact with smoked trout for ready-to-eat Smoked Trout Spread. Further, employees wear footwear outside on dirt surfaces, in the barn area, in areas where dogs, cats, chickens, and pigs are kept, and then into the processing area without sanitizing or changing their shoes.
c. Pests are not excluded as evidenced by flies too numerous to count in the processing area during the manufacture of ready-to-eat Smoked Trout and Smoked Trout Spread.
7. 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 Trout does not list the food safety hazard of aquaculture drugs.
8. Your smoked trout products are misbranded within the meaning of section 403(k) of the Act, 21 U.S.C. § 343(k), in that they contain a color additive that is not declared in the ingredient statement. Specifically, the color additive Astaxanthin is an ingredient found in the feed you use for your trout. Astaxanthin is a carotenoid pigment that may be safely used in the feed of salmonid fish under the conditions set forth in 21 CFR 73.35. The family Salmonidae includes salmon, trout, and whitefish. Under 21 CFR 101.22(k)(2), all color additives that are not subject to FDA certification and not otherwise required by applicable regulations in 21 CFR 73 must be declared in the product labeling of foods sold at retail either by their listed names or as “Artificial Color,” “Artificial Color Added,” “Color Added” or by an equally informative term that makes clear that a color additive has been used in the food. Alternatively, such color additives may be declared as “Colored with _____” or “_____ color,” the blank to be filled in with the name of the color additive listed in the applicable regulation in 21 CFR 73. Under 21 CFR 101.100(a)(2), trout sold at retail in bulk fish containers must display labeling on the container or a counter card that includes a list of ingredients with similar information given for the color additive.
We may take further action if you do not promptly correct these violations. For instance, we may 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 Compliance Officer Rebecca L. Caulfield at the address on the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Caulfield at (612)758-7194.
Gerald J. Berg