| Public Health Service Food and Drug Administration |
Minneapolis District Office |
Department of Health and Human Services
November 12, 2010
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 - 06
Jenny L. Anderson
Owner
Artesian Trout Farm
N8320 Fifth Lane
Westfield, Wisconsin 53964
Dear Ms. Anderson:
We inspected your seafood processing facility located at N8320 Fifth Lane, Westfield, WI, on June 24,30 and July 7,2010. 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 air packed hot-smoked trout and salmon are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Furthermore, our review of your product labels reveals that your smoked trout and salmon products are in violation of the Act in that your products are misbranded within the meaning of sections 403(e)(1), (i)(2) and (w)(l) of the Act, 21 U.S.C § 343(a). 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:
1. You must have a HACCP plan that lists the critical limits that must be met to comply with 21 CFR 123.6(c)(3). However, your firm's HACCP plan for smoked trout and salmon does not list a critical limit for temperature during the brining process at the CCP of "Brining" to control growth of Staphylococcus aureus and toxin formation. We recommend the refrigerated temperature of 40°F for control of pathogen growth and toxin formation during brining and refrigerated storage. We also recommend the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated storage.
2. 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 trout and salmon does not list the critical control point of cooling for controlling the food safety hazard of pathogen growth. Your HACCP plan, under the critical control point of smoking, lists a critical limit of no more than (b)(4) hours hold time before refrigeration. Further, you are not monitoring the time and temperature of the smoked fish during your cooling process. On June 30, 2010, (b)(4) hours after fish were removed from your smoker, including (b)(4) minutes in the cooler, the fish were observed to be 79.7°F with an FDA thermometer.
3. 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 and salmon does not list the monitoring procedures and frequency at the storage critical control point to control pathogen growth. Your HACCP plan monitoring procedure at the storage step lists: "(b)(4)
4. Your smoked trout product is misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the label states "Rainbow Trout" but fails to declare the major food allergen present in this product as required by section 403(w)(1). Section 201(qq) of the Act, 21 U.S.C. § 321 (qq), defines as "major food allergens" milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:
• The word "contains," followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients [section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1l)(A)], or
• The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, (e.g. "Rainbow Trout ("Fish")," except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B)].
5. Your smoked trout, fresh trout, and smoked salmon products are misbranded within the meaning of section 403(i)(2) of the Act in that you fail to list the type of fish in the ingredient statement. We reviewed the labels provided and note that the statement of identity for your products should read:
Smoked Rainbow Trout
Ingredients: Smoked Rainbow Trout, brown sugar, maple sugar, salt, spices
Smoked Salmon
Ingredients: Smoked Salmon, brown sugar, maple sugar, salt, spices
6. Your rainbow trout, smoked rainbow trout, and smoked salmon products are misbranded within the meaning of section 403(e)(1), 21 U.S.C. § 343(e)(1), in that the packages do not contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5, in that the business must include the street address, city, and ZIP code; however, the address may be omitted if it is shown in a current city directory or telephone directory.
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.
We note that you label the products as "FDA INSPECTED." Please be aware that this statement is not authorized by FDA and should be removed from your label.
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: Rebecca L. Caulfield, Compliance Officer, at the address on this letterhead. If you have questions regarding any issues in this letter, please contact Ms. Caulfield at (612)758-7194.
Sincerely,
/s/
Geald J. Berg
Director
Minneapolis District
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