| Public Health Service Food and Drug Administration |
Cincinnati District Office |
Department of Health and Human Services
VIA United Parcel Service
July 18, 2011
Takashi Takenaka, President & Owner
Pacific Food, Inc.
1167 Old Henderson Rd.
Columbus, OH 43220-3607
WARNING LETTER CIN-DO 11-170592-23
Dear Mr. Takenaka:
We inspected your seafood processing facility, located at 1173 Old Henderson Rd., Columbus, OH, on February 18 - February 25, 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 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor offish 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 sushi products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Additionally, product labels collected during the inspection revealed that your Spicy Shrimp Roll product is adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because it bears or contains an unsafe color additive. The product label also revealed that your Spicy Shrimp Roll product is misbranded under section 403 of the Act [21 U.S.C. § 343]. You may find the Act, the seafood HACCP regulations, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations are as follows:
Seafood HACCP
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 sushi rolls does not list the food safety hazard of pathogen growth and toxin formation at the finished product storage critical control point. Your HACCP plan for sushi rolls lists the critical limit, "maintained at or below 40° F" at the finished product storage critical control point to control histamine development. Your HACCP plan is specific to histamine fish, because not all of your sushi products contain histamine species fish, the hazard of pathogen growth and toxin formation must be addressed during refrigerated storage to cover all products.
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 sushi rolls does not list the critical control point of thawing/storage of frozen vacuum-packed tuna to control the food safety hazards of histamine formation and pathogen growth and potential toxin formation, specifically Clostridium botulinum growth and toxin formation during the thawing/storage of unopened frozen vacuum-packed tuna.
Histamine formation is a reasonably likely hazard associated with your scombroid species products as a result of time and temperature abuse during the thawing process. Furthermore, the vacuum package creates a potential for Clostridium botulinum growth and toxin formation during refrigerated thawing. Consequently, because this hazard is associated with the packaging type, rather than with the fish species, a critical control point for thawing will apply to any raw frozen vacuum-packed fish that you process. We acknowledge that during the inspection, your firm discussed opening the vacuum packages when placing bags in the cooler for refrigerated thawing, which would introduce oxygen and thus eliminate the potential for Clostridium botulinum growth and toxin formation. However, the products will continue to pose a hazard for aerobic pathogens during thawing, even if the vacuum packages are opened. In the event that you include the opening of vacuum packages in your process, your plan will need to address the opening of the packages and the time and temperature limits during the thawing process for this procedure. Please refer to Chapter 13 of the Hazard Guide for additional information related to the hazard of Clostridium botulinum.
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 sushi rolls lists a monitoring procedure at the finished product storage critical control point that is not adequate to control the food safety hazard of histamine formation and pathogen growth and toxin formation. Specifically, your finished product storage monitoring frequency, (i.e., at the beginning and ending of storage as listed in your plan) is not adequate because intermittent temperature monitoring does not ensure that the sushi rolls are held at a consistently safe temperature throughout storage. FDA recommends that cooler storage temperatures be monitored by some continuous monitoring method. If you have a method in place for continuously monitoring storage temperatures, your plan should be corrected to reflect the method. In addition, if you choose to use a method where equipment continuously records the temperature of your cooler, FDA recommends that you visually check the monitoring records generated by the equipment at least once a day to ensure that your critical limit is not exceeded.
We acknowledge your response letter dated April 21, 2011, which indicates that you have installed a time-temperature recorder in the walk-in storage cooler to continuously monitor storage temperature. Your HACCP plan for sushi rolls must be revised to reflect your use of this time-temperature monitoring device. We will verify the adequacy of this correction during our next inspection.
Labeling
4. Your Spicy Shrimp Roll product is misbranded within the meaning of Section 403(x) of the Act [21 U.S.C. § 343(x)] in that this product contains a coloring that is a food allergen (other than a major food allergen), which is not disclosed in accordance with 21 CFR 73.100(d). Specifically, your Spicy Shrimp Roll product contains the ingredient, premium shrimp combo. The label for the premium shrimp combo that your firm uses in the manufacturer of your Spicy Shrimp Roll product declares carmine as an ingredient. Carmine is a color additive that is an allergen for a subset of the allergic population [74 Federal Register 207-01, January 5, 2009]. Under 21 CFR 73.100(d)(2), the label of food products intended for human use that contain carmine must specifically declare the presence of the color additive by listing its common or usual name, "carmine," in the statement of ingredients in accordance with 21 CFR 101.4. However, the label for your Spicy Shrimp Roll product fails to declare the presence of carmine.
Your Spicy Shrimp Roll product is also adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because this product bears or contains a color additive which is unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive's listing regulation. As noted above, your Spicy Shrimp Roll product contains the color additive carmine. The listing regulation for carmine requires that the color additive be listed by its common or usual name, "carmine," in the statement of ingredients [21 CFR 73.100(d)(2)]. However, the label for your Spicy Shrimp Roll product fails to declare the presence of carmine in the statement of ingredients.
5. Your Spicy Shrimp Roll product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients and each ingredient is not declared on the label. Specifically, your finished product label for your Spicy Shrimp Roll product fails to declare all the sub-ingredients for the blended grain vinegar and premium shrimp combo ingredients, as required by 21 CFR 101.4(b)(2). In addition, your finished product label for your Spicy Shrimp Roll product declares vinegar and sorbitol as sub-ingredients in the pickled ginger ingredient used in this product, but based on the labeling for the pickled ginger, vinegar and sorbitol are not ingredients. If vinegar and sorbitol are not ingredients in this component ingredient, therefore, they should not be declared in the ingredient statement
The requirement to list sub-ingredients may be met by either parenthetically listing the sub-ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component ingredient itself [21 CFR 101.4(b)(2)]. Under the first alternative, the sub-ingredients must be listed in descending order of predominance within the multi-component ingredient. Under the second alternative, the sub-ingredients must be listed in descending order of predominance in the finished food.
6. Your Spicy Shrimp Roll product is misbranded within the meaning of Section 403(q) of the Act [21 U. S.C. § 343(q)] in that your product fails to bear a nutrition fact panel, as required by 21 CFR. 101.9.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm is in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123), and the Food Labeling regulation (21 CFR 101). 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 products and/or enjoin your firm from operating.
Based on our review of your Spicy Shrimp Roll product label, we also have the following comment:
• Your Spicy Shrimp Roll product declares the fish species, "Pollock" in the contains statement on the label; however you fail to declare the species, "Pacific Whiting," which is listed along with Pollock as a possible ingredient in the Premium Shrimp Combo ingredient used in your Spicy Shrimp Roll product. We note that under section 403(w)(2) of the Act [21 U.S.C. § 343(w)(2)], the label of a product containing fish, a major food allergen; must list the name of the specific type of fish in the product.
You should respond in writing within fifteen (15) working days from your receipt of this letter. You should include in your response documentation such as revised HACCP plans, HACCP monitoring and verification records, revised labeling, 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.
Your reply should be sent to the U.S. Food and Drug Administration, Attention: Karen Gale Sego, Compliance Officer, 6751 Steger Dr., Cincinnati, OH 45237. If you have questions regarding any issue in this letter, please contact Karen Gale Sego at (513) 679-2700 extension 2164.
Sincerely,
/S/
Virginia R. Connelly
Acting District Director
Cincinnati District
8995 East Main Street
Reynoldsburg, OH 43068-3399
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