| Public Health Service Food and Drug Administration |
New Orleans District |
Department of Health and Human Services
April 14, 2011
WARNING LETTER 2011-NOL-11
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Ken Trinh, President
Jensen Tuna, Inc.
5885 Highway 311
Houma, Louisiana 70360
Dear Mr. Trinh:
On January 27-28 and February 2, 4, 10, 11, and 15, 2011, a U.S. Food and Drug Administration (FDA) investigator inspected your seafood processing facility, located at 5885 Highway 311, Houma, Louisiana. We found 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 of fish or fishery products to have and implement a HACCP plan which 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 United States Code (USC) 342(a)(4)]. Accordingly, your fishery products are adulterated because 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 Internet home page at www.fda.gov.
We received your response provided to FDA on March 18, 2011. The following includes our assessment of the documents provided in your response packet:
1. You must conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product you produce to determine whether there are food safety hazards which are reasonably likely to occur. In addition, you must have and implement a written HACCP plan to control any food safety hazards which 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 the frozen (b)(4) tuna to control the food safety hazards of Clostridium botulinum and metal fragments. This product poses a hazard for Clostridium botulinum growth and toxin development while the fish are held under modified atmospheric conditions during (b)(4 and final vacuum packaging. In addition, the product poses a hazard for metal inclusion, based on the use of a (b)(4) to inject (b)(4) into the fish loins.
In addition, we note all of your plans include storage conditions (b)(4). However, for this product which will be exposed to a cold storage period where the injected tuna loins are held in temporary modified atmosphere (b)(4) bags prior to freezing and vacuum packaging, we do not recommend the products be held under ice. During this operation, temperatures of the product should be continuously maintained at 38° F or below to control the hazard of Clostridium botulinum toxin formation. Controlling the botulinum toxin hazard by subjectively checking for the adequacy of ice is not recommended.
2. You must conduct a hazard analysis to determine whether there are food safety hazards which are reasonably likely to occur and have a HACCP plan which, at a minimum, lists the food safety hazards which 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 which may cause a food to be unsafe for human consumption.” However, your firm’s revised HACCP plan for “Fresh Tuna” submitted with your March 18, 2011, response does not list the food safety hazard of pathogen growth. Although the plan indicates an intended use of (b)(4) our inspection revealed some of your tuna is sushi-grade and intended for raw consumption (i.e., as ready-to-eat sushi).
3. You must conduct a hazard analysis to determine whether there are food safety hazards which are reasonably likely to occur and have a HACCP plan which, 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 revised HACCP plan for “Fresh Tuna” provided in your March 18, 2011, response does not list the critical control point of raw material storage for the tuna to control scombrotoxin (histamine) formation. Specifically, the “Fresh Tuna Flow Chart,” the “Hazard Analysis Worksheet,” and the revised “Fresh Tuna” HACCP plan, each do not include any raw material storage processing steps for your tuna. However, during the inspection, our investigator observed your firm processing refrigerated whole tuna which were retrieved from your cooler. Cooler storage of raw material should be identified as a critical control point to control scombrotoxin (histamine) formation in the tuna products, and in the case of tuna intended for raw consumption, also the hazard of pathogen growth.
This same critical control point is also missing in the additional revised HACCP plan submitted with your March 18, 2011, response which includes all fish, other than tuna, and would be pertinent to the scombrotoxin hazard for other scombrotoxin (histamine) forming species and for the hazard of pathogen growth when any of the other fish species processed by your firm are destined for a raw consumption market.
4. You must have a HACCP plan which, at a minimum, lists the critical limits which 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 revised HACCP plan for “Fresh Tuna” submitted with your March 18, 2011, response does not list adequate critical limits at the “Receiving Raw material” critical control points (CCP1 and CCP2) and the “Storage” critical control point (CCP4) to control scombrotoxin (histamine) formation. Specifically, at the “Receiving Raw material” critical control points (CCP1 and CCP2), your firm’s revised HACCP plan lists (b)(4) which is not adequate to control scombrotoxin (histamine) formation. In order to ensure all the fish were safely transported with temperatures maintained at 40° F or below, FDA recommends that the fish should be received completely surrounded by ice when ice is used as the control for the hazards of scombrotoxin formation or pathogen growth. Fish received with ice only covering the upper surfaces, as indicated in your plan, will not ensure all products in the shipment are safe.
This also applies at the “Storage” critical control point (CCP4). In addition, this would be applicable to the revised HACCP plan you provided that encompasses all fish, other than tuna, and is pertinent to any of those fish for which scombrotoxin (histamine) formation and pathogens are hazards.
5. You must have a HACCP plan which, 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 revised HACCP plan for “Fresh Tuna” submitted with your March 18, 2011, response lists a monitoring procedure/frequency at the “Receiving Raw material” critical control points (CCP1 and CCP2) which are inadequate because the procedures do not identify how many units in each lot are to be examined for the adequacy of ice at receiving.
This also applies to the “Receiving Raw material” critical control points (CCP1 and CCP2) and at the “Storage” critical control point (CCP3) in the revised HACCP plan which encompasses all fish, other than tuna, and is pertinent to any of those fish for which scombrotoxin or pathogens are hazards.
6. 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 actions listed at the “Receiving Raw material” critical control points (CCP1 and CCP2) and at the “Storage” critical control point (CCP4) in your firm’s revised “Fresh Tuna” HACCP plan; as well as the corrective actions listed at “Receiving Raw material” critical control points (CCP1 and CCP2) and at the “Storage” critical control point (CCP3) in the submitted HACCP plan encompassing all fish, other than tuna, are all the same corrective actions, which are (b)(4). This is inappropriate because your firm’s critical limits rely solely on the adequacy of ice rather than time and temperature controls to prevent the hazards, and so there is no reliable means for your firm to assess the actual time and “temperature” of exposures when the fish are received or have been stored with inadequate ice. Additionally it is inappropriate to measure the “temperature” of the fish at a single point in time and where your firm would need to make assumptions about conditions over the previous course of time in the absence of other documented monitoring or observations.
In cases where pathogen growth, particularly Clostridium botulinum growth and toxin formation are the hazards of concern, there are no feasible testing protocols which can provide adequate assurances the abused product is safe. In cases where scombrotoxin (histamine) formation is the hazard of concern, your firm’s listed corrective action to “test” the product provides insufficient information as to what is to be tested, how, and what criteria will be used to assess the safety of the product.
In addition, none of the listed corrective action procedures state how the cause of a critical limit deviation is to be corrected.
Additionally, your firm dismisses the need to control the hazard of parasites in the fish intended for raw consumption by stating in your “Hazard Analysis Worksheet” for the revised HACCP plan which encompasses all fish, other than tuna, at the “Receiving Raw material” critical control point, because (b)(4). This is inadequate. A processor of fish or fishery products should not pass controls for a hazard on to subsequent processors.
In addition, with regard to the importer verification requirements for the products you import, during the investigation your firm claimed you obtain HACCP and sanitation monitoring records for the lots of tuna received from Mexico, to fulfill the affirmative step obligations to ensure the products were processed in accordance with the HACCP requirements. However, rather than provide a full set of completed HACCP monitoring records for the processing of each lot received, your firm provided the HACCP plans and some blank monitoring records for the four Mexican firms. Three of the HACCP plans received were identical with only a change in the name and address of the firms. Even the identified “Supervisor,” “HACCP Rep.” and “Date” of the HACCP plans were not changed in the documents which represent the three different processors.
As an importer you are responsible for the safety and wholesomeness of the food you import. The importer verification requirements of the seafood HACCP rule provide a tool for firms to meet this responsibility. However, it appears that your firm may not be fully complying with these importer verification requirements or with your responsibility for ensuring the importation of safe food.
This letter may not list all the violations at your facility. You are responsible for ensuring 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 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. You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct these violations. You should include in your response documentation such as your revised HACCP plans, harvest records, sanitation records, and verification records, or other useful information to assist us in evaluating your corrections. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter offers you an opportunity to meet with the FDA New Orleans District staff. We believe a meeting may assist you in resolving your firm’s lack of compliance with federal regulations. A meeting would provide an opportunity for you to present any questions you may have regarding the implementation of corrections and for the FDA to provide guidance and sources of training to assist you in achieving full compliance.
Please send your reply to the U.S. Food and Drug Administration, Attention: Mark W. Rivero, at the address above. Should you wish to schedule a meeting at the New Orleans District, Metairie Resident Post or if you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.
Sincerely,
/s/
Laurie C. Farmer
Acting District Director
New Orleans District
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