Inspections, Compliance, Enforcement, and Criminal Investigations
Dragon Waves Frozen Food Factory Co., Ltd. 3/30/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
March 30, 2009
VIA OVERNIGHT MAIL
ID. # 51842
Dragon Waves Frozen Food Factory Company Ltd.
Lot C - No 1
Suoi Dau Industrial Zone
Khanh Hoa Province
Telephone Number: (84) 58 743296
FAX Number: (84) 58 743358
Dear Sir Madame:
On December 2, 2008, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of a fish and fishery products importer in the United States; Orca Bay Seafoods located at 900 Powell Avenue S.W., Renton, Washington 98057-2907. That importer was found to be importing Frozen Tuna Steaks from your processing facility. During the inspection of that importer, we collected a copy of your firm's HACCP plan for your "Frozen Tuna Steaks, Treated With CO to Promote Colour Retention". Our evaluation of that HACCP plan (copy attached) revealed serious deviations from the requirements of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation. Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 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 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 Frozen CO Treated Tuna Steaks 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 and Controls Guidance: 3rd Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.
We note the following deviations in your seafood HACCP plan:
1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met at each of the critical control points, 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 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 "Frozen Tuna Steaks, Treated With CO to Promote Colour Retention" does not list critical limits at the Receiving critical control point that are adequate to control the food safety hazard of scombrotoxin (histamine) formation. Specifically, your firm acts as a primary processor receiving the tuna directly from the fishing vessels. Your control strategy to address the handling practices on-board the fishing vessels is to obtain harvest vessel records. However, your critical limits associated with these harvest vessel records are not adequate to ensure control of scombrotoxin (histamine) formation on-board the vessels. For example, your critical limit does not specify the method of capture or the method of chilling of the fish once they are landed onto the boats. Listing that "chilling begin as soon as fish is landed on the vessel," as is currently in your plan, provides no information about the chilling practices or the actual time/temperature exposures of the fish. In addition, there is no information within the boat records concerning the estimated time of death, which is an important component because scombrotoxin (histamine) formation begins to develop as soon as death occurs. Of particular concern, for example, is long-lining, where fish are hauled back already dead on the line. In these instances, the time of death will be difficult, if not impossible, to determine.
In addition, your critical limits at receiving also include "Fish's center temperature <10°C (50°F) about 6 hours after death and <4.4°C (40°F) or below after that." This does not appear to be part of the information associated with the actual harvest vessel record (i.e., to be filled out on-board the boats). However, this information would be an important component of the harvest vessel records, in that it would provide the information discussed in the paragraph above, to ensure that chilling of the fish began as soon as the fish were landed on the vessel. As listed in your plan, however, these limits appear to mean that you, as the processor, are receiving some of the fish within 6 hours after death. But again, because the critical limits do not include time of death, it is not clear how either the boats or you as the processor receiving the fish will be able to ascertain this information.
Please provide copies of the harvest vessel and/or any additional receiving records that you are using and which you have listed in your plan. We will be better able to evaluate your HACCP controls at receipt with the actual records.
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point to ensure compliance with critical limits, to comply with 21 CFR 123.6(c)(4). However your firm's HACCP plan for your "Frozen Tuna Steaks, Treated With CO to Promote Colour Retention" fails to list adequate monitoring procedures and frequencies:
a. At the Receiving critical control point to ensure that the temperature and spoilage critical limits have been met. Specifically, the monitoring procedures related to measurement of "fish center temperature" do not list how many fish will be measured. FDA recommends that a minimum of 12 fish be measured for any lot of fish received by a primary processor. FDA recommends that more fish should be measured if the fish should be measured if the fish temperature are expected to be variable based on the harvest method and time of delivery of the fish since time of death. In addition, the monitoring procedures related to measurement of "spoiled fish" by "sensory examination" also do not list how many fish will be examined. FDA recommends that a minimum of 118 fish be examined for sensory indicators of decomposition in any lot of fish received by a primary processor (or all of the fish in the lot if there are fewer than 118 fish).
b. At the Chilling Raw Material critical control point to ensure that the temperature critical limit is met. Specifically, this critical control point lists that "fish center temperature" will be monitored with a "thermometer" at intervals of "every 2 hours." This will provide very limited information related to the storage conditions and/or temperatures at those intervals between the daily checks. FDA recommends that the ambient temperature of the room in which the fish are stored be maintained at a temperature of 40°F or below and that firms monitor the critical temperature limit by measuring the temperature in the storage room using equipment capable of continuously monitoring and recording the temperatures. Alternatively, FDA recommends monitoring to ensure that the fish are all completely surrounded in ice at least twice a day when fish are stored on ice. Moreover, we recommend these procedures for any extended chilled storage periods and recommend that your firm assess the need to include additional chilled storage periods as critical control points in your plan. In addition, appropriate corrective actions, consistent with temperature monitoring and/or monitoring of ice should be adopted for any chilled storage critical control points.
c. At the Refrigerated Storage Critical Control Point to ensure that the temperature and time critical limits are met. Specifically, your plan lists that product temperatures will be monitored "Every day" by use of a "thermometer" to ensure product is "53°C." This will provide limited information related to the storage conditions and/or temperatures at those intervals between the daily checks. As discussed in the above paragraph, FDA recommends that the ambient temperature of the room in which the fish are stored be maintained at temperatures of 40°F or below and that firms monitor the critical temperature limit by measuring the temperature in the storage room using equipment capable of continuously monitoring and recording the temperatures. In addition, FDA recommends a daily check of the continuous monitoring device once per day to make sure the data shows that the critical temperature limits have been met each day. Time-temperature data loggers are customarily used for monitoring storage temperatures.
3. Because you chose to include corrective actions in your HACCP plan, your described corrective actions must be appropriate (1) to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation and (2) the cause of the deviation is corrected, to comply with 21 CFR 123.7(a)(1) and (b). However, the corrective actions listed in your HACCP plan are inadequate. Specifically,
a. Your corrective actions at the Receiving critical control point, listed as "Reject spoiled fish," are not adequate to control the decomposition ("spoiled fish") element that you have listed in your plan at the Receiving critical control point. FDA recommends that primary processors examine incoming fish for decomposition at a receiving control associated with prevention of scombrotoxin formation because decomposition can serve as an indicator that the fish have been time-temperature abused such that scombrotoxin could form. This control is not intended to have processors cull out or reject individual decomposed fish from the lot. As the primary processor, your firm should be assessing the suitability of the entire lot at the time of receipt based on this control parameter. For example, FDA recommends that a lot of fish should be subject to corrective action (i.e., rejected) if 2.5% or more of the fish in the lot received are decomposed. As mentioned above, we recommend examining at least 118 fish in the lot for decomposition; or examining all the fish when the lot consists of less than 118 fish.
b. The corrective actions in your HACCP plan associated with histamine testing at the "Chilling Raw Material" and "Refrigerate Storage" critical control points are not adequate because the number of fish to be tested is not listed, making it possible that the sampling plan does not represent the entire lot. FDA recommends that a minimum of 60 fish from each affected lot be tested for histamine content as part of any corrective action plan following a critical limit deviation associated with scombrotoxin (histamine) formation during any storage periods.
c. With the exception of your corrective action for the hazard of metal inclusion at the metal detector critical control point, none of your listed corrective actions address correcting the cause of the critical limit deviations at any of the critical control points.
For more information related to the hazard of scombrotoxin (histamine) formation, please refer to the Fish and Fisheries Products Hazards and Controls Guidance, Third Edition, Chapter 7, found at: www.cfsan.fda.gov/~comm/haccp4.html.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation, such as: a copy of any revised HACCP plans; at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen (15) days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. This alert can be found on FDA's web site at: http://www.fda.gov/ora/fiars/ora import iaI6120.htm1.
This letter may not list all your deviations from the requirements of the Act or applicable regulations. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the Current Good Manufacturing Practice regulations (21 CFR Part 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: Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Benjamin by phone at (301) 436-1424 or via email at Mildred.Benjamin@fda.hhs.gov
Office of Compliance
Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration