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U.S. Department of Health and Human Services

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Enforcement Actions



Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD 20740 


November 7, 2013
Mr. Tran Thi
Lot B3, Hoa Hiep Industrial Zone
Hoa Hiep Bac Commune, Dong Hoa Village
Phu Yen, VN-32 VN
Reference No. # 408274
Dear Mr. Thi:
In response to a request by a representative of the United States Food and Drug Administration (FDA) for a copy of your firm’s HACCP plans for the fish and fishery products your firm imports into the United States, your firm provided copies of the following HACCP plans along with corresponding monitoring records in an email dated June 17, 2013:
  • Scombroid Species Freshness Product
  • Tuna Cut CO Treated Frozen
  • Freshness Tuna Fillet
Our review of the HACCP plans (copies enclosed) and the monitoring records revealed serious deviations from the requirements of the seafood HACCP regulation.
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 tuna products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and FDA’s 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov. 
The Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
We noted the following significant deviations:
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 plans for “Tuna Cut CO Treated Frozen” and “Freshness Tuna Fillet” do not list the food safety hazard of Clostridium botulinum toxin formation. Specifically:
a.    For “Tuna Cut CO Treated Frozen” products, your firm is conducting an “(b)(4)” step as a critical control point for up to (b)(4) at temperatures between (b)(4) to control histamine. However, because this step is conducted under a reduced oxygen environment, your firm also needs to control Clostridium botulinum toxin formation. We recommend that your firm conduct the treatment at temperatures below 3.3° C and that you continuously monitor and record the cooler temperatures for the entire duration of the treatment period, with a daily check of the temperatures and the equipment, to ensure that the fish are consistently maintained at or below 3.3° C.
Additionally, you must ensure that the finished product is appropriately labeled with handling instructions, such as to “(b)(4) Before Use.”
b.    For “(b)(4)” products, the product is (b)(4). Clostridium botulinum growth and toxin formation is a reasonably likely hazard for the refrigerated vacuum packaged product. Your firm should maintain the(b)(4) monitor and record the cooler temperatures. Additionally, since raw seafood products do not have secondary controls that inhibit Clostridium botulinum growth and toxin formation, your firm must implement controls that can demonstrate to the final consumer that the product has been distributed and held under safe conditions.                                      
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 plans for “(b)(4),” do not list the critical control point or points for controlling the food safety hazard of scombrotoxin (histamine) formation. Specifically:
a.    Receiving fish at the dock: Your firm is the primary processor receiving the fish directly from the harvest vessel. While your plan includes temperature monitoring at the time the fish are received at your facility, FDA recommends measuring the internal temperatures of a representative number of fish at the time of offloading at the dock to ensure proper onboard handling practices. We further recommend documenting the date and time of offloading from the harvest vessel. These measurements should be made at the time the fish are offloaded from the harvest vessel and prior to transit to the processing facility.
b.    Unrefrigerated processing steps: According to the documents you provided, your firm conducts several processing steps such as (b)(4). These steps may cumulatively result in extended exposures to unrefrigerated conditions conducive to scombrotoxin (histamine) formation. FDA recommends implementing controls throughout these processing steps which strictly limit cumulative exposure times to unrefrigerated temperatures (e.g., >4.4° C) during processing.
In addition, when conducting your hazard analysis, your firm should assess the need for any storage critical control points in any of your HACCP plans to prevent scombrotoxin (histamine) formation when fish are held for long periods of time in ice, ice slurries, or coolers.
3.    You must have a HACCP plan that, at a minimum, lists the critical limits that 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 has not set appropriate critical limits, as follows:
a.    Your firm’s HACCP plans for “(b)(4)” do not list a critical limit for decomposition at the “(b)(4)” critical control point. FDA recommends that primary processors include not only a strategy associated with harvest vessel records (or histamine testing) and internal temperature monitoring, but that firms also include a third strategy associated with monitoring the level of decomposition in each lot of fish to assess the handling conditions on board the vessels. FDA recommends that firms set a critical limit of less than 2.5% decomposition (persistent and readily perceptible) in each sample of fish. We recommend conducting a sensory examination on a representative sample of a minimum of 118 fish per lot, or conducting sensory analysis on the entire lot if you receive fewer fish. This means that no more than 2 fish in a sample of 118 fish should show signs of decomposition. Each vessel and each different species of scombrotoxin-forming fish from a vessel should constitute “a lot” for that fish species.
Your HACCP plans all reference harvest vessel record collection at the receiving critical control points. Additionally, your cover letter indicates that some or all of your fish are caught via long line. When using harvest vessel records as the control strategy for fish that were captured with long lines, FDA recommends that firms have a method of identifying those fish that were harvested already dead.
b.    Your firm’s HACCP plan for “(b)(4)” lists critical limits at the “(b)(4)” critical control point that are not adequate to control scombrotoxin (histamine) formation. Specifically:
i.    The harvest vessel record critical limit states, in part, that if “individual fish time of death was within (b)(4) of icing if maximum fish exposure temperature was (b)(4).” FDA recommends when air or water exposure temperatures are 83°F or below, the fish should be placed in cooling medium within 9 hours of death.
ii.    The sensory critical limit of “(b)(4) fish sampled may exhibit sensory indicators of (b)(4).” FDA currently recommends a critical limit of less than 2.5% of a representative sample shows decomposition (persistent and readily perceptible). For example, no more than 2 fish in a sample of 118 fish should show signs of decomposition. 
c.     Your firm’s HACCP plans for both “(b)(4)” list critical limits associated with internal/core temperature monitoring that are not adequate to control scombrotoxin (histamine) formation. Specifically, your HACCP plans (b)(4) as the critical control point.   FDA recommends that processors establish critical limits to control ambient temperature or time exposures to unrefrigerated conditions, rather than internal/core temperature, because the surface areas of the fish are expected to increase in temperature before the core areas.
4.    You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6 (c)(4). However, your firm’s HACCP plans list monitoring procedures that are inadequate to control scombrotoxin (histamine) formation, as follows:
a.    Your HACCP plans for “(b)(4)” list a critical limit of “(b)(4),” however the monitoring procedures only describe taking the internal temperature of the product. This does not ensure that adequate ice surrounds the fish. FDA recommends monitoring procedures to ensure that fish are visually monitored to ensure that fish are completely surrounded by ice at the time of delivery.
b.    Your HACCP plan for “(b)(4)” lists a monitoring frequency of “(b)(4)” at the "(b)(4),” and “(b)(4)” critical control points. FDA recommends the use of a continuous temperature monitoring and recording device with a visual check of the recorded data at least once per day.
c.    Your HACCP plan for “(b)(4)” does not state the minimum number of fish you will examine or that the sample will be representative of the lot. FDA recommends testing a minimum of 18 fish collected throughout the lot, or the entire lot if there are fewer than 18 fish in the lot.
We note that this plan also references (b)(4). In your response, please clarify whether your firm intends to implement the (b)(4) strategy or the histamine testing strategy.
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 firm did not follow your monitoring procedures at the “(b)(4)” critical control point to control scombrotoxin (histamine) formation as listed in your HACCP plan for “(b)(4).” Specifically, the “(b)(4)” monitoring form submitted with your documentation does not show that the critical limits were met or that the captain and crew of the vessel recorded their observations at the time those observations were made. The (b)(4) should include the actual observations for method of capture, date and time of landing, earliest time of death, ambient air and water temperature, and date and time cooling began.
6.     Predetermined corrective action plans included in a firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b). However, your corrective action plan for “(b)(4)” are inadequate.
When your critical limits are exceeded, your corrective action plans state “(b)(4) the (b)(4) and test histamine. Eliminating if histamine is (b)(4). Your corrective action plan does not describe the parameters you will use to perform your histamine determination, what you will do to prevent further deviations, or that you will address the root cause of the deviation.
If your firm chooses to test for histamine, FDA recommends that you ensure the fish are adequately chilled, and that you hold the affected product until the histamine analysis is completed. FDA further recommends testing a minimum of 60 fish collected from throughout the lot, or every fish if the lot consists of fewer than 60 fish; and destroying the lot or diverting it to a non-food use if any fish is found with histamine ≥ 50 ppm. Alternatively, a sample of 60 fish may be composited into 20 units of 3 fish each, provided the critical limit is reduced from 50 ppm to 17 ppm for each composite.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Seafood HACCP regulation, and the 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.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan or plans, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the applicable laws and regulations. Submission of the information in English will assist in our review. 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.
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. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html
Because vacuum packed, refrigerated (fresh) tuna fillets pose a serious risk for Clostridium botulinum formation, these products are subject to detention without physical examination under Import Alert #16-125 “Detention Without Physical Examination of Refrigerated (not frozen) Raw Fish and Fishery Products That Are Vacuum Packaged or Modified Atmosphere Packaged of Packaged in Material That is Not Oxygen-Permeable Due To The Potential For Clostridium botulinum Toxin Production.” Manufacturers that provide evidence to demonstrate that the food safety hazard of Clostridium botulinum formation is controlled may apply to be listed on the exempt (green) list of IA #16-125. Please review the following link for more information: http://intranetapps.fda.gov/scripts/vts/imports/default.cfm?page=importalert
Please send your reply to Food and Drug Administration, Attention: Denise Beuttenmuller, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment 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. Beuttenmuller via email at: denise.beuttenmuller@fda.hhs.gov.

William A. Correll, Jr.
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition