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WARNING LETTER

Pacific Tuna MARCS-CMS 482779 — Dec 10, 2015

Pacific Tuna - 482779 - 12/10/2015


Recipient:
Pacific Tuna


United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

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

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

DEC 10, 2015 

WARNING LETTER
 
 
VIA EXPRESS DELIVERY
 
Mr. Yann Ching, Chief Executive Officer
S.A.R.L. Pacific Tuna
B.P.6331
Faa’a, Tahiti
French Polynesia, 98702
 
Reference No. CMS # 482779
 
Dear Mr. Ching:
 
In response to a request by a representative of the United States Food and Drug Administration (FDA) on September 10, 2015 for a copy of your firm’s HACCP plan for the fish and fishery products your firm imports into the United States, your firm provided HACCP plans entitled “Whole Fresh Fish Export” and “Export of Fresh Vacuum Packed Loins”, as well as 5 complete sets of monitoring records associated with the HACCP plan entitled “Whole Fresh Fish Export” on September 21, 2015.
 
Our review of the HACCP plans and records (copies attached) revealed that the plans demonstrate 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 fish products covered by your HACCP plans entitled “Whole Fresh Fish Export” and “Export of Fresh Vacuum Packed Loins” that include your large Tuna, Mahi-Mahi, Stripe Marlin, Blue Marlin, Spearfish, and Wahoo 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 & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.   
 
 
We found the following significant deviations:
 
1)    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 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 “Whole Fresh Fish Export” and “Export of Fresh Vacuum Packed Loins” do not list the food safety hazard of pathogen growth.
 
Specifically, in the “Intended end use” identified in both of your HACCP plans, you acknowledge that some of the fish listed in the “Description of product” “(b)(4).” Prevention of the hazard of pathogen growth is critical to processing safe fish for raw consumption. It is not sufficient to rely on standard sanitation operating procedures alone to control this hazard as suggested in your Hazard Analysis documents to control time and temperature abuse conducive to pathogen growth.
 
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 “Export of Fresh Vacuum Packed Loins” does not list any critical control points associated with the use of TTIs or oxygen permeable packaging material on your reduced oxygen packaged fresh seafood to control the food safety hazard of Clostridium botulinum growth and toxin formation.
 
Although your hazard analysis indicates that you will “(b)(4),” your HACCP plan fails to include any critical control points to ensure the use of TTIs on oxygen impermeable packages. Although your Product Description and Process Narrative suggest that your firm (b)(4), your HACCP plan fails to include a critical control point to ensure the appropriate material is utilized for product to be exported to the U.S.
 
We advise that your fresh fish products in reduced oxygen packaging may be subject to Detention Without Physical Examination under Import Alert #16-125 until your firm submits appropriate documentation, including a demonstration that proper HACCP controls are included in your HACCP plan, to be included on the “Green List” of the Import Alert. And you should also be aware that FDA recommends that every package of fresh refrigerated fish in reduced oxygen packaging should bear an appropriate TTI, not just “(b)(4).” 
 
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’s HACCP plans for “Whole Fresh Fish Export” and “Export of Fresh Vacuum Packed Loins” list critical limits that are not adequate to control the hazards identified at the following critical control points. Specifically:
 
a)    At the (b)(4) critical control point, the critical limits listed in the plans are not adequate to control scombrotoxin formation. Your firm is implementing a harvest vessel record strategy that includes critical limits coupled with detailed instruction that are included in a document that you provided entitled “VSOP”. Your critical limits do not ensure that fish accepted by your firm directly from the harvest vessels were placed in ice or refrigerated sea water in sufficient time after the time of death and do include an estimated time of death to prevent scombrotoxin formation. 
 
Your “Whole Fresh Fish for Export” HACCP plan lists a critical limit of “(b)(4)” at the (b)(4) critical control point. In your Product Description you state that “(b)(4).” Under the “Fresh Fish Storage” section of the detailed VSOP instructions that you submitted, you include chilling parameters from time of death of the fish that could be sufficient to yield safe fish. However, the chilling instructions in that document are not identified as “critical limits” and, instead, are presented as procedures “(b)(4).” More importantly, the actual VSOP records that you are receiving with each delivery do not provide actual observations of the activities onboard the vessels that will ensure you that the desired chilling or cold storage parameters to prevent the hazard of scombrotoxin formation were accomplished. A document that “certifies” that the fish “were handled in accordance with the current signed VSOP document” does not serve as an adequate or appropriate substitute for a critical limit requiring records that document actual observations of safe handling of the fish.
 
Our review of the VSOP vessel records you are receiving revealed that there is no indication that the onboard handling achieved a cooling rate or cold storage that would prevent scombrotoxin formation in the specific fish lots you are accepting for processing. The records show the date/time when the first and last fish are caught, date/time of off-loading, and quantity in tons of ice vs. fish in the vessel’s hold. It is not at all clear what the time the “first fish caught” represents in terms of the time of death of the fish or that those fish were chilled in a timely manner to prevent scombrotoxin formation. Because the records show that the fish are caught using a (b)(4), some fish may be dead hours before being pulled from the water.It is not known if the time “caught” refers appropriately to the earliest time of death of the fish, which should represent the time the first hook of each set is first deployed in a (b)(4), or something else. Moreover, for example, your VSOP record for fish accepted from the (b)(4), suggests the harvest vessel was out fishing for (b)(4) from the time fish were “first caught” until off-loaded. But the record provides no observation that any of the fish caught during that time period were gilled and gutted prior to being placed in ice, or were placed in ice within an appropriate time of the estimated time of death, or were held at appropriate temperatures or under appropriate chilled conditions throughout the fishing trip until delivered to your firm. For that matter, the vessel records provided appear to be only approximations as they are dated by the captains on the day the fish are delivered. Further, the vessel owner/captain attestations agreeing to follow the VSOP are, in some cases, more than 7 years old.
 
While the VSOP approach may have some utility in your communicating vessel handling expectations to your suppliers and receiving confirmation that they understand and agree to adhere to those expectations, the VSOP records you are receiving with each lot do not provide you with adequate information that documents and ensures each lot of fish accepted had been handled safely. Consequently, the VSOP critical limit listed in your plan as a receiving control to prevent scombrotoxin formation is ineffective and inadequate to ensure safe acceptance or production of fishery products by your firm.
 
In addition, the monitoring procedures listed in your “Export of Fresh Vacuum Packed Loins” HACCP plan includes the same language as that listed in the “Whole Fresh Fish Export” HACCP plan with reference to the VSOPs at the (b)(4). However, the vacuum packed plan does not include a critical limit specifically for either harvest vessel records or histamine testing as a control to prevent scombrotoxin formation in your primary processor capacity. Consequently, the critical limits listed in your “Export of Fresh Vacuum Packed Loins” HACCP plan are also inadequate.
 
b)    Your HACCP plans for “Whole Fresh Fish Export” and “Export of Fresh Vacuum Packed Loins” list a similar critical limit of, “internal fish temperature +/- melting ice – (b)(4)” harvest vessel records “(VSOP)” are available, at (b)(4) that is not adequate to control scombrotoxin (histamine) formation. Your internal fish temperature critical limit suggests that fish temps (b)(4) are accepted as long as a VSOP vessel record is available. Accepting scombrotoxin-forming species of fish with internal temperatures (b)(4) only be appropriate if you were receiving reliable documentation that the fish were received less than 24 hours after death of the fish and that you could reliably distinguish which fish in the delivery died within a given timeframe. This is not a functional critical limit as listed within your existing control system.
 
Your critical limit refers to the VSOP vessel records as a response to fish received in (b)(4). And your detailed VSOP instructions provide for scenarios whereby fish (b)(4) from the estimated time of death. However, the actual VSOP records you are receiving from the vessels at the time of receipt of the fish do not provide sufficient documentation of which fish may have died less than (b)(4) or which died greater (b)(4) before receipt. You cannot apply the temperature criteria associated only with the very last caught fish to all fish in the delivery when some fish may have been dead greater than (b)(4) and only the most recent caught fish have been dead within (b)(4) and not yet chilled all the way to (b)(4). To make the distinctions, the vessel records would need to identify the location of fish in the hold in connection with the time of death, at least for those fish dead for less than (b)(4)
 
Further, our review of the VSOP vessel records you are receiving show that the “last fish caught” (whether that means the time the last fish of the last set is captured, G&G’d, and iced in the hold, or the most recent time of death of fish within the delivery, or something else, is not known) to the time offloading of the vessel commenced, was (b)(4) (see (b)(4) offloaded on (b)(4)). Yet, on several occasions, the VSOP records your firm received and verified with signature, identified the last fish caught as having been dead less than (b)(4) from delivery, or even less than (b)(4) from delivery (e.g., see (b)(4) offloaded on (b)(4) or (b)(4) offloaded on (b)(4)). This adds further discrediting of the value of the harvest vessel records your firm is receiving as a HACCP control for the receipt of scombrotoxin-forming fish. And when tied to the receiving temperature critical limit, the VSOP component renders the listed critical limit inadequate.
 
4)    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 “Whole Fresh Fish Export” lists monitoring procedures or frequencies which are not adequate to control the hazard of scombrotoxin formation (or pathogen growth). Specifically:
 
(b)(4).” FDA recommends a frequency of continuous monitoring during refrigerated storage accomplished by a continuous temperature-recording device with daily visual check of the recorded data.
 
None of the monitoring records you submitted include records for this CCP. Please include monitoring records representative of all of your CCPs, including the “(b)(4)” and a completed DSE 011, in future submissions.
 
5)    Predetermined corrective action plans included in your 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: 
 
a)    Your “Whole Fresh Fish Export” HACCP plan lists inappropriate corrective actions at the (b)(4). Specifically:
 
i.    Your plan lists a corrective action to “(b)(4) (but see exception VSOP).” In addition to concerns with your VSOP described elsewhere in this letter, your corrective actions permit the culling of fish within a delivery when some of the temperatures of the measured fish should actually be signaling to your firm that inadequate chilling or cold temperature storage controls occurred onboard the harvest vessel. The intended action does not ensure that other fish within the delivery are safe even if the culling by temperature is extended to all of the fish in the delivery. In this regard, your listed critical limit of “(b)(4)” is a further concern because it could also be interpreted as a culling control. The temperature measurement is intended to provide an inference about the condition of all of the fish in the vessel delivery (not just some fish or some species) and to signal to the processor when temperature abuses may have occurred that could be conducive to scombrotoxin formation. Consequently, an appropriate corrective action should be applied to the entire harvest vessel delivery.
 
ii.    Your plan lists an alternative corrective action to “(b)(4).” (b)(4) is an inappropriate corrective action. FDA recommends a minimum of 60 fish per species per vessel as a corrective action when the temperature monitoring critical limit at receiving is exceeded. Although your listed corrective actions refer to your “Sampling Protocol for HACCP Plan Verification and for Corrective Actions…Histamine,” that document instructs (b)(4) 
               
iii.    The listed corrective actions also fail to ensure that the cause of a critical limit deviation is corrected.
 
b)    Your “Export of Fresh Vacuum Packed Loins” HACCP plan includes the same inappropriate corrective actions at the (b)(4) as those identified in your “Whole Fresh Fish Export” HACCP plan related to the internal temperature control critical limit. In addition:
 
i.    The procedures in this plan permit (b)(4). Re-icing and re-chilling fish that have already been time-temperature abused will not mitigate any scombrotoxin that was permitted to form during the abuse period.
 
ii.    Following histamine testing as a corrective action, your plan states “(b)(4).” It is not clear what the alternative “(b)(4)” protocol is intended to provide or how it is intended to be executed. However, these procedures further diminish the intended controls by allowing the culling of individual fish or groups of fish (b)(4) and (b)(4) from the harvest vessel delivery. 
 
These protocols do not ensure that any of the fish that proceed into commerce are safe for consumption. 
 
c)    Your “Whole Fresh Fish Export” HACCP plan lists inappropriate corrective actions at the (b)(4) related to the VSOP and the sensory examination for decomposition critical limit components of your scombrotoxin formation control. Specifically, your plan lists a corrective action to “(b)(4) (this is not made clear in the plan), which is inappropriate to prevent the hazard of scombrotoxin formation.   As written, your listed corrective actions could result in the culling of only the “(b)(4)” from the sensory sample that were found decomposed and to proceed with processing of all other fish in the vessel delivery.  The inclusion of the “(b)(4)” in your listed corrective actions makes the testing for histamine (b)(4). Further, when histamine analysis is performed following findings of decomposed fish within the vessel delivery, or when the vessel fails to provide appropriate and meaningful harvest vessel records, FDA recommends that a minimum of 60 fish, not (b)(4), of each species be tested for histamine as an appropriate corrective action.  
 
Furthermore, the listed corrective action that “(b)(4)” is more of a verification procedure than a corrective action procedure. If the examiners are, in fact, detecting decomposed food, they are effectively providing the intended protections and something must be done to ensure the cause of the critical limit deviation, i.e., a harvest vessel delivering decomposed fish to your facility, is corrected. Similarly, the failure of a supplier to provide appropriate harvest vessel records when you require them as a control is a critical limit deviation for which the cause must be corrected. However, there are no corrective action elements in your HACCP plan to address the cause of these critical limit deviations.
 
d)    Your “Export of Fresh Vacuum Packed Loins” HACCP plan lists inappropriate corrective actions at the (b)(4). Specifically, your plan lists a corrective action to “(b)(4).” When decomposed fish are detected in a harvest vessel delivery, simply (b)(4) is not an appropriate action to control the hazard of scombrotoxin formation. And, as with your “Whole Fresh Fish Export” HACCP plan, (b)(4)” is not an appropriate corrective action when decomposition is detected in the fish from a harvest vessel delivery, nor when elevated fish temperatures are detected in the vessel delivery and nor when the vessel operators fail to provide meaningful harvest vessel records when you require them.
 
Also, similar to the “Whole Fresh Fish Export” HACCP plan, the listed “(b)(4)” is more of a verification procedure than a corrective action, and the corrective actions listed for (b)(4) do not include actions to ensure the cause of critical limit deviations are corrected.
 
e)    Your “Whole Fresh Fish Export” and “Export of Fresh Vacuum Packed Loins” HACCP plans list inappropriate corrective actions at the (b)(4). When your raw material cold brine storage temperatures exceed your critical limit, your corrective action procedures state that ice may be added and that, provided “(b)(4)” no further corrective action would be indicated. (b)(4)” according to your HACCP plan. The corrective action procedures are inappropriate. Re-icing or re-chilling time-temperature abused fish will not mitigate any scombrotoxin (or pathogen growth) that was permitted to form during the abuse period. And the (b)(4) provides insufficient assurances following known time-temperature abuse of large lots of fish. (b)(4), as indicated in your “Export of Fresh Vacuum Packed Loins” HACCP plan at the (b)(4), is even more inappropriate.
 
Your firm should also be cognizant that a gradient of temperatures from the surface of time-temperature abused fish to the deep core temperatures could be significant, especially in large fish such as those that you process. Temperatures nearer to the surfaces of fish undergoing warming due to loss of temperature control may become far more conducive to harmful bacterial growth and multiplication than what can safely be surmised by deep core temperatures that might not warm for many hours later. You should not be reliant on evidence from deep core temperatures of fish when any cold storage temperature control critical limit deviation has occurred. Deep core fish temperatures should not be used to dismiss losses of control of cold temperatures to which the fish are exposed. 
 
Also, the corrective action procedures listed at this (b)(4) fail to ensure that the cause of the critical limit deviation is corrected. 
 
f)    Your “Fresh Vacuum Packed Loins” HACCP plan lists inappropriate corrective action procedures at (b)(4). The corrective actions (b)(4) provides insufficient assurances of the prevention of the hazard of scombrotoxin formation (or pathogen growth) following the loss of temperature controls in cold storage. 
 
In addition, although your firm did not fully develop a control strategy for Clostridium botulinum growth and toxin formation in your reduced oxygen packaged fish, we note that Clostridium botulinum toxin control is (b)(4). Your listed corrective actions permit (b)(4). Testing for the Clostridium organism is not an appropriate corrective action. Once a processor introduces a reduced oxygen environment such as vacuum packaging, it is obligated to maintain the exposures of the product below 3.3 °C to prevent growth and toxin formation of C. botulinum. It should be assumed that C. botulinum is present on any raw fishery product from the beginning. Some of the time-temperature parameters in your corrective action procedures are clearly conducive to C. botulinum toxin formation. For example, your procedures listed (b)(4)” would allow the vacuum packaged product to be exposed to (b)(4) for as (b)(4) and result in testing for Clostridium. The parameters listed could result in toxin formation that will not be mitigated by re-icing or re-chilling the product and it is inappropriate to rely on testing for the presence of Clostridium to ensure that the abused product is safe for distribution and consumption.  
 
Also, the corrective action procedures listed at these CCPs fail to ensure that the cause of the critical limit deviation is corrected.
 
g)    Your “Whole Fresh Fish Export” HACCP plan lists inappropriate corrective action procedures at the (b)(4). The listed parameters do not invoke any corrective action (b)(4).” Scombrotoxin forming fish could thus be exposed, for example, to 35 °C for 23 hours and 59 minutes without resulting in any corrective action by your firm. The use of the term “(b)(4)” in this application is further disconcerting as it suggests that the cold storage unit temperatures could be oscillating in and out of the critical limit for days and, as long as the abuse is (b)(4), your firm is not prepared to take corrective action. Your firm should be concerned about cumulative exposures of your products while in your possession, not just continuous exposures, to control the hazard of scombrotoxin formation (and pathogen growth). 
 
The listed corrective actions at this CCP are further inappropriate as they default to (b)(4) of the fish following known serious temperature abuse exposures to determine if any further corrective action is necessary. As explained previously, deep core internal temperatures are a poor representation of the effect of temperature abuse on the fish, especially on large fish. This type of measurement is even more misleading if the refrigeration system is oscillating in and out of the critical limit because, in such circumstances, the measurement reflects the fish temperature only at the point in time it is measured and does not provide reliable information about temperature exposures over time. Worse, your corrective actions allow your firm to make this inappropriate evaluation (b)(4).
 
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, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, 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 seafood HACCP regulation.  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.
  
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.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Aleta T. Flores, Compliance Officer, Food Adulteration Assessment Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: aleta.flores@fda.hhs.gov. Please reference CMS# 482779 on any submissions and within the subject line of any emails to us. You may also contact Aleta T. Flores via email if you have any questions about this letter. 
  
Sincerely,
/S/ 
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition

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