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Enforcement Actions

General Tuna Corporation 3/2/12


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

Public Health Service
Food and Drug Administration

College Park, MD 20740

MAR 2, 2012

Warning Letter
Re: Case ID #279637

VIA E-mail -PDF copy

Rhona C. De Guzman, Quality Assurance Manager
General Tuna Corporation
Bo. Tambler
General Santos City,
Re: 279637

Dear Ms. De Guzman: 

In response to a request by the U.S. Food and Drug Administration for documentation associated with your firm's processing operations for your fish and fishery products, your firm provided a copy of your firm's HACCP plan for your pouch packed tuna, as well as the corresponding process flow diagram, process flow narrative, hazard analysis and process monitoring records. Our review of that HACCP plan as well as the additional support.itlg documentation revealed that your firm has serious deviations from the requirements of the seafood HACCP regulation.

In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section, or otherwise operate in accordance with the requirements of 21 CFR part 123, renders the fishery products adulterated within the meaning of section 402(a)(4) of the U.S. Federal Food, Drug and Cosmetic Act (the Act), [21 USC 342(a)(4)]. Accordingly, your firm's pouch packed tuna is adulterated within the meaning of the Act, in that the product has been prepared, packed, or held under conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 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.

The 4th Edition of the Hazards Guide can be found on our web site at:: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm

We note the following serious 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 plan for pouch packed tuna does not list the food safety hazard of Staphylococcus aureus (S. aureus ) growth and potential toxin formation.

We note that in your hazard analysis your firm identifies S. aureus in the group of pathogens associated with the "Thawing" and "Evisceration/Butchering" operations, but is not identified in any of the subsequent processing steps. Because S. aureus is not considered a good competitor with other organisms in raw fish we would not expect controls to be necessary during thawing and evisceration/butchering. The elimination of competitive organisms during your firm's precooking operation, however, will render the fish conducive to S. aureus growth and toxin formation beginning with the first opportunity for recontamination of the precooked fish, e.g., from the skinning operation until the packaged product is in the retorts and reaches inhibitory temperatures at the cold spot. Any opportunity for recontamination following the precooking operation, starting at cooling, should be considered as part of the cumulative exposure and factored for as potential opportunities for S. aureus growth and toxin formation. This should include, for example, your firm's "Rework of Defective/Damaged Seals" steps referenced in your hazard analysis, as well as any additional post-precooking operations.

Additionally, your "Process Flow Diagram" references (b)(4)  between the precooking operation and the retort operation, and (b)(4) between the skinning and retort operations, all with no temperature controls associated with these extended time periods. The residual heat in the fish following the precooking, coupled with the ambient temperatures in your facility, would likely result in exposure temperatures in excess of 21 °C. FDA recommends a maximum of only 3 hours of exposure time when ambient temperatures exceed 21 °C to control the hazard of S. aureus growth and toxin formation.

In addition, in your HACCP Manual your firm describes receipt, storage, preparation, etc., of ingredients other than tuna and your hazard analysis identifies the potential for Staphylococcus aureus contamination during these non-tuna ingredient steps. Your firm may need to assess in your hazard analysis the need for critical control points associated with these other non-descript procedures, assessing all cumulative time and temperature exposures related to your firm product to determine the steps that may support S. aureus growth and toxin formation.

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 pouch, packed tuna does not list critical control points as necessary for controlling the food safety hazard scombrotoxin (histamine) formation.

Your firm's HACCP plan lists only one critical control point to control the hazard of scombrotoxin formation, i.e. "CCP1: Fish Receiving." However, your "Process Flow Diagram," lists many steps/operations between receiving of the fish until thermal processing of packed product in the retorts. Your firm identifies none of these other steps/operations or the cumulative time of exposure as presenting a concern for the scombrotoxin hazard, either in your hazard analysis or as critical control points in HACCP plan. Moreover, your "Process Flow Diagram" references a (b)(4) following the precooking operation until retorting, coupled with a (b)(4), per your firm's HACCP Manual. The cumulative such as thawing, evisceration, racking, and precooking referenced in your supporting documentation are not included in the cumulative time period. Additionally, the time that may be associated with "Rework of Defective/Damaged Bags," is not addressed. Based on the assessment of the various steps/operations conducted by your firm and because temperatures in tuna canneries are expected to expose the fish to ambient conditions above 21 °C for at least some of the cumulative exposure times, your firm should assess in your hazard analysis any cumulative exposure times exceeding 4 hours for fresh fish and 12 hours for previously frozen fish and include those steps/operations as critical control points included your HACCP plan, as needed.

Moreover, your "Process Flow Diagram" shows all fresh fish going directly from receiving to processing. We recommend that you also assess any type of storage or holding or delays involved with the fresh fish at any time following arrival at your processing facility, and include these as critical control points to ensure that proper temperatures of the fish are maintained during those periods to control scombrotoxin formation.

3. 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 action plans for your pouch packed tuna are not appropriate at the following critical control points to control scombrotoxin (histamine):

a. At the "Fish Receiving" critical control point ("CCP1") in your HACCP plan, your corrective action procedures listed for the histamine testing component include "re sampling" of lots that do not meet the critical limit. Your firm's monitoring record forms, i.e., "Incoming Fish Inspection Report - CCP1," instruct that lots found to include any fish with (b)(4) or more histamine are to be divided into sub-lots and retested at the rate of (b)(4). Please be advised that FDA no longer recommends subdividing and retesting lots when the histamine critical limit has been exceeded.

FDA recommends rejecting the entire lot when the initial histamine sampling results reflect time-temperature abuse of the fish based on findings of elevated histamine within some fish in the lot.

b. At your firm's "Fish Receiving" critical control point ("CCP1"), your corrective action procedures listed for the internal temperature measurement component for fresh fish state, "If temperature is above (b)(4). For immediate preparation & precooking, If temp. is above (b)(4): Reject fish lot.” The listed procedure does not prevent distribution of potentially unsafe products and appears to only modify the critical limit from (b)(4) or below which is not appropriate. 

Because the "Process Flow Diagram and Description" depicts fresh fish going directly to processing upon receipt, the listed corrective action relates to no change in the process or treatment of the fish as a consequence of (b)(4) critical limit (i.e., the temperature critical limit listed in your at control point). FDA recommends monitoring internal temperatures as the fish are off-loaded from the harvest vessels as an indicator of adequate handling by the vessel operators to prevent scombrotoxin formation. A processor should expect that the fish would have been chilled to below 4.4 °C when properly held onboard the boat (i.e., for more than 24 hours). Modifying the control to (b)(4) without scientific studies to support the modification is not recommended.

B. Additional Concerns

1. Receiving - Truck Transport, Storage, Vessel Lot Identification

In your firm's "Process Flow Description" (i.e., section "c.1.1 Fish Receiving Frozen & Fresh") fresh fish are described as "unloaded from the truck ... [and sampled] per delivery per supplier." However, section "c.1.2 Cold Storage" describes ''rented cold storage" facilities near the port and delivery of "truckloads" of fish to the plant at a later time. These descriptions raise the following concerns related to fresh fish, for a processor such as yourself, as a primary processor (i.e., receiving the fish directly from the harvest vessels), and whom is also not located at the wharf where the fish are off-loaded:

o When processors are not located at the wharf where the fresh fish are off-loaded but are located a distance away from the wharf where the fish are in transit for an extended time period from the wharf to the processing facility, FDA recommends an additional critical control point associated with receiving to ensure the fish are safely transported from the wharf to the facility. For example, this should include monitoring temperatures or adequacy of ice at receipt;

o Additionally, when processors are not located at the wharf where the fresh fish are off-loaded, the primary processor's receiving controls related to temperatures of fish while held on board the harvest vessels should be accomplished at the wharf and not after transport to the processing facility;

o FDA's primary processor receiving control recommendations are intended to be specific to each harvest vessel lot. Consequently, when the fish are received at the processing facility by truck, the fish should be delivered in a manner whereby each vessel lot is intact and readily identifiable to the processor for purposes of monitoring.

2. Request for Clarification Regarding the Following HACCP Plan Controls

a. Receiving

At the "Fish Receiving" critical control point ("CCP1"), there are several elements of the HACCP plan that need attention or should be clarified.
i Histamine Testing Component

o As previously addressed in this letter, we note the fish are expected to be exposed to many hours at elevated temperatures during numerous processing steps. We recommend your firm reconsider your histamine receiving critical limit of 50 ppm at receiving. Firms who are aware that fish are to be exposed to multiple periods of elevated temperatures during processing will often reduce their histamine critical limit accordingly as an added measure of safety.

o The monitoring procedures in your plan state "Sample location: (b)(4) FDA recommends that a minimum of 250 grams muscle should be collected from the lower anterior loin of each fish to be tested.

o Your plan references compositing the histamine samples. For compositing, FDA recommends that the 250 gram samples should each be ground independently. A 100 gram sample from each of the individually ground samples should then can be combined and further homogenized to create the composite sample. The test portion can then be obtained from the homogenized composite sample.

o Your monitoring procedures list histamine testing (b)(4) from "Each incoming fish lot; Frozen: (b)(4) FDA recommends that the sampling represent the lot, using a minimum of 18 fish per harvest vessel lot, per species. Your firm's procedures do not specify testing of each species for this component and it is not clear whether the "lot" is specific to each harvest vessel. Moreover, (b)(4) of fish is an exceptionally high number of fish in a lot, to be represented by a representative sample of (b)(4). For example, this could equate to 4 or 5 reefer containers worth of fish or the equivalent of only 3 to 5 fish samples per reefer container, which does not reflect adequate representation of the "lot." Your firm should consider this is adequate in order to the condition of lots of this size, when applying only the minimum number of samples recommended by FDA.

o The listed critical limit for histamine is (b)(4) for composites or (b)(4) for individual fish. A more accurate limit would be less than 16.7 ppm for 3-fish composites, and less than 50 ppm for any individual fish.

ii. Internal Temperature Measurement Component

o The critical limit listed in your firm's HACCP plan for this temperature component is (b)(4) for fresh fish. We recommend a more accurate listing of 4.4 °C or below for fresh fish.

o Your firm does not identify the number of fish to be measured related to internal temperature monitoring. Your monitoring procedures state "Per fish delivered." FDA recommends measuring a minimum of 12 fish per species per vessel lot by the primary processor at the time of off-loading from the vessels. Measuring more fish is recommended for large lots or when variability in the temperatures is expected or found.

o Your listed monitoring procedures identify temperature measurements of each species, which however was not identified in your histamine testing component. The procedures also identify temperature monitoring "per supplier." Temperature measurements are intended to give the primary processor an indication of handling conditions on board the harvest vessel and the measurements should be specific to a harvest vessel lot at the time the fish are off-loaded from the vessel. Because your firm refers to the receipt of truckloads of fish, it is unclear whether the measurement is specific to each harvest vessel at the time of off-loading, or some other measurement inferred by your term "per supplier."

iii. Decomposition Component

o The critical limit listed in your HACCP plan for the decomposition component is (b)(4).” The listed corrective action procedure further states “If more than (b)(4) were rejected due to odors of decomposition…”  The critical limit for this control component should more accurately state less than (b)(4) of the fish showing evidence of decomposition.  Corrective action should be initiated when 2.5% or more of the fish have sensory indicators of decomposition, e.g., 3 or more of 118 fish with decomposition should result in corrective action.

o The listed monitoring procedures and critical limit in your HACCP plan specify “odors of decomposition” to control the scombrotoxin hazard.  A primary processor should be using the sensory examination control to detect evidence of time-temperature abuse of the fish that could suggest conditions conducive to scombrotoxin formation.  The sensory evidence need not be restricted to only odors.   Your firm’s “Incoming Fish Inspection Report” suggests that you evaluate more than just the odors as part of the assessment and we recommend that this be included in your HACCP plan.

In the latter report, records show only a singular grade for each group of fish evaluated and then provide a separate overall assessment of “Odor of Decomposition” signified only by “0/118” for the records submitted.  We would appreciate an explanation regarding the protocol used by your firm to assess the fish. For example, please explain whether the letter grades for each sensory aspect assessed reflect the worst grade fish within the 118 fish examined or some other entity.  Overall, we would appreciate the written protocol for performing sensory evaluations and your firm’s interpretation of the records.

o The monitoring procedures list in your HACCP plan reference “(b)(4) Per fish lot delivered per supplier.”  FDA recommends that the sampling should be representative of the lot using a minimum of 118 fish per harvest vessel lot, per species.  Your firm’s procedures do not specify testing of each species for this component and it is not clear whether the “lot” or “supplier” is specific to a harvest vessel.  Moreover, (b)(4) of fish is an exceptionally high number of fish to be represented by a sample of (b)(4).  Your firm should consider if it is getting adequate information about the condition of lots of this size by applying only the minimum recommended number of samples.  

o The corrective action procedures listed in your HACCP plan for the decomposition control component are inappropriate.  The procedures call for (b)(4) to the remaining fish lot” when the critical limit for decomposition is exceeded and “no individual histamine content is greater than (b)(4).”  FDA recommends that a minimum of 60 fish from the lot should be tested for histamine when 2.5% or more of the fish are found to contain sensory indications of decomposition.  The fish tested should include any of those found to have decomposition.  And the testing approach is valid only if none of the original 18 or more fish tested had 50 ppm or more histamine.  Only then, and following the results of the additional 60 fish or more for histamine, is the 100% culling of the lot for decomposed fish appropriate.

3. Receiving Records Clarifications

FDA requests an explanation of the differences and importance of the monitoring observations recorded and collected in the submitted “Frozen Fish pre-Inspection on Vessel Report,” the “Histamine & Salt Analysis Report,” the “Incoming Fish Inspection Report – CCP1” and the “Pre-Production Fish Sample Evaluation Report” as they relate to each other and to the critical limits at the “Receiving Fish” CCP in your firm’s HACCP plan.

For example: 

(b)(4), recorded on the submitted records only as “P” for “Pass.”  The record appears to be some type of preliminary wharf receiving report.  However, histamine also appears to be tested when the fish arrive at the processing plant and are reported on the “Histamine & Salt Analysis Report” with actual values.

Your firm’s “Process Flow…Description” suggests that histamine is analyzed on “representative samples” “prior to unloading…fish from the vessel,” and again “during unloading” “per truck load” when fish are received “at the plant.”   Please explain the reason that the histamine results are reported as “Pass” or “Fail” on the “Frozen Fish pre-Inspection on Vessel Report”. We would expect actual values.  Is a different method of analysis used at the “pre-Inspection” step?  And are there criteria for accepting or rejecting a vessel lot on the basis of this examination?

The histamine results on the “Histamine & Salt Analysis Report” can be interpreted as a composite value or as an individual value based on the report form column heading. In the records you submitted, there doesn’t appear to be a means for the record reviewer to be sure what the value represents. For example, if the histamine values represented in the (b)(4)(b)(4) were composites, it appears that the third value of (b)(4) exceeded your firm’s critical limit of (b)(4) for a composite and should have invoked a corrective action rather than marked as “Pass.”  And if the value denotes a number other than (b)(4), the range of histamine values of approximately (b)(4) should probably have invoked additional sampling and testing due to the variability within the lot and because some samples were approaching the critical limit.

In the “Incoming Fish Inspection Report – CCP1,” histamine samples are again reported for raw fish “per truck load,” but these values appear to be simply a transfer of the values reported on the “Histamine & Salt Analysis Report.”  Please clarify.

The histamine values recorded in the “fish unloading” section of your firm’s “Pre-Production Fish Sample Evaluation Report” appear to be results from fish tested from the same lots as that reported in your other records but collected and analyzed from the test protocol lot rather than the overall lot.  However, it is not clear whether these values are generated before or after the other evaluations or are part of the same evaluations, whether the values are for composites or individual fish, and/or whether the critical limit applies to these findings or what actions are to be taken when the limit is exceeded during these evaluations.

Similar clarifications for temperature and decomposition components of your firm’s practices and recordkeeping and how and when the listed critical limits apply are requested.

You should respond in writing within thirty (30) 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 plan or plans; at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan(s); any verification records; and any other useful information that would assist us in evaluating your corrections.  If you cannot complete all corrections within fifteen 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, 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 Food and Drug Administration, Attention: Mildred Benjamin, 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. Benjamin via email at: Mildred.Benjamin@fda.hhs.gov



Michael Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition