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U.S. Department of Health and Human Services

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Pacific Fishing Company Limited 10/20/10


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

Public Health Service
Food and Drug Administration

College Park, MD

Warning Letter
I.D. # 120210

OCT 20 2010


Chandra Prakash
Pacific Fishing Company limited
P.O. Box 41
Beach Street
Levuka, Fj-Nota

Dear Mr. Prakash:

In response to a request by the United States Food and Drug Administration for a copy of your firm’s HACCP plan and additional supporting documents including monitoring records for your tuna loins, your firm responded by email on June 4 through 6, 2010 (via 13 separate email messages) with the requested documents. Our evaluation of the HACCP plan you provided (dated May 18, 2010) and supporting documentation 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 tuna loins 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:

1. You must conduct a hazard analysis to determine whether there are food safety hazard 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 acceptable levels.”  However, your firm’s HACCP plan for “Tuna Loins” does not list critical control point(s) at the pre-cook operation or at any subsequent steps following the pre-cook, (b)(4) as necessary critical control points to ensure control of exposures during the operations to control scombrotoxin formation.

Specifically, your firm identifies the operations leading up to the pre-cook step, (b)(4) as a critical control point; however, there is no indication in your HACCP plan to suggest that concerns with scombrotoxin formation end at the staging operation. 

For example, the pre-cook step is a likely critical control point when the critical limits are sufficient to terminate further scombrotoxin formation. In this instance, the HACCP plan should include the pre-cook as a critical control point and should include all appropriate critical factors to achieve an adequate cook. 

When the pre-cook step is not a controlling step for scombrotoxin formation, then the concern for temperature exposures above 70 oF are pertinent to exposures all the way from the beginning of the thawing operation right through to the bagged product entering the freezer…inclusive of the pre-cook, cooling, skinning/cleaning, and bagging steps.

2. 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 your HACCP plan lists inappropriate corrective actions at the “Receiving of frozen fish” CCP (CCP 1a). (b)(4) 

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 and address the listed concerns. 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 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_ia16120.html.

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.

During our review, we also identified the following additional concerns:

1. Sample for Histamine Determinations

At the “Receiving of frozen fish” critical control point (CCP 1a), your firm lists monitoring procedures that include “[c]ollect a (b)(4) from the nape of each fish…”  Studies by FDA in recent years have shown that the region of the fish being sampled by firms, i.e. the “nape” of the fish, is highly unlikely to reveal elevated histamine even in severely time-temperature abused fish that have become scombrotoxic. The studies show that the lower anterior loin of the fish is the more likely region to find elevated histamine. It is an ineffective use of resources and an inadequate control for scombrotoxin formation to sample and analyze the nape of the fish for histamine.

In addition, FDA recommends the sampling of a minimum of 250 grams of fish muscle from each fish for scombrotoxin controls, rather than the (b)(4) listed in your firm’s plan.

2. Applicability of Histamine Test Kit Used for Monitoring

Your firm identifies use of the (b)(4) test kit in the monitoring procedures for the “Receiving of frozen fish” critical control point (CCP 1a) for histamine testing of the incoming tuna. The (b)(4) test kit is a qualitative test, not a quantitative test. It is designed to indicate the presence of histamine equal to or greater than 50 ppm, not at your firm’s critical limit target of (b)(4). Please provide additional details regarding your use of the (b)(4) as an appropriate monitoring measure for histamine at (b)(4) including the preparation of positive and negative controls.

3. Receiving Fish by Various Modes; Application/Effectiveness of Primary Processor Controls

In various places within the plan, your firm refers to the receipt of tuna directly from (b)(4) Please provide clear descriptions of the physical vehicle or apparatus used to convey the fish as received, the typical contents of fish within, and the typical history of fish from the water to receipt, in each of these receiving modes or forms of conveyance. In those instances where your firm is not off-loading the fish directly from the individual harvest vessels, please 1) identify the suppliers of the fish (back to the primary processor if possible), and 2) identify the reasons for any confidence that your firm may have that the fish are processed in compliance with the seafood HACCP regulation by its suppliers.

In the HACCP monitoring records, it was noted that larger sample sizes are collected and analyzed for certain sample lots.  However, your firm does not consistently identify the source of the fish in the monitoring records submitted and it is not evident what is triggering additional sampling in some cases.


a. Your firm includes a (b)(4) critical control point (CCP3a and CCP3b) that includes histamine testing and organoleptic examination for evidence of decomposition. FDA would like more information about the makeup of the (b)(4) and its sources. 

• Please provide a detailed description of the (b)(4) What ingredients does the tuna slurry consist of and how is it manufactured?  Who produces the (b)(4) at each step starting from the raw fish?
• What does the “accompanying certificate of analysis” from “an accredited supplier” attest to or ensure with regard to the (b)(4) 
• What is involved in a (b)(4) supplier becoming accredited?
• Provide an example certificate of analysis and the HACCP plans of your suppliers of the (b)(4) product, with trace back to the primary processor
• Please describe how the (b)(4) and other ingredients making up the (b)(4) is consistent with the standard of identity for canned tuna (21 CFR § 161.190) for which your product is intended.

b. In your HACCP plan, your firm describes a process related to the (b)(4) starting material along with other additives into the tuna (Figure 1, Process Flow Diagram; section C. Process Flow Diagram and Description; section D. Hazard Analysis, pages 10-11, and section E. Tuna Loins HACCP Plan, pages 19-20). Your firm’s hazard analysis suggests that other time and temperature control parameters are deemed necessary to control the scombrotoxin (histamine) hazard during the (b)(4) but dismisses the need for a critical control point because “[t]here is a program in place to monitor and document times and temperatures.” This monitoring and documentation is not part of the HACCP plan and such monitoring documentation was not included in the submission. 

Whenever a hazard can be introduced in the absence of appropriate controls, then the controls should become part of the HACCP plan.  If the processing of the (b)(4) component can introduce the hazard of scombrotoxin (histamine) formation or other hazards in the absence of time-temperature controls, then a critical control point with appropriate time-temperature controls should be included in the HACCP plan.

5. Corrective Action Procedures

a. At the “Receiving of Frozen Fish” critical control point (CCP 1b), your firm lists corrective action procedures, (b)(4)  

The random sampling should also selectively include those fish that were found to be decomposed. Because scombrotoxin cannot reliably be detected by sensory analysis, and because sensory analysis is recommended only as a trigger to indicate time-temperature abuse in the lot, upon a finding of decomposed fish, a processor’s interest should be to determine if the time-temperature abuse detected also permitted scombrotoxin formation in the lot. Consequently, inclusion of those fish found to be decomposed in the samples to be tested for histamine will assist your firm in making that determination. 

In addition, at CCP 1b, the listed corrective action procedures in (b)(4) state that decomposed fish will be rejected if histamine levels are found to be acceptable. The procedures should also specify that 100% of the lot will be inspected for decomposition when those conditions occur. 

b. At the (b)(4) CCP (CCP2), the listed corrective action procedures do not ensure the cause of the critical limit deviation is corrected. (Note: the critical limit at this CCP should also more appropriately specify “less than 12 hours,” “maximum of 12 hours,” “not to exceed 12 hours” or something more descriptive than “12 hours.”)

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 



Jennifer Thomas
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition