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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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P.T. Bonecom aka Bone Commercial Company 9/14/11


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

Public Health Service
Food and Drug Administration
 College Park, MD 


September 14, 2011
Reference No. 219735
Mr. Eri Setio Prabowo
PT. Bonecom aka Bone Commercial Company 
Blok L. No.1
Jakarta, Utara,
Indonesia 14440
Dear Mr. Prabowo:
We inspected your seafood processing facility, located at J1. Muara Bam Ujung Blok L. No.1, Jakarta Utara, Indonesia on May 15 and 16, 2011. During that inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). That inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection listing the deviations found at your firm.   We acknowledge receipt of your response to the FDA-483 received via email on June 15, 2011.   The June 15, 2011 response included some data and information related to your products and two pages that reflected changes to your HACCP plan for your “Frozen Tuna CO Treatment”.  Our review revealed that the response was not adequate, as further described in this letter. 
Upon further review of the inspectional findings collected during the inspection and the information and documentation provided in your June 15, 2011 response, we find that your firm is in violation of the Federal Food, Drug, and Cosmetic Act (the Act).  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 Act [21 U.S.C. 342(a)(4)]. Accordingly, your firm’s frozen, vacuum-packaged fish products appear to be adulterated in that the products 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: 4th Edition (the Hazard Guide) through links in FDA’s home page at www.fda.gov. FDA recently published a 4th Edition of the Hazard Guide. This new version of the Hazard Guide can be found on our web site.
Based on our review of the inspectional findings and the June 15, 2011 response documents, we find that you have 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, none of your HACCP plans for your frozen, vacuum-packaged fish identify the food safety hazard Clostridium botulinum. Specifically,
a.       Your firm’s HACCP plan “Frozen Tuna CO Treatment” (i.e., including the original collected during the inspection and the revised page 16 of that plan provided in your corrective action response) fails to list the food safety hazard of Clostridium botulinum at the “Chilling” critical control point. As discussed during the inspection, this step creates a potential for Clostridium botulinum toxin formation because it is conducted under reduced oxygen (i.e., anaerobic) conditions.   In order to ensure that toxin does not develop under the reduced oxygen conditions, FDA recommends maintaining the products at or below 38°F (3.3°C) for the duration of the CO treatment.
b.      Your revised HACCP plan for “Frozen Tuna CO Treatment” (i.e., page 24 of the corrective action response) lists a critical limit at the “Packing & Labeling” critical control point as (b)(4).  While we acknowledge that you have provided instructions on the labels, FDA recommends that these label instructions include a warning statement such as “Important, keep frozen until used, thaw under refrigeration immediately before use”, rather than expressing this warning as an option to keep frozen or thaw under refrigeration (see page 282 of FDA’s 4th edition of the Fish and Fishery Products and Hazards and Controls Guidance document (Hazards Guide).
c.       All of your raw frozen fish products that are vacuum-packaged need to identify the hazard of Clostridium botulinum and include a critical control point for the label review to ensure that the labels have the warning statement (as mentioned above), “Important, keep frozen until used, thaw under refrigeration immediately before use”.  Your firm did not provide any revised plans, other than the two pages provided for the revised frozen CO treated tuna product. Your firm needs to include this hazard in all of your vacuum-packaged, raw frozen fish products.  
d.      All of your HACCP plans need to identify the hazard of undeclared allergens and include a labeling critical control point to ensure that the labels of the products declare the appropriate market names of the fish.
Please refer to Chapter 13 of the 4th Edition of the Hazard Guide for additional information on the hazard of Clostridium botulinum; and Chapter 19 for additional information on the hazard of undeclared major allergens.
2.      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 collected during the inspection for “Frozen Tuna” and “Frozen Tuna CO Treatment” list a critical limit at the “Receiving” critical control point as (b)(4) that is not adequate as a sensory evaluation strategy to control histamine.  The plans need to list that your firm will monitor to ensure that no more than 2.5% of the fish examined show decomposition (persistent and readily perceptible) in the lot, in addition to monitoring each fish for decomposition. We acknowledge that your firm includes this 2.5% limit as part of your corrective action plan in your HACCP plan; however, this needs to be included as a critical limit (see page 132 of the 4th Edition of the Hazard Guide).
3.      Because you chose to include corrective action plans in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for your “Frozen Tuna CO Treatment” are inadequate to control scombrotoxin (histamine) in the following:
a.       At the “Receiving Raw Material” critical control point, your firm’s HACCP plan includes a corrective action procedure associated with the fish temperature measurements that states, “If the temperature high but there is no decompose, re-iced and check histamine.” The listed criteria do not specify how many fish from a lot will be tested for histamine or what criteria will be used to ensure that no product that is either injurious to health or otherwise adulterated will enter commerce. 
b.      At the “Chilling” critical control point, your firm’s HACCP plan includes a corrective action procedure that states, “Check the temperature of product and check histamine.” Checking the temperatures of product following an excursion from the critical limits is not an adequate strategy. Because your firm has adopted a monitoring strategy that includes continuous monitoring of the chilling room, FDA recommends that your firm evaluate any time-temperature exposures of the chill room records to assess whether the time/temperature abuses were excessive and would result in a hazard. Alternatively, for histamine control, the Hazard Guide does include a recommendation for performing histamine analysis on a minimum of 60 fish and that firms destroy the lot or divert to a non-food use if any fish is found with histamine greater than or equal to 50 ppm (see page 147 of the 4th Edition of the Hazard Guide).   However, because the chilling step is also intended to prevent the hazard of Clostidium botulinum toxin formation in the fish under the anaerobic conditions of the CO treatment (as described in bullet 1.a. above), there is no sampling and/or testing that is considered safe and effective as a corrective action when there is a potential for time-temperature exposures conducive to toxin formation
In addition to the deviations discussed earlier in this letter, we also have additional concerns stemming from our review of the data and information provided in your June 15, 2011 response. These additional concerns are as follows:
1.      With regard to your monitoring procedures at the following critical control points:
a.       “Receiving Raw Material” critical control point:
Your firm’s response to our investigator’s observation on the FDA-483 related to sample collection for histamine testing indicates that your firm now recognizes the importance of collecting the histamine test samples from the lower anterior loins of the fish. However, the photographs of the histamine sample extraction from a fish depict a very small sample with no indication that the sample is being removed from the anterior portion, rather than the middle portion of the loin.
FDA recommends that, for histamine testing: 
-        A minimum of 250 grams of muscle from the lower anterior loin of each fish should be collected. Portions collected from other areas on the fish are far less likely to detect elevated histamine levels even in time-temperature abused fish.
-        The entire 250 gram sub-sample from each fish should be individually ground, even when compositing is to be conducted, and the test aliquot should be taken from this ground sample.
-        When compositing, a minimum of 100 grams from each of the individually ground sub-samples should be combined and homogenized before collecting the test aliquot from the composite sub-sample (see page 120 of the 4th Edition of the Hazard Guide).
In addition, our review of the histamine testing worksheets provided in your response reveals that some values exceeded the critical limit in your plan listed as (b)(4) for composited samples of fish. However, the worksheets did not clearly indicate whether the sample was a composite where results need to be less than (b)(4) or whether the sample reflected an individual fish where the critical limit listed in the plan is (b)(4). While the computer-generated analytical worksheet printouts include entry of a “Positive Cut-Off Value” of (b)(4) “Step 6,” it might be prudent for your analyst to declare that the analysis is being conducted on individual fish samples or composites somewhere in the record such as under “Other Notes” at “Step 1.”
b.      (b)(4) critical control point:
In response to our investigator’s observation on the FDA-483 related to the issue of butchering the unfrozen tuna following the CO treatment and the potential for exposure of the fish to unrefrigerated conditions conducive to scombrotoxin (histamine) formation, your firm added the (b)(4) critical control point to your HACCP plan for “Frozen Tuna CO Treatment”.  
The plan lists (b)(4) and the monitoring procedure indicates that your firm intends to check product temperatures with a digital thermometer (b)(4)      
FDA recommends that processors manage and control time and temperature of exposures throughout all processes to ensure that no product is subjected to cumulative time and temperature abuse throughout all the processing operations rather than spot checking product for temperature during processing.  Specifically, FDA recommends that scombrotoxin-forming fish and fish products (that have not been previously frozen) be limited to a maximum cumulative exposure of 8 hours at temperatures above 4.4 °C, as long as none of that exposure is at temperatures above 21°C (see pages 142 – 145 of the 4th Edition of the Hazard Guide).
2.      With regard to the possible need for additional critical control points in your HACCP plan for “Frozen Tuna CO Treatment” and possibly the “Frozen Tuna” products:
a.       Separate controls for primary processing activities versus secondary processing activities:
The “Receiving Raw Material” critical control point in your firm’s HACCP plan lists elements consistent with your firm acting as a primary processor receiving the fish directly from the harvest vessels. However, our investigator noted that tuna was received by truck where internal temperatures and sensory examinations of the fish took place. Unless your firm’s processing plant is a very short distance from the wharf whereby the time to off-load the fish from the vessels, load them onto trucks, and off-load the trucks is very brief, your firm may need two separate receiving critical control points, one at the wharf when receiving the fish from the vessels (primary processor responsibilities) and one at the processing plant when receiving from the trucks (secondary processor responsibilities). 
This same recommendation will apply to all of your frozen tuna products, since the receiving controls are expected to the identical. 
b.      Additional intermediate processing steps as critical control points:
According to your firm’s “Process Flow Chart,” the fresh fish are subjected to many processing steps (b)(4) following receipt of the raw fish at your facility up to the time of the start of the controlled “Chilling” step for refrigerated storage during the CO treatment. The “Process Flow Chart” then shows an additional (b)(4) unrefrigerated processing steps following the CO treatment “Chilling” critical control point up to freezing. Your firm’s “Hazard Analysis Worksheet” dismisses the need for a critical control point in your plan at most of these processes by stating “Properly controlled by GMP and SSOP, maintaining low temperature…” Although your firm included a butchering step in the revised HACCP plan, (b)(4) in response to the investigator’s observation that the tuna were exposed to unmonitored conditions outside of refrigeration) there appears to be numerous additional processing steps in your operations that are not controlled to prevent scombrotoxin (histamine) formation. 
Your firm should assess the cumulative time and temperature exposures for the tuna from the time the fish are off-loaded from the vessel or the truck, as applicable, to the time the lot of tuna is placed into the cold storage chilling room for the CO treatment, in addition to the cumulative time and temperature for the lot of tuna from the time the fish are first removed from the CO treatment “Chilling” storage to the time that the fish are all in the freezer. If the cumulative unrefrigerated exposure of a lot on both sides of the “Chilling” critical control point approaches the critical limit recommendation on page 142 of the 4th Edition of the Hazards Guide, additional critical control points to ensure safe processing of the fish may be warranted. If hazards are controlled by “maintaining low temperature,” the strategies for maintenance of the low temperature during processing may need to be included in the HACCP plan with appropriate critical control points, critical limits, monitoring procedures, etc.  
To better document and assess the cumulative maximum exposure and the need for controls, it is advantageous for a processor to show the maximum time and temperatures of exposures at temperatures above 4.4 °C for the fish at each processing step or through sequential processing steps within its hazard analysis worksheet.
These same recommendations may apply to all of your frozen tuna products when there are multiple processing steps involved prior to final freezing.
3.      With regard to the use of the continuous monitoring procedures and evidence of exceeding the critical limits:
a.       Your firm indicated that it has implemented a continuous time-temperature data logger at the “Chilling” CO operation, in order to address the investigator’s observation that your firm had not been implementing its listed monitoring procedures. However, the evidence submitted suggests that your firm is not using the data to properly ensure that the critical limit is met.  In the records provided in the FDA-483 response associated with the second part of the first FDA-483 item, your firm appears to have elected one-hour recording intervals. FDA does not recommend this extended time period between recordings. More frequent recording increments would assist your firm in refining and addressing problems in the chiller and increase assurance of control.
Additionally, we note that the record submitted with your response shows that your firm’s critical limit of (b)(4) was exceeded for each of the days recorded, (b)(4).  These exposures exceed the critical limits recommended for the control of scombrotoxin (histamine) formation in fresh (not previously frozen) fish, such as tuna. 
4.     (b)(4) HACCP plan:
Your firm’s (b)(4) HACCP plan appears to include scombrotoxin-forming (histamine forming) species because the plan lists the hazard of “histamine (for scombroidae species)” at receiving and includes histamine testing as a control strategy.  Thus, we interpret this plan to cover scombroidae species such as marlin and escolar. However, because many pelagic fish are not scombrotoxin-forming fish, your firm may have a difficult time in determining when to implement the critical limits and monitoring procedures associated with histamine and histamine testing for the scombroidae species at receipt. We suggest that you may want to draft a separate plan for the scombroidae species or include these species in the same plan for the tuna, since tuna poses the same scombrotoxin (histamine) hazard as all other scombrotoxin-forming species.   
5.      (b)(4) HACCP plan:
1.      During the inspection, our investigator observed that some of the fish covered under the (b)(4) HACCP plan were subject to ciguatera contamination and recommended the need for a control for ciguatera fish poisoning at the receiving critical control point. In your response, your firm acknowledged that you harvest fish within the latitudes known to produce toxic reefs. However, your firm dismissed the need for a critical control point by stating that you do not receive “fish from Indonesian water…contaminated with the Ciguatera toxin” and that testing of some unspecified fish samples by the Indonesian government for ciguatera had resulted in negative findings.
FDA has information to substantiate that the waters surrounding Indonesia are capable of introducing the ciguatera toxin hazard.  Additionally, the World Health Organization describes the Indian Ocean as having endemic toxic reef areas around parts of Indonesia. Consequently, your firm’s HACCP plan needs to list and control the ciguatera fish poisoning hazard at the “Raw Receiving Material” critical control point for those species included in the plan that are subject to the hazard, namely grouper and snapper, and possibly some of the other species. Please refer to pages 108 – 109 in the 4th Edition of the Hazard Guide for information on natural toxins. 
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 that would assist us in evaluating your corrections, such as a copy of any revised HACCP plans (i.e. please provide the HACCP plans in their entirety and not just the amended portions), 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. If you cannot complete all corrections within thirty (30) 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 [21 CFR Part 123] is Import Alert #16-120. This alert can be found on FDA’s web site at: http://www.accessdata.fda.gov/cms_ia/importalert_25.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 regulations, 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 via email at Mildred.Benjamin@fda.hhs.gov 
Michael Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition