Inspections, Compliance, Enforcement, and Criminal Investigations
Southeast Asian Packaging and Canning Limited. 5/15/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|5100 Paint Branch Parkway|
College Park, MD 20740
MAY 15, 2014
VIA EXPRESS DELIVERY
Southeast Asian Packaging and Canning Limited
233 Moo 4, Bangpoo Industrial Estate
Sukhumvit Road, Praksa
Muang Samut Prakan, Samutprakan
Reference No. # 423596
Dear Mr. Chomchanok:
In response to a request from the U.S. Food and Drug Administration, your firm Southeast Asian Packaging and Canning Limited (SEAPAC) provided your HACCP plan and supporting HACCP documentation via email on January 6, 2014. We have reviewed the HACCP documentation and have found that your firm's fish and fishery products are not in compliance with the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 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 pouch-packed tuna is adulterated, in that it 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 and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatorylnformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
Your significant deviations are as follows:
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(±) 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 "(b)(4)" does not list the food safety hazard of Staphylococcus aureus growth and toxin that can occur due to handling of the precooked fish before the product is retorted.
To prevent the hazard of Staphylococcus aureus growth and toxin formation during handling and when the product temperatures are (b)(4), FDA recommends limiting the time of exposure to no more than 3 hours from the start of handling the precooked fish (typically at the skinning step) until the cold spot of the tuna product in the pouches reaches 50 °C during the retort cycle.
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 "(b)(4)" does not list the critical control point or points for controlling the food safety hazard of scombrotoxin (histamine) formation during all holding or storage of your fresh tuna following receipt.
For example, your process flow diagram includes an "(b)(4)" step following the step entitled "(b)(4)." This raw material holding or storage (b)(4) step should be included in your HACCP plan as a critical control point with appropriate controls to ensure the fish are maintained at (b)(4). Alternatively, this step could be included as a critical control point that limits cumulative exposure times of the fresh fish to (b)(4) from the time the first fish of a lot is off-loaded from a harvest vessel until the last fish of the harvest vessel lot or batch is in the (b)(4). FDA recommends that, when the fish is fresh (not previously frozen), the time limitation in the latter scenario should not exceed 4 hours, cumulatively, when any of the ambient temperatures exceed 21 °C (see the critical limit deviation below). Any additional holding and storage steps should also be assessed via your hazard analysis for inclusion as critical control points to control scombrotoxin (histamine) formation for fish received fresh.
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 plan for "(b)(4)" does not list critical limits at the following critical control points that are adequate to control scombrotoxin (histamine) formation, as follows:
a. "CCP II: (b)(4)" critical control point.
i. Because your firm receives fresh (not previously frozen) fish, your critical limit permitting (b)(4) of exposure (b)(4) is not adequate to prevent scombrotoxin formation in the fresh fish. FDA recommends that fresh fish exposures should be limited to a maximum of 4 cumulative hours above 4.4 °C when any portion of that exposure includes ambient temperatures above 21 °C. Your records demonstrate that the exposure temperatures during this period routinely (b)(4) for at least a portion of the exposure period.
ii. The cumulative exposure time periods to (b)(4) included in your critical limit are not clearly defined and do not include all exposures outside of a controlled temperature environment. The critical limit states "(b)(4) " Because the time when (b)(4) begins can be interpreted very differently, and may not include time of exposure while the fish are being prepared, delivered, and staged for (b)(4), the control is inadequate. Moreover, as listed in your plan, the control does not ensure that all of the fish are in a precooker and the steam is turned on before the cumulative time for the batch has ended. The controls should list definitive points in time, such as the time when the first fish of the (b)(4) batch (or process batch for fresh fish) is removed from cold storage (i.e., the freezer or refrigerated/iced storage) until the last fish of the (b)(4) (or process) batch is placed in a precooker and the cooker steam is turned on.
b. "CCP IV: (b)(4)" critical control point.
i. The cumulative exposure period included in your critical limit is not clearly defined and does not include all exposures that could contribute to the accumulation of histamine in your final product.
The critical limit states "(b)(4)" The time of the "(b)(4)" can be interpreted very differently and is not an adequate control. The start of the timed control should be specific to a distinct, observable occurrence that would be recognized identically by every individual; for example, turning off of the steam to the precooker or opening of the door to the precooker after the cook.
In addition, while your listed monitoring procedures elaborate on the end of the control time as "(b)(4)" or "(b)(4)," these do not take into account additional time of incubation and histamine formation that may occur prior to the cold spot in the pouches reaching inhibitory (b)(4). This additional time, which can typically be ascertained from the low acid canned food heat penetration and process schedule determinations, should be calculated into the total cumulative time for this control.
Moreover, the critical limit and controls listed in the plan do not ensure that all of the fish from the precooker batch are in a retort before the cumulative time for the batch is calculated. The controls should list definitive points in time to include in the critical limit, for example, from the time when the doors of the precooker are opened (or when the steam to the precooker is turned off) until the cold spot of the tuna product in the pouches reaches (b)(4) cycle.
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 plan for "(b)(4)" does not list monitoring procedures at the following critical control points that are adequate to control scombrotoxin (histamine) formation:
a. The "CCP I: (b)(4)" critical control point includes monitoring procedures that do not list how many individual fish in a lot of (b)(4) your firm will monitor for internal temperature.
We note that your monitoring procedures reference document number (b)(4) that was not included with the documentation you submitted to us. If your sampling procedures and numbers of fish are included in the (b)(4) document, this document should be included in your HACCP plan package and the key elements of the protocol from this document should be included in your HACCP plan.
b. The "CCP III: (b)(4)" critical control point lists monitoring procedures to "(b)(4)" at a frequency of (b)(4); however, the procedure provides no direction as to which fish and where on each rack the measurements should best be taken in accordance with appropriate validation studies.
We note that your monitoring procedures reference document (b)(4) that was not included with the documentation you submitted to us. If the (b)(4) document provides clarification to these procedures, the document should be included in the HACCP plan package and the key elements of the protocol should be included in the HACCP plan.
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.
As part of your response, please include the following documentation:
• Your precooker validation studies, including precooker temperature distribution studies, heat penetration studies, statistical sampling design determinations based on the cook validation studies, and any other validation studies your firm used to establish your precooker monitoring procedures.
• Relative to receipt of fresh fish as a primary processor
o Information regarding the proximity of your processing plant to the location where the fresh fish are off-loaded from the harvest vessels
o A description of how the fish are transported or delivered to your processing facility or to cold storage, as well as from cold storage to your processing facility.
o Information related to how the fish are handled from cold storage to your processing facility.
o Describe at what point in time the temperature monitoring listed in your plan takes place, such as whether the internal monitoring is conducted as the fish are off-loaded from the harvest vessel or conducted after the fish have been in transit to your facility from the wharf where the fish were off-loaded.
• Monitoring records for receiving
• Your written protocol identifying the criteria used by your firm to categorize the fish as a reject due to decomposition at the receiving critical control point
• Protocols for your sensory training program listed in your verification procedures
Further, your firm includes references to what appear to be numbered documents or protocols at various places within the monitoring procedures of your HACCP plan. If these documents provide additional details related to your controls, you should include them in your submission and ensure that key elements of the documents are reflected in your HACCP plan.
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_ialialist.html.
In addition to the deviations noted above, we have the following additional comments:
1. Critical Limits
At the "CCP I: (b)(4)" CCP for the histamine testing component, your HACCP plan lists a critical limit of "Histamine content: (b)(4), in all fish in the analysis sample." When fish in a lot reach this level, the lot is typically out of control and broad ranges of histamine levels in the fish can be detected. Moreover, in an operation such as yours, when the fish received are subjected to further exposures at elevated temperatures for up to (b)(4) (for previously frozen fish), continued increases in histamine levels are unavoidable due to a pre-established presence of histamine-forming bacteria and/or enzymes in the fish due to the prior abuse. Therefore, a lower histamine critical limit level is recommended at this critical control point. Also, a correspondingly lower critical limit for composited samples should be included in the critical limits column when compositing is included as an option in the monitoring procedures.
Additional information can be found in the F AO/WHO Meeting Report on the Public Health Risks of Histamine and other Biogenic Amines from Fish and Fishery Products, 2013, and the associated FAO/WHO Histamine Sampling Tool. These can be found at the following Internet sites:
2. Monitoring Procedures
a. The monitoring frequency listed for the "CCP I: (b)(4)" critical control point lists "Every fish lot received (Lot size of similar fish: max. (b)(4))." It is not clear what is meant by "similar fish." FDA recommends that the sampling for temperatures, sensory examinations, and histamine analysis should all be specific to a harvest vessel and a single species at the receiving CCP. Portioning very large vessel deliveries into manageable (b)(4) is acceptable, but each "lot" should be a single species derived from a single harvest vessel.
Also, the manner of collecting the sample from the fish and preparation of the sample for histamine analysis is as important to meaningful controls as the analysis itself. Please provide an explanation or, if available, a copy of your written sample collection and sample preparation protocols for the histamine analyses.
b. At the "CCP III: (b)(4)" critical control point, your firm 's HACCP plan lists a critical limit to ensure the "(b)(4) of cooked fish after precooking must be at least (b)(4)." This is coupled with: 1) a monitoring procedure that measures the temperature of a sample of fish as the racks exit the cooker; and 2) a corrective action procedure to continue cooking the batch if the backbone temperatures do not meet the critical limit. This appears to not represent true process controls. If there are other control parameters your firm uses to ensure the proper heat delivery is applied to the fish that results in the target critical limit outcome, then those parameters of control should also be included in the HACCP plan monitoring procedures to provide greater assurances that every fish in the batch is likely to meet the (b)(4) target. Additional monitoring controls might include temperature-probed fish (largest in the batch) at known slow heating or cold spots within the cooker as determined by proper temperature distribution and heat penetration validation studies; and adherence to a specific process schedule that has been validated to deliver the appropriate heat for specified groups of fish sizes and species. The statistically-determined exit temperature sampling then becomes more of the confirmation of the effectiveness of each cook batch.
3. Corrective Actions
a. At the "CCP I: (b)(4)" critical control point
Your plan lists corrective actions for monitoring the internal temperature, histamine analysis, and sensory examination components of the critical control point that provide for rejection of the "lot" when the critical limit is exceeded. The corrective actions also provide instructions on further testing or handling of the lot as remedial action when the critical limit is exceeded which also, in some cases, can result in rejection of the lot. However, within your HACCP plan, you have defined a lot as a "(b)(4)." It is common for tuna packers to receive harvest vessel deliveries consisting of considerably more than (b)(4) of fish. When partitioning very large harvest vessel deliveries into smaller, more manageable "lot" quantities for sampling purposes, it does not change the purpose of the control measurements, i.e., to determine if the fish from the specific harvest vessel have been properly harvested, handled, and stored onboard, to ensure they are safe to accept for further processing. The sampling representation is very small in comparison to the size of the vessel delivery and in comparison to any particular (b)(4) "lot." Exceeding the critical limit for any one of the measurement parameters serves as a warning signal to a processor that the harvest vessel operators may not be taking appropriate care and preventative precautions with all of the fish.
It is possible that, after a thorough investigation of the harvest vessel operators' and/or the supplier's production records, a root cause for a critical limit deviation could be identified that would ensure the conditions that gave rise to the deviation were restricted to a certain distinguishable portion or portions of the harvest vessel delivery. For those circumstances, a processor could develop a corrective action plan that provides for the rejection of only the portions identified to have been adversely affected as determined by investigation and include appropriate confirmatory histamine testing of the remaining portions presumed to be safe.
b. At the "CCP II: (b)(4)" critical control point
Your firm's HACCP plan includes a corrective action procedure to "Hold the affected fmished product lot to check histamine for representatively collected from throughout the affect lot. Reject the lot if histamine result of finished product (b)(4) ppm." It is not clear if your firm conducts a second round of sampling and histamine analysis of the affected batch after the product is packed and retorted in addition to the in-process sampling and testing described earlier in your corrective action procedures. Because the fish of a thaw batch lose their identity throughout the cleaning and packing processes, it is difficult to establish appropriate assurances of safety by examining the finished packed product.
Even if the procedure was appropriate, your corrective action is not adequate because you do not specify the number of pouches that will be sampled and tested.
c. At the "CCP II: (b)(4)" and "CCP IV: (b)(4)" critical control points
Your firm 's HACCP plan includes an initial corrective action procedure to rush the fish through processing to avoid exceeding the critical limit time. This procedure may be appropriate in connection with an operating limit that identifies an in-process point and time when the batch must be expedited. However, because the procedure is intended to prevent a critical limit deviation, it is inappropriate since the critical limit deviation has already occurred.
d. At the "CCP III: Precooking" critical control point
Your firm's HACCP plan lists a corrective action instruction to "continue cooking the whole cooking batch" when the internal temperature critical limit isn't met. It is assumed that your corrective action entails reassembly of all of the racks of fish that were in that cook batch, including those racks that may have proceeded to the spray chilling operation, and placing them back into a cooker. This reassembly and reconfiguration of fish could potentially present challenges to the validation-based exit temperature sampling protocol and the level of temperature measuring should be more rigorous following a second cook.
Moreover, because the temperature of the fish from a deviating batch will have not definitively reached the target temperature to terminate histamine-forming bacteria and enzymes, the time that has elapsed, from the time when the precooker steam was initially turned on until the time when the steam is turned on for the following corrective action recooking of the fish, should be added to the total cumulative exposure associated with your "(b)(4)" CCP. If the added time results in (b)(4) cumulative (b)(4), then corrective action associated with CCP II should also be implemented.
e. At the "CCP IV: (b)(4)" critical control point:
Your firm's HACCP plan includes corrective action as "Hold the affect [sic] precooked fish batch to check histamine ... " The listed instruction does not describe what to "hold' the affected product means, e.g., in what state or in what condition. This holding of the fish when prior to the retorts could potentially lead to additional scombrotoxin (histamine) formation for fish that had already been subjected to excessive exposure times. The delay to reach inhibitory temperatures within the retort could permit additional histamine formation, as well as growth and toxin formation by Staphylococcus aureus.
Moreover, because the full effect of the bacterial activity will not be realized until the processing is complete, the affected tuna product will be in final packaged retorted form. The fish product will no longer be in the form of individually identifiable fish and the meat from different parts of the fish and from different fish may be comingled in any single pouch, and the meat from any particularly scombrotoxic fish may be packed in several pouches. As such, your listed corrective action procedure to test a "(b)(4)" no longer has any meaning. In order to assess the affected precook batch for histamine, only a very intense statistically valid sampling and testing of affected finished product pouches would be appropriate. Alternatively, the affected batch should be destroyed or converted to a non-food use.
We suggest that one way to minimize losses due to a critical limit time deviation at this processing step could be to modify the definition of the lot for this critical control point from "every precooking batch" to every precooking rack or trolley. This may be feasible because, while all of the racks from any particular precooker batch have the same start time for the CCP control, the racks may enter the cleaning process at slightly different times and the last fish product from any particular precooker rack may be completely packed and started within a retort before product from other racks from the same precooker batch are completed. In such a case, not all of the racks from the same precooker batch might exceed the critical time limit and only the product from the affected racks need be subject to corrective action.
Further, your firm's HACCP plan also includes a corrective action procedure to "Hold the affected finished product lot to check histamine for representatively collected from throughout the affect lot. Reject the lot if histamine result of finished product (b)(4)." It is not clear whether your firm intended to conduct two phases of sampling and histamine analysis of the affected precooker batch. Nonetheless, for the reasons stated above, adequate sampling of the finished product to ensure the product is safe is problematic and difficult. This element of your corrective action procedure does not specify the number of pouches that will be sampled and tested. Again, this sampling and testing of finished product would not be adequate or appropriate without statistically sound sampling and testing criteria and protocols which your plan does not include.
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 Food and Drug Administration, Attention: Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 51 00 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: email@example.com.
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