Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
SEP 4, 2014
VIA EMAIL AND EXPRESS DELIVERY
Ana Marie Costa
Senior Manager, Corporate Quality Assurance
Los Esteros Manta
Reference # 432107
Dear Ms. Costa:
In response to a request from the U.S. Food and Drug Administration, your firm StarKist (Ecuador) provided your Hazard Analysis and Critical Control Point (HACCP)) plan and supporting HACCP documentation via email on May 13, 2014, for your canned, pouch packed and frozen loin tuna products. Our evaluation of that HACCP plan and supporting documentation revealed serious deviations from the requirements of the seafood Hazard Analysis 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 tuna products (canned, pouched packed and frozen loins) 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 the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on 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/GuidanceRegulation/GuidanceDocumentsRegulatoryinformation/Seafood/ucm2018426.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(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 "Canned, Pouch Tuna and Frozen Tuna Loins" does not list the food safety hazard of metal inclusion. In your Hazard Analysis you acknowledge that "metal particle could end up on finish product" and state that the "presence of metal is controlled through inspection and control procedures," but you fail to include the hazard or appropriate controls for the hazard in your HACCP plan.
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 plan for "Canned, Pouch Tuna and Frozen Tuna Loins" lists critical limits at the following critical control points that are inadequate to control the identified hazards:
a. At the "(b)(4)... " ("CCP 4A") critical control point, your critical limits are inadequate to control the hazard of scombrotoxin formation because the time limits do not take into consideration all temperature exposures that may contribute to cumulative abuse of the fishery product. Specifically, you list a (b)(4)." Neither of these scenarios considers the time lag for continued incubation that may occur prior to the fish product in the final packages (i.e., cans, pouches, or bags) reaching inhibitory conditions of (b)(4) in the cold spot for the retorted product or (b)(4) in the warm spot for the frozen loin packages. Your firm should develop procedures to include the total time exposure to unrefrigerated (i.e., ambient) conditions until all products have achieved temperatures that will control and prevent further histamine formation in the packaged tuna products.
b. At the "(b)(4)... " ("CCP 4B") critical control point your critical limits are inadequate to control the hazard of Staphylococcus aureus toxin formation because the time limits do not take into consideration all temperature exposures that may contribute to toxin formation in the fishery product. Specifically, you list a (b)(4) from first handling of the fish in the precook batch until: (b)(4) Neither of these scenarios considers continued incubation time that may occur prior to the fish product in the final packages (i.e., cans, pouches, or bags) reaching inhibitory conditions of (b)(4) in the cold spot for the retorted products or (b)(4) in the warm spot of the packages for the frozen loin product. Your firm should develop procedures to include the total time exposure to unrefrigerated (ambient) conditions until all products have achieved temperatures that will control and prevent Staphylococcus aureus growth and toxin formation in the packaged tuna products.
For both items referenced above, the time references "the start of the freezing process" in relation to processing of the frozen loin product. It is unclear what "the start of the freezing process refers to," and this does not provide a specific observable point in time to be measured.
3. 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 adequate monitoring procedures at the "(b)(4)" ("CCP 1") critical control point to control scombrotoxin (histamine) formation.
Specifically, you list a histamine sampling and testing control strategy to control the hazard of scombrotoxin formation at receiving of harvest vessel deliveries of fish; however, your strategy does not provide adequate assurances that the fish accepted at receipt are safe for processing. Your firm collects only (b)(4) for histamine testing to represent (b)(4) of incoming fish. There is nothing in your operations to mitigate histamine once you accept a lot of fish; therefore, it is vital that your procedures are adequate to detect elevated histamine in the incoming lots of fish.
In addition, we note from the information provided that your firm combines all light meat species of tuna into one group for purposes of sampling and testing. FDA recommends that each species is sampled and tested individually.
4. Corrective action plans when included in HACCP plans must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans included in your "(b)(4)" plan are inadequate at the following critical control points to control the identified hazards:
a. At the "(b)(4)... " ("CCP 4A") critical control point, the corrective action plan is not adequate to prevent product that poses a risk for the hazard of scombrotoxin (histamine) from entering commerce. Specifically, you list a corrective action procedure to "(b)(4)" and "analyze for histamine." However, your procedures do not state how much of the finished product will be tested to ensure none of the time/temperature abused product contains elevated histamine. Your procedures should include, for example, the parameters for sampling and testing, and any additional parameters your firm uses in making a decision on final disposition of the affected product.
b. At the "(b)(4)... " ("CCP 4B") critical control point, the corrective action plan is not adequate to prevent product that poses a risk for the hazard of Staphylococcus aureus toxin formation from entering commerce. Specifically, you list a corrective action procedure to "(b)(4)" for the "(b)(4)" when the critical time limit is exceeded. Your procedures do not state how the product will be sampled or tested to ensure none of the time/temperature abused product contains toxin. Your procedures should include, for example, the parameters for sampling and testing, and any additional parameters your firm uses in making a decision on final disposition of the affected.
You should respond in writing within 15 working days from your receipt ofthis 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 ofthe 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 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 also have the following questions and comments about your HACCP plan and other documentation.
1. Histamine Sampling Location
At your "(b)(4)" ("CCP 1 ") critical control point, you include instructions for where on the fish a sample should be taken for histamine analysis. Your documents describe this as taking a portion of fish from both sides of each fish tested; however, your sampling strategy does not include the amount offish to be collected and does not ensure that a representative sample offish is collected. For example, FDA recommends that a minimum 250 gram sample is collected from smaller fish. The suggested order of sampling location preference is: 1) the lower anterior loin of one side of the fish; 2) the upper anterior loin of the same side of the fish; 3) the lower mid-section loin of the same side of the fish. When the fish are so small that these 3 sections do not yield 250 grams, a second fish should be included in the sample following the same sampling location order.
2. Sensory Information at Receiving
At your "(b)(4)" ("CCP 1 ") critical control point, you list the collection of (b)(4)"lot" for sensory evaluation. The HACCP monitoring records that you provided on June 3, 2014, do not appear to reflect that (b)(4) are collected.
We also have questions related to the "(b)(4)" records you provided, as follows:
a. The records include singular sensory assessments with check marks for odor characteristics in the viscera and belly of the fish. It is unclear whether these singular characterizations represent the worst fish in the lot or the average fish or something else, or how the record documents the true condition observed in the lot.
b. The records include three predetermined categories for representing characteristic odors of the viscera and belly flap. The characteristics listed are very limited and ineffective for the intended purpose of identifying any fish in the lot with sensory attributes of decomposition.
c. The records appear to include the number of "(b)(4)" or fish examined at the butchering step; however, this number does not appear to always equate to the poundage of fish in the lot examined as shown on the "(b)(4)" record. For example, on the Sensory Evaluation record for fish from well A62 off-loaded from the (b)(4) and examined on February 16, 2014, your record shows (b)(4), an average of (b)(4) fish. However, the Chemical Analysis record for this well suggests all of the fish examined were (b)(4) or more, which would yield only (b)(4) if all were (b)(4) each.
Please provide an explanation, or a written protocol, of the sensory criteria (including sensory descriptors if applicable) used by your firm to assess deliveries of fish when implementing CCP 1 of your HACCP plan. Please clearly identify the criteria that
results in a rejection of a fish. Please provide evidence that your firm is, in fact, conducting sensory on a (b)(4) in each lot. Also, please provide an explanation, or a written protocol, that your firm uses to train the employees conducting the sensory analyses. If there is a separate worksheet showing the sensory evaluation of each fish rather than this summary record, please include representatives of those records as well.
3. Corrective Action Procedures at Receiving
At the "(b)(4)" ("CCP 1 ") critical control point, the corrective action procedures listed, even when taken together, may not be adequate in preventing your firm from accepting time or temperature abused fish at delivery.
a. Histamine Testing Corrective Actions
Your firm includes a corrective action provision to increase the level of histamine sampling from (b)(4) after a critical limit deviation (elevated histamine detected in the delivery) only "if trip history is not available or does not support a conclusion that other lots from vessel are unaffected." Trip history documentation does not provide sufficient information to isolate problem fish within a delivery without confirmation sampling and testing of portions believed to not have been affected. Moreover, the corrective action provision places too much emphasis on limited sampling when evidence has signaled that the delivery contains abused fish and there is no evidence showing that the problem fish are restricted to any given portion of the delivery. An increased sampling scheme would be more effective to show that the affected fish are likely restricted within the delivery.
Your firm relies further on very limited sampling by including a corrective action procedure that only doubles the amount of sampling for only two additional deliveries from a supplier that has delivered mishandled and abused fish in the past. Your listed procedures to scrutinize only two additional deliveries following a rejected delivery does not ensure a permanent and committed change in harvesting and handling practices by the supplier.
b. Sensory/Decomposition Examination Corrective Actions
Your firm's corrective actions to be taken when your critical limits for sensory analysis of decomposition have been exceeded do not ensure that your firm will prevent distribution of potentially adulterated products from the affected harvest vessel. For example, exceeding the critical limit for decomposition should result in rejection of the entire delivery or increased sampling of all lots within that harvest vessel's delivery to ensure the abuse did not result in elevated histamine. The entire delivery should not be subject to histamine testing only after both decomposition and elevated histamine have been detected in the delivery; it is more appropriate to reject the delivery at that point. All lots should also be 100% examined for decomposition when the critical limit for decomposition is exceeded but when elevated histamine is not detected in the additional sampling.
More specifically, the purpose of the sampling and testing is to make an overall assessment of all of the fish from the vessel's delivery. If decomposition is detected in any sample from any portion, it should signal to the processor that the vessel's delivery contains abused fish. Therefore, the corrective action should be directed at the entire vessel, not just the portion in which the critical limit deviation was detected.
4. Conflicting Elements at the "Thawing, Butchering and Precook Staging" critical control point
In the information you provided, you included a summary table as one of the three parts of your plan. However, the summary table is not consistent with other information you provided.
At the "(b)(4)" ("CCP 2") critical control point, the summary table lists a critical limit as a time control, specifically as no more than (b)(4) for "Time of product exposure from the time the first fish of the thaw batch exits the freezer, (through thawing, butchering, precook staging) to the time the last fish of the thaw batch start precook process (steam on)." However, the text portion in the plan at this same critical control point refers to a temperature control; specifically, that "exposure time offish to ambient (b)(4)." Further, you should be concerned about any exposure (b)(4), not just the exposure above (b)(4).
Also, your HACCP plan summary table at the "(b)(4)" ("CCP 2") critical control point includes critical limits and monitoring procedures that signal the start of the controlled timing when the first fish of the process batch is (b)(4). However, the text portion of the plan includes statements in the "Overview" that "the thawing cycle starts" ... only after the fish are (b)(4). Please clarify.
5. Listed Precooker Controls
Your "(b)(4)" ("CCP 3") critical control point relies on the internal temperature of (b)(4) precooker rack at the end ofthe cook to ensure either that all of the fish in the cooker reached a (b)(4) or to determine if the fish need to be further cooked.
FDA requests copies of your validation studies that demonstrate that 3 measurements per rack provides reliable control regardless of the number of racks in the cooker or the manner in which the cooker is operated. Please include information such as
applicable temperature distribution trials, heat penetration trials, and statistical assessments to support your procedure.
The listed corrective action procedures for CCP3 instruct that precooker batches that don't meet the temperature critical limits are to be placed back in the cooker and further cooked. This process raises concerns as it suggests that the fish may not have been subjected to the targeted inhibitory heat as early in the process as intended. Because the control for CCP 2 is dependent on the fish having been subject to heat to deliver the (b)(4) internal temperatures to the fish, and because that will not have been accomplished in the corrective action scenario listed in your plan, the corrective actions should also account for the additional overall CCP 2-related exposure times until the corrective action precook is re-initiated. If the critical time limit to CCP 2 is exceeded as a consequence of failing to meet the initial CCP 3 critical limit, then the corrective actions for CCP 2 should also be implemented.
Finally, the monitoring procedure listed in your HACCP summary table to measure "(b)(4)" is not consistent with the text of the plan, which states to measure "(b)(4)." FDA recommends that measuring 3 of the largest fish per rack is more appropriate.
6. Finished Product Labeling Controls
At your "(b)(4)" ("CCP 5") critical control point, your listed corrective action procedures include "Open and Re-pack Pouch product" when the incorrect label had been affixed. Your corrective action plan should consider the hazard of Staphylococcus aureus toxin formation during reworking of such product, e.g., extension of the time lapse associated with CCP 4A when the pouches had not yet been retorted or renewing the exposure monitoring for batches of reworked product that may have already been retorted beginning with opening of the first pouch of the rework batch.
Please explain the correlation between the raw material lot test results identified by vessel and well in the "(b)(4)" reports and the lots identified by vessel but no apparent well in the Raw Material Process Control reports.
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, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 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 firstname.lastname@example.org.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition