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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pesnusan Cia Ltda 10/22/10

  

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

Public Health Service
Food and Drug Administration
 

College Park, MD

WARNING LETTER

October 22, 2010

VIA OVERNIGHT DELIVERY

Mr. Nerio Nunex (Santana)
President
Pesnusan Cia Ltda.
KM 7.5 Via Manta Montecristi
Manta, Ecuador


Re: I.D. # 125370


Dear Mr. Nunex:

The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility Pesnusan Cia Ltda., located at KM 7.5 Via Manta Montecristi, Manta, Ecuador on May 10 - 11, 2020.  In response to a request by the United States Food and Drug Administration for a copy of your firm’s HACCP plan and supporting documents, including monitoring records, for your fish and fishery products, your firm responded by email on May 20, 2010 with the requested documents.  Our evaluation of your HACCP plan 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 scombrotoxin-forming fish, such as your Fresh Fish HG, Fresh Cuts and Frozen Cuts, 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 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." 

• Your firm’s revised HACCP plan for Fresh Fish HG does not list the critical control point of “Storage Before Loading on Trucks” for controlling the food safety hazards of pathogen growth and toxin formation or scombrotoxin formation.

In the absence of monitored controls during this period, pathogens are a hazard of concern in the fish intended for raw consumption.  The (b)(4)  storage timeframe is at the maximum recommended critical limit for several pathogens, and beyond the 2-hour recommended critical limit for Vibrio parahaemolyticus for exposures above 21 °C; (temperatures above 21 °C should be assumed in the absence of monitored controls).  Additionally, your firm identifies a  (b)(4) exposure to uncontrolled conditions during the “Cleaning/Trimming” operation and another (b)(4)exposure to uncontrolled conditions during the “Weighing” operation (revised HACCP plan, page 22).  Consequently, from the time the fish are off-loaded from the trucks at the processing plant to the time the fish are loaded onto distribution trucks represents a cumulative (b)(4) of uncontrolled unmonitored exposure.  This represents a potential hazard for pathogen growth and toxin formation as well as scombrotoxin formation.

• Your firm’s HACCP plan for Fresh Fish HG does not list the critical control point of “Transportation By Truck” for controlling the food safety hazards of pathogen growth and toxin formation and scombrotoxin formation. Specifically, your firm states that “it is a (b)(4) transport time to the plant” after off-loading the fish from the harvest vessels “at Port or Beach.”  Because your firm receives fish directly from the harvest vessels, but also has a transportation operation involved in moving the fish from the wharf to the processing facility, your firm has both primary and secondary processor responsibilities.  However, your firm’s HACCP plan addresses only the primary processor types of controls, i.e. histamine testing, sensory examination, and internal temperatures.

In addition, your firm does not include or address the transportation operation from the wharf to the processing facility in your hazard analysis.  The process described by your firm for off-loading boats, transit in unrefrigerated trucks, and off-loading trucks may take much longer than the actual transit time itself.  You should consider the full length of exposure from the time the first fish is off-loaded from ice in the boat and placed on the truck, until the time that the last fish of the truck load is off-loaded and taken into the plant, as the total exposure time of concern for the processing step in its hazard analysis to determine if monitored controls are appropriate. 

Furthermore, the internal temperature measurement control recommended by FDA as a component of the primary processor controls is intended to provide a general indicator of safe handling onboard the vessel.  This measurement loses its intended purpose as a primary processor control when the measurement is taken after the fish have been off-loaded from the vessels, re-iced, and transported to the processing facility.  While histamine analyses and sensory examinations for decomposition can be delayed until the fish are received at the processing facility, the internal temperature measurement component of the primary processor controls should be conducted as the fish are off-loaded from the vessel. 

• Your firm’s HACCP plan for Fresh Cuts does not list the critical control point of “TTI Application” for controlling the food safety hazard of Clostridium botulinum growth and toxin formation.  Specifically, your firm introduces the hazard of Clostridium botulinum growth and toxin formation by vacuum packaging the raw, refrigerated cut fish products intended for raw consumption.  When this occurs, FDA recommends precautions in addition to refrigeration to ensure the safety of the fish through distribution and to consumers.  Your firm should include Time Temperature Integrators (TTIs) on each package of vacuum, packaged, raw, refrigerated fish manufactured.  FDA recommends that the application of the TTIs and appropriate verifications of the functionality of the TTIs selected, should be incorporated into your HACCP plan as a CCP consistent with the introduction of the hazard, i.e. during packaging. 

2. You must have a HACCP plan that, at a minimum,  lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4).  However, your firm’s revised HACCP plan for Fresh Fish HG, Fresh Cuts and Frozen Cuts lists a monitoring procedure frequency at the “Receiving” critical control point that is not adequate to control scombrotoxin formation.

• Your firm’s HACCP plan for Fresh Fish HG, Fresh Cuts and Frozen Cuts lists a monitoring procedure associated with the histamine critical limit element  that states “histamine reconfirmed with (b)(4) for the “How” component, which is inadequate.  Monitoring (b)(4) does not ensure that each batch or group of fish will meet the listed critical limits.  In addition,  (b)(4) criteria does not correspond with the procedures listed under the “Frequency” component of the plan which calls for testing (b)(4) per group”, since “per group” would appear to apply to each batch at receipt. The (b)(4) testing in the “How” is more closely associated with a verification procedure than a monitoring procedure and is, in fact, repeated in the verification procedures of your firm’s plan.  This leaves the “How” component of the plan non-established and inadequate.

In addition, your firm’s HACCP plan for Fresh fish HG, Fresh Cuts and Frozen Cuts lists only “histamine…analytical  test” as the monitoring procedure for the “How” component associated with the histamine critical limit element at the “Receiving” critical control point.  The listed procedures should identify the specific test method validated by your firm to be implemented as a control.  While inspecting your firm in May 2010, the investigator noted that your firm used a (b)(4) for your histamine testing.  The kit you are using is not adequate for the intended HACCP purpose.

Moreover, your firm’s practices for collecting samples for histamine testing that was observed during the inspection at the “Receiving” critical control point are not adequate.  The investigator observed that your firm collected the muscle portions for histamine testing from the removed heads of selected fish.  The sample will not provide the processor with an opportunity to detect histamine in time-temperature abused fish except in the most egregious situations and is inappropriate for HACCP purposes.  FDA recommends collection of a minimum of 250 grams of muscle from the lower anterior loin of each fish to be tested for histamine.  The entire 250 grams should be ground and the test aliquot should be obtained from the ground portion of each fish to be tested.

The monitoring procedures listed for the hazards of “Temperature” and “Decomposition” at the Receiving critical control point state “Probe of sample” for the “How” component.  The specific temperature measuring device to be used should be identified in the HACCP plan.  In addition, the monitoring for decomposition by a “probe” suggests the use of some type of instrumental device rather than sensory examinations and should be further described.

• Your firm’s revised HACCP plan for Fresh Fish HG, Fresh Cuts and Frozen Cuts lists a monitoring procedure at the “Storage of fresh fish” critical control point that is not adequate to control pathogen growth and toxin formation or scombrotoxin (histamine) formation.  The “How” component of the listed monitoring procedures calls for “Visual” monitoring of the temperature without specifying the temperature measuring device to be used while the “Frequency” of the monitoring is listed in your plan as (b)(4).

3. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b).  However, it was observed during the inspection that your firm did not follow the monitoring procedure/frequency of “Each piece” at your “Receiving” critical control point to control scombrotoxin (histamine) formation listed in your HACCP plans for Fresh Fish HG, Fresh Cuts and Frozen Cuts in effect at the time of our inspection.

Only (b)(4)  were examined for decomposition for lots of tuna and dorado that ranged from (b)(4)  in the lot despite a HACCP plan in effect at the time that called for evaluation of “each piece.”  In the cover memo of your response to the FDA 483, dated May 20, 2010, your firm did not specifically address the failure to implement your HACCP plan as written.  The implementation of the HACCP plan as required is an important step in ensuring a safe product and the protection of consumers.

4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b).  However, it was observed during the inspection that your firm did not monitor maintenance of hand washing, hand sanitizing, and toilet facilities with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by the absence of hot water at the hand washing stations.

5. 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.” 

• Your firm’s HACCP plan for Fresh Fish HG, Fresh Cuts and Frozen Cuts lists a critical limit (b)(4)  at “Receiving” critical control point that is not adequate to control scombrotoxin formation, listed in your HACCP plan with the hazard of “Decomposition.” The criteria listed, without elaboration, do not establish a meaningful minimum or maximum value that must be met to control the hazard and is inadequate.  The numerical designations of (b)(4) does not represent an adequate critical limit without descriptors or an explanation of the numerical assessment identified somewhere in the HACCP plan.

Moreover, for example the critical limit listed in your firm’s “Summary HACCP…” plan (revised HACCP plan for Fresh HG , page 24) does not specify the amount of decomposition in a lot or sample that would trigger a corrective action.  FDA recommends a critical limit of less than 2.5% decomposition in a representative sample.  A sample with 2.5% or more decomposed fish should result in a corrective action to the lot.  While your “Critical Control Point Worksheet…” describes a limit at the “Receiving” CCP of “no evidence of decomposition” (revised HACCP plan, page 25), which could be interpreted as resulting in a corrective action if decomposition is detected in any single fish, this doesn’t convey into your “Summary HACCP…” plan on page 24.

FDA recommends monitoring lots for decomposition as an indicator of time-temperature abuse in the fish from a vessel lot that could alert the processor to the possibility of conditions that could have permitted scombrotoxin formation.  Scombrotoxin (histamine) formation is the actual hazard of concern, not the decomposition itself as reflected in your revised HACCP plans. 

• Your firm’s revised HACCP plan for Fresh Fish HG, Fresh Cuts and Frozen Cuts lists a critical limit ,(b)(4) “Receiving” critical control point to control that is not adequate to control the hazard of scombrotoxin (histamine) formation.  The plans should specify that the limits are applicable to all fish in the sample.  While your “Critical Control Point Worksheet…” describes a limit at the “Receiving” CCP of “Histamine level in all samples (b)(4) (revised HACCP plan for Fresh HG, page 25), this doesn’t convey to your Summary Fresh HG HACCP plan on page 24.  And, the “Critical Control Point Worksheet…” doesn’t clarify if the maximum temperature limit pertains to all fish measured or something else. 
  
Also, the temperature critical limit should specify to what the temperature criteria is applicable, e.g. the internal temperature of the fish. And, it should also be noted that the hazard of concern is scombrotoxin (histamine) formation, not “Temperature.”

6. Predetermined corrective action plans included in your HACCP, to be taken whenever there is a deviation from a critical limit, must be appropriate, to comply with 21 CFR 123.7(b). 

• Your corrective action plan for Fresh Fish HG, Fresh Cuts and Frozen Cuts at the “Receiving” critical control point to control scombrotoxin formation is not appropriate.

Your HACCP plans lists the following inappropriate corrective action procedures:

1.) (b)(4)
2.) (b)(4)
3.) (b)(4)
4.) (b)(4)

The listed procedures above do not specify what “further evaluations” are expected to be done on the fish following the critical limit deviations and the type of re-sampling intended is not specified.  In most situations, it is inappropriate to dismiss previous findings that caused the critical limit to be exceeded simply by conducting additional testing of the same type. 

It is also not an appropriate corrective action to reject or discard individual fish or “pieces” that exceeded the critical limit in the sample that are intended to represent the safety of the entire lot.  This means that your firm will assume the remainder of the lot is safe.  In each case, the sample provides only an indicator to the processor that the fish in the lot may have been mishandled and are unsafe which should invoke an appropriate corrective action on the entire lot.  Scombrotoxin cannot be reliably culled from a lot simply on the basis of temperature measurements or sensory examinations of the fish.

Moreover, taking actions to lower the temperature of the fish in a lot that has not met the temperature critical limit is not appropriate because it will not mitigate the opportunity for any scombrotoxin (histamine) to have formed during the period of elevated temperatures.  Additionally, none of the listed corrective action elements at the Receiving CCP ensure that the cause of the critical limit deviation is corrected as required. 

• Your corrective action plan for Cut Fresh Fish at the “Storage of fresh fish” critical control point to control the hazards of pathogen growth and toxin formation and scombrotoxin formation is not appropriate.

Your corrective action plans lists a corrective action of (b)(4).  However, your firm should recognize that doing so will not mitigate any pathogens, toxins, or scombrotoxin that may have been permitted to form during the period of exposure wherein the cooler temperature controls were lost.  In addition, it is not apparent from the floor plan provided by your firm during the May 2010 inspection, that you have more than one cooler unit.

Defaulting to reliance on the “product temperature” at the time the loss of cold storage control is discovered, or worse, after fish have already been placed in another functioning cooler, to meaningfully determine if the exposed fish are safe is an unreliable correction.

Temperature measurements at a single point in time provide information of temperature of the object at that point in time only.  The point measurement does not provide a history of the temperature of the fish previously and is an unreliable indicator of whether the conditions resulting in the loss of storage control could have resulted in pathogen growth and toxin formation or the formation of scombrotoxin in the fish.

Measuring the “product temperature,” even selectively of those fish presumed to be most susceptible to the time-temperature abuse nearer to the surface of containers within the storage unit, does not provide assurances of safe fish.  Even if exposures to warming is an uninterrupted continuum, the deep core temperatures of fish, especially in the large fish, can predictably be cooler than edible muscle portions nearer to the surface of the exposed fish which can undergo more significant abuse and bacterial activity and which will likely also be consumed if the fish are permitted to continue in commerce. 

Conversely, should you intend to measure surface temperatures of the fish where warming might be presumed to be most severely manifested when cooling controls were lost, the measure could again be misleading.  Should the cooler be unstable and oscillate in temperature, the surfaces of the fish may be cooler than deeper muscle at the time of the measurements.  A surface measurement could be all the more deceiving if the product were to undergo further chilling from the surface inward when placed in an alternate functioning cooler prior to making the measurements, as reflected in your revised HACCP plan.

The concerns above make it logistically extremely difficult to meaningfully select and perform sufficient temperature measurements within different regions of individual fish, within sufficient numbers of fish, within different lots, within different areas of the cooler unit, prior to affecting the temperatures with re-chilling in a colder environment.  And even with that, assessing the inference of those measurements as to their representation of other fish within the lots within the affected cooler, to reliably ensure pathogen growth and toxin formation or scombrotoxin formation had not occurred in any of the fish distributed into commerce, would be a significant risk at best.  These factors can be all the more complicated if different species of different sizes and different lots of fish had varying residence times within the cooler. 

(b)(4) can be feasible if the (b)(4) means assessing the cumulative time-temperature exposures of the fish during the cold storage temperature critical limit deviation.  However, as stated above, your firm does not have reliable continuous monitoring data of the cooler over time from which to make a safe evaluation of the exposures.  In addition, FDA requests that you identify the specific parameters you intend to use to deem the fish to be safe during the listed (b)(4).

Because there is no actual sampling indicated for this CCP in your firm’s revised HACCP plan, it is not clear what you intend to (b)(4) as a component of the listed corrective action.  Re-measuring temperatures of the cooler or the product following the critical limit deviation and dismissing prior measurements is not an appropriate corrective action if that is what was intended by the (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.  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 issues:

1. On page 17 of your revised HACCP plan, a summary description is given of the harvesting practices of the vessels from which your firm receives its fish.  Your firm describes longline vessels “at sea from (b)(4) with fish “caught on smaller boats” called “lancheros.”  It is not made clear if the larger boats simply act as collection vessels for the lancheros or if the larger boats are actually longliners themselves.  In addition, your firm states that the “company owns and operates its own fishing vessels” in your hazard analysis, while conflicting information was obtained during the inspection to suggest that your firm owns only one fishing boat and purchases a majority of its fish from other suppliers.  Your firm should more clearly explain the harvesting operations and practices of each of the vessel types from which it receives fish.

Your firm describes the harvest operations as “fish are gutted on board the smaller boats and later transferred to the large boat, where they are…iced in the hold” (page 17 of your revised HACCP plan).  (Note that page 15 of your revised HACCP plan provides conflicting information stating “fish gutted…on board mother [vessel].”)  The explanation also states that “all vessels have ice on board.”  It is critical for scombrotoxin control that fish are chilled soon after death.  Longlining operations often delay chilling from the time the fish die because some of the fish can die in the sea prior to being landed in the boat.  The longer the longline and the soak time, the greater the risk of scombrotoxin formation while the fish lie dead in the sea prior to chilling on the vessels.  Your firm makes it clear that the fish are iced on the larger collection vessels but does not make it clear that the fish are iced on the lancheros.  Instead, the description suggests that the fish may not be iced until transferred to the larger vessels.  This is an inadequate practice for control of scombrotoxin formation.  Your firm’s explanation of the harvesting operations should address these aspects in more detail, including the length of longlines used by the boats, the total length of time from beginning of deployment of the longlines until the end of the haul back of the line from each set, the number of sets fished by each lanchero before delivering the fish to the larger vessel, and the holding practices of the fish while on the lancheros and on the collection vessel. 

2. Because each lanchero can introduce different conditions of exposures to the fish it harvests, your firm, as the processor should make an assessment of the fish coming from each lanchero, not from a comingled lot of fish on the larger collection vessel representing the catches of several lancheros.  Your firm’s revised HACCP plan refers to the testing of fish “per group” for histamine and “per lot” for decomposition.  It is not clear what your firm considers to be a “group” or a “lot” in context of the fish you receive from the harvest vessels (or larger collection vessels) or, as it appears, from the transport trucks that deliver the fish to your firm.  Your firm’s summary states that the fish are “tagged” when “transferred to the large boat” (page 17 of your firm’s revised HACCP plan).  Your firm should describe the information available on the fish tags and how the information is used to evaluate the scombrotoxin hazard in the fish received from the vessels or trucks. 

The receiving controls recommended by FDA for primary processors to prevent the hazard of scombrotoxin formation are intended to give primary processors sufficient consideration of the safety of fish received from each harvest vessel.  If the fish from harvest vessels become comingled on the “mother” boat or on the trucks that deliver the fish to the processing plant, the controls recommended are minimized and may no longer be adequate. 

Your firm should also recognize that FDA’s recommendations for sampling at receiving for histamine and sensory evaluations are both advised as minimum sample numbers, not maximum sample numbers as reflected in your firm’s HACCP plan.  And both types of testing are generally recommended to be applied to each species from the vessel, not to the entire vessel lot of mixed species.  Nonetheless, if the vessels off-loaded contain only small numbers of mixed species of scombrotoxin-forming species, it is acceptable to sample and analyze a cross representation of species.  And if the number of fish in the vessel lot is fewer than the maximum to be examined in the HACCP plan criteria, then all of the fish in the lot should be examined.  The revisions in the HACCP plan related to identifying the number of fish to be examined are a good step toward addressing the deficiency identified during the May 2010 inspection but should be refined.

Please send your reply to the Food and Drug Administration, Attention:  Dwayne Johnson, 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 Mr. Johnson by phone at (301) 436-1782 or via email at Dwayne.Johnson@fda.hhs.gov.  

 

Sincerely,

/s/

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


 

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