Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
AUG 12, 2015
VIA EXPRESS DELIVERY
Alejandro A. Chaljub Velasco, Director General
Procesamiento Especializado De Alimentos S.A.P.I. De C.V.
Calle Marina Azul #1
Col. Puerto Chiapas
Mexico CP 30830
Reference No. 469864
Dear Mr. Chaljub Velasco:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, Procesamiento Especializado De Alimentos S.A.P.I. De C.V., located at Calle Marina Azul #1, Col. Puerto Chiapas, Tapachula, Chiapas, Mexico CP 30830, on April 4 to 6, 2015. During that inspection, we found that you had serious deviations from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR 108)), Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113), and the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA 483, Inspectional Observations, listing the observations made at your firm.
We acknowledge receipt of your response to the FDA 483, sent via email on April 21, 2015. Your response included a written procedure labeled as “(b)(4),” heat penetration data, and an Audit Corrective Action Plan. There was no revised HACCP plan included in your response. Review of your March 16, 2015, HACCP plan entitled “Atun en Pouch, revision 6” collected during the inspection, and other documentation, revealed the response was not adequate, as further described in this letter.
As a manufacturer of LACF products intended for export to the United States, you are required to comply with the Food, Drug and Cosmetic Act (the Act) and the federal regulations relating to the processing of low-acid foods packaged in hermetically sealed containers. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for thermally processed low-acid foods packaged in hermetically sealed containers whenever a processor has failed to fulfill the requirements of 21 CFR 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR Parts 113. Regulations specific to the processing of LACF products are described in 21 CFR 108 and 21 CFR 113. As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.35 and 21 CFR 113 could be subjected to an immediate application of the emergency permit control provisions of Section 404 of the Act (21 U.S.C. § 344). As stated in 21 CFR 108.35(k), for imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. § 381) when offered for entry into the United States. Violation of the mandatory requirements set forth in 21 CFR 108.35 and 21 CFR 113 renders your LACF products adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4).
Furthermore, 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 pouched tuna products 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. Your firm failed to chlorinate as necessary the container cooling water used in your cooling canals and recirculated water supplies as required by 21 CFR 113.60(b). Specifically, our inspection revealed that your firm does not use chlorine or other sanitizer and considered the recirculation of the cooling water through a heat exchange to be sufficient.
Your response includes a description of a chlorine residual testing procedure and photographs of testing equipment; however, you did not provide actual completed processing records that show the implementation of this new procedure.
2. Your firm failed to record observations of visual closure examinations performed by a qualified person to ensure proper closure as required by 21 CFR 113.60(a). Specifically, observations of visual seam closure examinations which occur immediately after the pouches are sealed are not recorded for your LACF products.
Your response indicates that these examinations are performed later and recorded at that time; our inspection revealed similar examinations are performed after retort and the observations are recorded, however, any time such examinations are performed the observations must be recorded to comply with 21 CFR 113.60(a).
3. Your firm failed to examine the pouch container closures in appropriate detail of your LACF tuna pouches to ensure proper closing machine performance and consistently reliable hermetic seal production as required by 21 CFR 113.60(a)(3). Specifically, you conduct and document container closure examinations of LACF products packed in pouches for only the bottom seal and not the sides or top seal.
Your firm’s response states that your firm will perform inspections on all seams of your pouches by May 15, 2015; however, you did not include examples of completed records that demonstrate you have implemented the examinations and recording of the examinations during production of your LACF products.
Seafood HACCP 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, your firm does not have a written HACCP plan for pouched tuna product to control the food safety hazards of:
a. Staphylococcus aureus growth and toxin formation, specifically, the inspection of your facility revealed that your firm manually (b)(4). The Process Flow Chart in your HACCP manual, Page 9, suggests the exposures following the contact with employees at the skinning and cleaning operations until reaching the retorts can take (b)(4). The explanations of these operations in the Process Description section, on Pages 13-15 of your HACCP manual, suggest these operations (b)(4). These exposures may be conducive to S. aureus growth and toxin formation. Retorting will not destroy the toxin once formed. To prevent the hazard of S. aureus growth and toxin formation in your pouched tuna product, your HACCP plan should identify the hazard and include controls to limit the exposures of the tuna above 21 °C to less than 3 hours from the time the precooked fish are first handled at the skinning/cleaning operation until the packed product is placed in the retort, and the cold spot of the pouches reaches 50 °C.
b. Allergens, specifically, the inspection revealed that your pouched tuna contains major food allergens, i.e., tuna and soy. Because you package some tuna products with soy and some without, FDA recommends that firms visually examine each batch of labels at the “Packaging” processing step to ensure that the labels accurately declare the allergens in each of the final product labeling.
We acknowledge your response via email dated April 21, 2015, stating that you consider this deviation to not apply to your operation because your firm has a prerequisite program; however, we disagree with your interpretation of the guidance referenced. A prerequisite program may be sufficient to prevent the hazard of unintentional introduction of allergenic proteins; however, (b)(4). Therefore, control measures must be included in your HACCP plan to ensure the allergens are properly declared.
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 pouched tuna does not list a critical control point to control the food safety hazard of scombrotoxin (histamine) formation during unrefrigerated exposures of the many processing operations between the antechamber ((b)(4)) and the retort.
Specifically, our investigator observed that your firm performs processing steps under unrefrigerated conditions which cumulatively may lead to scombrotoxin (histamine) formation as a result of time and temperature abuse. These steps include for example, (b)(4). The Process Flow Chart included in your HACCP manual (page 9) suggests these exposures in excess of 21 °C could be for as long as (b)(4). In addition, the Process Descriptions in your HACCP manual (pages 12-15) suggest the total exposures could be more than 28 hours. FDA recommends that fish that have been previously frozen should not be exposed to ambient temperatures above 4.4°C for more than 12 hours, cumulatively, if any portion of that time is at temperatures above 21.1 °C.
We acknowledge your response via email dated April 21, 2015, stating that you consider this deviation to not apply to your operation because you believe that your established times comply with the recommendations established in FDA’s Fish and Fishery Products Hazards and Controls Guidance to control scombrotoxin formation. However,we disagree with your interpretation of the referenced guidance and its applicability to your operations.
Specifically, your firm has three groupings of process exposures for fish product moving between the antechamber and the retort in connection with the potential for scombrotoxin formation. In the first exposure group, fish are (b)(4) for the precookers. The second exposure group is while the fish are subjected to the (b)(4). And the third exposure group occurs when the fish exit the precooker and are exposed to (b)(4). To prevent scombrotoxin formation, FDA recommends a maximum of 12 hours of unrefrigerated exposure for previously frozen fish or fish that have been heat processed sufficiently to destroy scombrotoxin-forming bacteria.
According to your HACCP manual, the exposures between the antechamber to the precooker may be up (b)(4) depending on the information in your Process Flow Chart or your Process Description within your HACCP manual. While it is an acceptable scombrotoxin control approach to ensure the total cumulative exposure time between the frozen antechamber and the retorts (b)(4), the evidence within your HACCP manual suggests that this is not a realistic capability under your current operations which may take as many as (b)(4), and may result in scombrotoxin formation in your product.
An alternative approach is to ensure proper controls to prevent scombrotoxin formation at each of the three exposure groups:
a) The time from when the first fish of a thaw batch is removed from the frozen antechamber until the last fish of the thaw batch is within a precooker and the steam is turned on does not exceed 12 hours;
b) Controls are in place to ensure that the precooker delivers sufficient heat to bring the cold spot of every fish in the precooker up to a minimum temperature of 60 °C (in essence, to terminate scombrotoxin-forming microbial activity due to the previous exposure and to take advantage of a renewed exposure timeframe following the precooker); and
c) The time from when the precooker doors are opened until the last fish product of the precooker batch is cooled, cleaned, packed, placed in a retort and the cold spot of the pouches achieves 60 °C or higher does not exceed 12 hours.
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 HACCP plan lists “(b)(4)” as a critical limit at the “(b)(4)” CCP 1 that is inadequate to control histamine formation. Properly handled fresh frozen fish should not contain more than 15 ppm histamine. Fishery products containing histamine in excess of (b)(4) histamine are adulterated due to decomposition. It takes significant time and temperature abuse to initiate sufficient bacterial growth and enzyme production to achieve (b)(4) ppm histamine in the fish. Your process exposes the fish to unrefrigerated processing steps following receipt, which will result in increased histamine content in some fish to be greater than (b)(4). A (b)(4) histamine receiving control is not appropriate for your operation.
4. Pre-determined corrective action plans, when included in a HACCP plan must be appropriate, to comply with 21 CFR 123.7(b). However, the listed corrective action procedures for both the histamine testing and the sensory examination control components fail to ensure that the cause of a critical limit deviation is corrected in accordance with 21 CFR 123.7(b)(2).
FDA requests your response to the following concerns to better understand your HACCP program.
- Your HACCP plan has a potential problem with the listing of the receiving critical control point listed as “(b)(4).” Section 4.1, on Page 10 of your HACCP manual suggests that your firm receives only frozen fish. However, as listed, the CCP in your HACCP plan does not limit reception to frozen fish. If fresh fish were to be received, the controls listed in your HACCP plan at receiving, and the appropriate time limits to process the fish outside of refrigeration, would need to be very different than for frozen fish. You should clarify the CCP as the “(b)(4).”
- For the “sensorial evaluation” control component at the “(b)(4)” CCP in your HACCP plan, the critical limit listed “(b)(4) do not comply with the sensory evaluation.” This critical limit is typically adequate when the sample size to which it is based is (b)(4). FDA recommends a minimum of 118 fish for sensory evaluation by the primary processor as a scombrotoxin control at receiving. Because your listed monitoring procedures do not specify the number of samples to be collected or define a “batch,” it is unclear if the “(b)(4)” is an appropriate critical limit or if (b)(4) is an appropriate sample size for your operations.
- Your HACCP plan includes a critical limit of “Operating time of no greater than 4 hours” at the “Reception of whole fish” CCP 1. This time restriction appears to be intended to limit the time between removing the fish from frozen storage on the harvest vessel until the fish are placed back into frozen storage at the processing plant. This exposure, with ambient temperatures (b)(4), could permit considerable warming of the surfaces of exposed fish. It is not only the deep core internal temperatures of the fish that your firm needs to be concerned about to prevent scombrotoxin formation. If there is any enzyme already formed in the fish, which is likely when the fish already (b)(4) histamine, any defrosting that may begin to occur in regions of the fish that contain enzyme will be conducive to enzyme activity that could form additional histamine. The affected fish do not have to fully thaw before additional histamine begins to form in the presence of the enzyme. Your firm may want to investigate the exposure effects on the fish and reassess the amount of exposure time to which the fish will be permitted to be subjected between the two frozen storage points.
- The monitoring procedures for histamine determination at receiving are not clear in CCP 1 for both the histamine testing and sensory examination control components of the “Reception of whole fish.” You reference procedural documents, i.e., “(b)(4)” for histamine analytical procedures, and “(b)(4)” for sensory procedures that are not identified in the listing of Contents within your HACCP manual. Your HACCP manual does not provide the necessary information for monitoring procedures such as sample sizes, manner of collection of samples, and analytical procedures.
a) Please provide the documents referenced in your HACCP plan, in addition to other explanations if necessary, outlining these elements as well as the location and size of the sample obtained from the fish for histamine testing and the sensory criteria your firm trains with and utilizes to assess the fish.
b) For both the histamine testing and sensory examination control components of the “(b)(4)” CCP 1 in your HACCP plan, your stated monitoring frequency is listed simply as “(b)(4).” This monitoring element is not sufficiently descriptive to ensure effective implementation of your HACCP plan. The “(b)(4)” should be definitively defined so that those implementing the plan clearly understand the application.
5. Your corrective action procedures listed at the Receiving CCP specifically,
a. For the histamine testing control component at the “Reception of whole fish” CCP 1 in your HACCP plan, the listed corrective action procedures include the previously explained ill-advised (b)(4) critical limit trigger and states that “(b)(4).” It is not clear what the “(b)(4)” is in relation to the monitoring procedure listing of a “(b)(4).” FDA’s recommendation for primary processors of scombrotoxin-forming fish to use histamine testing is so that the processor can make an inference about the harvesting, handling, and storage conditions applied by the vessel operators in relation to the fish in a specific harvest vessel delivery. Detection of fish with elevated histamine in the samples collected should serve as an alarm to the processor that the handling operations are not adequate onboard the vessel and the corrective action should be directed at the harvest vessel delivery.
b. For the sensory examination control component at the “(b)(4)” CCP 1 in your HACCP plan, the listed corrective action procedures rely on a (b)(4) histamine trigger, which is too high for your application. It also refers to action related to the undefined “(b)(4),” which is unclear. Because the controls are intended to provide the processor with information about the harvest vessel operations, and because evidence of decomposed fish signal inappropriate time and temperature exposure controls at the vessel level, a sensory critical limit deviation should invoke corrective action on the entire harvest vessel delivery, which is not clear in your HACCP plan.
6. Your HACCP plan lists a monitoring frequency of “Continue” at the “X-rays” CCP 4 to control the hazard of metal, which does not specifically state whether every finished product pouch is monitored. This might be better detailed in the referenced monitoring procedure document “(b)(4)” but it is not included in the HACCP manual provided to FDA.
Also, item 4 of your listed verification procedures states that “a lure detection verification must be performed” “at the start, (b)(4).” Verification that the x-ray equipment is properly operating by the use of checks with calibration standards should also be conducted at the end of operations to ensure that all of the product passed through the equipment since the last verification check were also exposed to a properly operating detector.
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. Responding in English will help to assist us in our review of your documentation.
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 LACF 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. An example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the LACF and acidified food regulations (21 CFR 108, 113, and 114) is Import Alert #99-38, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods due to Inadequate Process Control. You may view these alerts at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
Additionally, Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
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 the U.S. Food and Drug Administration, Attention: Catherine Vieweg, Compliance Officer, Food Adulteration Assessment Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Catherine.Vieweg@fda.hhs.gov. Please reference #469864 on any submissions and within the subject line of any emails to us. You may also contact Catherine Vieweg via email if you have any questions about this letter.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition