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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Mommy Gina Tuna Resources (MGTR), Inc 12/4/13


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

Public Health Service
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20742 

December 4, 2013                                                                                                                                        

Ebenezer C. Bustamante
Mommy Gina Tuna Resources (MGTR), Inc.
MGTR Compound, Tambler
General Santos City, 9500 Philippines
Reference No. 415189
Dear Mr. Bustamante:
In response to a request by the United States Food and Drug Administration (FDA) for a copy of your firm’s Hazard Analysis and Critical Control Points (HACCP) plan for the fish and fishery products your firm imports into the United States, your firm provided a HACCP plan entitled “Frozen CO-Treated Yellowfin Tuna, Blue Marlin and Mahi Mahi Finished Products as standard cut Loins, Fillets, Steaks, Pieces, Ground Meat and Portions” along with a product description, process flow diagram, and corresponding monitoring records in emails dated July 24, 2013.
Our review of that HACCP plan (copy attached) and associated documentation revealed serious deviations from the requirements of the seafood 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 frozen vacuum packaged yellowfin tuna, blue marlin and mahi mahi 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 Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov. The Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
Your significant deviations are as follows:
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.” However, your firm’s HACCP plan for “(b)(4)” does not list the following critical control points for controlling the food safety hazard of scombrotoxin (histamine) formation.
a.    Your process flow lists “(b)(4),” which suggests that the fish are transported from the port to the plant. Consequently, when receiving the fish at the plant, controls are necessary to ensure that the fish were transported in a manner to prevent the formation of histamine from the port to the plant.
b.    Your process flow lists “(b)(4),” which appears to be a fish storage step. FDA recommends that firms include all storage periods as critical control points to ensure proper temperature control to prevent the hazard of scombrotoxin (histamine) formation; for example maintaining the fish at proper refrigeration temperatures, and maintaining proper icing of fish during storage.
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 “(b)(4)” lists a critical limit that is not adequate to control scombrotoxin (histamine) formation.
Your critical limit at the “Inspection & Receipt of Fish at Fish Port, CCP 1a” critical control point states “less than 3 decomposed fish (persistent and readily perceptible) in a 118-fish sample” for sensory examination. However, based on your monitoring records and procedures, you are receiving lots that are smaller than 118 fish. FDA recommends that sensory examination of a representative sample of scombrotoxin-forming fish show decomposition in less than 2.5% of the fish in the sample; and FDA recommends conducting a sensory evaluation on all fish when lots contain less than 118 fish. Therefore, when the lot contains less than 118 fish, your firm should be conducting a sensory evaluation on all of the fish in each lot, and should ensure no more than one fish in a sample of 79 fish, and no fish in a sample of 39 fish show signs of decomposition.
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)” list monitoring procedures and frequencies at the “Process steps (b)(4)” critical control point that are not adequate to control scombrotoxin (histamine) formation or pathogen growth (a hazard identified at this critical control point).
Your monitoring procedure for scombrotoxin (histamine) formation indicates that you will monitor the ambient temperature and track the (b)(4); and your monitoring procedure for pathogen growth indicates that you will check the internal temperature of marked product moving through the processing lines and track the exposure time of one fish (b)(4). Your process of monitoring ambient temperature and internal temperature of product does not take into account product described as being returned for reprocessing. According to your process flow, some of your products may be returned to a previous processing step for reprocessing; for example, when the product requires more carbon monoxide treatment. In order to ensure that all of the fish are processed within the applicable critical limits for exposure time, FDA recommends that you monitor the exposure time of every lot or in batches, beginning when the first fish in the lot or batch is removed from storage (i.e., “(b)(4)”) and ending when the last finished product from the lot or batch is sent to freezing, including any portions of time when product is returned for reprocessing.

4.    You must implement the monitoring procedures that you have listed in your HACCP plan to comply with 21 CFR 123.6(b). However, review of your monitoring records revealed that your firm did not follow the monitoring procedures at the “(b)(4)” critical control point to control scombrotoxin (histamine) formation or pathogen growth as listed in your HACCP plan for “(b)(4).”
Your monitoring procedures in your HACCP plan list “Temperature checking using (b)(4) to control scombrotoxin (histamine) formation. Your procedures also list “(b)(4)” and “(b)(4)” for one fish (b)(4) to control pathogen growth. However, based on our review of your monitoring records, you did not monitor (record) the ambient temperature, the internal temperature, or exposure time during the processing steps “(b)(4).”
Additional Comments:
Your HACCP plan for “(b)(4)” lists the critical control point “(b)(4),” which encompasses another critical control point “(b)(4)”, and where each lists various time and temperature parameters. You may wish to clarify that these are separate critical control points, for example by renaming the processing critical control point to “(b)(4),” to more accurately reflect your operation and to ensure that the critical limits for the exposure time and temperature parameters are met.
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 or plans, five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan or plans, 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 applicable laws and regulations. Submission of the information in English will assist in our review. 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 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_ia/ialist.html
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act 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:  Sheena Crutchfield, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Sheena Crutchfield via email at sheena.crutchfield@fda.hhs.gov.
William A. Correll, Jr.
Acting Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition