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WARNING LETTER

PT Tritunggal Lintas Benua


Recipient:
PT Tritunggal Lintas Benua


United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

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

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

 

WARNING LETTER
JUL 26, 2016 
 
VIA EXPRESS DELIVERY
 
 
Frendy Samuel Leimena, Director
PT Tritunggal Lintas Benua
S No. 50 Jln. Muara Karang
A 5; UTARA
Jakarta, Jabotabek
Indonesia
 
Reference No. # 499102
 
Dear Mr. Leimena:
 
In response to a request by a representative of the United States Food and Drug Administration (FDA) on May 4, 2016, for a copy of your firm’s HACCP plan for the tuna products your firm imports into the United States, your firm provided a HACCP plan entitled “Frozen Tuna Product” as well as a procedure document, a flow diagram and samples of monitoring records associated with the HACCP plan on May 9, 2016.
 
Our review of the HACCP plan (copy attached) revealed that the plan demonstrates serious deviations from the requirements of the seafood HACCP regulation.
 
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 fish products covered by your HACCP plan entitled “Frozen Tuna Product” that includes Yellowfin Tuna loin, saku, steak, and cubes 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 FDA’s 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.  
 
 
 
We found the following significant deviations:
 
1.    You must conduct or have conducted a hazard analysis for each kind of fish and fishery product produced 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 HACCP plan entitled “Frozen Tuna Product” does not list the food safety hazard of Clostridium botulinum growth and toxin formation. Review of your procedure document revealed two steps entitled “(b)(4)” and “(b)(4)” that are further described as placing the fish in a (b)(4) and (b)(4) prior to storing the (b)(4) at (b)(4) temperatures of (b)(4). Holding fresh fish in impermeable packages under reduced oxygen, creates an anaerobic condition conducive to Clostridium botulinum toxin formation. FDA recommends that you establish controls in your HACCP plan for the “(b)(4)” and “(b)(4)” steps to ensure the in-process product that has been (b)(4) and where the oxygen has been evacuated out is held at a cooler temperature of less than 38°F (3.3°C) for the entire duration of the treatment. FDA also recommends that you establish controls to ensure that all finished product labels contain a statement to advise “keep frozen” (e.g., “Important, keep frozen until used, thaw under refrigeration immediately before use”).
 
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 HACCP plan entitled “Frozen Tuna Product” does not list the critical control points of raw material storage, in-process storage and unrefrigerated processing for controlling the food safety hazard of scombrotoxin (histamine) formation. Once your firm has included these as critical control points, FDA recommends that the following critical limits be established at these critical control points:
 
a.  For raw material, in-process product, or finished product storage, when fish are stored under ice, that the fish are completely and continuously surrounded by ice throughout the storage time.
b.  For raw material, in-process product, or finished product storage, when fish are stored under refrigeration that the fish are held at a cooler temperature of 40°F (4.4°C) or below.
c.  During processing (e.g., butchering, cleaning, incubating, smoking, packing, labeling, and staging) of scombrotoxin-forming fish that have not been previously frozen or heat processed sufficiently to destroy scombrotoxin-forming bacteria:
  • The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 4 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C);
OR
  • The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 8 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C).
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 entitled “Frozen Tuna Product” lists critical limits, at the “Receiving” critical control point that are not adequate to control the food safety hazard of scombrotoxin (histamine) formation. Specifically, your HACCP plan does not list critical limits for decomposition; harvest vessel records or histamine testing (i.e., firms only need to implement one strategy, either the harvest vessel record strategy or the histamine testing strategy); and internal temperature monitoring of a representative number of the largest fish in the lot, at the time of off-loading from the harvest vessel to ensure that the fish were properly handled onboard the harvest vessel.
 
a.  For sensory (decomposition) examination FDA recommends:
  • Sensory examination of a representative sample of scombrotoxin-forming fish to ensure that there is less than 2.5% decomposition (persistent and readily perceptible) in the fish in the sample. For example, no more than 2 fish in a sample of 118 fish may show signs of decomposition. ;
b.  For harvest vessel records, FDA recommends that all scombrotoxin-forming fish lots received are accompanied by harvest vessel records that show:
  • Fish exposed to air or water temperatures above 83°F (28.3°C) were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not longer than 6 hours from the time of death;
OR
  • Fish exposed to air and water temperatures of 83°F (28.3°C) or less were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not longer than 9 hours from the time of death;
OR
  • Fish that were gilled and gutted before chilling were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not longer than 12 hours from the time of death;
OR
  • Fish that were harvested under conditions that expose dead fish to harvest waters of 65°F (18.3°C) or less for 24 hours or less were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not more than the time limits listed above, with the time period starting when the fish left the 65°F (18.3°) or less environment;
OR
  • Other critical limits for onboard handling (e.g., maximum refrigerated brine or seawater temperature, maximum fish size, maximum fish to brine/seawater/ ice ratio, maximum initial temperature of the fish) necessary to achieve a cooling rate that will prevent development of an unsafe level of histamine in the specific species, as established through a scientific study.
AND
  • For fish held refrigerated (not frozen) onboard the vessel:
o   The fish were stored at or below 40°F (4.4°C) after cooling;
 
OR
 
o   The fish were stored completely and continuously surrounded by ice after cooling.
 
c.  For histamine testing, FDA recommends:
  • Analysis of a representative sample of scombrotoxin-forming fish that show less than 50 ppm histamine in all fish in the sample.
d.  For the internal temperature monitoring of a representative number of the largest fish in the lot, at the time of off-loading from the harvest vessel by the processor, FDA recommends:
  • For fish held iced or refrigerated (not frozen) onboard the vessel 24 or more hours after death:
o   The internal temperature should be 40°F (4.4°C) or below;
 
OR
  • For fish held iced or refrigerated (not frozen) onboard the vessel from 15 to less than 24 hours after death:
o   The internal temperature should be 50°F (10°C) or below;
 
OR
  • For fish held iced or refrigerated (not frozen) onboard the vessel from 12 to less than 15 hours after death:
o   The internal temperature should be 60°F (15.6°C) or below;
 
OR
  • For fish held iced or refrigerated (not frozen) onboard the vessel less than 12 hours after death:
o   The internal temperature should be sufficiently below water and air temperatures to indicate that appropriate chilling methods were implemented onboard the harvest vessel. Chilling of the fish should begin on the harvest vessel regardless of the time from death until off-loading from the vessel by the processor, unless the environmental conditions (e.g. air and water temperatures) are below 40°F (4.4°C) from the time of death until off-loading from the vessel by the processor;
 
OR
  • For fish held iced or refrigerated (not frozen) onboard the vessel:
o   Elapsed time from death and internal temperatures at the time of off-loading from the vessel by the processor should be consistent with cooling curves that will prevent development of an unsafe level of histamine in the specific species, as established through a scientific study.
 
You should respond in writing within fifteen (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.
 
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 frozen tuna 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 the U.S. Food and Drug Administration, Attention: Brandon Bridgman, Compliance Officer, Food Adulteration Assessment Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-607, 5001 Campus Drive, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: brandon.bridgman@fda.hhs.gov. Please reference CMS# 499102 on any submissions and within the subject line of any emails to us. You may also contact Brandon Bridgman via email if you have any questions about this letter. 
 
 
Sincerely,
/S/ 
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition