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  5. MAY YU MARINE PRODUCTS CO. LTD - 494183 - 05/09/2016
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WARNING LETTER

MAY YU MARINE PRODUCTS CO. LTD MARCS-CMS 494183 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Daw Soe Yu Maw
Recipient Title
Q.A Manager
MAY YU MARINE PRODUCTS CO. LTD

No.525, May Yu Street, Zone- (1)
South Dagon Industrial Zone
Yangon, 11181
Myanmar (Burma)

Issuing Office:
Center for Food Safety and Applied Nutrition

5001 Campus Drive
College Park, MD 20740-3835
United States


WARNING LETTER
Reference No.# 494183

Dear Daw Soe Yu Maw,

On December 9-14, 2015, a representative of the United States Food and Drug Administration (FDA) collected a copy of your firm 's HACCP plan for "vacuum packed frozen fresh water fish" and "vacuum packed head-on frozen shrimp" during an inspection of South Asian Food Inc., an importer of fish and fishery products located at 56-27 56th Drive, Maspeth, NY 11378, U.S.A. That importer was found to be importing frozen hilsa product from your processing facility. We have conducted an assessment of that plan to determine your firm's compliance with the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Titled 21, Code of Federal Regulations, Part 123 (21 CPR 123). Upon further review of that HACCP plan we find that your firm is in serious violation of the Federal Food, Drug, and Cosmetic Act (the Act).

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 21 CFR 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 vacuum packed frozen fresh fish and vacuum packed head-on frozen shrimp 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.

We found the following significant deviations:

1. You must conduct or have conducted for you 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 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 plans for vacuum packed frozen fresh water fish and vacuum packed head-on frozen shrimp do not list the food safety hazards of Clostridium botulinum toxin formation and aquaculture drugs.

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 vacuum packed frozen fresh water fish does not list the critical control point of unrefrigerated processing for controlling the food safety hazard of scombrotoxin (histamine) formation. FDA recommends that during processing (e.g., butchering, cleaning, brining, salting, smoking, drying, fermenting, pickling, mixing, fermenting, stuffing, packing, labeling, and staging) of scombrotoxin-forming fish ( e.g., hilsa) that have not been previously frozen or heat processed sufficiently to destroy scombrotoxin-forming bacteria:

a. 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

b. 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)

Unless you have a critical control point for storage prior to processing, unrefrigerated processing begins when the first fish is removed from the truck at receiving until the last fish is placed in the freezer. If you have a critical control point for storage prior to processing, unrefrigerated processing begins when the first fish in a marked batch is removed from storage until the last fish, or product, from the marked batch is placed in the freezer.

In addition, your firm's HACCP plan for vacuum packed head-on frozen shrimp does not list the critical control point of "(b)(4)" for controlling food safety hazard of undeclared sulfiting agents. FDA recommends that, if you are controlling undeclared sulfiting agents based on a review of suppliers' certificates, all finished product packages must bear a label that contains a sulfiting agent declaration unless they are processed from raw materials that are accompanied by a supplier's lot-by-lot certificate that states that no sulfiting agents were used.

3. Your HACCP plan must, at a minimum, list the critical limits that must be met, to comply with 21 CPR 123.6(c)(3). A critical limit is defined in 21 CPR 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 Ian for vacuum packed frozen fresh water fish lists critical limits, at the "(b)(4)" critical control point, that are not adequate to control the food safety hazard of scombrotoxin (histamine) formation. To ensure that appropriate harvesting and onboard practices were used onboard the harvest vessel, or at the fish farm (if applicable), FDA recommends that your firm's HACCP plan lists critical limits for:

a. Harvest Vessel Records or Histamine Testing.

    • For Harvest Vessel Records, FDA recommends:

        o 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:

                -  The fish were stored at or below 40°F (4.4°C) after cooling;

            OR

            -  The fish were stored completely and continuously surrounded by ice after cooling.

• For Histamine Testing, FDA recommends:

    o Analysis of a representative sample of scombrotoxin-forming fish shows less than 50 ppm histamine in all fish in the sample.

AND

b. Sensory examination.

• Sensory examination of a representative sample of scombrotoxin-forming fish shows decomposition (persistent and readily perceptible) in less than 2.5% of the fish in the sample. For example, no more than 2 fish in a sample of 118 fish may show signs of decomposition. Note that the FFD&C Act prohibits interstate commerce of any decomposed fish whether or not the HACCP critical limit has been exceeded.

AND

c. The internal temperature of a representative number of the largest fish in the lot, at the time of off-loading from the harvest vessel by the processor.

• 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 (l 5.6°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 on board 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.

To ensure that appropriate transportation-handling practices were used during transit from the harvest vessel, or fish farm (if applicable), to the processing plant, to control scombrotoxin (histamine) formation, FDA recommends that:

a. For fish delivered refrigerated (not frozen):

• All lots received are accompanied by transportation records that show that the fish were held at or below an ambient or internal temperature of 40°F (4.4 °C) throughout transit. Note that allowance for routine refrigeration defrost cycles may be necessary;

OR

b. For fish delivered under ice:

• Fish are completely surrounded by ice at the time of delivery;

OR

c. For fish delivered under ice on an open-bed truck:

• Fish are stored completely surrounded by ice;

AND

• The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;

OR

d. For fish delivered under chemical cooling media such as gel packs:

• There is an adequate quantity of cooling media that remain frozen to have maintained product at an internal temperature of 40°F (4.4°C) or below throughout transit;

AND

• The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;

OR

e. For fish delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less (optional control strategy):

• Time of transit does not exceed 4 hours;

AND

• Internal temperature of the fish at the time of delivery does not exceed 40°F (4.4°C).

4. Because your firm chose to include a corrective action plan in your HACCP plan, the described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your firm's corrective action plan for vacuum packed frozen fresh water fish, at the "(b)(4)" critical control point, to control for the food safety hazard of scombrotoxin (histamine) formation, is not appropriate. Specifically, your firm's corrective action plan does not ensure that the cause of deviation is corrected. FDA recommends that, in addition to rejecting the lot, you discontinue use of the supplier or carrier until evidence is obtained that the identified transportation-handling practices have been improved.

The above-identified deviations are not intended to be an all-inclusive list of deficiencies 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.

In addition, we have the following comment: It is not clear whether your HACCP plan for Frozen Fresh Water Fish Whole/Gutted is intended to cover the frozen sea water fish. If it is intended to cover the frozen sea water fish, your firm's HACCP plan does not list the food safety hazard natural toxins ( e.g., Ciguatera toxin). If it is not intended to cover the frozen sea water fish, please provide a copy of your HACCP plan for frozen sea water fish.

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 imported fish or fishery products under Section 80l(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/ems_ia/ialist.html.

Please send your reply to U.S. Food and Drug Administration, Attention: Philip Bermel, 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. Please identify your response with CMS #494183. You may send any questions you may have regarding this letter to Philip.Bermel@fda.hhs.gov.

Sincerely,

/S/

William A. Correll
Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition