CLOSEOUT LETTER

Ba Hai Company Limited MARCS-CMS 517525 — March 21, 2017

Delivery Method:: Electronic Mail

Recipient:: Recipient Name

Hong V. Le; Ba Hai Company Limited; Lot A9, A11 Hoa Hiep Industrial Zone
Dong Hoa District
Phu Yen Province 00057
Vietnam

Issuing Office:: Center for Food Safety and Applied Nutrition; United States

5001 Campus Drive
College Park, MD 20740

WARNING LETTER

MAR 21, 2017

VIA EXPRESS DELIVERY

Hong V. Le, Owner

Ba Hai Company Limited

Lot A9, A11 Hoa Hiep Industrial Zone

Dong Hoa District, VN-32 00057, Vietnam

Reference No. # 517525

Dear Mr. Le:

On October 13, 2016, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of a fish and fishery products importer located in the United States, Crystal Cove Seafood Corporation located in Floral Park, NY to assess that importer’s compliance with the United States’ Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123), referred to as the seafood HACCP regulation. That importer was found to be importing various fish and fishery products from your processing facility. During the inspection of that importer, we collected a copy of your firm’s HACCP plan for scombroid species of fish. Our evaluation of that HACCP plan (copy attached) revealed that this plan demonstrates 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 scombroid species of fish 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 4^th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.

The 4^th Edition of the Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm

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 for frozen scombroid species of fish does not list the food safety hazard of Clostridium botulinum toxin formation. Your firm is packaging the fish in an (b)(4) material which creates an environment conducive to Clostridium botulinum growth and toxin formation. FDA recommends that firms ensure all finished product labels contain a statement to “keep frozen” and also include “Important, keep frozen until used, thaw under refrigeration immediately before use” to control toxin formation in frozen products.

2. Your firm 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 for frozen scombroid species of fish does not list the critical control point of unrefrigerated processing for controlling the food safety hazard of scombrotoxin (i.e., histamine) formation. FDA recommends that during processing (e.g., butchering, cleaning, packing, labeling, and staging) of scombrotoxin forming fish that have not been previously frozen or heat processed sufficiently to destroy scombrotoxin forming bacteria prior to processing:

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);

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).

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 for scombroid species of fish lists critical limits at the Receiving critical control point, that are not adequate to control the food safety hazard of scombrotoxin formation. Your HACCP plan includes information that indicates your firm acts as a primary processor receiving the fish directly from the harvest vessels. Your plan states “(b)(4)”. Moreover, this appears to also indicate that your firm (b)(4). As a primary processor receiving the fish directly from the harvest vessels, FDA recommends to control scombrotoxin formation that is reasonably likely to occur onboard the harvest vessel that firms include critical limits for decomposition; harvest vessel records or histamine testing; and internal temperature measurements at the time of off-loading from the harvest vessel by the processor. In addition, when firms are not located at the wharf where the fish are off-loaded from the harvest vessel, FDA recommends including critical limits to control scombrotoxin formation during the transit period from the wharf to the processing plant. Specifically,

a. For sensory examination, FDA recommends 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. Specifically, FDA recommends firms monitor the amount of decomposition in the lot by examining at least 118 fish, collected representatively throughout each lot (or the entire lot, for lots smaller than 118 fish) for every lot of scombrotoxin-forming fish received. Additional fish should be examined if variability in fish-to-fish histamine content is expected to be high. Lots should consist of only one species of fish; for vessels delivering multiple species, testing should generally be done separately on each species.

b. For harvest vessel records, FDA recommends that all scombrotoxin forming fish lots received are accompanied by harvest vessel records that show:

o 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;

o 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;

o 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;

o 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;

o 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.

c. For histamine testing (when used in lieu of harvest vessel records), FDA recommends analysis of a representative sample of scombrotoxin-forming fish shows less than 50 ppm histamine in all fish in the sample. Specifically FDA recommends firms monitor the histamine content in the scombrotoxin forming fish flesh by testing a minimum of 18 fish, collected representatively throughout each lot (or the entire lot when there are fewer than 18 fish in the lot) for every lot of scombrotoxin forming fish received. Additional fish should be examined if variability in fish-to-fish histamine content is expected to be high. Lots should consist of only one species of fish; for vessels delivering multiple species, testing should generally be done separately on each species. Reject the lot if any fish are found with histamine greater than or equal to 50 ppm. The fish collected for analysis may be composited if the critical limit is reduced accordingly. For example, a sample of 18 fish may be composited into 6 units of 3 fish each, provided the critical limit is reduced from 50 ppm to 17 ppm for each unit.

d. For internal temperature measurements at the time of off-loading from the harvest vessel by the processor, FDA recommends:

o For fish held iced or refrigerated (not frozen) onboard the vessel 24 or more hours after death the internal temperature should be 40°F (4.4°C) or below;

o For fish held iced or refrigerated (not frozen) onboard the vessel from 15 to less than 24 hours after death the internal temperature to ensure should be 50°F (10°C) or below;

o For fish held iced or refrigerated (not frozen) onboard the vessel from 12 to less than 15 hours after death the internal temperature should be 60°F (15.6°C) or below;

o For fish held iced or refrigerated (not frozen) onboard the vessel less than 12 hours after death 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:

o For fish held iced or refrigerated (not frozen) onboard the vessel 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.

e. To control scombrotoxin formation that is reasonably likely to occur during transit from the harvest vessel to the plant, FDA recommends:

o For fish delivered refrigerated (not frozen) that 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:

o For fish delivered under ice that fish are completely surrounded by ice at the time of delivery;

o For fish delivered under ice on an open-bed truck that all fish are stored completely surrounded by ice and that the internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;

o For fish delivered under chemical cooling media such as gel packs that 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 that the internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;

o 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) that the Time of transit does not exceed 4 hours and that internal temperature at the time of delivery does not exceed 40 °F (4.4°C).

f. At the Preserve, Preserve (Anneal), and Pre-chill critical control points, FDA recommends that firms measure the cooler temperature using a continuous temperature-recording device, with continuous monitoring by the device itself and a visual check of the recorded data at least once per day for refrigerated storage. Or if chilled with ice, that firms make a visual observation of the adequacy of ice in a representative number of containers from throughout the cooler with sufficient frequency to ensure control for storage under ice.

4. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for your scombroid species of fish fails to ensure injurious or adulterated product is kept out of commerce and the cause of the deviation is corrected at the Receiving, Preserve, Preserve (Anneal), and Pre-chill critical control points to control scombrotoxin formation.

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 scombroid species of fish 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

Please send your reply to the U.S. Food and Drug Administration, Attention: Kerry Kurdilla, 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: Kerry.Kurdilla@fda.hhs.gov. Please reference CMS# 517525 on any submissions and within the subject line of any emails to us. You may also contact Kerry Kurdilla 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

Close Out Ltter

Ba Hai Company Limited - Close Out Letter 11/3/17