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U.S. Department of Health and Human Services

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Rayong Fish Sauce Industry Co., Ltd. 02-Jun-08

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

Public Health Service
Food and Drug Administration


Washington, DC

Warning Letter

JUNE 2, 2008


Mr. Kawin Yongsawasdigul
Rayong Fish Sauce Industry Co., Ltd.
29 Moo 4 Banga-Trad 36 Rd.,
Tambol Tubma„ Rayong 21000

Dear Mr. Yongsawasdigul;

On January 24, 2008, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of a fish and fishery products importer in the United States; LAX-C Inc., located at 1100 N Main St., Los Angeles, CA 90012-1872 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 fish sauce from your processing facility. During the inspection of that importer, we collected a copy of your firm's HACCP plan for your fish sauce made from anchovies. Our evaluation of that 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 to have and implement a HACCP plan that complies with this section, or otherwise operate in accordance with the requirements of 21 CFR Part 123, renders the fishery products adulterated within the meaning of section 402(a)(4) of the U.S. Federal Food, Drug, and Cosmetic Act (the Act), [21 USC § 342(a)(4)]. Accordingly, your firm's fish sauce is adulterated within the meaning of the Act, in that the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and FDA's Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.

We note the following violations in your seafood HACCP plan:

I. 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 and implement a written 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 your anchovy-based fish sauce does not include the following critical control points to control the food safety hazards of histamine formation and pathogen growth:

1. Receiving of raw anchovies (for further processing into sauce)

a. A primary processor receiving the fish directly off the boats is responsible for ensuring that scombrotoxin (histamine) formation was prevented and the fish received are known to be safe.

FDA recommends that primary processors, i.e. those processors receiving the fish directly off-loaded from harvest vessels, either:

- obtain meaningful harvest vessel records, and conduct appropriate sensory examinations and internal temperature measurements of fish upon receipt; or

-conduct appropriate histamine testing along with sensory examinations and internal temperature measurements of fish upon receipt.

b. As a secondary processor, i.e. those processors receiving the fresh fish following transit from the point of off-loading from the vessels or from another processor, a firm is responsible for ensuring that the fish are delivered to the facility under adequate cooling to prevent histamine formation and pathogen growth. Secondary processors should monitor for the presence of adequate ice when fish are received on ice; or monitor the temperatures of the transit container, to ensure that proper temperatures (i.e., 4.4°C/40°F or below) were maintained throughout the transit time to the processing facility.

Moreover, this type of control strategy will additionally prevent pathogen growth, as identified in your plan as "growing of pathogen from harvest area (Fresh Fish) during transportation." We note that rather than include this as a control strategy at receipt, you identified this as a hazard for your "Salting" critical control point. However, disregarding pathogen growth during transit with the intention of inhibiting the organisms by salt later is inadequate as a control strategy. More importantly, any histamine or histidine decarboxylase enzymes that form during previous operating steps prior to adequate salting, will not be destroyed by the salting operation.

2. Storage of raw anchovies (prior to further processing into sauce)

a. Temperature controls (i.e., 4.4°C/40°F or below) should be maintained to prevent scombrotoxin (histamine) formation and pathogen growth after receipt of the fish and prior to attaining reliable alternative controls, such as sufficiently high water phase salt, to inhibit bacterial growth in the absence of chilling. You should consider the need to include any storage or holding periods as critical control points, and conduct appropriate monitoring, if the time and conditions of the exposure could result in the hazards. This may include monitoring for the presence of adequate ice or continuous monitoring of the cooler temperatures with equipment capable of providing a record reflecting the temperatures on 24 hours a day/7 days a week basis.

3. Evisceration or Destruction of Preformed Toxin (Costridium botulinum) prior to processing into sauce

Fish that are un-eviscerated are at risk of Clostridium botulinum toxin formation. The following processing procedures are necessary to control Clostridium botulinum toxin formation:

a. Fish that are five (5) inches in length or longer (head to tail), should be eviscerated. FDA is unaware of any other processing procedure, other than evisceration, that can be applied to control Clostridium botulinum toxin formation in fish that are five inches or greater in length. Neither your HACCP plan nor your flow chart suggest or include an evisceration step during any processing operations prior to the salting critical control point. Complete evisceration is necessary for these fish prior to salting if they are five inches in length or longer.

b. Fish that are smaller than five (5) inches in length and which are un-eviscerated, should have an operating step, such as boiling, prior to the salting process to destroy any toxin that may have formed prior to salting to address the risk of preformed Clostridium botulinum toxin formation. Again, there is no indication in your HACCP plan or flow chart that a processing step or critical control point is identified to ensure destruction of preformed Clostridlum botulinum toxin in small un-eviscerated fish prior to the salting operation.

4. Brining of Fermented Mash

a. Your "Main Flow Chart" indicates that the fermenting fish mash may undergo sequential extractions followed by brining and further fermentation of the remaining mash. However, your HACCP plan does not include a processing critical control point to ensure that the residual mash after each extraction is prepared in a manner to ensure that a sufficient water phase salt concentration is maintained to prevent pathogen growth and/or scombrotoxin (histamine) formation.

II. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met at each of the critical control points, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR Part 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 anchovy-based fish sauce lists inadequate critical limits at the following critical control points to control the food safety hazards of histamine formation and pathogen growth:

1. Saltine and Semi-Salting (CCP1 and CCP2)

a. Your listed critical limit "30% salt" does not specify what the salt percentage represents, e.g., the percentage of salt to be mixed in with the fish or a minimum or maximum salt concentration achieved in the fish, or the water phase salt in the fish. Your monitoring procedures suggest that the critical limit may represent, presumably, a minimum "amount of salt in a salted fish." However, in order to establish inhibitory effects for a salting process, water phase salt should monitored.

Further, the critical limit is apparently determined by some type of measure of the salt concentration as "amount of in a salted fish" sample from "every processing lot". The limits listed in the plan do not ensure that the sample is representative of the batch or lot and the processing lot is not specific enough to ensure an adequate frequency for monitoring. Moreover, the Agency is currently unaware of a method of determining the concentration of salt in fish by the procedure listed in your plan "concentrated brine and weighing."
In addition, your listed corrective action states to simply "adding [more] salt" presumably until a sample of fish indicates that the target salt concentration may have been achieved. This critical limit, monitoring procedure, and corrective action procedure combination does not represent an effective HACCP control.

Appropriate verification studies should be conducted in advance to establish the appropriate salting controls, so that an adequate water phase" salt level will consistently be achieved in each production batch or lot. The parameters to consider should include, for example the minimum salt-to-fish ratio or minimum brine salt concentration and minimum brine-to ratio, maximum fish size, and the required time and temperature of-fish exposure (conducted under refrigerated conditions if necessary), using worst case processing conditions. Critical limits and monitoring procedures can then be established that ensure that these established parameters are met with each batch. The water phase salt concentration in the fish can be confirmed as a verification procedure at a frequency you
determine to be necessary.

Moreover, your HACCP plan fails to identify the hazard of histamine formation at the salting critical control point. As pointed out previously, proper chilling of the fish is needed unless or until the concentration of water phase salt is achieved to inhibit histamine-forming bacteria. You should have scientific evidence, or have conducted a study, to determine the appropriate target salt concentration that reliably inhibits histamine. In addition, if the salting operation is going to be conducted with fish smaller than 5 inches in length without the benefit of refrigeration, you need to ensure that the fish are processed in a manner to reach a water activity below 0.85 within 2 hours under HACCP controlled and monitored conditions to prevent the hazard of Clostridium botulinum toxin formation.

2. Blending 1 and 2 (CCP4 and CCP6)

a. Your critical limit of "<500 ppm (<200 ppm for EU, and Canada)" at the "Blending 1" and "Blending 2" critical control points (CCP 4 and CCP 6) are not adequate to control scombrotoxin (histamine) formation.

Fish sauce at 500 ppm or greater histamine poses a health concern. Your firm has an obligation to ensure that the processing of the fish sauce is conducted in compliance with HACCP principles to ensure that a hazard is prevented throughout processing.

Blending portions of product with high histamine levels, in order to decrease, dilute, or mask the concentration of the hazard, is not a means to control histamine formation and causes the product to be adulterated.

A means of control for the scombrotoxin (histamine) hazard is to incorporate preventative measures earlier in the process to ensure the histamine-forming organisms and enzymes are inhibited throughout the production of the sauce. Measurement of the histamine content of the sauce could serve as an ongoing verification procedure at an appropriate frequency to ensure the HACCP plan is adequate and the plan is being effectively implemented.

In addition to the above cited deficiencies, FDA is concerned about your listed monitoring procedures and corrective actions at your "Blending 1" critical control point (CCP 3) to control pathogen growth by ensuring "<20% w/v of NaCl" in "every lot" While end-product testing is usually contrary to HACCP principles, your approach at this processing operation may provide adequate protections. However, the monitoring methods and inference to test results are critical to making valid safety decisions and your HACCP plan is not clear in this regard. When responding to the above deficiencies, please also provide an explanation of this operation, the product, and your sampling and testing, including:

i. The condition, nature, and viscosity of the product at this stage. In order for your approach to be effective, the product must be completely homogenous so that the sampling and testing will be reliable, accurate and repeatable;

ii. A better definition of your "lot" to ensure accuracy. At present, there is no way to determine if your "lot" represents a bowl, a hopper, a drum, a vat, a shift, a day's production, a week's, a month's, etc. from the information in your HACCP plan;

iii. A better description of your sampling criteria, e.g. amount of product collected and the number of subsamples from each "lot" drawn for analysis. Currently, the sampling is only inferred in your plan;
iv. A better description of your "Modified Mohr Method" for the determination of salt concentration. FDA uses the methods described in AOAC, 17th Ed., 952.08, Sec. 35.1.13, for moisture content, and AOAC, 17th Ed., 937.09, Sec. 35.1.18, for the determination of salt in seafood, to calculate water phase salt in the seafood.

For more information related to the hazards of scombrotoxin (histamine) formation, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: Third Edition. Chapter 7, found at: www.cfsan.fda.gov/~comm/haccp4.html. For additional information related to the hazard of pathogens, please refer to Chapter 12 of the Guide.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as a copy of any revised HACCP plans, at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan, any verification records, and any other useful information that would assist us in evaluating your corrections, including the studies you rely on to determine the appropriate salt concentration to prevent histamine formation in the fermenting fish product without refrigeration. If you cannot complete all corrections within fifteen (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 [21 CFR Part 1231 is Import Alert #16-120. This alert can be found on FDA's web site at: http://www.fda.gav/ora/fiars/ora_import_ia16120.html.

This letter may not list all your deviations from the requirements of the Act or applicable regulations. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the current Good Manufacturing Practice regulations (21 CFR Part 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 Food and Drug Administration, Attention: Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration 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. Benjamin by phone at (301) 436-1424 or via email at Mildred.Benjamin@fda.hhs.gov



Roberta Wagner
Acting Director
Office of Compliance
Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration

Ms. Supatra Bovornsivamon, President
LAX-C Inc.
1100 N Main St
Los Angeles, CA 90012-1872