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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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

Public Health Service
Food and Drug Administration
  Washington, DC

Warning Letter
I.D. # 66404

August 14, 2009


Mr. Arnulfo Singca
General Manager
609 Sirloin Rd. Bldg 6
FTI Complex
Taguig City, Metro Manila,

Telephone Number: (632) 838-4301
FAX Number: (632) 837-7447

Dear Mr. Singca:

We inspected your seafood processing facility MICA BY THE SEA, located at 609 Sirloin Rd. Bldg 6, FTI Complex, Taguig City, Metro Manila, Philippines on May 7 - 8, 2009. During that inspection, we found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, (21 CFR Part 123). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm. During further review, we noted additional deviations, which are listed below.

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 dried herring products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:

1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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." Your firm's HACCP plan for Dried Herring does not list the food safety hazard of Clostridium botulinum growth and potential toxin formation. Clostridium botulinum growth and toxin formation is a hazard likely to occur in uneviscerated fish that are exposed to time/temperature abuse (i.e., because the viscera is intact). We note that your HACCP plan identifies the significant hazard of "pathogen survival" at the drying critical control point. However, your uneviscerated fish pose a potential hazard specifically for the pathogenic organism Clostridium botulinum, and consequently your HACCP plan will need to include controls specific to this pathogen.


FDA recommends for control of Clostridium botulinum in a dried fish product such as yours, that firms control:

►  Fish size from tip of the head to the end of the tail, to a limit of 5 inches or less. We acknowledge that your HACCP plan references a critical limit for fish size at receiving as "Fish size less than 5 inches"; however, in your plan this limit is associated with histamine control rather than pathogen control.


►  Processing to prevent the formation of Clostridium botulinum toxin, by ensuring that the drying is conducted in a sufficiently short time period to preclude toxin formation. This is the reason fish size is important, since the process should ensure that the final target water activity is reached within 24 hours. Moreover, we note your firm's "Hazard Analysis Worksheet" states that the "Drying step will destroy pathogens". However, according to FDA's scientific research, neither the heating conditions at the Drying step described in your firm's Hazard Analysis Worksheet as "Control Heating temp. to a high of 145°F and ave. of 135°F for 12-14 hours", or "12-14 hours at a controlled temperature varying from 90° F to 145° F", will be sufficient to control or destroy preformed Clostridium botulinum toxin (i.e., toxin that developed prior to the drying operation).

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."

Specifically your firm lists two hazards, histamine (scombrotoxin) formation and pathogen survival. The following addresses the critical limits listed in your plan for each separately.

► With regard to the hazard of histamine, your firm's HACCP plan for Dried Herring lists critical limits in your plan as "Must be <50ppm" and "Fish size less that 5 inches" at the "Receiving" critical control point. These controls are not adequate to control scombrotoxin (histamine) formation for an operation such as yours, which receives fish both directly from the harvest vessels and after those fish have been in transit for an extended time from the vessels to your facility (i.e., because you are located several hours away from the docks).

Your firm acts as a primary processor, receiving fish directly from the harvest vessels. Consequently, the histamine determinations you currently have listed in your HACCP plan at receiving alone are not adequate. As two possible strategies for primary processors of histamine forming fish, FDA recommends either (1) a program of histamine testing; or, (2) a program for obtaining appropriate harvest vessels records. While your plan includes elements of both, you do not appear to have developed an adequate strategy for either one.

o For example, relative to histamine testing:

Your plan includes a critical limit associated with histamine testing at <50ppm; however, the monitoring frequency is listed only as every 3 months. Histamine testing of any type once every 3 months does not serve as an adequate frequency to determine if scombrotoxin formation had been controlled in lots of herring received from vessels on a daily basis. When histamine testing is the primary control strategy, FDA recommends testing every vessel lot received as a monitoring procedure.

The monitoring procedures listed in your plan do not list the numbers of fish to be examined using the histamine testing control strategy approach. As pointed out by the investigator, FDA recommends testing of a minimum of 18 fish per lot received when testing is done as a receiving control for scombrotoxin formation.

o For example, relative to harvest vessel records:

Your plan includes references to harvest vessel control records as a verification procedure only, rather than including harvest vessel records as a monitoring strategy at receiving. As such, there are no critical limits or criteria established in your HACCP plan that would suggest that the harvest vessel records are to provide any kind of assurances of safe fish. Moreover, a review of the "Harvest Vessel Control Record" your firm provided revealed no assurances of adequate control parameters onboard the vessels. The information on the record presented as a "Harvest Vessel Control Record" appears to be information recorded at the time of receiving the fish by your firm, rather than observations made by the vessel's operators that would ensure the fish were chilled in a timely manner after death and held in a chilled state for the duration of the trip.

FDA recommends that, in addition to either histamine testing or harvest vessel records to control scombrotoxin formation at Receiving, firms monitor internal temperatures of the fish and conduct sensory examinations. During the inspection your firm referred to sensory checks and temperature checks offish at receipt; however, this is not included as a component of your corrected HACCP Plan, nor are there any appropriate critical limits associated with these measurements or determinations included in the HACCP plan.

Moreover, your firm's HACCP plan for Dried Herring does not include critical limits at receiving associated with receipt of the fish from the dock to your facility. These are controls associated with your firm's activities similar to a "Secondary Processor" receiving fish while in transit for an extended time period, to control the food safety hazard scombrotoxin formation. The inspection found that fish are transported from the docks to your firm on ice; however, there is no critical control point associated with this transport control in your firm's HACCP plan.

► Specifically with regard to the hazard of pathogens, your firm's HACCP plan for Dried Herring lists a critical limit "Aw should be <0.97" at the "Drying" critical control point. That critical limit is not adequate to control pathogens. In the "Hazard Analysis Worksheet," your firm identifies the potential for pathogen contamination of the product at several processing steps in your operations. A target water activity of less than 0.97 during the drying operation is insufficiently low to inhibit many pathogens let alone "destroy" them as suggested in several of the processing steps preceding the drying step in your "Hazard Analysis Worksheet." Moreover, as discussed above in bullet #1, your firm should assess the critical limits necessary to control Clostridium botulinum growth and toxin formation. For example, in order to destroy preformed toxin of Clostridium botulinum, the heat exposures will need to exceed 145 ◦F, coupled with adequate controls related to process time, salt concentrations, amendment of the final Aw, as well as assessment of any additional necessary critical control points such as cooling.

Moreover, unless the salting or drying steps are sufficient to render the product shelf-stable (i.e., in that the finished product is stored without refrigeration or freezing) the vacuum packaged, frozen fish product should bear a label stating something like "Keep Refrigerated" or "Important: Keep Frozen until used, thaw under refrigeration before use", as advised by the investigator during the inspection.

3. 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 Dried Herring at both the "Receiving" and 'Drying" critical control points to control histamine and pathogens is not appropriate. The corrective actions in your HACCP plan do not ensure that the cause of a critical limit deviation is corrected.

4. 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." Your firm's HACCP plan for Dried Herring does not list the critical control point of "Processing" for controlling the food safety hazards of pathogen growth and toxin formation and scombrotoxin formation. The inspection documented your firm's processes of removing the fish from coolant (ice) for washing in tap water, followed by a brining operation for up to 1 hour at room temperatures (in excess of 70 ◦F during the inspection), followed by a hand "layering" operation, and then at least an initial 2 additional hours in the drier at temperatures in the vicinity of 85 to 100 ◦F" Consequently, your firm's fish may be exposed to optimal bacterial growth temperatures for very nearly, or in excess of FDA recommended limit of four hours

For more information related to the hazard of scombrotoxin (histamine) formation, pathogen growth, and specifically Clostridium botulinum growth and toxin formation please refer to the Fish and Fisheries Products Hazards and Controls Guidance, Third Edition, Chapters 7, 12, and 13 found at: www.cfsan.fda.gov/~comm/haccp4.html.

You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include 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. 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 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. This alert can be found on FDA's web site at: http://www.fda.gov/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: Dwayne Johnson, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607)/Room 2C-067, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Mr. Johnson by phone at (301) 436-1782 or via email at Dwayne.Johnson@fda.hhs.gov.


Roberta Wagner

Office of Compliance
Center for Food Safety
and Applied Nutrition

Enclosure: Revised HACCP plan