| Public Health Service Food and Drug Administration |
| College Park, MD |
Department of Health and Human Services
WARNING LETTER
JUL 27 2010
VIA OVERNIGHT MAIL
Ms. Adeline Tan, Chief Operating Officer
GroPoint Fisheries SDN BHD
Unit No.b2, Lot No. 205 3151 211,
Manmohan's Patau-patau Warehouse,
Labuan, Malaysia
Re: I.D. # 120208
Dear Ms. Tan:
In response to a request by the United States Food and Drug Administration for a copy of your firm's HACCP plan and supporting documents, including monitoring records, for your fish and fishery products, your firm responded by email on June 4, 2010 with the requested documents. Our evaluation of your HACCP plan and supporting documentation revealed serious deviations from the requirements of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 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 scombrotoxin-forming fish, such as your tunas and Mahi Mahi, 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.
We note the following deviations:
1. You must conduct a hazard analysis to determine whether there are food safety hazard 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 acceptable levels." However, your firm's HACCP plan for your scombrotoxin-forming fish, such as your tunas and Mahi Mahi, does not list a critical control point for the overnight refrigerated storage of the fish, that is part of the carbon monoxide treatment, to control scombrotoxin formation.
Processing step (b)(4) that your firm provided clarifies that this step is an overnight refrigerated storage of the fish that is part of the carbon monoxide treatment. The document, however, dismisses the need for a critical control point for this operation by stating that the "temperature is covered by GMP" in the hazard analysis.
Any processing step that could result in the introduction of a food safety hazard should be identified as a critical control point in the HACCP plan. Overnight storage of scombrotoxin-forming fish in a reduced oxygen environment without temperature controls could result in scombrotoxin formation, as well as the growth and toxin formation of pathogens including Clostridium botulinum.
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for scombrotoxin-forming fish, such as your tunas and Mahi Mahi, lists monitoring procedures at the "Receiving at Dock" critical control point that are inadequate to control scombrotoxin formation.
Your firm uses a (b)(4) control strategy that rely on interviews with (b)(4) to document how the fish was handled during the (b)(4) fishing period. This does not represent an adequate control to prevent scombrotoxin formation in the fish. HACCP controls are intended to include monitoring procedures that ensure that the critical limits are being met and the records used to document the implementation of the monitoring procedures should include the actual values and observations obtained during monitoring and entered at the time the observation is made. Most of the elements included in your firm's "(b)(4)" that are pertinent to the listed critical limit could not be meaningfully observed or accurately and reliably recalled in detail without documentation of the real time observations by the harvest vessel operators. Your firm's monitoring approach through interviews after the fact does not provide assurances that the critical limits were met for fish received from the (b)(4) nor does it prevent receipt of time or temperature abused fish where the fish could have formed excessive scombrotoxin or where the time or temperature abuse permitted growth and enzyme production of the organisms that will form scombrotoxin.
In addition, chilling on board should bring the fish to 4.4oC or below (not (b)(4) or below as listed in your firm's HACCP plan) and held at that temperature for the duration of the fishing trip.
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, the corrective actions listed in your HACCP plan at the "Plant Receiving and Wash Fish" critical control point are not appropriate to control scombrotoxin formation. Your firm relies on visual inspections of the adequacy of ice surrounding the fish when the fish are received at the processing facility after transport from the wharf by truck. Your firm's corrective action plan states, (b)(4) ..."
The listed corrective action suggests that your firm does not understand the importance of the listed critical limit of ensuring adequate ice surrounding the fish at receipt at the processing plant and instead to default to the corrective action of taking internal temperatures in the situations when the critical limit associated with ice is not met. Taking internal temperatures offish at the point of receipt is not generally a reliable means of ensuring the safe handling of fish throughout the entire transit time. Moreover, the listed corrective action procedures do not ensure that the cause of a critical limit deviation is corrected.
You should respond in writing within thirty (30) 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 fifteen 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 is Import Alert #16-120. This alert can be found on FDA's web site at: http://www.fda.gov/ora/fiars/ora_import_ial6120.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.
During our review, we also identified the following issues:
1. At the "Receiving at Dock" critical control point, your HACCP plan lists (page 8), "Maximum fish exposure temp. was less than (b)(4) as one of the critical limits. Your firm's "Product Description" (page 4 of the firm's HACCP plan) identifies that the fish are "caught... in [the] (b)(4)." Our data indicates that the air temperatures in that region of the world are routinely in excess of (b)(4). Exposures to these temperatures will reduce the recommended exposure time for safe handling of the fish to (b)(4) after death of the fish. While this should not present an obstacle for hand-line type of fishing operation, it may affect the critical limit and the type of recordkeeping applicable to your operations.
2. (b)(4) from the wharf to the processing plant. Your firm may want to give further consideration to its hazard analysis for this processing step.
For example, the hazards and controls associated with "Plant Receiving" and "Wash Fish" may be distinct operations and might better be considered independently rather than combined as they currently are in the HACCP plan.
In addition, if the transport of the fish is extremely fast from the wharf to the processing facility, such that time or temperature abuse leading to hazards is not reasonably likely to occur, there might not be a need for a critical control point for this processing step. However, before concluding this, you should consider not only the physical time of transport, but the time of exposure of the lot from the time the first fish of the truckload is removed from the controlled iced environment of the hold of the harvest vessel being off-loaded until the time the last fish of the truckload is restored to a controlled temperature environment in a firm's processing scheme. Because your firm does not include a raw fish storage step, the next operation that the fish return to a controlled temperature environment may be the (b)(4) processing step. Consequently, under the circumstances, you may be dependent on control of the temperatures via proper icing of the fish from the wharf to the processing facility, and possibly, beyond if the fish are held on the trucks prior to processing, similar to a storage operation.
3. Your firm's HACCP plan specifies the use of chlorinated water from (b)(4) as a component of the critical limit for pathogen controls at the "Plant Receiving and Wash Fish" critical control point. However, neither the monitoring procedures in the plan nor the monitoring records provided call for or show that the chlorine concentration is monitored. When a firm has identified the need for chlorine control to control the pathogen hazard at this processing step, the control should be measured and recorded as part of the HACCP plan.
4. A the "Receiving at Dock" critical control point (pages 8 - 9) of your HACCP plan, your firm lists, "At least quarterly submit (b)(4) of finished product for histamine testing by a certified independent laboratory" as a component of the verification procedures.
Histamine is most likely to be detected at elevated levels in the lower anterior loin of fish that have been time and temperature abused in a manner that permits scombrotoxin formation. Waiting until the fish are further processed, e.g. butchered, portioned, and packaged, such that the lower anterior loin is no longer discernable in the final product substantially reduces a processor's opportunity to use the histamine testing verification procedure to obtain assurances that the fish it receives and processes are safe. To be an effective scombrotoxin control at the receiving critical control point, collection of the samples to be tested on the fish is important. FDA recommends that:
• A minimum of (b)(4) to be tested should be collected. Portions collected from other areas on the fish are far less likely to detect elevated histamine levels even in time or temperature abused fish.
• The entire (b)(4) should be individually ground from which the test aliquot can be obtained from the comminuted result of each sub-sample.
In addition, the best opportunity for your firm to conduct the quarterly verification would be on those occasions when a marginally acceptable lot is received or a lot containing some fish discerned to have undergone some time or temperature abuse rather than a lot full of pristine fish. In addition, we suggest that processors collect a verification sample of (b)(4), rather than the (b)(4) listed in your HACCP plan, for routine histamine sampling for processors that elect the histamine testing control strategy.
5. Your firm's monitoring procedures at the "Receiving at Dock" critical control point (page 9) of the HACCP plan, state, in part, that a "minimum of (b)(4) are to be measured for "internal temperature" with "every lot received" from the harvest vessels. The monitoring procedures parenthetically also state "(One lot is defined as all the fish of a single species unloaded from one harvest vessel for this HACCP plan.)."
In review of your records, it appears that you are not following this procedure. For examine, one of the monitoring records provided for (b)(4) of tuna received on April 27, 2010, from the (b)(4)", shows the recording of internal temperatures of only (b)(4) from the lot of tuna, not the minimum of (b)(4) listed in your HACCP plan. This appeared on other processing dates as well.
It is not clear whether your firm is fully implementing its HACCP plan in this regard. Because different species of fish have very different morphology and cooling curves, it would be prudent to ensure an adequate representation of each species of fish is measured for internal temperature.
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
Sincerely,
/S/
Jennifer Thomas
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
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