| Public Health Service Food and Drug Administration |
| College Park, MD |
Department of Health and Human Services
JUN 15 2010
WARNING LETTER
Case ID #113369
Mr. Chao Ching Chen
President
Union Development Frozen
5 Tong Lin Road
Hsiao Fang District
Kaohsiung,
Taiwan, Republic of China
Dear Mr. Chao Ching Chen:
The United States Food and Drug Administration (FDA) recently requested a copy of your most current HACCP plan, in order to assess the level of compliance of your HACCP plan 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. Your firm responded via email on May 10, 2010 with a HACCP plan dated May 3, 2010 entitled "HACCP System Plan For The Frozen Whole Gutted Salt Water Fish." According to the plan, it is intended to cover various species offish including scombrotoxin (histamine) forming species of fish such as Yellowfin, Spanish Mackerel/King Fish (i.e., Scomberomorus spp.) and Mahi Mahi. Our evaluation of that HACCP plan, dated May 3rd, 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 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 scombroid (histamine) forming species of fish such as your Yellowfin, Spanish Mackerel/King Fish (i.e., Scomberomorus spp.) and Mahi Mahi are adulterated within the meaning of the Act, in that the products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they 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:
1. 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 "Frozen Whole Gutted Salt Water Fish" intended to cover various species of fish including scombrotoxin (histamine) forming species of fish such as Yellowfin, Spanish Mackerel/King Fish (i.e., Scomberomorus spp.) and Mahi Mahi lists monitoring procedures/frequencies at the "Receiving" and "Thawing" critical control points (CCP) that are not adequate to control scombrotoxin (histamine)formation. Specifically,
a. At the "Receiving" CCP, it appears that the monitoring procedures are inadequate. Specifically,
i. With regard to the critical limit associated with the hazard of histamine listed as #3 under the "hazard" column and under #5 in the "critical limit" column, the monitoring procedures/frequencies listed in the "how" column indicate in #5 that (b)(4) (single supplier) will be collected; and in #4 (i.e., the number that corresponds to the histamine critical limit in #5) that (b)(4) (single vessels) will be collected. However, collecting and analyzing either (b)(4) of fish per batch or (b)(4) per batch are inadequate as sampling strategies for a primary processor to establish or make any determination concerning excessive histamine development in that batch. The sample size should be adequate in number to provide a representative sample. Depending on the types of vessels being off-loaded and the variability of histamine content expected or observed in any particular vessel, more than (b)(4) and most likely more than (b)(4) may be warranted to provide a representative sample of the conditions on board each vessel.
ii. Histamine sample collection is as important as the actual testing, if the histamine results are to be useful as a HACCP control. For example:
1. A minimum of 250 grams of muscle from the lower anterior loin of each fish to be tested should be collected. Portions collected from other areas on the fish are far less likely to show elevated histamine levels even in time-temperature abused fish.
2. The entire 250 gram sub-sample from each fish should be individually ground, and the test aliquot should be taken from this ground sample.
3. The analytical method should be verified by your firm (using your own protocols and analysts) to provide reliable results at the critical limit level consistent with your HACCP plan. It is helpful to identify the specific method used within the HACCP plan. For example, your plan references your method only as an (b)(4) method. Please provide a more detailed description of your histamine testing methods and procedures.
We note that at the "Receiving" CCP, your firm has constructively numbered each element to correspond to the critical limits. However, these elements do not align well, in that the listed hazards that range in number from #1 to #4, do not align or correspond with the critical limits and the monitoring procedures/frequencies that range in number from #1 to #6.
b. At the "Thawing" CCP, the monitoring procedures list that "Temp" will be monitored by thermometer once/hr; however this does not specify the temperature value that is to be monitored. According to the corrective action procedure that is included in the plan, and the hazard analysis document, your firm intends to monitor the "fish body temp" or the "Internal temp of fish," rather than the ambient exposure temperatures, and that the temperature value is >5°C. The listed procedure is inadequate and may be difficult to manage in a meaningful way.
Bacteria that cause scombrotoxin formation may exist in the viscera, gills, and on the surfaces of the fish. As the fish thaws, these bacteria will become active. The deep core or backbone temperature of large fish such as yellowfin tuna may take a great deal of time to thaw while edible portions offish nearer to the surface may have thawed well before the core. Measuring just the core temperature of the fish does not ensure that the bacterial activity and scombrotoxin formation nearer to the surface of the fish is prevented.
Furthermore, the listed monitoring procedures do not list how many fish or what ratio offish are to be measured during the control activity. For example, measuring a single fish is an inadequate control. In addition, it becomes difficult to determine how many fish, which sizes of fish, where within the lot, and where on each of the fish, a measurement should be taken to represent the condition of all of the fish in the lot.
Instead of testing individual fish, FDA recommends controlling the time and temperature of the ambient exposure. For example, your firm may ensure that the thawing medium, i.e. the thaw water or the air, that is in contact with the fish is maintained at 4.4 °C or below during the thawing step.
c. At the "Gutted" CCP, your firm lists two critical limit elements, i.e. "Internal temp of fish <4°C" and "operation time less than (b)(4)". The monitoring procedures listed for this control include "Temp Time" by "Thermometer Timer" "once/hr batch." For reasons identified above for the "Thawing" CCP, monitoring internal temperatures offish as a HACCP control can be accomplished, but is difficult to implement.
Moreover, the time limit listed "operation time less than (b)(4) may pose a potential risk for time and temperature abuse, when this time period becomes part of the cumulative exposure times above 4.4 °C. When fish (all of the fish, not just the cores) are maintained below 4°C, processing time is generally not a critical factor. However, if any portions of the fish exceed 4.4 °C and a processor then intends to rely on the time of exposure above 4.4°C to control the hazard, each cumulative exposure time above 4.4 °C will be a concern from the standpoint of scombrotoxin (histamine) formation. In general, FDA recommends that previously frozen fish should not be exposed to (ambient) temperatures above 4.4 °C for more than 12 hours when any portion of that exposure time is above 21°C; when the exposure temperatures do not exceed 21 °C then the previously frozen fish should not be exposed to temperatures above 4.4 °C for more than 24 hours. These parameters are not pertinent for each individual processing step, but would be pertinent for the cumulative exposure from the time the fish leave a controlled environment (e.g. freezer storage) to the time they re-enter a controlled environment (e.g. finished product freezer). Consequently, these recommended times need to take into consideration all steps in the processing, when the fish are exposed to temperatures above 4.4 °c. These may include, for example, thawing, gutting, washing, and hanging ("suspend"), for each fish in each batch. However, when the total cumulative exposure time is well within 12 hours, a firm may be able to justify that no additional CCPs are needed for processing steps between the raw product freezer and the finished product freezer.
You should perform a detailed hazard analysis that takes into account the worst case temperature exposures and timeframes at each processing step, to help you establish a cumulative exposure profile and help determine which CCPs are needed or where controls need to be incorporated and monitored. You should assure that the size of batches to be worked from the controlled thawed environment to the final product freezer are small enough so that the batch can be worked well within the recommended timeframes to protect against food safety concerns.
2. 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 plan for your "Frozen Whole Gutted Salt Water Fish" intended to cover various species of fish including scombrotoxin forming species of fish such as Yellowfin, Spanish Mackerel/King Fish (i.e., Scomberomorus spp.) and Mahi Mahi at the "Thawing" and "Gutting" critical control points are is not appropriate. Specifically,
a. At the "Thawing" CCP, your firm's HACCP plan lists a corrective action that states "fish body temp >5°C: for non-food grade use of that specific batch," and "Lower the temp down to 4°C by ice." However, the reference to lowering the temperature to 4°C may be inappropriate if this procedure is intended to accept fish that have exceeded SOC as long as the temperature can be brought down to 4°C or lower (i.e., after exceeding 4°C for some undesignated time period). This will not prevent distribution of fish that are potentially unsafe, due to time/temperature abuse. Moreover, as previously stated above measuring the temperatures of sufficient numbers of fish in a meaningful way to know when a corrective action is warranted would be difficult.
b. At the "Gutted" CCP, your corrective action procedures relate to the fish body temperature similar to those listed at the "Thawing" CCP and, consequently, present the same deficiencies and concerns (see item 2. a., above). However, the inclusion of the time-related correction i.e. "operation time over 4 hours: histamine inspection first," and "Regarding as non-food grade use if over critical limit" is not adequate. If your firm intends to conduct histamine testing on lots of fish that have been time and temperature abused, the procedures need to be very explicit regarding such considerations as which fish to select for testing, where on the fish to collect the samples, how many fish should be samples and tested (FDA recommends a minimum of (b)(4) for each affected lot) and what should be the "critical limit" value applicable in that situation (FDA recommends that any fish sample with histamine of (b)(4) or more should prompt rejecting the lot). These elements need to be included in your firm's HACCP plan, as part of the corrective action plan.
We note that your HACCP plan refers to king fish with the scientific name, Scomberomorus commerson. The appropriate market name for this species of fish is Spanish mackerel. A product is misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act if it is not labeled with the appropriate common or usual name. You can find more information about appropriate fish market names on the Seafood List, posted on FDA's website at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/ucm113260.htm.
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. Your response should include documentation that would assist us in evaluating your corrections, 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. 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 123] is Import Alert #16-120. This alert can be found on FDA's web site at: http://www.accessdata.fda.gov/cms ia/importalert 25.html
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations, 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
Sincerely,
/S/
Jennifer Thomas
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
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