Inspections, Compliance, Enforcement, and Criminal Investigations
Songkla Canning Public Company Limited 2/16/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|College Park, MD|
FEB 16 2010
VIA OVERNIGHT MAIL
Mr. Chaiwat Charoenrujitanon, Vice-President Management
Songkla Canning Public Company Limited
333 Moo2, Kamjanavanich Road
Re: MARCS-CMS Case #89744
Dear Mr. Charoenrujitanon:
We inspected your seafood processing facility, located at 333 Mo02, Kamjanavanich Road Tumbol Pavong, Amphur Muang, Thailand on December 7 - 9, 2009. Upon further review of our investigator's inspection report and findings during the inspection, we determined 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 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 canned tuna, pouch packed tuna and pasteurized crab meat 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 & Controls Guidance through links in FDA's home page at www.fda.gov.
We note the following deviations in your Seafood HACCP plans for your canned tuna, pouch packed tuna and pasteurized crab meat:
1. 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 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 plans for your canned tuna and pouched packed tuna each list only the "Receiving" critical control point as the sole processing step or operation to control scombrotoxin (histamine) formation; however, additional steps are listed in your Hazard Analysis Worksheet that pose a reasonably likely hazard for scombrotoxin (histamine) formation.
Specifically, there several processing steps listed in your Hazard Analysis Worksheet as part of your operation that occur between the time of receipt of the fish, until the time the filled and seamed cans enter the retorts, where the fish are exposed to potential time and temperature abuse. Your firm needs to ensure that the time and temperature exposures during these cumulative periods are properly controlled to prevent the formation of scombrotoxin (histamine) or other heat stable toxins, such as from Staphylococcus aureus. These steps include, for example, storage of raw fresh fish, thawing of frozen fish, butchering, pre-cooking to prepare the fish for meat removal (i.e., not a pathogen reduction cook), cooling of pre-cooked fish, deskinning, cleaning (removal of meat), flaking/chopping, metal detecting, defect sorting, packing, and other processing steps after receiving and prior to when the product enters the retorts.
We note that, in your Hazard Analysis Worksheet, your firm indicates that some of these processing steps are not necessary critical control points in your plan because of your determination that the these steps are low risk due to control by "SOP" or "SSOP". For example, at several steps in your hazard analysis, you indicate "controlled...time and temperature by SOP". Under the requirements of the seafood HACCP regulation, processing steps that are critical to the safety of the products, i.e., those which, in the absence of controls, are reasonably likely to result in food safety hazards, are required as part of the HACCP plans. As such, processing steps that, in the absence of time and temperature controls, are reasonably likely to result in excessive histamine development or other hazards need to be listed as critical control points in the plan, with corresponding critical limits, corresponding monitoring procedures and frequencies, and appropriate monitoring records to ensure that those preventative controls are effectively implemented. Standard Operating Procedures (i.e., SOPs and SSOPs) are not adequate substitutes or alternatives for necessary critical controls points to control time and temperature abuse to prevent or reduce the likelihood for hazards.
In addition, if your firm also acts a secondary processor, receiving fish via any other means than directly off the fishing vessels, such as by truck of other transport vehicle, you may need additional controls at receiving for these products to ensure that the fish were transported safely to your processing facility. We suggest monitoring for adequate ice surrounding the fish, when receiving fish that are on ice from a previous processor.
2. 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 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 firm's HACCP plans for your canned tuna and pouch packed tuna and your pasteurized crab meat list inadequate critical limits to control the identified hazards. Specifically:
a. your HACCP plans for canned tuna and pouch packed tuna list critical limits at the "Receiving" critical control point for frozen or fresh fish that are not adequate to control the hazard of scombrotoxin formation. Your HACCP plans list scombrotoxin (histamine) critical limit controls at Receiving that include only "no more than (b)(4) histamine" as determined by histamine testing. Histamine testing alone is not an adequate control for the prevention of scombrotoxin formation at receiving by firms, such as yourself, that are primary processors receiving fish directly from the harvest vessels. FDA recommends that, in addition to histamine testing, primary processors implement critical limit controls related to maximum decomposition levels through sensory evaluations, as well as maximum internal temperatures limits of fresh fish at receiving.
Our investigator noted during the inspection that your firm "checked for backbone temperature [and] organoleptic freshness" in "all fish received." These are the types of procedures that we recommend including in your firm's HACCP plans at receiving.
In addition, we suggest you include critical limit descriptions in your HACCP plans associated with the methods or procedures used by your firm in conducting the histamine testing of fish. FDA suggests:
o assurances that the analytical method used is verified by your firm (i.e., using your own protocols and analysts) to provide reliable results at the critical limit levels consistent with your firm's HACCP plans (b)(4) It is helpful to identify the specific method your firm is using, in the HACCP plan.
o that a minimum of (b)(4) of muscle from the lower anterior loin of each fish be collected for the analyses. Portions collected from other areas on the fish are far less likely to detect elevated histamine levels even in time-termperature abused fish.
o that the entire (b)(4) individually ground, even when compositing the sub-sample.
o that when compositing, a minimum of (b)(4) from each of the individually ground sub-samples should be combined and homogenized before collecting the test aliquot from the composite sub-sample.
b. your pasteurized crab meat HACCP plan lists inadequate critical limits at the "Pasteurization" critical control point to control the hazard listed as "Pathogen Survival" identified specifically as Clostridium botulinum. Your HACCP plan lists the critical limit "I.T. no lower than process schedule" and "No deviations from process schedule"; however, no temperature critical limit is listed for the initial temperature (i.e., I.T.); and no time and temperature limits are listed for the process schedule (i.e., the pasteurization process). Please note that, as discussed above, SOPs are not adequate alternatives to critical limits that are necessary to prevent, eliminate or reduce to an acceptable level a reasonably likely hazard. Consequently, the critical time and temperature limits necessary to control the hazard of Clostridium botulinum growth and toxin formation at each critical control point are required as part of your HACCP plan.
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your HACCP plan for pasteurized crab meat does not list monitoring procedures/frequencies at the "pasteurization" and "refrigerate store" critical control points that are adequate to control pathogens. Specifically
a. monitoring (and recording) the pasteurization "time, temperature and water level during retorting ....(b)(4) .." as listed in your plan is not adequate to ensure that each retort batch receives an adequate pasteurization process for the entire duration of the process. We suggest equipment that is capable of continuously monitoring the schedule process time and temperature for the entire duration of the pasteurization process.
b. monitoring the temperature of the cooler with a visual check of the thermometer every (b)(4) as listed in your plan at the refrigerated storage critical control point is not adequate, unless your firm is capable of conducting the monitoring on a 24 hour a day/7 day a week basis, including those times when your firm is not in operation. Alternatively, we recommend the use of equipment capable of continuously monitoring and recording cooler temperatures on a 24 hour a day/7 day a week basis.
For more information on the hazard associated with the hazard of scombrotoxin (histamine) please refer to the Fish and Fisheries Products Hazards and Controls Guidance: Third Edition, Chapter 7, found at: www.cfsan.fda.gov/~commlhaccp4.html. For more information on the hazard of Staphylococcus aureus, please refer to Chapter 15. For more information on the hazard of pathogen survival through pasteurization, please refer to Chapter 17.
In addition, the observations on the FDA Form 483 that was issued at the conclusion of the inspection listed our concerns related to your low-acid canned food (LACF) operations. These items still require your attention. Regarding observation #1 associated with the can
seam specifications, please be advised that the can seam specifications provided by the can manufacturers are designed specifically for each can size and are not expected to require any changes. Thus, although changing those specifications may reduce confusion among your employees, as discussed during the inspection, these changes could potentially prevent a proper hermetic seal. In addition, observation #2 associated with the location of the bleeders should be addressed to ensure that the bleeders are readily visible to the retort operator.
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. 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 plans, any verification records, and other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before the 30 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. This procedure is generally based on past history or other information, such as an inspection of a facility or HACCP plan review, indicating that the factory producing the product or the product itself may not be in compliance with FDA's laws and regulations. DWPE information is conveyed in FDA's Import Alerts. 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.fda.gov/ora/fiars/ora import ia16120.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 regulation, and the Good Manufacturing Practice regulation (21 CFR 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 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@hhs.fda.gov
Office of Compliance
Center for Food Safety
and Applied Nutrition