Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|5100 Paint Branch Parkway|
College Park, MD 20742
APR 12, 2013
VIA EXPRESS DELIVERY
CONSERNOR S.A. (III)
4 Rue el Bahara
Quartier Industriel Anza
Reference No.# 394358
Dear Mr. Kabbaj:
In response to a request by a representative ofthe New York District Office of the United States Food and Drug Administration (FDA) for a copy of your firm's HACCP plan for the fish and fishery products your firm imports into the United States, your firm provided a HACCP plan that includes the following fish and fishery products:
- Carmed sardines, whole skinless/boneless steaks, smoked or not, packed in oil, in water or in various sauces;
- Carmed mackerel packed in oil or in various sauces; and
- Carmed tuna packed in oil or tomato sauce.
Our review of that HACCP plan (copy attached) found that this plan demonstrates serious deviations from the requirements of the seafood HACCP regulation.
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 sardines, carmed mackerel and canned tuna products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition of FDA's Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.
The Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatorylnformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
We found the following significant deviations:
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 canned sardines, canned mackerel, and canned tuna products does not list the food safety hazard of undeclared allergens which include finfish and soy. FDA recommends controls to ensure that all finished product labeling lists the appropriate allergenic substances.
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 hazard." Your firm's HACCP plan for canned sardines, canned mackerel and canned tuna products lists critical limits that are not adequate to control the hazard of scombrotoxin (histamine) formation in your products. Specifically:
a. At the "(b)(4)" critical control point, your plan identifies "time between harvest and icing no more than (b)(4)" to be recorded on a control document as a strategy to prevent the hazard of scombrotoxin (histamine). This is not adequate to ensure that fish were not exposed to time and temperature abuse onboard the fishing vessels. This listed critical limit should define that the (b)(4) hour time limit should start at the capture of the first fish and end when the last fish is placed in a (b)(4). Please provide information about the harvest techniques and type of vessel(s) you use in your response to this letter.
Your listed critical limit implies that the harvest vessels from which you receive your fish do not routinely (b)(4) and do not (b)(4). FDA recommends that vessels ice their fish onboard because failure to chill onboard may permit bacteria and enzymes, including those that form scombrotoxin (histamine), to increase unnecessarily. FDA also recommends monitoring internal temperatures of a representative number of chilled fish as they are off-loaded from the vessels. Monitoring internal temperatures helps to ensure that appropriate onboard chilling was accomplished in a timely manner and is one component of an overall scombrotoxin (histamine) prevention strategy.
b. At the "(b)(4)" critical control point, your plan identifies the critical limit "(b)(4)." It appears from the information you provided that your firm is not located near the wharf where the fish are off-loaded from the harvest vessels; therefore, FDA recommends critical limits for receipt of the fish following transit from the wharf to your facility that specify the fish be completely surrounded by ice at the time of delivery; this ensures proper icing during the transit period to your facility.
c. At the "(b)(4)" critical control point, your plan lists critical limits of "(b)(4)" and "(b)(4) of fish with freshness (b)(4)" that are not adequate to control decomposition. FDA's current recommendations for detecting decomposition in scombrotoxin-forming species are based on the detection of odors of persistent decomposition in a representative sample from each lot. Your listed critical limits do not fully describe your criteria for freshness so we are unable to determine if that criterion provides an adequate level of assurance of safety.
In addition, your monitoring procedure for controlling "Altered fish" does not include a critical limit for the number of sample units to be tested. FDA recommends conducting sensory evaluation on 118 fish per lot, or all fish when the lot is less than 118 fish.
d. At the "(b)(4)" critical control point, your plan identifies the critical limit of "(b)(4)/each reception (for canned product of USA)." Monitoring internal temperature of (b)(4) is recommended when off-loading fish from the vessel, but is not appropriate during storage periods. FDA recommends continuously monitoring the ambient temperature of the refrigerated storage room using a continuous time and temperature recording device, with a visual check of the record at least once daily. Alternatively, if the fish are stored under ice, your firm has the option of establishing a critical limit for the adequacy of the ice surrounding the fish and monitoring the adequacy of the ice as conditions warrant.
3. 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). Your firm's HACCP plan for canned sardines, canned mackerel and canned tuna products lists monitoring procedures at the "Fish Reception (Factory) (CCP1)" critical control point that are not adequate to control the hazard of scombrotoxin (histamine) formation. Specifically:
a. Your plan lists a monitoring procedure of controlling a "high level of histamine in the fish" by using the Spectrofluorimetric method at "Each reception." However, the HACCP plan does not indicate the number of sample units to be tested from each lot as part of the procedure. FDA recommends a minimum of 18 or more units, containing 250 - 454 grams of edible portion, collected randomly and representatively from each lot, with a greater number of sample units collected when the variability within a lot is expected to be large; please provide a description of your firm's sampling and testing procedures in your response to this letter.
4. Predetermined corrective action plans included in a firm's HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b). Your corrective action plans for canned fish at the "(b)(4)," and "(b)(4)" critical control points to control histamine formation are not appropriate.
a. At the "(b)(4)" critical control point, your listed corrective actions of "(b)(4)." and "No USA Or Reject the fish" do address the disposition of the product, but do not ensure that the cause of the critical limit deviation will be corrected.
b. At your "(b)(4)" critical control point, your listed corrective action plan of "(b)(4)" fails to include a corrective action to address the root cause of the deviation and does not ensure that the cause of the deviation will be corrected. Please provide a description of the analysis to which you referred in your HACCP plan in your response to this letter.
In addition, we suggest that when conducting your hazard analysis, your firm should also consider periods or processing steps where the fish are not refrigerated (e.g., not held under ice or held at ambient temperatures above (b)(4)). Processors must consider the overall cumulative exposures to the aforementioned non-refrigerated temperature conditions throughout processing, which may include multiple processing steps (e.g., (b)(4), to control histamine formation. FDA recommends that, because you are receiving fresh fish, the cumulative time exposure to ambient temperatures above 4.4°C (40°F) when the temperature exceeds 21°C (70°F) at any point in time at these unrefrigerated processing steps should be less than (b)(4) hours. The (b)(4) limit starts when the first fish is exposed to unrefrigerated conditions (i.e., ambient temperature above 40°F) and ends when the last fish undergoes the sterilization process.
We also note that your flow chart includes reference to a "(b)(4)." This may be a "(b)(4)" that many firms implement prior to the sterilization process. An adequate precook step that achieves a (b)(4) in the number of viable organisms associated with scombrotoxin (histamine) formation would allow your firm a cumulative exposure time of 4 hours from the start of unrefrigerated processing to the (b)(4)(i.e., rather than to the sterilization process). However, time and temperature exposures both before the (b)(4) and after the (b)(4) may still need to be limited to control scombrotoxin (histamine) formation as well as Staphylococcus aureus growth and toxin formation.
Additionally, when you receive fish that were not iced or properly (b)(4) on board the vessels, scombrotoxin (histamine) formation may continue during the (b)(4) window during processing. Your receiving critical limit for histamine is (b)(4); this critical limit is at the high end of FDA's recommended level and therefore does not provide for additional histamine formation that may occur during unrefrigerated processing. Please provide a study demonstrating that your HACCP controls will ensure that the histamine level of the fish you process will consistently remain (b)(4) throughout processing under "worst case" conditions in your response to this letter.
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 and all applicable regulations, including 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.
You should respond in writing within 15 working days from your receipt ofthis letter. Your response should outline the specific steps you are taking to correct the deviations cited. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans; five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan or plans; and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the applicable laws and regulations. Submission of the information in English will assist in our review. 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 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. You may view this alert at: http://www.accessdata.fda.gov/cms_ialialist.html.
Please send your reply to the U.S. Food and Drug Administration, Attention: Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment 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 via email at: Mildred.Benjamin@fda.hhs. gov.
Office of Compliance
Center for Food Safety
and Applied Nutrition