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Enforcement Actions

Blue Marine Seafoods Trading 11/9/12

  

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

Public Health Service
Food and Drug Administration
 College Park, MD  20740

 

November 9, 2012
WARNING LETTER
 
 
VIA EXPRESS DELIVERY
 
Marelle U. Villa
Quality Assurance Officer
Blue Marine Seafoods Trading
9500 Fish Port Complex
Barangay Tambler,
General Santos City, South Cotabato
Philippines
 
Reference number:  328901
 
Dear Ms. Villa:
 
This letter is in response to the documentation your firm provided on April 18, 2012, in response to the request by the U.S. Food and Drug Administration (FDA). In our request, FDA asked for copies of your firm’s most recent HACCP plans, monitoring records, hazard analysis and product flow diagrams for your tuna products. The documentation your firm provided on April 18th included the HACCP plan for “Fresh Frozen Yellowfin Tuna Fillet Treated With Filtered (Tasteless) Smoke,” monitoring records, and a process flow diagram. Our evaluation of the documentation found that your firm has 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). This letter describes the deviations found as a result of our review of the documentation, provides next steps for your firm, and gives our contact information.
 
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 frozen tuna products are adulterated, in that they have been prepared, packed, or held 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: 4th Edition (the Hazard Guide) through links in FDA’s home page at www.fda.gov.
 
We note the following significant deviations:
 
  1. 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 (CCPs) to comply with 21 CFR 123.6(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." However, your firm’s HACCP plan for your frozen tuna products does not list the following critical control points for controlling the food safety hazards of histamine formation and pathogen growth in fish intended for raw consumption:
    1. A processing CCP to control excessive histamine formation and pathogen growth.
1) To control histamine formation, FDA recommends monitoring ambient (e.g., air) temperatures.
2)  To control pathogen growth, FDA recommends:
a)  monitoring product surface temperature or ambient temperature when the ambient temperature is warmer than the product internal temperature.
b) monitoring internal fish temperature in the center of the thickest part of the fish when the ambient temperature (e.g. air, ice, and brine) is cooler than the product internal temperature.   
    1. A pre-chilling CCP to control pathogen growth and histamine formation.
    1. A (b)(4) CCP to control Clostridium botulinum toxin formation and histamine formation. (b)(4) pose a hazard for Clostridium botulinum growth and toxin formation because they are conducted for an extended time period under anaerobic conditions. Consequently, once your HACCP plan has been revised to include a critical control point for the (b)(4) and/or the (b)(4), your HACCP plan needs to include adequate critical limits. Specifically, your plan needs to ensure that temperatures are maintained below 3.3° C for the duration of the (b)(4) to control toxin formation. Additionally, FDA recommends that firms use equipment capable of continuously monitoring and recording the temperatures for the entire duration of the (b)(4).
    1. (b)(4) CCPs to control Clostridium botulinum toxin formation, pathogen growth and histamine formation
    1. A (b)(4) CCP to control Clostridium botulinum toxin formation during those instances where there is an accumulation of product prior to freezing.  Your processing records suggest that product is accumulated prior to freezing, subsequent to (b)(4). Consequently, the product should be maintained below 38°F (3.3°C) until it is (b)(4).
  1. 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." However, your firm’s HACCP plan for your frozen tuna products does not list a critical limit at the Receiving critical control point adequate to control histamine formation. 

a.  As a primary processor receiving the fish directly from the harvest vessels, your firm needs to include critical limits at receiving associated with sensory evaluation to monitor for decomposition, in addition to the listed critical limits associated with harvest vessel records and internal/backbone temperatures. FDA recommends conducting sensory evaluation on a minimum of 118 fish in each lot (i.e., each harvest vessel) or on all fish when the lots consists of less than 118 fish; and accepting the lot when less than 2.5% of the fish in the lot exhibit persistent odors or indicators of decomposition. Individual fish that exhibit persistent odors of decomposition should be rejected.

b.  It appears from the records your firm provided, specifically the (b)(4), that although you are a primary processor, your facility is not located directly at the wharf where the fish are unloaded from the boats. Consequently, your firm’s HACCP plan needs to include critical limits associated with receipt of the fish when in transit to your facility (i.e., from the wharf). Your firm needs to include critical limits to assure adequate and safe temperature conditions during transport to the plant. You may list the critical limits for transit control at receipt of product as a separate critical control point, or you may list the critical limits of this transit control as part of your overall receiving CCP that covers both receipt of product directly from the harvest vessels and receipt at your facility after transport.
 
  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 your frozen tuna products lists monitoring procedures/frequencies at the following critical control points that are not adequate to control histamine formation and pathogen growth for fish intended for raw consumption.
    1. The Receiving critical control point lists a monitoring procedure/frequency of “(b)(4)” that is not adequate because it does not specify that monitoring will be conducted at the wharf at the time of off-loading from the boats. This monitoring activity is intended to demonstrate adequate chilling of the fish while onboard the boats. Consequently, the temperatures need to be taken at the wharf, before the fish are loaded onto the vans for transit to your facility. 
    1. The “(b)(4)” critical control point lists a monitoring procedure/frequency (b)(4) that is not adequate because it does not address control of temperatures between those (b)(4). FDA recommends the use of equipment capable of continuously monitoring and recording temperatures for the entire duration of the chilling/curing time period, instead of (b)(4).
    1. The listed critical limits associated with harvest vessel records in your HACCP plan do not include the necessary monitoring parameters associated with the harvest vessel record strategy, to ensure that the fish were properly handled onboard the vessels. For example, your plan does not list that the harvest vessel records will include the following:
1)    method of capture
2)    time of capture of the fish/time of death
3)    method of cooling onboard the vessel
4)    time for the start of cooling after capture
5)    whether fish is headed and gutted
6)    time of landing the vessel
7)    water/air temperatures
8)    evidence of daily monitoring of refrigeration or icing aboard the vessel when applicable. 
 
  1. 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 are not appropriate, as follows:
    1. The “(b)(4)” critical control points do not include product disposition or address any actions to correct the cause of the deviation such as correcting chiller problems or identifying other causes for failure to meet the critical limit. In addition, the corrective action should include holding the product and evaluating the cumulative time and temperature exposures.
    1. The “(b)(4)” critical control does not include steps to correct the cause of the deviation, such as communication back to the supplier or discontinuation of use of the supplier and does not clearly define when corrections are to be taken.  (b)(4) of the fish is listed as a corrective action when backbone temperature is (b)(4) is not defined. 
 
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 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 or plans, any verification records, and any other useful information. 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 (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 and all applicable regulations, including the Seafood HACCP regulation and the current Good Manufacturing Practice regulation (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: Philip Bermel, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Assessment and 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 Mr. Bermel via email at Philip.Bermel@fda.hhs.gov 
 
                                                                       
Sincerely,
/S/ 
Michael Roosevelt                                                                                                                 
Acting Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition