Inspections, Compliance, Enforcement, and Criminal Investigations
Sol Fish Traders 11/21/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD
November 21, 2012
VIA EXPRESS DELIVERY
Sol Fish Traders
General Santos City, Philippines
I.D. # 328899
Dear Ms. Yap:
In response to a request by the US Food and Drug Administration (FDA) for information associated with the processing of your tuna products, your firm provided your HACCP plan and supporting documentation for your tuna in an email dated May 19, 2012. Our evaluation of these documents revealed 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, 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 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 serious 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." However, your firm’s HACCP plan for (b)(4) does not list the food safety hazards of parasites and undeclared allergens.
a. With regard to parasites, your product description indicates that the tuna may be intended for raw consumption. Additionally, your Hazard Analysis Worksheet indicates that parasites (b)(4). Consequently, your firm is responsible for control of the parasite hazard.
b. With regard to undeclared allergens, your firm is responsible for ensuring the fish species is accurately declared on the labels to control the hazard of undeclared allergens (i.e., from the fish protein).
2. You must have a HACCP plan that at a minimum lists the critical control points 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 HACCP plan for (b)(4) lists only one critical control point, which is receiving.
Your process flow diagram references steps in your process such as (b)(4). Based on the reference to (b)(4), your firm needs to include a critical control point to ensure that the fish are maintained at or below the referenced temperature limit. Furthermore, because histamine formation is cumulative and because your products are intended as ready to eat (i.e., without a cook step), your firm needs to assess all processing steps where the fish are held unrefrigerated for significant periods of time to prevent time and temperature abuse. Alternatively, your firm may control temperatures at or below 4°C or implement the use of ice, to include monitoring the adequacy of the ice during processing with sufficient frequency to ensure proper cooling.
3. 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 (b)(4) does not list a critical limit at the receiving critical control point for decomposition. FDA recommends a sensory examination that includes checking for noticeable and persistent odors of decomposition be completed. FDA also recommends that a processor reject the lot if 2.5% or more fish are found to be decomposed.
4. 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 (b)(4) does not list adequate monitoring procedures and frequency at the receiving critical control point associated with your histamine testing strategy to control histamine formation. Specifically, FDA recommends that firms test a minimum of 18 fish collected representatively throughout each lot (or the entire lot when there are fewer than 18 fish in the lot) to ensure a sufficient number of samples are collected to check for histamine formation. Additionally, the plan should also include the specific method of testing for histamine analysis.
5. Since you chose to include corrective actions 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 Fresh Chilled Whole Tuna at the Receiving critical control point is not adequate to control histamine formation.
a. The HACCP plan fails to include a corrective action for regaining control over the operation after a critical limit deviation. FDA recommends discontinuing the use of the supplier until evidence is obtained that the supplier’s practices have improved.
b. The corrective action related to internal temperature monitoring is inappropriate because it does not prevent distribution of potentially adulterated products. For example, when internal temperatures exceed the listed critical limits, FDA recommends that firms conduct histamine analysis on a minimum of 60 fish representatively collected from throughout the lot, including any fish found to have temperatures that exceed the critical limit.
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 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: 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
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition