Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD|
AUG 28, 2012
VIA EXPRESS DELIVERY
Neil del Rosario
Rell & Renn Seafood Sphere, Inc.
RRCS Complec, Banisil, Brgy. Tamlber
General Santos City 9500
Dear Mr. Rosario:
The US Food and Drug Administration (FDA) has evaluated your firm’s HACCP plan for tuna products and supporting documentation. Our evaluation 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). You provided these documents in response to FDA’s request for a copy of your firm’s HACCP plan or plans for your various fish and fishery products. Your firm responded by email on April 10 and 21, 2012. 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 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 Fresh-Frozen Yellowfin Tuna does not list the following food safety hazards:
a. Clostridium botulinum: Your products are raw, frozen, and vacuum-packaged. Vacuum packaging creates an anaerobic environment that may, under certain conditions, be conducive to Clostridium botulinum toxin formation. Your firm should identify the hazard of Clostridium botulinum as a food safety hazard in your HACCP plan.
The sole barrier to toxin formation by certain Clostridium botulinum organisms during finished product storage and distribution is freezing. Once your plan identifies the hazard, your plan should be revised to include a critical control point to address the hazard. FDA recommends that the critical control point include a label review to ensure that all labels instruct the end users to maintain the product under frozen conditions. Some examples of language include “Keep Frozen” and “Important, keep frozen, thaw under refrigeration immediately before use.”
b. Pathogen growth: Some of the products covered by this plan are reasonably likely to be consumed raw. Consequently, your plan should identify the hazard of pathogen growth and should include appropriate time and temperature controls to control the hazard.
c. Undeclared allergens: Fish is identified as one of the eight major allergens. Your HACCP plan should identify allergens as a food safety hazard. Once identified as a food safety hazard, your HACCP plan should include a critical control point for a label review to ensure that the finished product labels accurately identify the species of fish.
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 Fresh-Frozen Yellowfin Tuna plan does not list critical control points to control the hazard of histamine formation. Specifically, your HACCP plan only lists two critical control points, one for (b)(4) and the other for (b)(4). We note however, that your Product Flow Diagram and your Hazard Analysis Worksheet include references to numerous other steps that need to be accounted for in your HACCP plan. For example:
a. Your hazard analysis worksheet includes multiple processing steps such as (b)(4) that, when combined, may cumulatively expose the fish to time and temperature conditions that are conducive to excessive histamine formation when uncontrolled. Consequently, your HACCP plan for Fresh-Frozen Yellowfin Tuna should either list these steps as individual critical control points; or list them together, as one critical control point to ensure that cumulatively the fish are not exposed to excessive time periods at unrefrigerated (i.e., ambient) temperatures. FDA recommends that the processing steps ensure that fresh fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 4 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C). Alternatively, your firm may choose to continuously control temperatures at or below 40°F (4.4°C) during processing, in which case your firm will not need to control any corresponding time limits.
b. Your hazard analysis worksheet includes a (b)(4) step and a (b)(4) step that each may expose the fish to potential time and temperature abuse conducive to excessive histamine development when uncontrolled. FDA recommends during extended holding, chilling, or in-process storage periods that firms ensure the products are continuously maintained at proper temperatures to prevent excessive histamine development. This could include critical limits and monitoring procedures at these critical control points, either ensuring that the fish are completely and continuously surrounded by ice throughout all storage periods for fish that are held on ice; or ensuring the ambient temperatures of the coolers are continuously monitored and recorded to ensure that fish are maintained at or below 40°F during all storage periods for fish held in refrigerated rooms or chilling units.
3. 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-Frozen Yellowfin Tuna at the Receiving critical control point to control histamine is not appropriate.
a. When your critical limits for histamine testing and decomposition are exceeded, your corrective action within your plan does not address correcting the cause of the deficiency to prevent its re-occurrence.
b. When your critical limit for internal temperature is exceeded, your corrective action within your plan lists that you will conduct verification testing on fish that (b)(4). FDA recommends that when your temperature critical limit has been exceeded, your firm test a minimum of 60 fish in the lot or test the entire lot for histamine, rather than testing only the individual fish exhibiting elevated temperatures. The condition of the entire lot should be assessed because elevated internal temperatures of individual fish indicate that the entire lot may have been exposed to abusive conditions.
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
Office of Compliance
Center for Food Safety
and Applied Nutrition