DEPARTMENT OF HEALTH & HUMAN SERVICES
January 31, 2012
Xavier I. Sanchez
Km 34 ½ Carretera Nueva A Leon
Frente a cementeria Hocim
Dear Mr. Sanchez:
We inspected your seafood processing facility, located at Km 34 ½ Carretera Nueva A Leon, Leon, Nicaragua, on August 15-16, 2011. 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 scombrotoxin (histamine) forming fish are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
The seafood HACCP regulation requires that you implement a preventative system of food safety controls known as Hazard Analysis Critical Control Point (HACCP). HACCP involves:
- Identifying food safety hazards that, in the absence of controls, are reasonably likely to occur in your products; and
- Having controls at each “critical control point” in the processing operation to eliminate or minimize the likelihood that the identified hazard will occur.
HACCP provides a systematic way to identify, implement, and document those measures that demonstrate to FDA, to your customers, and to consumers that you are routinely practicing food safety by design. During our review of your plan, we found shortcomings that are violations of the seafood HACCP regulation.
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 serious deviations from the requirements of the Seafood HACCP regulation:
- 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 plans for “Fresh Whole Fish” and “Frozen Whole Fish” intended as your plan to address the hazard of scombrotoxin (histamine) formation,
- Fails to list adequate critical limits at the Receipt of raw material critical control point (CCP) to control histamine formation. In addition to the sensory evaluation and internal temperatures, FDA recommends that your firm also include controls, such as histamine testing or obtaining harvest vessel records to ensure that the fish were handled safely after capture aboard the vessel. Some examples of control strategies are noted on page 125-149 of the 4th Edition of the Hazard Guide.
- List an inadequate critical limit for the CCP of “Raw Material Storage Conservation.” and The plan lists “ ”.b(4) FDA does not consider monitoring cumulative exposure times during storage appropriate as a critical limit because of the difficulty in tracking the specific products and the individual cumulative temperatures exposures of those products. FDA recommends for products stored under ice that firms ensure that products are completely and continuously surrounded by ice throughout the storage period. FDA further recommends that firms make a visual observation of the adequacy of ice on a representative number of containers with sufficient frequency to ensure control. Please refer to pages 146-149 of the 4th Edition of the Hazard Guide.
Your firm may want to consider the need for a processing CCP, to address exposure times when the fish are held at unrefrigerated temperatures/un-iced. For additional information related to processing please refer to pages 142-145 of the 4th Edition of the Hazard Guide.
- Because you chose to include a corrective actions in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for “fresh whole fish” and “frozen whole fish” at the Raw Material Storage and Conservation CCPs to control histamine is not appropriate. Your corrective action at the Raw Material Storage and Conservation CCP, that lists only “histamine test”, is not adequate because it does not provide any information related to your sample strategy and the outcome of the tests. For example,
FDA recommends that you also specify how many fish you will test and your criteria for the rejection of the lot. Currently FDA recommends when histamine testing is performed as a corrective action, a minimum of 60 fish collected from throughout each affected lot should be sampled. Destroy the lot or divert it to a non-food use if any fish is found with histamine greater than or equal to 50 ppm.
Your firm’s labeling for wild caught fresh whole fish lists b(4) a unique identifier that should not be made available to the public. We suggest that your firm remove this number from your labels.
For additional information regarding FDA’s recommended controls for Scombrotoxin (Histamine) Formation please refer to Chapter 7 of the Fish and Fisheries Products Hazards and Controls Guidance; Fourth Edition, which can be found on FDA’s website at”
This letter may not list all your deviations from the requirements of the Act or applicable regulations. You are responsible for ensuring that your processing plant operates in compliance with the Act, 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 respond within thirty (30) working days from your receipt of this letter. You should include in your response documentation such as a copy of your revised HACCP plan, copies of monitoring and verification records, or other useful information that would assist us in evaluating your corrections.
Please send your reply to the Food and Drug Administration, Attention: Standra Purnell, 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. Purnell by phone at (240) 402-1613 or via email at firstname.lastname@example.org.
Kathleen Lewis, J.D.
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition