Inspections, Compliance, Enforcement, and Criminal Investigations
Land Ice and Fish Limited 1/9/08
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
JAN 09 2008
VIA OVERNIGHT MAIL
Land Ice and Fish Limited
Mariner's Haven Compound
Western Main Road
Chaguaramas, Trinidad West Indies
Dear Sir or Madam:
On September 4th through 10th, 2007 a representative of the United States Food and Drug Administration (FDA) conducted an inspection of a fish and fishery products importer located in the United States(Nu-Wave Seafood Consultants, LLC in Barnegat Light, New Jersey) to assess that importer's compliance with the United States' Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123), referred to as the seafood HACCP regulation. That importer was found to be importing various fish and fishery products from your processing facility. During the inspection of that importer, we collected a copy of your firm's HACCP plan for fish you provide to the importer, namely, Yellow Fin Tuna, Big Eye Tuna, Albacore Tuna, Mahi Mahi, and Wahoo. Our evaluation of that HACCP plan (copy attached) revealed 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 to have and implement a HACCP plan that complies with this section, or otherwise operate in accordance with the requirements of 21 CFR Part 123, renders the fishery products adulterated within the meaning of section 402(a)(4) of the U.S. Federal Food, Drug and Cosmetic Act (the Act), [21 USC § 342(a)(4)]. Accordingly, your firm's Yellow Fin Tuna, Big Eye Tuna, Albacore Tuna, Mahi Mahi, and Wahoo are adulterated within the meaning of the Act, in that the products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP regulation through links in FDA's home page at www.fda.gov.
We note the following significant deviations from the seafood HACCP regulation:
o Receiving of fish directly from the harvest vessels. Your firm's HACCP plan for Yellow Fin Tuna, Big Eye Tuna, Albacore Tuna, Mahi Mahi and Wahoo does not list a critical control point for receipt of the fish to control the hazard of histamine development. Histamine formation is expected to begin upon death because the defense mechanisms of the fish no longer inhibit the histamine forming bacteria. Histamine formation will continue if the fish are not properly handled on-board the vessels. As a control strategy, we suggest either obtaining harvest vessel records; or conducting histamine testing at the point of receipt. In addition, with regard to a sampling plan for decomposition, we suggest that you ensure that there is no more than 2.5% decomposition in each incoming lot by sampling a minimum of 118 fish per lot or the entire lot if the lot contains less than 118 fish.
o Storage of fish prior to distribution. Your HACCP plan does not list a critical control point for "Storage" that describes the procedures for proper packing to ensure temperature control of the fish prior to distribution. As such, this step is critical for control of histamine development, especially if the holding/storage time is extended.
For more information on the hazard of scombrotoxin (histamine) formation, as well as guidance in setting critical control points and critical limits, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: Third Edition, Chapter 7, found at: www.cfsan.fda.gov/~comm/haccp4.html
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as a copy of any revised HACCP plans, any verification records, and any other useful information that would assist us in evaluating your corrections. 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 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 regulations, 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: Mildred Benjamin, 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. Benjamin by phone at (301) 436-1424 or via email at Mildred.Benjamin@fda.hhs.gov
Joseph R. Baca
Office of Compliance
Center for Food Safety and Applied Nutrition