| Public Health Service Food and Drug Administration |
College Park, MD |
Department of Health and Human Services
WARNING LETTER
VIA OVERNIGHT MAIL
Chairman
International Fish Canners (Scotland) Ltd.
Bath Street
Fraserburgh,
United Kingdom AB43 9DY
Reference: #156832
Dear Mr. Cook:
On October 7 and 8, 2010, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of your canned seafood processing facility, located at Bath Street, Fraserburgh, United Kingdom. Upon review of our investigator’s inspection report and findings during the inspection, we determined that you have serious violations of 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. 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 canned sardines are adulterated, in that the products have been prepared, packed, or held under insanitary conditions 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 & Controls Guidance through links in FDA’s home page at www.fda.gov.
Your significant violations are as follows:
- 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 to comply with 21 CFR 123.6(a) and (c)(2). However, your firm’s HACCP plan for “Canned Sardines” lists only one critical control point, i.e., “receiving” prior to the start of the canning operation, to control scombrotoxin (histamine) formation. However, our inspection revealed several steps prior to the start of the canning operation that may result in time and temperature abuse conducive to the development of excessive scombrotoxin (histamine) formation. Scombrotoxin (histamine) formation is cumulative and all steps in the handling of the sardines, prior to the start of the canning operation, need to be evaluated to determine whether collectively or individually, the exposure times and temperatures occurring during those steps, will result in the need for one or more critical control points.
In addition, in accordance with 21 CFR Part 123.6 (b)(2), firms may only group product methods together if the food safety hazards, critical control points, critical limits and procedures, etc. are identical. However, your firm uses the same HACCP plan, i.e., “Canned Sardines” for both fresh sardines received directly from the harvest vessel and frozen sardines. It is expected that the critical control points, monitoring procedures, etc., will be different for these different activities associated with the two forms of the sardines. We suggest that you conduct a thorough hazard analysis for each form of sardines to assess the steps that are reasonably likely to result in histamine development due to time and temperature abuse, and develop a written HACCP plan, or separate plans, based on the results of the analysis. Using one plan for both types of sardines may be acceptable provided that the plan meets the more stringent receiving controls for receiving fresh product, as a primary processor receiving fish directly from the harvest vessels, as well as the more stringent controls for handling the frozen products prior to the start of the canning operation, such as during thawing of the frozen product.
With regard to handling the fish prior to start of the canning operation, we noted the following steps that may individually or cumulatively, pose a risk for histamine development:
- Holding chill step (immediately after receipt of fresh product);
- Factory chill step when thawed sardines are held in brine overnight until the next processing morning; and,
- Processing steps that may result in time and temperature abuse, for example, thawing of the frozen fish, head cutting, grading, brining, and hand packing).
With regard to your firm’s activities as a primary processor, receiving fish directly from the harvest vessels, your firm appears to be using a histamine testing strategy at receiving to control scombrotoxin (histamine) development and assess handling of the fish on-board the harvest vessels. Your HACCP plan lists a critical limit of “Histamine levels shall not exceed customer acceptance levels of (b)(4) at the “Fish Receiving” step; however, this is not adequate to control scombrotoxin (histamine) formation. Your firm currently analyzes (b)(4), which is not enough fish to represent the entire lot. FDA recommends that the analysis be done on a representative number of fish in the lot (i.e., 18 fish minimum). When a vessel lot consists of very small fish, multiple fish should be collected until (b)(4). The histamine test your firm is using is not quantitative as it produces a color change only if (b)(4) histamine in the sample. In addition, FDA recommends that, when compositing the sample, the histamine critical limit be reduced according to the number of samples comprising the composite (i.e., if compositing 3 fish then histamine critical limit should be (b)(4)). We suggest that your firm validate your histamine test method such that it provides reliable results under the specific conditions for which you are using as it applies to your HACCP plan.
Your HACCP plan does not include temperature monitoring and sensory examination critical limits as receiving controls for fresh fish when your firm acts as a primary processor receiving fish directly from the harvest vessels.
- You must 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). However your firm’s HACCP plan for “Canned Sardines” does not list the food safety hazard of metal inclusion. Your sardines are mechanically transported and processed throughout preparation (grading, head cutting, brining) prior to being packed into cans and therefore metal inclusion is a hazard that is reasonably likely to occur in your facility. In addition, fish are conveyed on metal mesh baskets which move above open cans of product.
- You must adequately monitor sanitation conditions and practices during processing to comply with 21 CFR 123.11(b). However, your firm is not maintaining sanitation control records that document monitoring and corrections of sanitation deficiencies for protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, and control of employee health conditions. We acknowledge that your firm has written standard sanitation operating procedures and pre-requisite programs in place for the majority of items that need to be monitored, but there is no evidence that demonstrates that your firm is monitoring these areas with sufficient frequency.
You should respond to us in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations, including documentation such as copies of any revised HACCP plans, at least five (5) product days worth of HACCP and sanitation monitoring records to demonstrate that you have implemented the revised plan, any verification records, and other useful information that would assist us in evaluating your corrections. In addition, we would like you to provide explanation of how your firm determines each “lot” of product to ensure that a lot pertains to specific lots of fish from individual vessels.
If you cannot complete all corrections before the 30 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 action to refuse admission of your canned sardine 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. This procedure is generally based on past history or other information, such as an inspection of a facility or HACCP plan review, indicating that the factory producing the product or the product itself may not be in compliance with FDA’s laws and regulations. DWPE information is conveyed in FDA’s Import Alerts. 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, the Seafood HACCP regulations, the Low-Acid Canned Food regulations (21 CFR 108 and 113), 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: Robyn Jones, 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. Jones by phone at (301) 436-2575 or via email at Robyn.Jones@fda.hhs.gov.
Sincerely,
/S/
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety and Applied Nutrition
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