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Recipient NameMr. Mr. John Luff
Recipient TitleManaging Director
- Apia Export Fish Packers LTD
P.O. Box 2273
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park, MD 20740
Jan 8, 2020
Dear Mr. Luff:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Apia Export Fish Packers Ltd located at Fisheries Warf Savala lo, Apia, Western Samoa. on August 26 and 27, 2019. During that inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA-483, lnspectional Observations, listing the observations made at your firm. We acknowledge receipt of your response received via email on September 10, 2019. Your response included an undated revised HACCP plan, entitled "Chilled and Frozen Fish," as well as blank monitoring records. This documentation does not demonstrate that your firm has corrected the violations listed below.
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 fresh tuna, is adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page at www.fda.gov.
Your significant deviations are as follows:
1. 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). 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 firm's revised HACCP plan for "Chilled and Frozen Fish", which covers your fresh tuna products that you provided with your September 10, 2019, response does not list the critical control point of chilled storage (i.e., holding prior to shipping/flights) for controlling the food safety hazard of scombrotoxin (histamine) formation.
2. 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 revised HACCP plan for "Chilled and Frozen Fish", which covers your fresh tuna products that you provided with your September 10, 2019, response lists critical limits at the "(b)(4)" critical control point that are not adequate to control the food safety hazard of scombrotoxin (histamine) formation that is reasonably likely to occur onboard the harvest vessels. Your firm is was observed to be a (b)(4) processor, receiving the fish directly from the harvest vessels. Consequently, in order to ensure that fish were properly handled while onboard the vessels in manner that controls scombrotoxin (histamine) formation that is reasonably likely to occur onboard the harvest vessels, FDA recommends that, in addition to your critical limits of internal temperature of the fish and sensory examination at receipt, you establish critical limits for harvest vessel records or histamine testing.
• For the harvest vessel record strategy, FDA recommends that all scombrotoxin-forming fish lots received are accompanied by harvest vessel records that show:
o Fish exposed to air or water temperatures above 83°F (28.3°C) were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not longer than 6 hours from the time of death;
o Fish exposed to air and water temperatures of 83°F (28.3°C) or less were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not longer than 9 hours from the time of death;
o Fish that were gilled and gutted before chilling were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not longer than 12 hours from the time of death;
o Fish that were harvested under conditions that expose dead fish to harvest waters of 65°F (18.3°C) or less for 24 hours or less were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not more than the time limits listed above, with the time period starting when the fish left the 65°F (18.3°) or less environment;
o Other critical limits for onboard handling (e.g., maximum refrigerated brine or seawater temperature, maximum fish size, maximum fish to brine/seawater/ ice ratio, maximum initial temperature of the fish) necessary to achieve a cooling rate that will prevent development of an unsafe level of histamine in the specific species, as established through a scientific study.
o For fish held refrigerated (not frozen) onboard the vessel:
• The fish were stored at or below 40°F (4.4°C) after cooling;
• The fish were stored completely and continuously surrounded by ice after cooling.
• For the histamine testing strategy, FDA recommends:
o Analysis of a representative sample of scombrotoxin-forming fish shows less than 50 ppm histamine in all fish in the sample.
Further, it is not clear whether your corrective action plans at the "(b)(4)" critical control point ensure that no adulterated product enters commerce. The corrective action of "(b)(4)" should clarify that the you will "(b)(4)", not just individual fish from the lot.
3. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm was observed to not be monitoring the "(b)(4)" or "(b)(4)" at the "(b)(4)" critical control point to control the scombrotoxin (histamine) formation hazard listed in your HACCP plan for "Chilled and Frozen Fish", which covers your fresh tuna products.
4. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan in your revised HACCP plan for "Chilled and Frozen Fish", which covers your fresh tuna products that you provided with your September 10, 2019, response is not adequate at the "(b)(4)" critical control point to control the hazard of scombrotoxin (histamine) formation. In addition to your listed corrective action of rejecting the lot when deviations occur from your critical limits for internal temperature of the fish, FDA recommends that you also discontinue use of the supplier until evidence is obtained that the identified harvesting and onboard practices and controls have been improved to ensure the cause of the deviation is corrected.
FDA recommends that firms include the following monitoring procedures in their HACCP plans at receiving:
For internal temperature measurement:
o The internal temperature of fish using a temperature-indicating device (e.g., a thermometer) to measure the internal temperature of a representative number of the largest fish in each lot at the time of off-loading from the harvest vessel. concentrating on any that show signs of having been mishandled (e.g., inadequately iced) for every lot of scombrotoxin-forming fish received. For example, when receiving 10 tons or more of fish, measure a minimum of one fish per ton, and when receiving less than 10 tons of fish, measure a minimum of one fish per 1,000 pounds. Measure a minimum of 12 fish, unless there are fewer than 12 fish in the lot, in which case measure all of the fish. Randomly select fish from throughout the lot. Lots that show a high level of temperature variability or lots of very small fish may require a larger sample size.
o Date and time of off-loading by visually determining the date and time of off-loading for every lot of scombrotoxin-forming fish received.
For sensory examination:
o Amount of decomposition in the lot by examining at least 118 fish, collected representatively throughout each lot (or the entire lot, for lots smaller than 118 fish) for every lot of scombrotoxin-forming fish received. Additional fish should be examined if variability in fish-to-fish histamine content is expected to be high. Lots should consist of only one species of fish; for vessels delivering multiple species, testing should generally be done separately on each species. All fish within a lot should have a similar history of harvest.
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. More specifically, your response should include documentation and information that would assist us in evaluating your corrections, such as a copy of your revised HACCP plan, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, and any additional information that you wish to supply. 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 believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.
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 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 Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117 Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Additionally, section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
Please send your reply to Food and Drug Administration, Attention: Kerry Kurdilla, Compliance Officer, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Kerry Kurdilla via email at firstname.lastname@example.org. Please reference CMS# 598015 on any submissions and within the subject line of any emails to us.
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition