NOTE: The revision of this Import Alert (IA), dated 04/8/2025, updates the reason for alert section, guidance section, agency contacts, and charge section. Changes are bracketed by asterisks (***). Decomposition is detected by organoleptic (sensory) evaluation of fish and fishery products and/or by the presence of chemical indicators, such as histamine levels in ***scombrotoxin-forming (histamine-forming) fish species, and indole levels in shrimp. Sensory evidence of decomposition in scombrotoxin-forming (histamine-forming) species*** also serves as an indicator that the fish may have been exposed to time and temperature conditions suitable to scombrotoxin (histamine) formation, which can result in the product being unsafe. Histamine, when ingested at high levels, may result in scombrotoxin fish poisoning (SFP). Outbreaks of SFP have been traced to the consumption of multiple species of raw, frozen, canned, and processed scombrotoxin-forming fish such as tuna and mahi-mahi. In the United States (U.S.) between 1998 and 2017, there were 463 outbreaks of SFP involving 1,775 illnesses. ***In 2019 a multistate SFP outbreak occurred involving 51 illnesses from 11 states traced to imported frozen tuna, and between 2020 and 2024, FDA tracked 65 reported SFP outbreaks involving 110 illnesses.***
Seafood and seafood products, except: Mahimahi from Ecuador and Taiwan covered under Import Alert #16-05; Shrimp covered under Import Alerts #16-18 (from Bangladesh, Hong Kong, Indonesia, Taiwan, and Thailand); and #16-35 (from India); Canned shrimp from Thailand covered under Import Alert #16-22; Fresh and fresh frozen lobster/lobster tails from India covered under Import Alert #16-23; Frozen Raw and Cooked conch meat covered under Import Alert #16-31 (from the Dominican Republic)
For decomposition ***(including sensory evidence of decomposition in two subsamples or histamine greater than or equal to 35 ppm but below 200 ppm in one subsample or indole greater than or equal to 25 micrograms indole per 100 grams in two subsamples):*** "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food."[Adulteration, Section 402(a)(3)] OASIS charge code: FILTHY For histamine ***(single subsample with histamine greater than or equal to 200 ppm): *** "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance which would ordinarily render the article injurious to health. Contains: [Adulteration, Section 402(a)(1)] OASIS charge code: POISONORD
Divisions may detain without physical examination, shipments of the specified products from the firms identified on the Red List of this alert. ***When divisions encounter: 1. Multiple violative shipments of seafood products for: a. Sensory evidence of decomposition (Per RPM criteria detailed below) b. An appropriate chemical indicator of decomposition such as histamine (greater than or equal to ***35*** ppm but less than ***200*** ppm), or c. Indole (greater than or equal to 25 micrograms indole per 100 grams) from the same manufacturer or shipper, or 2. A single shipment where histamine levels could have adverse health consequences (greater than or equal to ***200*** ppm), a recommendation for addition to the Red List of this IA should be forwarded to DIO. *** If the above criteria is not met requests will be referred to HFP, Office of Compliance & Enforcement (OCE)/Imports Enforcement Branch (IEB)for evaluation on a case by case basis.*** *** Refer to Compliance Program CP 7303.842 � Seafood Processor, Products, and Importer Inspection Program for sample collection guidance and instructions on methodology for histamine or indole analysis. Compliance Policy Guide (CPG) 540.525 contains guidance for evaluating decomposition in scombrotoxin-forming fish and fishery products; Compliance Policy Guide (CPG) 540.370 contains guidance for evaluating decomposition in all other fish and fishery products.*** Per Chapter 9 of the Regulatory Procedures Manual (RPM), specific product(s) from an individual firm may be added to the Red List of this alert for decomposition violations when: a. There have been at least three (3) detentions in a recent six-month period or less; and b. These detentions represent at least 25% of the total shipments of that product examined in the applicable time period as known to the recommending district or unit. Release of Articles Subject to Detention Without Physical Examination (DWPE) under this Import Alert: In order to secure release of an individual shipment subject to DWPE under this import alert, the owner, consignee, or another responsible party to the shipment should provide the results of private laboratory analysis of a representative sample of the detained product which demonstrates that the product does not contain decomposition, histamine, or indole. For scombrotoxin-forming (histamine-forming) species of fish, both decomposition and histamine analyses are required to be submitted. ***Relevant sampling and analytical records should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. For further information regarding private laboratory analyses, please reference FDA's ORA Lab Manual, Volume III, section 7. Following receipt and review of private laboratory results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article. *** Removal from Detention Without Physical Examination (REMOVE FROM RED LIST): In order to remove a firm's product from DWPE, information should be provided to FDA to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). FDA recommends a firm requesting removal from DWPE provide the following information: 1. Results of the firm's investigation(s) into the problem (i.e. failure to prevent contamination with decomposition), 2. Documentation showing corrective action(s) taken in response to the findings of this investigation. This should include, at a minimum: a. A description of current manufacturing processes; and b. Documentation confirming a minimum of five (5) consecutive import entries have been released by FDA based on private laboratory analyses. For further guidance on removal from DWPE refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)" https://www.fda.gov/media/71776/download If a firm and/or a representative thereof would like to request removal from DWPE under this Import Alert, all relevant information supporting the request should be forwarded to Importalerts2@fda.hhs.gov ***Questions or issues involving import operations should be addressed to OII Division of Import Operations (DIO) at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov. Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov. Questions or issues with regard to human food on policy, sample collection recommendations or any additional questions not directly related to a detained (or live) entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov ***
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: NOTE: The revision of this Import Alert (IA), dated 04/8/2025, updates the reason for alert section, guidance section, agency contacts, and charge section. Changes are bracketed by asterisks (***). Decomposition is detected by organoleptic (sensory) evaluation of fish and fishery products and/or by the presence of chemical indicators, such as histamine levels in ***scombrotoxin-forming (histamine-forming) fish species, and indole levels in shrimp. Sensory evidence of decomposition in scombrotoxin-forming (histamine-forming) species*** also serves as an indicator that the fish may have been exposed to time and temperature conditions suitable to scombrotoxin (histamine) formation, which can result in the product being unsafe. Histamine, when ingested at high levels, may result in scombrotoxin fish poisoning (SFP). Outbreaks of SFP have been traced to the consumption of multiple species of raw, frozen, canned, and processed scombrotoxin-forming fish such as tuna and mahi-mahi. In the United States (U.S.) between 1998 and 2017, there were 463 outbreaks of SFP involving 1,775 illnesses. ***In 2019 a multistate SFP outbreak occurred involving 51 illnesses from 11 states traced to imported frozen tuna, and between 2020 and 2024, FDA tracked 65 reported SFP outbreaks involving 110 illnesses.***
Country-specific information is available in the full alert detail on the FDA website.
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