"Detention Without Physical Examination of Mahimahi from Ecuador and Taiwan Due to Histamine and Decomposition"

Reason for Alert

Note: The revision of this Import Alert (IA) dated 02/21/2025 updates the guidance section, agency contacts and charge code section. Changes to the import alert are bracketed by asterisks (***). In March 1980, the Center for Disease Control reported that mahi-mahi (dolphin fish) accounted for 40% of the scombrotoxin-fish poisoning (SFP) outbreaks reported in the United States. Also, during March 1980, FDA received reports of 10 separate scombrotoxin-fish poisoning incidents involving about 70 people. As a result, on April 28, 1980, the districts were instructed to sample and analyze, for histamine, 100% of all shipments of mahi-mahi offered for entry from all countries. On July 8, 1980, the districts reported that they sampled and analyzed 73 shipments of mahi-mahi from China, Ecuador, Peru, and Taiwan. From this data, it was determined that all shipments of mahi-mahi from Ecuador and Taiwan met the criteria for detention without physical examination (DWPE). In the latter part of FY 80, LOS-DO organoleptically detected decomposition in 11 of 24 (46%) of mahi-mahi samples from Ecuador and Taiwan. Mahi-mahi may be decomposed without toxicologically significant levels of histamine. Thus, all Division import personnel must be alert to the possibility of significant decomposition problems in mahi-mahi, even when toxicologically significant histamine levels are not noted. Odors of spoilage are not necessarily found in the same part of fish where histamine is found. Sample results as well as a number of reported illnesses attributed to imported mahi-mahi indicate continuing problems with histamines and decomposition in mahi-mahi from Ecuador.

Product Description

Mahi-mahi (Coryphaena spp.,dolphin, dolphinfish) raw, fresh or frozen, including all product types/forms

Charge

*** 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 and/or *** For decomposition: (including sensory evidence of decomposition in 2 subsamples or histamine greater than or equal to 35 ppm but below 200ppm in 1 subsample): *** 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

Guidance

Divisions may detain, without physical examination, all shipments of mahi-mahi from Ecuador and Taiwan, except those firms identified on the Green List of this alert. Mahi-mahi entries found to have Decomposition and/or Histamine from countries other than Ecuador and Taiwan are covered under Import Alert # 16-105, �Detention Without Physical Examination of Fish and Fishery Products from Specific Manufacturers/Shippers Due to Decomposition and/or Histamine, and/or Indole.� Compliance Policy Guide (CPG) 540.525 contains guidance for evaluating histamine and/or decomposition in scombrotoxin-forming fish and fishery products. Release of Articles Subject to Detention Without Physical Examination 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 or histamine. Both decomposition and histamine analyses are required to be submitted. Third-party laboratories may use any methods that are found acceptable to FDA.*** 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 (Add to Green List): In order to remove a firm's product from DWPE, information should be provided to the Agency 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 detention without physical examination, refer to FDA's 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 would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be sent via email 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 Imports@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 HFP-OCE-Office of Enforcement at HFP-OCE-OfficeofEnforcement@fda.hhs.gov ***

Affected Countries (2)