"Detention Without Physical Examination of All Dried Shark Fins, Dried Fish Maws and Dried Shark Cartilage Powder from Shark Fins Due to Filth"

Reason for Alert

Note: The revision of this Import Alert (IA) dated 07/25/2024 updates the name of the alert, reason for alert, guidance section including agency contacts, product description section and product codes. Changes to the import alert are bracketed by asterisks (***). Insect, rodent or other animal filth have long been a problem with dried shark fins of all types and dried fish maws (***fish maws are fish swim bladders***). The FY-93 national detention data identified over 160 detentions from more than 20 countries. This import alert replaces Import Alert #16-01 "Automatic Detention of Shark fins (Sharkfin Cake) From Hong Kong", and Import Alert #16-02, "Automatic Detention of Dried Shark Fins And Dried Fish Maws From Talle, Ecuador " and combines and expands both alerts. The violation rate for both products has remained the same, and criteria for detention without physical examination have been met for expansion to world-wide. Because no non-violative geographical area can be identified, both products are on detention without physical examination on a world-wide basis.

Product Description

***Dried Shark Fins (All types, e.g., whole, shredded, cakes) Dried Fish Maws and Dried Shark Cartilage Powder (utilizing dried shark fins as the source material)***

Charge

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or to be otherwise unfit for food [Adulteration, Section 402(a)(3)]. OASIS charge code - FILTHY

Guidance

***Divisions may detain, without physical examination, all shipments of dried shark fins, dried fish maws, and dried shark cartilage powder derived from shark fins, except those listed on the Green List of this Import Alert. Dried shark fins (all types, e.g., whole, shredded, cakes) dried fish maws, and shark cartilage powder shall be examined for filth.*** Release of Articles Subject to Detention without Physical Examination Under this Import Alert: In order to secure release of an individual shipment identified for detention without physical examination under this import alert, the owner, consignee and/or another responsible party ***for the affected goods should provide the results of private laboratory analysis of a representative sample(s) of the shipment as evidence that the product does not bear or contain unacceptable levels of filth.*** The responsible parties should use the following information as a template when submitting third party sampling and private lab analytical results in an attempt to overcome the apparent violation: 1. Samples should be collected by a third party and tested by a private laboratory qualified in the analyses; 2. Each sample should consist of ***6 subsamples, containing minimum 900g -> 1.36kg (2-3lb) per subsample (see CP7303.842; or, 6 subsamples*** per lot of consumer sized packages containing up to one pound (1 lb.); or; For consumer sized packaging in excess of one pound (1 lb.) or other unique sample collection situations, please contact CFSAN for further guidance. Proper sampling and analytical records should be submitted to the appropriate FDA Division compliance office for consideration per the notice of detention. All analytical findings should be submitted to FDA regardless of the final results. For further information regarding private laboratory analyses, please reference FDA's Laboratory Procedure-Private Laboratory Analytical Packages. 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 (ADDITION TO THE GREEN LIST): In order to **add a firm to the Green List***, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future shipments will be in compliance. For guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, Chapter 9, Detention Without Physical Examination (DWPE). If a firm would like to petition to be added to the Green List of this Import Alert, all relevant information supporting the request should be forward to the following address: Food and Drug Administration Division of Import Operations 12420 Parklawn Drive, ELEM-3109 Rockville, MD 20857 Or, be sent via email to: Importalerts2@fda.hhs.gov Questions or issues involving import operations should be addressed to OII/DIO (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 entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov ***

Affected Countries (1)