Detention Without Physical Examination of All Dried Shark Fins and Dried Fish Maws Due to Filth

NOTE: Revision to this Import Alert dated June 28, 2012 contains minor editorial corrections and updated sampling instructions. Changes noted and bracketed by three asterisks (***).

Insect, rodent or other animal filth have long been a problem with dried shark fins of all types and dried fish maws. 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.

Districts may detain, without physical examination, all shipments of dried shark fins, dried fish maws, and dried shark cartilage powder derived from shark fins/maws, 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 according to the procedures outlined in LIB 2957, Examination of Dried Fish for Microscopic Filth. Contact the Division of Field Science for a copy of the Laboratory Information Bulletin.

***In order to secure release of an individual shipment subject to detention without physical examination under this import alert, the owner, consignee and/or another responsible party to the shipment should provide the results of private laboratory analysis of a representative sample of the shipment. The evidence submitted should demonstrate compliance of the article in that the product does not appear to 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 10 subsamples, containing one pound (1 lb.) per subsample;
or,
10 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 District 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 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.

In order to remove a firm from detention without physical examination, 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 wishes 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 and Policy (HFC-170)
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or, be sent via email to: Importalerts2@fda.hhs.gov

For questions or issues involving import operations, contact the Division of Import Operations & Policy at (301) 796-0356.

For questions or issues concerning preparation of sample for analysis or analytical methodology, contact the Division of Field Science at (301) 796-6600.

For questions on policy or sample collection recommendations, contact the Office of Compliance, Division of Enforcement, CFSAN at (240) 402-1750 or via email at: CFSANEnforcement@fda.hhs.gov

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

"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, (insect, rodent, and/or other animal filth), or to be otherwise unfit for food [Adulteration, Section 402(a)(3)]."

OASIS charge code - FILTHY