Import Alert 16-31

Import Alert # 16-31

Published Date: 05/07/2024

Type: DWPE

"Detention Without Physical Examination of Frozen Raw and Cooked Conch Meat"

Note: The revision of this Import Alert (IA) dated 5/7/2024 updates the IA name, reason for alert, guidance section including agency contacts and product description. Changes to the import alert are bracketed by asterisks (***).

***This alert was published in 1985 for firms in the Dominican Republic, when it was determined that conch meat was being detained at a rate of 89.7% due to decomposition.

Decomposition occurs when fish and fishery products are not properly chilled or handled in accordance with Good Manufacturing Practices. Improper holding conditions may occur within the processing facility or prior to receipt of the conch meat by the facility. Since cooking will not eliminate decomposition, this import alert applies to both raw and cooked conch meat products.***

Divisions may detain without physical examination, all shipments of conch meat ***from the Dominican Republic, except from those firms listed on the Green List, which are exempt from detention without physical examination (DWPE).***

***Release of Articles Subject to Detention without Physical Examination Under this Import Alert:

In order to secure release of an individual shipment detained pursuant to this Import Alert, the importer (or owner, consignee and/or another responsible party to the shipment) should provide evidence which demonstrates that the product does not contain odors of decomposition. Such evidence could include private laboratory analysis of a representative sample from a lot of the detained product.

Evidence should be submitted to the appropriate FDA Division compliance office for consideration per the Notice of FDA Action (Notice of Detention). If private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, volume III, section 7 https://www.fda.gov/media/73540/download. All analytical findings should be submitted to FDA regardless of the final results. 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.

SAMPLED IMPORTED PRODUCTS MUST BE HELD PENDING THE ANALYSIS RESULTS IN ACCORDANCE WITH 21 CFR 1.90 ***

Removal from Detention without Physical Examination (***ADDITION TO THE GREEN LIST***):

In order to ***add a firm's product to the Green List of this Import Alert***', information should be provided to the Agency that adequately demonstrates that the ***controls are in place to exclude decomposed raw materials and to prevent conditions that potentially allow decomposition to occur.*** 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 assessment of their processing operations to prevent the presence of decomposition(e.g., failure to prevent contamination with decomposition). This should include, at a minimum:

A) A description of current manufacturing processes; and

B) Descriptions of the controls in place including written operating procedures used to prevent the presence of decomposition.

2. Documentation confirming a minimum of five (5) consecutive commercial import entries have been released by FDA based on non-violative 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 the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email to: Importalerts2@fda.hhs.gov

Requests for removal from detention without physical examination will be reviewed by DIO.

Questions or issues involving import operations should be addressed to ORA/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 ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov

*** Questions or issues on policy, sample collection recommendations, or any other additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov

                                                                                                                                                                ***

Frozen raw and cooked ***conch meat**

"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 to be otherwise unfit for food. [Adulteration, Section 402(a)(3)]"

OASIS charge code - FILTHY

Notes: Exempt date - 5/17/2002

Notes: Exempt date - 5/17/2002

Notes: Exempt date - 5/17/2002

Notes: Exempt date - 5/17/2002

Notes: Exempt date - 5/17/2002

Notes: Exempt date - 5/17/2002

Notes: Exempt date - 6/7/1996

Notes: Exempt date - 6/7/1996

Notes: Exempt date - 6/7/1996

Notes: Exempt date - 6/7/1996

Notes: Exempt date - 6/7/1996

Notes: Exempt date - 6/7/1996