Import Alert 16-13

Import Alert # 16-13

Published Date: 01/31/2022

Type: DWPE

"Detention Without Physical Examination of Anchovy or Bagoong Products from the Philippines"

Note: The revision of this Import Alert (IA) dated 1/31/2022 updates the type of alert, guidance, agency contacts, PAC, and charge section. Changes to the import alert are bracketed by asterisks

(***).

During the six-month period from November 16, 1982, through May 18, 1983, 12 out of 18 lots of anchovy products sampled and examined for filth were detained (a 67% violation rate). Ten detentions were for insect and/or rodent filth and two detentions were for E. Coli and Coliforms. Product detained included salted anchovies, anchovy sauce (bagoong), dried anchovies, and frozen anchovies. Dual declaration of the products which are subject to this action are bagoong monamon-dilis, dilis-monamon, and bagoong mabgas dilis.

Review of FY 91 detention data indicates that 41 detentions of these products were made. Further review indicated that the majority were refused due to lack of private laboratory analyses, requested refusals and physical analyses showing presence of filth. Of 8 samples collected and analyzed 15 (63%) were violative.

No detentions were noted for presence of E. Coli.

*** Divisions may detain, without physical examination, all anchovy products from the Philippines, except the firms/products identified on the Green List of this Import Alert.

When entries declared as bagoong, bagoong manomon-dilis, dilis-monamon, and bagoong mabgas dilis are encountered, they should be checked to determine if they are anchovy 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 detention without physical examination (DWPE) under this import alert, the owner, consignee and/or other responsible party for the affected goods should provide evidence which demonstrates that the product does not contain filth or E. Coli. Such evidence may include Private laboratory analysis of samples.

Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration, per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.

When examining audit samples from entries that have been found acceptable by private laboratory results, in addition to an examination for filth, analyze for E. Coli and coliforms.

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 FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act).

For guidance on removal from DWPE, refer to FDAs Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to be added to the Green List of 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, be sent via email to: Importalerts2@fda.hhs.gov

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 human food policy, sample collection recommendations, or other any addition questions, should be addressed to CFSAN, Division of Enforcement's Food Adulteration Assessment Branch or CFSANEnforcement@fda.hhs.gov

                                                                                                                                                                        ***

Anchovies; Bagoong, a sauce made from anchovies or small fish which have been salted and fermented or products from Bagoong.

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

OASIS charge code: FILTHY ***

Notes: Exempt - 1/2/2008

Notes: Exempt - 1/2/2008