IA #16-13 - 6/5/96, ***"Detention Without Physical Examination*** of Anchovy
or Bagoong Products from Philippines" ATTACHMENT 1/9/08
TYPE OF ALERT : ***Detention Without Physical Examination***
Note: this alert is being revised to provide changes to
format and/or terminology and are bracketed by asterisks
(***).
***(Note: This import alert contains guidance to FDA
field personnel only. It does not establish any
requirement, or create any rights or obligations on FDA
or on regulated entities.)***
PRODUCT : a. Anchovies
b. Bagoong, a sauce made from anchovies or small fish
which have been salted and fermented or products from
Bagoong.
PRODUCT CODE : 16A[][]01
PROBLEM : Filth (FLNF, Insert; FLRF-Rodent)
E. Coli, Coliforms (FLEC)
COUNTRY : Philippines (PH,725)
MANUFACTURER/
SHIPPER : N/A
MANUFACTURER
SHIPPER I.D.# : N/A
IMPORTER'S
I.D.# : N/A
CHARGE : For Filth, Charge:
"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 is otherwise unfit for food, in that it
contains insect, rodent, animal or other filth"
[Adulteration, Section 402(a)(3)].
For presence of E. Coli/Coliforms, Charge:
"This 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 is otherwise unfit for food in that it
contains E.Coli/Coliforms" [Adulteration, Section
402(a)(3)].
RECOMMENDING
OFFICE : Division of Import Operations and Policy, HFC-170
REASON FOR
ALERT : 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.
GUIDANCE : 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.
***Districts may detain, without physical examination***,
all anchovy products from the Philippines except the
packers/products identified on the attachment to this
Import Alert.
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.
***For questions or issues concerning science, science
policy, sample collection, analysis, preparation, or
analytical methodology, contact the Division of Field
Science at (301) 443-3320 or 3007.***
PRIORITIZATION/
GUIDANCE : III
FOI : Bagoong, Anchovy, Dilis, Monamon, Filth, Coliforms. E.
Coli
KEYWORDS : No purging required
PREPARED BY : Linda A. Wisniowski, DIOP, (301 )443-6553
ATTACHMENT- IMPORT ALERT #16-13 1/9/08
PACKER/PRODUCTS EXCLUDED FROM DETENTION WITHOUT PHYSICAL EXAMINATION
1. Ayala Corporation Fish (Patis) Sauce
Makati, Metro Manila
Philippines
2. Rufina Patis Factory Fish (Patis) Sauce
Manila, Philippines
3. Mica By the Sea 16A[][]01/16Y[][]03
Zone II, Building 19, Lanka Street 1/2/2008
809 Sirloin Street, FTI complex
Taguig City, Metro Manilla, Philippines
FEI# 3004252912
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