IA#16-74, -----REVISED 03/03/97, ATTACHMENT ----REVISED 5/13/97
SUBJECT: "***DETENTION WITHOUT PHYSICAL EXAMINATION*** OF SALT-CURED, AIR-
DRIED, UNEVISCERATED FISH"
This alert is being revised to provide changes to format and/or
terminology and are bracketed by by asterisks (***).
(Note: This Import Alert contains guidance to FDA field personnel only. It
does not establish any requirements, or create any rights or obligations on
FDA or on regulated entities.)
TYPE OF ALERT : ***Detention Without Physical Examination***
PRODUCT : Salt-cured, Air-dried, Uneviscerated Fish
PRODUCT CODE : 16A[]P[][] (Salt Cured)
16A[]H[][] (Air Dried)
16I[][][][]
16S[][][][]
PROBLEM : Potential for Clostridium botulinum (botulism)
PAC FOR
COLLECTION : 03844, 03819C
COUNTRY : All
MANUFACTURER : All
SHIPPER : All
IMPORTER'S
SHIPPER I.D.# : N/A
CHARGE : "The article is subject to refusal of admission pursuant to
Section 801(a)(1) of the Act in that it appears to have been
prepared, packed, or held under insanitary conditions
[Adulteration, Section 402(a)(4)]."
RECOMMENDING
OFFICE : Division of Import Operations & Policy (HFC-170).
Exemption guidance recommended by CFSAN, Program and
Enforcement Branch (HFS-417), Office of Seafood
REASON FOR
ALERT : FDA's current compliance policy, found in Section 540.650 of
the Compliance Policy Guides Manual (reference CPG 7108.17
dated 10/27/88), states that "The FDA considers ready-
to-eat, salt-cured, air dried, uneviscerated fish, which may
or may not be smoked, to be a potentially life-
threatening acute health hazard because of the possible
presence of C. botulinum toxin."
On January 14, 1992, FDA began to audit a level B firm
initiated recall (Class I) of salted/frozen, uneviscerated,
yellow corvina fish from Korea. The reason for the recall
was the potential for Clostridium botulinum toxin.
GUIDANCE : Districts may detain, without physical examination,
shipments of salt-cured, air dried, uneviscerated fish
except if exempted from coverage. There is no procedure
that will assure the safety of the manufacture, processing,
or packing of such products.
IMPORT ALERT #16-74 REVISED 03/03/97 PAGE 2
According to CFSAN/Office of Seafood, products that meet the
following criteria are exempted from coverage under this
import alert:
Small species of fish (generally 3-5 inches in length), such
as anchovies and herring sprats, that are processed in a
manner that results in either water-phase salt level of at
least 10 percent, a water activity below 0.85, or a pH of
4.6 or less.
In addition, the process should preclude the formation of C.
botulinum toxin, for example, the drying process is
sufficiently short to preclude the proper conditions for
growth of C. botulinum (e.g., water activity reached within
24 hours).
(Note: Private laboratory analyses to ensure that these
criteria have been met may be provided by the importer to
support that the product is not covered by this alert.)
For questions regarding these criteria and/or whether
products are covered, contact CFSAN/DOEP/Imports Branch,
HFS-606, 202-205-4606.
When a determination has been made that a product of a
specified manufacturer is not covered under this alert, the
district should inform the Division of Import Operations and
Policy, HFC-170, who in turn will place the firm/product on
Attachment A to this alert. A notation will indicate that
the product is exempted from coverage based on the criteria.
Firms and products removed from ***detention without
physical examination***, based on compliance with the
requirements for removal of firm/product under RPM Chapter
9-25, Automatic Detention, will be listed on Attachment B.
Currently there are no firms listed on this Attachment.
For any issues and/or questions regarding science, science
policy, sample collection, analyses, preparation, analytical
methodology or confirmation tests, districts should contact
the Division of Field Science at 301-443-3320 or 3007.
PRIORITIZATION
GUIDANCE : Priority I
KEYWORDS : Salt-cured fish, air-dried fish, uneviscerated fish,
botulism
FOI : No purging is required.
Prepared by : Fredda Shere Valenti, DIOP, 301-443-6553.
Date Loaded
into Fiars : 03/03/97
Attachment A - Import Alert #16-74 Page 1 5/13/97
FIRMS WHICH ARE EXEMPT FROM DETENTION WITHOUT PHYSICAL EXAMINATION
BASED ON CRITERIA
Manufacturer/Shipper Product
Kaneso 22 Co., Ltd Dried Sardines
1694-11 Mobra Nishiyoshihara (Ohba Dashi Iriko)
Kasaoka City, Okayama Pref 3/5/96
Japan
MID# JPKAN221694KAS
Uonoya Co., Ltd Dried, Boiled Anchovies
213-11 Shizumacho 16A01
Shimane, 694, Japan 5/13/97
Yugen Kaisya Yamomoto Shoji Dried Kaeri Anchovy
Kobe, Japan Dried Ohba Kaeri Anchovy
MID #JPYUGKAIKOB 2/10/94
Attachment B - Import Alert #16-74 Page 1 11/27/95
FIRMS REMOVED FROM DETENTION WITHOUT PHYSICAL EXAMINATION
BASED ON REQUIREMENTS OF RPM CHAPTER 9-25