IA #16-128 12/18/06, "IMPORT ALERT #16-128, "MISBRANDED CATFISH"
NOTE: This revision is based on information that several countries are
aquaculturing Ictaluridae species and exporting them to the United
States. This revision provides guidance to prevent the refusal of
properly labeled, imported aqualculture catfish. Changes are bracketed
by asterisks (***).
TYPE OF ALERT: Guidance
(Note: This import alert represents the Agency's current
guidance to FDA field personnel regarding the
manufacturer(s) and/or products(s) at issue. It does not
create or confer any rights for or on any person, and does
not operate to bind FDA or the public).
PRODUCT: Catfish
PRODUCT
CODE: Non-Aquaculture Products:
16A[][]10, 16A[][]67, 16A[][]82, 16A[][]99
16B[][]10, 16B[][]67, 16B[][]82, 16B[][]99
16C[][]10, 16C[][]67, 16C[][]82, 16C[][]99
16I[][]10, 16I[][]67, 16I[][]82, 16I[][]99
16S[][]10, 16S[][]67, 16S[][]82, 16S[][]99
Aquaculture Products:
16X[][]02, 16X[][]99, *** 16X[][]43 ***
PROBLEM: Misbranding
PAF: LBL (Labeling)
PAC FOR
COLLECTION: 21844
COUNTRY: All (ZZ)
MANUFACTURER/
SHIPPER FEI#: N/A
IMPORTER'S
FEI#: N/A
CHARGE: "The article is subject to refusal of admission pursuant to
section 801(a)(3) in that it appears to be misbranded
because it purports to be or is represented as catfish but
is not a fish classified within the family Ictaluridae
[Misbranding, Section 403(t)]."
OASIS CHARGE
CODE: FALSECAT
RECOMMENDING
OFFICE: CFSAN, Office of Seafood (HFS-400)
*** CFSAN, Office of Compliance (HFS-600) ***
REASON FOR
ALERT: Because of the new provision added by Section 403(t) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343
Misbranded Foods), only catfish from the Ictaluridae family
can be labeled as catfish.
FDA's Seafood List provides Agency guidance on common or
usual names for fish that meet the provisions of 21 CFR 102.
The species that are scientifically listed in the
Ictaluridae family and thus may be labeled as catfish under
Section 403(t) are listed by their genus name below:
Ictalurus spp.
Ameiurus spp.
Pylodictis spp.
Trogloglanis spp.
Satan spp.
Noturus spp.
Prietella spp.
GUIDANCE: In the past, several non-Ictalurid fish species have been
labeled using the term "catfish" as part of their common or
market name. The non-Ictalurid fish that have been or were
to be listed in the Seafood List as having common or usual
names containing the term catfish and are affected by the
new law are referenced in Attachment A. Market names that
have been suggested by importers are included under the last
column on Attachment A.
*** Ictaluridae species are indigenous to North America.
However, we have been made aware that currently several
countries are aquaculturing Ictaluridae species and
importing them into the United States. To assist in
preventing refusal of admission of properly labeled,
imported aquaculture-catfish, an importer/shipper may
provide to FDA with each shipment, the name and address of
the aquaculture farm and include at least one of the
following documents or equivalent assurances that support
the identity of the species:
1) Proof of original purchase of the eggs from North
America and documentation that the farm raised
catfish are from eggs that are a species within the
Ictaluridae Family.
2) Positive species identification through Isoelectric
focusing or an equivalent procedure performed by an
accredited laboratory. Private Laboratory Guidance can
be found at the following internet address:
http://www.fda.gov/ora/science_ref/lm/vol3/section/07.
pdf
If testing of product to provide authenticity of species is
performed or required, then all lots or codes should be
sampled. If only one lot or code is in the entry, the
testing lab should collect at least two units to test.
3) A letter from the country's competent authority
confirming that the shipment being imported into the
US is Ictaluridae catfish.
If the importer does not have any documentation supporting
the identity of the species, the shipment may be subject to
detention without physical examination. The district
compliance officer will determine whether the information
provided by the importer/shipper is sufficient to allow
entry.
For questions regarding these criteria and/or products
covered, contact CFSAN/DOEP/Imports Branch, HFS-606,
(301)436-2146 or HFS-417, (301)436-1421.
If a suspected catfish species substitution is encountered
that is not covered by this alert, refer to The Seafood List
("FDA's Guide to Acceptable Market Names for Seafood Sold in
Interstate Commerce") at internet address:
http://www.cfsan.fda.gov/~frf/seaintro.html for name
verification. If the name is not on the List or if you have
additional questions, contact the Office of Seafood at 301-
436-2300.
For questions or issues concerning science, science policy,
sample collection, analysis, preparation, or analytical
methodology, contact the Division of Field Science at
(301)827-7605.
PRIORITIZATION
GUIDANCE: III
FOI: No purging required
KEYWORDS: Catfish, misbranding, Ictalurus, Ameiurus, bullhead,
flathead
PREPARED BY: *** Angel M. Suarez, OC/DE/IB (HFS-606)
Spring Randolph, OS (HFS-417)
Doug Randes, DIOP (HFC-170) ***
Ted Poplawski, DIOP (HFC-170)
DATE LOADED
INTO FIARS: December 18, 2006
Attachment A for Import Alert #16-128
Non-Ictalurid Species that have been listed or intended to be listed in The
Seafood List as having common or market names containing the term catfish.
Scientific Name Previous Previous Current List of
Acceptable Acceptable Market Name
common name Market Name Derived through
FDA Consultation
with Importers
Arius felis Hardhead Sea Catfish Whiskered fish
Catfish
Arius thalassinus Giant Catfish Sea Catfish Giant Whiskered
Fish
Bagre marinus Gafftopsail Sea Catfish Sea Whiskered
Catfish Fish
Brachyplatystoma Gilded Catfish Gilded Catfish Gilded Fish
flavicans
Brachyplatystoma Piramutaba Piramutaba Piramutaba or
vaillanti Catfish or Laulao Fish
Laulao Catfish
Clarias Walking Catfish Walking Catfish Walking Clarias
batrachus Fish
Clarias Sharptooth Sharptooth Sharptooth
gariepinus Catfish Catfish Clarias fish
Clarias Hybid ------------ ----------- Hybrid Clarias
(macrocephalus Fish
and gariepinus)
Clarias Broadhead Broadhead Broadhead Clarias
macrocephalus Catfish Catfish Fish
Heteropneustes Stinging Stinging *
fossilis Catfish Catfish
Mystus aor Long Whiskered Long Whiskered Long Whiskered
Catfish Catfish Fish
Mystus vittatus Striped Catfish Striped Dwarf *
Catfish
Ompok pabda Pubdah Catfish Pubdah Catfish *
Pangasius Basa Catfish Basa or Bocourti Basa, Bocourti,
bocourti or Bocourti bocourti Fish,
Catfish Basa fish
Pangasius gigas Giant Pangasius Pangasius, Giant Giant Pangasius
or Mekong
Catfish
Pangasius Shortbarbel Pangasius, Pangasius,
micronemus Catfish Shortbarbel, or Shortbarbel
Shortbarbel pangasius
Catfish
Pangasius Swai Swai, Sutchi, Swai, Sutchi,
hypophthalmus Striped Catfish, Striped Pangasius
or Sutchi Catfish
Pinirampus Flat-whiskered Flat-whiskered Flat-whiskered
pirinampu Catfish Catfish fish
Pseudoplatystoma Barred Sorubim Barred Catfish *
fasciatum
Pseudoplatystoma Caparari Caparari or Caparari
tigrinum Tiger Catfish
* A proposed name has not been submitted to FDA. FDA is available to consult
on whether a proposed name might be false or misleading or otherwise
violative.
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