Import Alert 16-128
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(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).
Import Alert # 16-128
Published Date: 10/07/2011
Type: DWPE with Surveillance
Import Alert Name:
"Misbranded Catfish"
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.
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 this guidance section. Market names that have been suggested by importers are included in this guidance section.
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/Division of Enforcement/Labeling Compliance Branch, HFS-608.
If a suspected fictitious name or species substitution is encountered that is not covered by this alert, refer to the Regulatory Fish Encyclopedia (RFE) and the Guidance for Industry: "The Seafood List -FDA's Guide to Acceptable Market Name for Seafood Sold in Interstate Commerce" at the following internet address: http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/Seafood/RegulatoryFishEncyclopediaRFE/default.htm. If the name is not on the List or if you have additional questions, contact the Office of Food Safety, Division of Seafood Safety.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science.
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 Acceptable Common name.....Previous Acceptable Market Name.....Current List of Market Names Derived through
FDA Consultation with Importers
Arius felis.....Hardhead Catfish.....Sea Catfish.....Whiskered fish
Arius thalassinus.....Giant Catfish.....Sea Catfish.....Giant Whiskered
Fish
Bagre marinus.....Gafftopsail Catfish.....Sea Catfish.....Sea Whiskered Fish
Brachyplatystoma flavicans.....Gilded Catfish.....Gilded Catfish.....Gilded Fish
Brachyplatystoma vaillanti.....Piramutaba.....Piramutaba Catfish or Laulao Catfish.....Piramutaba or Laulao Fish
Clariasb atrachus.....Walking Catfish.....Walking Catfish.....Walking Clarias Fish
Clarias gariepinus.....Sharptooth Catfish.....Sharptooth Catfish Sharptooth Clarias fish
Clarias Hybid (macrocephalus Fishand gariepinus..... n/a common & market.....Hybrid Clarias
Clarias macrocephalus.....Broadhead Catfish.....Broadhead Catfish.....Broadhead Clarias Fish
Heteropneustes fossilis.....Stinging Catfish.....Stinging Catfish.....*
Mystus aor.....Long Whiskered Catfish.....Long Whiskered Catfish.....Long Whiskered Fish
Mystus vittatus.....Striped Catfish.....Striped Dwarf Catfish
Catfish.....*
Ompok pabda.....Pubdah Catfish.....Pubdah Catfish..... *
Pangasius bocourti.....Basa Catfish.....Basa or Bocourti or Bocourti Catfish.....Basa, Bocourti, Bocourti Fish, or Basa fish
Pangasius gigas.....Giant Pangasius.....Pangasius, Giant or Mekong
Catfish.....Giant Pangasius
Pangasius micronemus.....Shortbarbel Catfish.....Pangasius, Shortbarbel, or Shortbarbel Catfish.....Pangasius, Shortbarbel pangasius
Pangasius hypophthalmus.....Swai, Sutchi, Striped Catfish or Sutchi Catfish.....Swai, Sutchi, Striped Pangasius
Pinirampus pirinampu.....Flat-whiskered Catfish.....Flat-whiskered Catfish.....Flat-whiskered Fish
Pseudoplatystoma fasciatum.....Barred Sorubim.....Barred Catfish..... *
Pseudoplatystoma tigrinum.....Caparari.....Caparari or Tiger Catfish.....Caparari
* 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.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
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/Division of Enforcement/Labeling Compliance Branch, HFS-608.
If a suspected fictitious name or species substitution is encountered that is not covered by this alert, refer to the Regulatory Fish Encyclopedia (RFE) and the Guidance for Industry: "The Seafood List -FDA's Guide to Acceptable Market Name for Seafood Sold in Interstate Commerce" at the following internet address: http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/Seafood/RegulatoryFishEncyclopediaRFE/default.htm. If the name is not on the List or if you have additional questions, contact the Office of Food Safety, Division of Seafood Safety.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science.
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 Acceptable Common name.....Previous Acceptable Market Name.....Current List of Market Names Derived through
FDA Consultation with Importers
Arius felis.....Hardhead Catfish.....Sea Catfish.....Whiskered fish
Arius thalassinus.....Giant Catfish.....Sea Catfish.....Giant Whiskered
Fish
Bagre marinus.....Gafftopsail Catfish.....Sea Catfish.....Sea Whiskered Fish
Brachyplatystoma flavicans.....Gilded Catfish.....Gilded Catfish.....Gilded Fish
Brachyplatystoma vaillanti.....Piramutaba.....Piramutaba Catfish or Laulao Catfish.....Piramutaba or Laulao Fish
Clariasb atrachus.....Walking Catfish.....Walking Catfish.....Walking Clarias Fish
Clarias gariepinus.....Sharptooth Catfish.....Sharptooth Catfish Sharptooth Clarias fish
Clarias Hybid (macrocephalus Fishand gariepinus..... n/a common & market.....Hybrid Clarias
Clarias macrocephalus.....Broadhead Catfish.....Broadhead Catfish.....Broadhead Clarias Fish
Heteropneustes fossilis.....Stinging Catfish.....Stinging Catfish.....*
Mystus aor.....Long Whiskered Catfish.....Long Whiskered Catfish.....Long Whiskered Fish
Mystus vittatus.....Striped Catfish.....Striped Dwarf Catfish
Catfish.....*
Ompok pabda.....Pubdah Catfish.....Pubdah Catfish..... *
Pangasius bocourti.....Basa Catfish.....Basa or Bocourti or Bocourti Catfish.....Basa, Bocourti, Bocourti Fish, or Basa fish
Pangasius gigas.....Giant Pangasius.....Pangasius, Giant or Mekong
Catfish.....Giant Pangasius
Pangasius micronemus.....Shortbarbel Catfish.....Pangasius, Shortbarbel, or Shortbarbel Catfish.....Pangasius, Shortbarbel pangasius
Pangasius hypophthalmus.....Swai, Sutchi, Striped Catfish or Sutchi Catfish.....Swai, Sutchi, Striped Pangasius
Pinirampus pirinampu.....Flat-whiskered Catfish.....Flat-whiskered Catfish.....Flat-whiskered Fish
Pseudoplatystoma fasciatum.....Barred Sorubim.....Barred Catfish..... *
Pseudoplatystoma tigrinum.....Caparari.....Caparari or Tiger Catfish.....Caparari
* 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.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
Product Description:
Catfish
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
OASIS charge code - FALSECAT
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(16 A - - 10) Catfish, Freshwater (e.g. Channel, blue, white, yaqui, bullhead, flathead catfish)
(16 A - - 67) Catfish, Salt Water
(16 A - - 82) Freshwater Non-Ictalurus Fish
(16 A - - 99) Fish, N.E.C.
(16 B - - 10) Catfish, Fresh Water, Breaded (e.g. Channel, blue, white, yaqui, bullhead, flathead catfish)
(16 B - - 67) Catfish, Salt Water, Breaded
(16 B - - 82) Freshwater Non-Ictalurus Fish
(16 B - - 99) Fish, Breaded, N.E.C.
(16 C - - 10) Catfish, Fresh Water, Cakes, Balls, Etc. (e.g. Channel, blue, white, yaqui, bullhead, catfish)
(16 C - - 67) Catfish, Salt Water, Cakes, Balls, Etc.
(16 C - - 82) Freshwater Non-Ictalurus Fish, Cakes, Balls, Etc.
(16 C - - 99) Fish Cakes, Balls, Etc., N.E.C.
(16 I - - 10) Catfish, Freshwater, Hot Smoked (e.g. Channel, blue, white, yaqui, bullhead, flathead catfish)
(16 I - - 67) Catfish, Salt Water, Hot Smoked, Fish
(16 I - - 82) Fresh Water Non-Ictalurus Fish, Hot Smoked
(16 I - - 99) Fish, Hot Smoked N.E.C.
(16 S - - 10) Catfish, Freshwater, Cold Smoked (e.g. Channel, blue, white, yaqui, bullhead, flathead catfish)
(16 S - - 67) Catfish (salt water), Cold Smoked
(16 S - - 99) Fish, Cold Smoked N.E.C.
(16 X - - 02) Catfish, Aquaculture, Fresh Water
(16 X - - 43) Non-Ictalurus Fish, Aquaculture, Fresh Water
(16 X - - 99) Aquaculture Harvested Fishery/Seafood Products, N.E.C.,
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