IA #16-105, ------REVISED 06/04/96, ATTACHMENT REVISED 11/4/04
NOTE: This alert has been revised to incorporate uniform guidance for
decomposition, revise references to the CPG, and to update the
format. This revision incorporates firms and products covered by
Import Alert #16-38, "Automatic Detention of Shrimp Due to
Decomposition" and 16-41, "Automatic Detention and Increased
Surveillance of Scallops Due to Decomposition." Upon issuance of
this revision, Import Alerts #16-38 and 16-41 are cancelled.
Additional changes are bracketed by asterisks().
SUBJECT: "Automatic Detention of Seafood and Seafood Products from
Specific Manufacturers/Shippers Due to Decomposition and/or
Histamines"
TYPE OF ALERT: Detention Without Physical Examination
(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.)
PRODUCT : Seafood and seafood products, except:
-Mahimahi covered under Import Alert #16-05;
-Shrimp covered under Import Alerts #16-18 and 16-35.
-Canned shrimp from Thailand covered under Import Alert
#16-22;
-Canned tuna covered under Import Alert #16-95
PRODUCT CODE: See attachment
PROBLEM : Decomposition (MSDC)
Histamines (FLHS)
PAC : 03844
COUNTRY : See attachment
MFG/
SHIPPER : See attachment
MFG/
SHIPPERS ID#: See attachment
CHARGE : For decomposition:
"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 decomposed substance, or to be otherwise unfit
for food [Adulteration, Section 402(a)(3)]."
or
For histamine:
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to bear or contain
histamine, a poisonous and deleterious substance in such
quantity as ordinarily renders it injurious to health,
[Adulteration, Section 402(a)(1)]."
RECOMMENDING
OFFICE : Division of Import Operations and Policy (HFC-170)
REASON FOR
ALERT : DIOP has received recommendations from districts for
detention without physical examination of seafood and
seafood products from specific manufacturers/shippers due to
decomposition. This import alert has been developed for
manufacturers and shippers of decomposed seafood products
and products that contain histamines that meet the criteria
for detention without physical examination and cannot
readily be included in previously existing alerts.
Since early May 1992, the Agency has noted several separate
outbreaks of scrombroid poisoning attributed to fresh or
frozen tuna. The most recent outbreak occurred in Florida
and was traced to frozen tuna packed by a firm in Taiwan.
GUIDANCE : Districts may detain, without physical examination,
shipments of the specified products from the firms
identified on the attachment to this alert.
Surveillance sampling of all shrimp and scallop shipments is
warranted.
When districts encounter multiple violative shipments of
seafood products for decomposition, detected
organoleptically or as indole or histamines from the same
manufacturer or shipper, a recommendation for detention
without physical examination should be forwarded to DIOP.
DIOP, in turn, will coordinate with CFSAN.
Compliance Policy Guide (CPG)540.575 contains guidance for
evaluating decomposition in fish.
Refer to Compliance Program CP 7303.844 - Import Seafood
Products for sample collection guidance and instructions on
methodology for histamine or indole analysis.
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 : I
FOI : No purging required.
KEYWORDS : Decomposition, histamine, indole, seafood, crabmeat, fish,
shrimp
PREPARED BY : Ted Poplawski, DIOP (301) 443-6553
DATE LOADED
INTO FIARS : June 4, 1996
ATTACHMENT IA #16-105 REVISED 11/4/04
FIRMS/PRODUCTS ON DETENTION WITHOUT PHYSICAL EXAMINATION
IMPORT
FIRM PRODUCT ALERT PRODUCT REASON
DATE CODE
CHILE (CL, 275)
Antarfish Sociedad Fresh & frozen 12/2/93 16E[]A05 Decomposition
Anonima scallops
Moneda 920 OF. 205-206
Santiago, Chile
MID# CLANTSOC2052SAN
FEI# 1000145352
Pesquera Santa Frozen Whiting 8/19/94 16A[]G49 Decomposition
Lucia S.A. Fresh Whiting
Casilla 131
Quintero, Chile
MID# CLPESSAN131QUI
FEI# 1000128361
Productos Marinos Fresh & frozen 8/19/94 16E[]A05 Decomposition
Del Norte scallops
Gallo 395
Caldera, Chile
MID# CLPOMAR395CAL
FEI# 1000208181
CHINA (CN)
Zhejiang Zhongda Xinli Trading Frozen IQF 3/1/01 16J[][]05
Co. Ltd. Shrimp 16X[][]21
No 11f Tower A, Zhongda Plaza
Hangzhou, China
FEI# 3003040003
ECUADOR (EC, 325)
Bajaspec S.A. Fresh, Fresh Frozen 7/12/01 16A-D69 Histamines
aka Escolar
Especies de Bajamamar
Cdla Adace Mz
113 b Calle 5 ta
Guayaquil, Ecuador
FEI# 13428
Crimaxi S.A. Fresh, Fresh Frozen 7/13/01 16A-D69 Histamines
Santa Cecilia Escolar
Mz Xa Solar 14
Guayaquil, Ecuador
FEI# 3003024904
Docapes S.A. Fresh, Fresh Frozen 7/13/01 16A-D69 Histamines
Ave. De Las Americas Escolar
C.C. El Terminal
Guayaquil, Ecuador
FEI# 3001342367
Estemar S.A. Fresh & fresh 6/24/87 16J[][]05 Decomposition
aka Stella Maris frozen shrimp
Guayaquil, Ecuador
MID# ECESTSAGUA
FEI# 190
Marco Marchan Fresh, Fresh Frozen 7/13/01 16A-D69 Histamines
Fresh Fish Analore S.A. Escolar
Calle 14 y Ave.21
Manta, Ecuador
FEI# 3002769771
Pefresman Cia. Ltda. Fresh/Fresh 7/29/97 16A--54 Histamine
Calle 113, Avenida 103 Marlin Loins
Manta, Ecuador
FEI# 13375
Promarosa Fresh, Fresh Frozen 9/26/02 16A 69 Histamines
(Productos del Mar Santa Escolar
Rosa Cia. Ltda.)
Manzana No. 14
Santa Rosa, Salinas
Ecuador
FEI #1000155732
OFFICE
Promarosa
(Productos del Mar Santa Rosa Cia. Ltda.)
10 de Augosto 103 y Malecon P.B. OFC.11
Guayaquil, Ecuador
FEI #3000181496
GUYANA (GY, 418)
Tropical Products Fresh & fresh 8/30/93 16J[][]05 Decomposition
(Guy), Ltd. frozen shrimp
Lot 41 Boyle Place
Stabroek
Georgetown, Guyana
MID# GYTROPRO41GEO
FEI# 1000134187
INDONESIA (ID, 458)
Cv Puri Rasa Food Frozen yellow- 12/21/01 16A--45 Decomposition
Industry fin tuna fillet
Br. Carik Padang,
Desa Nyambu
Tabanan, Indonesia
FEI# 1000151855
PT. Bonecom All Tuna Products 7/19/04 16A- -45 Histamines
Aka 16S- -45
Bone Commercial Company
Jl. Muara Baru Ujung
Blok L, No. 1
Jakarta, Utara 14440
Indonesia
FEI# 3001776579
Pt. Fajar Insan Nusantara Frozen Tuna 4/29/02 16A[][]45 Decomposition
Jl Pejompongan
Dajam No. 5
Jakarta, Indonesia
FEI #3002952831
Pt. Lautan Murti Tuna Products 1/29/02 16A[][]45
JL. Lingkar Timur No. 23 Cliacap
Jawa Tengah, 52313, Indonesia
FEI# 3003399879
PT. Mandhaga Wiratama Frozen Raw Tuna 11/5/01 16A--45 Decomposition
Jl Cempaka Putih Tengah &
17 Blok F5 No. 34 Histamines
Jakarta Pusat Frozen Smoked/carbon 11/5/01 16S--45
Indonesia monoxide treated
FEI# 3002924671 Tuna Products
JAPAN (JP)
Sankyo Food Kogyo Co., Ltd. 8/13/01 Frozen Shrimp Decomposition
Tokiwa Bldg., 3-8 16J--05
Tsukiji 4 Chome 16X--21
Chu-Ku, Tokyo
Japan
FEI# 14102
MEXICO (MX, 595)
Baja Blue Foods de Cooked claw 5/9/03 16J[]T01 Decomposition
Mexico SA de CV crab meat 16J[]N01
Calle Durango S/N
Frente Esc. Primaria
Puerto Penasco
Sonora, Mexico
FEI# 3003813448
Crown Crab Company Pasteurized 7/25/95 16J[]G01 Decomposition
Calle 63, No. 15 Claw Crabmeat
Ciudad del Carmen
Campeche, Mexico
MID# MXCROCRA63CIU
FEI# 1000382750
Jose Tiburcio Frozen 10/7/94 16J[]G01 Decomposition
Otero Diaz Infante Crabmeat
Calle Norte 805, Fracc.
Villa California Ciudad
Obregon, Sonora, Mexico
MID #MXJOSTIB8050BR
FEI# 1000153625
MYANMAR (MM)
Myint Myat Hein Shrimp, frozen 11/19/03 16J -05 Decomposition
Trading Co., Ltd. 16X- -21
No.23(B)Kwin Kyaung Rd.
Ahlone T/S
Yangon, Myanmar
FEI # 3003684537
PAKISTAN (PK, 700)
Seapak Enterprises Fresh & fresh 8/30/93 16J[][]05 Decomposition
8-3 Fish Harbour frozen shrimp
W. Wharf
Karachi, Pakistan
MID# PKSEAENT83KAR
FEI# 1000455473
PERU (PE, 720)
Acuicola, S.A. Fresh & frozen 4/27/93 16E[]A05 Decomposition
Av. Las Gladiolus S/N scallops
Urbanizacion Castilla
Piura, Peru
MID# PEACUSAPIU
FEI# 1000133615
Administration Fresh & frozen 10/17/95 16E[]A05 Decomposition
General De Servicios scallops
(ADGESA) S.A.
General Borgono 309-201
Pueblo Libre, Lima 21, Peru
MID# PEADG309LIM
FEI# 1000375982
Ransanos S.A. Fresh & frozen 4/27/93 16E[]A05 Decomposition
El Prado 482 scallops
Lima, Peru
MID# PERANSA482LIM
FEI# 1000131559
Sur Pesca, S.A. Fresh & frozen 4/27/93 16E[]A05 Decomposition
Colon 311 Miraflores scallops
Lima, Peru
MID# PESURPES311LIM
FEI# 1000133614
PHILIPPINES (PH, 725)
Adelmar Marine Porudcts Tuna Cubes 6/5/02 16A[][]45 Histamines
Trading Corp Frozen
9749 Santan Street
Vitalez Compound, Baltao
Paranaque, Metro Manila,
Philippines
FEI #3003560632
Alyanna Enterprises Dried Herring 1/13/04 16A- -21 Histamines
#2 Mulawin Street (AKA Dried Tuyo)
Town & Country
Executive Village
Marcos Hi-Way
Antipolo
PHILIPPINES
FEI# 3004095862
Amor Nino International Dried Herring, 8/7/03 16A- -21 Histamines
Trading Inc. frozen
Taguiporo, Sta. Ignacia
Tarlac, Philippines Dried Mackerel,8/7/03 16A- -73 Histamines
FEI # 1000443882 frozen 16A- -22
Edlou Enterprises Dried Mackerel 8/20/03 Histamines
341 Constancia Street 16A-H73
Manila, Philippines
FEI# 3003542896
Mendoza Industries Dried Herring (Sardines) 12/18/02 Histamines
D'Beach Siyacab in Corn Oil and
Dipolog City 16A- - 21 Decomposition
Philippines 16A- - 33
FEI #3002668757
Star Exports Dried Herring 7/10/03 16A--21 Histamines
3 Kanduli Street Products
Silvina Village
Novaliches, Quezon City
Philippines
FEI# 3002838256
TAIWAN (TW)
Ching Yi Cheng Frozen Slipper Decomposition
Industrial Co., Ltd. Lobster Tails
Mfg. # 7F3 0083 and Meat
No. 6 Chang Tai St. 16J -08
Kaohsiung, Taiwan 4/16/03
FEI# 3003070527
Hochico Marine Processing Frozen Slipper Decomposition
Corp. Lobster Tails
29, Der Shin 1st Road and Meat
SU-AO, I-LAN
Taiwan 16J--08
FEI# 3002808707 8/5/04
VENEZUELA (VE,940)
Todamar S.A. Pasteurized 7/28/95 16J[]G01 Decomposition
Avenia San Francisco Canned
No. 131-443, 1 Crabmeat
Maracaibo, Venezuela
MID# VETODSA1314MAR
FEI# 1000181104
VIETNAM (VT)
Hai Vuong Co., Ltd. All Tuna Products Histamines &
Lot B, No. 1 St. 16A -- 45
Suoi Dau Industrial Zone 6/23/04 Decomposition
Khanh Hoa Province
Vietnam
FEI #3004277224
My Thanh Co., Ltd. All Mackerel 10/18/02 16A[][]22 Histamines
B1/16a Quoc Lo 1 Products 16A[][]73 & Decomposition
Binh Chanh Dist.
Ho Chi Minh City
Vietnam
FEI #3001224437