IA #16-05, Revised 5/7/98, Attch. A, Revised 9/28/04, Attch B, 10/21/04
SUBJ: "REVISION TO IMPORT ALERT #16-05 "DETENTION WITHOUT PHYSICAL
EXAMINATION OF MAHIMAHI BECAUSE OF HISTAMINE AND
DECOMPOSITION
NOTE: This alert is being revised to provide changes to
format and/or terminology and are bracketed by asterisks
(***).
TYPE OF ALERT: Detention Without Physical Examination and intensified
coverage
(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: Mahimahi (dolphin) raw, fresh or frozen, including fillets
PRODUCT CODE: 16A--51
PROBLEM: Decomposition, Histamines (FLHS, MSDC)
PAC: 03844
COUNTRY: Detention Without - Ecuador (EC, 325)
Physical Examination - Taiwan (Tw, 281)
Intensified Coverage - All, except Japan (ZZ,999)
MANUFACTURER/
SHIPPER: *** All shippers from Taiwan and Ecuador except those listed
on Attachment A.
Shippers on Attachment B***
MANUFACTURER/
SHIPPER I.D.#: N/A
CHARGE: "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)] and/or 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 appears to be decomposed [Adulteration, Section
402(a)(3)]."
RECOMMENDING
OFFICE: Division of Import Operations and Policy (HFC-170) and
CFSAN/Division of Field Program Planning and Evaluation
(HFS-635)
REASON FOR
ALERT: In March 1980, the Center for Disease Control reported that
mahimahi (dolphin fish) accounted for 40% of the scombroid
poisoning outbreaks reported in the United States.
Also, during March 1980, FDA received reports of 10 separate
scombroid poisoning incidents involving about 70 people. As
a result, on April 28, 1980, the districts were instructed
to sample and analyze, for histamine, 100% of all shipments
of mahimahi offered for entry from all countries.
On July 8, 1980, the districts reported that they sampled
and analyzed 73 shipments of mahimahi from China, Ecuador,
Peru, and Taiwan. From this data, it was determined that
mahimahi from Ecuador and Taiwan met the criteria for
detention without physical examination.
In the latter part of FY 80, LOS-DO organoleptically
detected decomposition in 11 of 24 Ecuador/Taiwan mahimahi
samples (46%). Mahimahi may be decomposed without
toxicologically significant levels of histamine. Thus, all
district import personnel must be alert to the possibility
of significant decomposition problems in mahimahi, even when
toxicologically significant histamine levels are not noted.
Odors of spoilage are not necessarily found in the same part
of fish where histamine is found. Sample results on
mahimahi entering from Japan have not indicated problems
with histamines and decomposition.
Recent sample results as well as a number of reported
illnesses attributed to imported mahimahi indicate
continuing problems with histamines and decomposition in
mahimahi from Ecuador.
GUIDANCE: Histamine:
Districts may detain without physical examination all
shipments of mahimahi from Ecuador and Taiwan, except those
packers *** identified on attachment A *** to this alert.
*** Attachment "B" contains individual shippers on detention
without physical examination from countries other than
Ecuador or Taiwan ***
Continue intensified coverage of all shipments of mahimahi
from all other countries except Japan. Districts may sample
Japanese mahimahi at their own discretion.
Note: Mahimahi from packers identified as exempt from
detention without physical examination should be
periodically audit sampled and analyzed for histamines.
METHODOLOGY: See Import Seafood Products Compliance
Program, 7303.844.
PRIORITIZATION
GUIDANCE: II
FOI: No purging necessary.
KEYWORDS: Mahimahi, Mahi Mahi, Dolphin Fish, Histamine, Decomposition,
Dorado
PREPARED BY: Jack Geltman, DIOP, 301-443-6553.
Attachment ***A*** to Import Alert #16-05, Revised 9/28/04
EXEMPT MANUFACTURERS/SHIPPERS FROM ECUADOR & TAIWAN
Agrol S.A. 9/5/97
Calle 25, Avenida M-3
Manta, Manabi
Ecuador
FEI# 1000496181
Alba Pino Leon 6/21/94
Salinas, Ecuador
Ammon International, Inc. Mahi Mahi
2F-2, NO. 12, Tien-Mu 16A--51
West Road 9/17/04
Shih Lin District
Taipei, Taiwan, R.O.C.
FEI #3000239551
Bajespec S.A. 3/7/94
MZ, No. 1, Solar No. 3
CALLE 7ma. Y CALLE A
Guayaquil, Ecuador
MID# ECBAJCAA1141GUA
Boris Buenaventura Trujillo 3/26/91
Manta, Ecuador
Brimon S.A. Mahi Mahi
Mapasingue Oeste Ave Iere 2/20/01
Guayaquil, Ecuador
FEI# 3002804141
Cepromar a/k/a Corporacion Ecuatorian de
Productos del Mar S.A.
Guayaquil, Ecuador
Chia Fong Frozen Food Co., Ltd 7/31/98
28 Fishing Harbor Road
P.O. Box 1719
Kaohsiung, Taiwan
FEI# 1000430969
Chun Success International Co. 08/22/01
7F, No. 63, Tien-Hou Street
Chien Chen District
Kaohsiung, Taiwan R.O.C.
FEI# 3003041368
Chupamar
Guayaquil, Ecuador
Comercial Santana (Cosace)
Ecuador
Conservas Marinas, S.A.
Esmeraldas, Ecuador
Costapesca 12/05/95
(Formerly Known As: Eduardo E. Calderon Z.)
Av. Colon #535, Piso 8, (NAME CHANGE
Oficina #804 ONLY 2/13/96)
Quito, Ecuador
MID# ECEDUCAL535QUI
ECCOS535QUI
Criaderos Acuatoico La Guita 5/10/96
EDIF. Torre Azul Piso 11
Guayaquil, Ecuador
MID# ECCRIACU11GUA
Docapes Mahimahi
Pescados Camarones Mariscos S.A. 16A--51
C.C. El Terminal Bloque F 6/4/04
Local No. 4
Guayaquil, Ecuador
FEI# 3001342367
* Ecuafish S.A. 8/29/02
3 2 Via Manta-Montecristi
Manta, Ecuador
FEI# 3001027795
* Name change formerly known as Fresmar Cia. Ltda
Ecuafresco S.A. 6/16/93
Manta, Ecuador (correct address)
Ecuamar S.A. 6/14/91
Calle 6
Guayaquil, Ecuador
El Rosario (ERSA) S.A. Mahi Mahi/16A[][]51
Av. Mons. D. Com¡n y 1/11/01
P.J. Bolo¤a
Guayaquil, Ecuador
FEI# 1000156451
Empacadora Bilbo, S.A. 7/6/95
AKA:BILBOSA
Carretera Manta - Montecristi KM 7
Montecristi
Ecuador
MID# ECEMPBIL7MAN
ECEMPBILMAN
ECEMPBILMON
Empacadora Diamante 7/22/02
Av. Eloy Alfaro SN Y Juncos
Esmeraldas, Ecuador
FEI# 3003528736
Emcopac S.A. 3/5/91
(Empacadora Coral de Pacifico)
Manuela Canizares 202 y Sucre (ADDRESS CHANGE)
Esmeralda, Ecuador 4/30/04
FEI# 3004316297
Escualem Cia. Ltda Fresh Mahi Mahi
Bolivia 1600 Y Ave 16A-B51
Del Ejercito 16A-C51
Guayaquil, Ecuador 16A-D51
FEI# 3004059370 10/20/03
Ever Hope International Co., Ltd. 4/7/98
No. 50 Lane 84, Kuo Bei Road
Feng San City
Taiwan
FEI# 3000972683
Ever Spring Foods Supplier Inc. 9/8/04
No. 27 Yu-Kangs 1st rd. Chien Jenn Dist.
Kaohsiung, Taiwan R.O.C.
FEI# 12975
Exportadora Del Oceano Pacifico 3/9/95
aka: OCEANPAC
KM. 7 1/2 via A Daule
Guayaquil, Ecuador
MID# ECEXPDEL712GUA
Exportadora Gamex 11/29/91
Apartado de Correos No. 2764
Corretero Monta
Montecristi, Ecuador
Exportadora Hantamar S.A. Mahi-Mahi
Villamil 210 y Calderon 16A--51
Guayaquil, Ecuador 5/23/01
FEI# 3002736567
Exportadora Yifar Express Sudamerica 2/14/92
S.A.
Empacadora:Km. 11 1/2 Via a Daule
Guayaquil, Ecuador
Fishcorp S.A. Mahimahi
Km 42 Via Manta Rocafuerte 4/17/00
Manta
Ecuador
FEI# 3002704341
Fortumar Ecuador S. A. 2/24/92
Guayaquil, Ecuador
Fresh Fish del Ecuador Mahi Mahi
Km 4 1/2 Via Manta San Mateo 2/21/01
Manta, Ecuador
FEI# 3003164547
Frigolab San Mateo Cia Ltda. 9/7/93
Manta, Ecuador
MID# ECFRISANMAN
Frigolandia S.A. 12/10/97
Km. 9 1/2 Via Daule
Guayaquil
Ecuador
FEI# 1000476279
Frigorificos Acuario S.A.
(FRACUSA)
Guayaquil, Ecuador
Frigorificos Y Frutas Tropicales Frutrosa S.A.
(a/k/a FRUTROSA)
Guayaquil, Ecuador
Frimar (Frio Y Mariscos)
Guayaquil, Ecuador
Frumaco S.A. 4/4/91
Avenida Juan Tanca y Marenco
Guayaquil, Ecuador
Gallant Seafoods Corporation Mahi Mahi/16A--51
23 Fishing Harbor S. 1st Road 10/7/03
Kaohsiung, Taiwan, R.O.C.
FEI# 3003884764
Gondi Cia. Ltda 5/31/95
P.O. Box 13-05-4761
Manta, Ecuador
MID# ECGONCIA1305MAN
Good Fish 5/31/01
La Pulida 157
Quito, Ecuador
FEI# 3003160292
Grumodu's 7/22/93
Avenida Primera No. 107
Mapasinque
Guayaquil, Ecuador
ID# ECGRU107GUA
Henmur S.A. 7/21/98
Ave. 23/121/Y Calle 12
Manta, Ecuador
FEI# 3001139454
Hochico Marine Processing Corp. 9/28/01
29 Der Shin 1st Road
Su-Ao, I-Lan
Taiwan
FEI# 3002808707
Hung Lou International Trading Co.
Kaohsiung, Taiwan
Hsien Pin Frozen Foods, Co., Ltd. 12/10/93
21 Pzyh Chyang Road
Su-Ao Chen, I-Lan HS
Taiwan R.O.C.
MID# TWHSIPIN21SUA
I-Mei Frozen Foods Co., Ltd 9/23/99
No. 244 Fu Der Road, Su-Ao
I-Lan, Taiwan
FEI# 1000152505
Industria Exportadora del Pacifico Cia Ltda 12/5/00
Km 6 1/2 Via Juan Tanca Marengo
Frente Colegio Americano
Guayaquil, Ecuador
FEI# 1000295122
Industrial Pesquera Monteverde C.A. 6/14/91
(INPECA)
Guayaquil, Ecuador
Industries Del Mar Lubar
Ecuador
Julieta Mera Capitan Merjera
Guayaquil, Ecuador
Mardex Cia. Ltda. 3/7/94
Avenida 102 Los Esteros
P.O. Box 3894
Manta, Ecuador
MID# ECMARCA3894MAN
Mardelit Cia. Ltda. 4/8/99
Avenida M-3, Calle 25
Manta, Ecuador
FEI# 1000453705
Mariscos (Marcrusa) Y. Crustaceos S. A.,
Guayaquil, Ecuador
Negocios Industriales Real S.A. 4/15/91
Guayaquil, Ecuador
Neptuna CIA. LTDA
Apartado Postal 352
Guayaquil, Ecuador
Ocean Beauty Corp. Frozen Mahi Mahi/16A--51
Room 16, 6th Floor 02/11/04
No. 1, section 3
Shin Sheng North Road
Taiwan, Republic of China
FEI# 3000325913
Oceanfish S.A. 2/20/96
Km. 4.5. Via Manta-Montecristi
Manta, Ecuador Address Change 3/13/01
FEI# 3004347364
Name Change 5/10/04
Ocean Majesty, Inc.
Taipei, Taiwan
Paexport S.A. 2/28/91
Guayaquil, Ecuador
Patricio Villamar 5/20/99
Agroseafod S.A.
Calle 3ra. No. 401 y Av
Miraflores, Guayaquil
Ecuador
FEI# 3002625582
Pefresco Mar CIA Ltd. 10/9/97
Avenida Flavio Reyes Y Calle 27
Manta, Ecuador
FEI# 3000280668
Pefresman Cia, Ltda. 5/6/91
Calle 113 Avenida 103
Manta, Ecuador
Pesca Ecuatoriana Cia Ltda. 6/10/93
Edificio El Vigia M-109
Apartado Postal No. 13-05-3817
Manta, Ecuador
ID# ECPESECU1305MAN
Pesnusan CIA, Ltda. 4/18/00
Km 7.5 Via Manta Montecristi
Manta, Ecuador
FEI# 1000360294
Pesquera Progalca C.A. 7/18/00
Mapasingque Oeste Ave
Jra. Nr.324 Entre
Guayaquil, Ecuador
FEI# 3000983518
Phillips Seafood of Ecuador, C.A. 7/25/01
Km. 9.5 Via a Daule
Guayaquil. Ecuador
FEI# 3001219367
Promarpasa Productos del
Mar Patico's, S.A.
Guayaquil, Ecuador
Promarosa Cia Ltda
(Productos del Mar Santa Rosa Cia Ltda)
Guayaquil, Ecuador
Rader S.A. 12/08/94
95 Via Daule
P.O. Box 09014934
Guayaquil
Ecuador
MID# ECRADSA95GUA
Sandra Ronquillo Perez 5/31/96
Calle 61 Y Ave 49
Guayaquil, Ecuador
MID# ECSANRON61GUA
* Sea Taste Foods Corporation 6/3/92
No. 26 Jong Heng Street
Hsiao Kang District
Kaohsiung, Taiwan, Republic of China
*Name Change formerly Ho Kee Frozen Foods
Foods Factory 7/21/98
Shianlin Frozen Foods Processing Address changed
Plant Co., Ltd. 5/23/95
90 7F Chien Kuo, 1st Road
Kaohsiung, Taiwan
MID# TWSHIFRO90KAO
Shin Evergreen Marine Products Co., Ltd. 9/28/04
1F, No. 47-39, Singdong Rd.,
Donggang Township
Pingtung, Taiwan
FEI# 3004688009
Super Fresco Seafood 10/18/01
Ave de Lo Motiones Lote 25
Quito, Ecuador
FEI# 3003189833
Tong Yeng Industrial Co. Ltd.
Tong-Sang, l-Lan, Taiwan
Transmarina C.A.
Induato 905
Guayaquil, Ecuador
Trife F Fresh Fishes Finest S.A. 9/19/00
Cdia Nva Kennedy Norte
Mz #4 Solar 91 er
Guayaquil
Ecuador
FEI# 3003002236
Union Development Frozen 2/5/02
Foods Co., Ltd.
5 Tong Lin Road
Hsiao Fang District
Kaohsiung
Taiwan, Republic of China
FEI# 1000145404
FACTORY LOCATION:
Yelin Enterprise Co., Ltd. 4/9/98
# 100 Chen Shin Village
Wu Gie District
I-Lan, Taiwan
FEI# 3001446720
OFFICE LOCATION:
Yelin Enterprise Co., Ltd. 4/9/98
6th Floor
No.70 Min Chuan West Road
Taipei, Taiwan
FEI# 1000262767 *** Attachment B - Import Alert #16-05 10/21/04
SHIPPERS ON DETENTION WITHOUT PHYSICAL EXAMINATION FROM COUNTRIES OTHER THAN
ECUADOR OR TAIWAN ***
Hai Vuong Co., Ltd. Mahimahi Decomposition
Suoi Dau Industrial Zone 16A--51 &
Khanh Hoa Province Histamines
Vietnam 8/5/04
FEI# 3004277224
Highland Dragon Enterprise Fresh, Fresh Frozen Histamines
# 15 Road 6 Mahi Mahi and Decomp
Song Than 1 Industrial Park 16A--51
Binh Duong Province 10/9/02
Vietnam
FEI# 3003467708
Nha Trang Seafoods-Factory 90 Mahi Mahi Decomposition
1 Phuoc Long, Binh Tan 16A[][]51
Nha Trang, Vietnam 9/17/04
FEI# 3004263028
P.T. Mirta Raya Mina Frozen Mahi Mahi Fillets Histamines &
Muara Baru Blok B, 18 16A51 Decomp
Jakarta, 14440, Indonesia 5/7/98
FEI# 3001245130