Import Alert 16-66
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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 # 16-66
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Shark and Tuna for Methyl Mercury"
Reason for Alert:
Based on new data on the consumption of shark and the toxicity of methyl mercury, CFSAN toxicologists have re-evaluated their previous positon and now can support regulatory action against shark containing methyl mercury residues in excess of 1 ppm. Recent samples of shark from Ecuador, Mexico, and Venezuela have been found to contain residues of methyl mercury exceeding 1 ppm.
Further, CFSAN has also supported recommendation for detention without physical examination of tuna found to contain residue levels of methyl mercury exceeding 1 ppm.
Further, CFSAN has also supported recommendation for detention without physical examination of tuna found to contain residue levels of methyl mercury exceeding 1 ppm.
Guidance:
Districts may detain, without physical examination, all entries of shark and tuna from the packers/shippers listed on the Red List for this alert.
Note that only the specific species of shark listed on the attachment, e.g., mako shark, is subject to detention without physical examination.
The attachment lists firms whose shipments of shark or tuna are subject to detention without physical examination.
Note that only the specific species of shark listed on the attachment, e.g., mako shark, is subject to detention without physical examination.
The attachment lists firms whose shipments of shark or tuna are subject to detention without physical examination.
Product Description:
Shark and tuna, all edible species, fresh or frozen, filets and steaks.
Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears to contain a poisonous or deleterious substance, excessive levels of mercury, which may render it injurious to health. [Adulteration, Section 402(a)(1)]"
OASIS charge code - POISONOUS
OASIS charge code - POISONOUS
BAHAMAS
Nassau Highliner One Limited
Date Published : 09/18/2009
P. O. Box N8969 , Nassau, BAHAMAS
16 A - - 35 Shark
Date Published: 09/18/2009
Notes:DWPE date - 1/12/1994
Problems:
MERCURY, METHYL;
PARADISE FISHERIES LTD.
Date Published : 09/18/2009
#16 Mt. Royal & Harley St. , Palmdale , NASSAU, BS-NP BAHAMAS
16 A - - 35 Shark
Date Published: 09/18/2009
Notes:DWPE date - 2/10/1994
Problems:
MERCURY, METHYL;
CHILE
Sociedad Commercial Seven Blue Seas (SBS) Ltd
Date Published : 09/18/2009
Avenida Americo Norte 1650 , San Antonio, Santiago CHILE
16 A - - 35 Shark
Date Published: 09/18/2009
Desc:Mako
Notes:DWPE date - 4/24/1992
Notes:DWPE date - 4/24/1992
Problems:
MERCURY, METHYL;
COSTA RICA
Exgo S A
Date Published : 09/18/2009
unknown , San Jose, COSTA RICA
16 A - - 35 Shark
Date Published: 09/18/2009
Desc:Mako
Notes:DWPE date - 12/31/1991
Notes:DWPE date - 12/31/1991
Problems:
MERCURY, METHYL;
Exportadora Frumar, S.A.
Date Published : 09/18/2009
1.5 Kms Oeste Pacto Del Jocote , Apartados 671 , Alejuela, Cr-A COSTA RICA
16 A - - 35 Shark
Date Published: 09/18/2009
Notes:DWPE date - 8/5/1996
Problems:
MERCURY, METHYL;
Industrias Martec, S.A.
Date Published : 09/18/2009
El Ranchon de Boca Vieja , Apartado 20 , Quepos, Cr-Nota COSTA RICA
16 A - - 35 Shark
Date Published: 09/18/2009
Desc:mako
Notes:DWPE date - 4/8/1992
Notes:DWPE date - 4/8/1992
Problems:
MERCURY, METHYL;
Montemar Coopemontecillos R.L. Unidad Pesca
Date Published : 09/18/2009
P.O. Box 4105-1000 , 26th Av., 20-24 Calle , San Jose, COSTA RICA
16 A - - 35 Shark
Date Published: 09/18/2009
Desc:Thresher
Problems:
MERCURY, METHYL;
Pesca Palmares S.A.
Date Published : 02/05/2010
Cedula Juridica 3-101-09527-03 , Puntarenas, San Jose COSTA RICA
16 A - - 35 Shark
Date Published: 02/05/2010
Notes:DWPE date - 3/10/1995
ECUADOR
Comercial Santana Cedeno
Date Published : 09/18/2009
Km 4.5 Via Manta Montecristi , Box 2738 , Manta, ECUADOR
16 A - - 35 Shark
Date Published: 09/18/2009
Desc:Thresher
Problems:
MERCURY, METHYL;
Ecuafresco Sa Planta
Date Published : 09/18/2009
Calle 113 Y Avenda , Manta, Ecuador, ECUADOR
16 A - - 35 Shark
Date Published: 09/18/2009
Desc:mako shark loin
Notes:DWPE date - 1/14/1995
Notes:DWPE date - 1/14/1995
Problems:
MERCURY, METHYL;
Empacadora Del Litoral Somar Cia. Ltda.
Date Published : 09/18/2009
Mapassigue Calle 60, 82A Y Av. la Costa , Guayaquil, ECUADOR
16 A - - 35 Shark
Date Published: 09/18/2009
Desc:thresher
Notes:DWPE date - 3/16/1992
Notes:DWPE date - 3/16/1992
Problems:
MERCURY, METHYL;
Pefresman Cia Ltda
Date Published : 09/18/2009
Calle 113 Avenida 103 , Manta, ECUADOR
16 A - - 35 Shark
Date Published: 09/18/2009
Desc:thresher
Problems:
MERCURY, METHYL;
Phillips Seafood Ecuador, CA
Date Published : 09/18/2009
Km. 9.5 Via A Daule , Urb. Inmaconsa , Guayaquil, EC-G ECUADOR
16 A - - 35 Shark
Date Published: 09/18/2009
Desc:thresher
Notes:DWPE date - 7/25/2001
Notes:DWPE date - 7/25/2001
Problems:
MERCURY, METHYL;
Promarpasa S.A. Productos del Mar aka Francisco Puig
Date Published : 09/18/2009
Av. Primera No. 107 , Guayaquil, ECUADOR
16 A - - 35 Shark
Date Published: 09/18/2009
Notes:DWPE date - 12/31/1991
Problems:
MERCURY, METHYL;
GUATEMALA
Distribuidora Libra
Date Published : 09/18/2009
1 Calle 4-40 Zona 3 , Guatemala City, GUATEMALA
16 A - - 35 Shark
Date Published: 09/18/2009
Desc:salted shark fillets
Notes:Misdeclared on FDA 701 as dried shark fins DWPE date - 3/16/1992
Notes:Misdeclared on FDA 701 as dried shark fins DWPE date - 3/16/1992
Problems:
MERCURY, METHYL;
MEXICO
Atunera Intercontinental S.A.
Date Published : 09/18/2009
Calle 62 No. 304 , Merida, Yucatan MEXICO
16 A - - 35 Shark
Date Published: 09/18/2009
Desc:mako
Problems:
MERCURY, METHYL;
URUGUAY
Trymmur Ltda
Date Published : 09/18/2009
Editt Torre Libertad Plza Cagancha 1335 , Av Luis A De Herrera 3909 , Montevideo, URUGUAY
16 A - - 35 Shark
Date Published: 09/18/2009
Desc:mako
Notes:Misdeclared as whitefish refer to Import Alert 16-04 DWPE date - 3/10/1995
Notes:Misdeclared as whitefish refer to Import Alert 16-04 DWPE date - 3/10/1995
Problems:
MERCURY, METHYL;
VENEZUELA
Antonio Oteiza
Date Published : 09/18/2009
2001 Calle Principal El Morro , Puerto Santo, VENEZUELA
16 A - - 35 Shark
Date Published: 09/18/2009
Desc:mako
Notes:DWPE date - 5/8/1997
Notes:DWPE date - 5/8/1997
Problems:
MERCURY, METHYL;
Trinkor Pesquera C.A.
Date Published : 09/18/2009
Unknown , Caracas, VENEZUELA
16 A - - 35 Shark
Date Published: 09/18/2009
Problems:
METHYL MERCURY;
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