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Import Alert 23-10
(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 # 23-10
Published Date: 03/11/2010
Type: DWPE with Surveillance
Import Alert Name:
"Surveillance of In-Shell Brazil Nuts"
Reason for Alert:
For In-Shell Brazil Nuts:
A Memorandum of Understanding with USDA, which has been issued by FDA as CPG 7155a.13, establishes the voluntary program whereby importers may contact the Agricultural Marketing Service of USDA and submit for sampling and aflatoxin analysis a lot of in-shell Brazil nuts intended for importation into the United States. The MOU program applies to importation from intermediate countries (a country other than where the nuts originated) and to reimportation into the United States after the nuts have been exported from this country, as well as to direct importation from the country of origin.
We have been informed that importers are often not participating in the program and therefore are importing Brazil nuts without submitting them to USDA for testing. As a result, untested lots of in-shell Brazil nuts are being introduced into United States commerce to a larger degree than anticipated. In order to fill this "gap" due to non-participation in the program, FDA will examine all untested lots.
For Shelled Brazil Nuts:
From September 19, 1989 through October 3, 1989, BUF-DO sampled and analyzed three shipments of shelled Brazil nuts which were entered at the ports of Buffalo and Niagara Falls, NY. Samples were adulterated with violative levels of aflatoxin ranging from 35 ppb to 153 ppb (check analysis). The samples were representative of the three referenced Canadian shippers.
A Memorandum of Understanding with USDA, which has been issued by FDA as CPG 7155a.13, establishes the voluntary program whereby importers may contact the Agricultural Marketing Service of USDA and submit for sampling and aflatoxin analysis a lot of in-shell Brazil nuts intended for importation into the United States. The MOU program applies to importation from intermediate countries (a country other than where the nuts originated) and to reimportation into the United States after the nuts have been exported from this country, as well as to direct importation from the country of origin.
We have been informed that importers are often not participating in the program and therefore are importing Brazil nuts without submitting them to USDA for testing. As a result, untested lots of in-shell Brazil nuts are being introduced into United States commerce to a larger degree than anticipated. In order to fill this "gap" due to non-participation in the program, FDA will examine all untested lots.
For Shelled Brazil Nuts:
From September 19, 1989 through October 3, 1989, BUF-DO sampled and analyzed three shipments of shelled Brazil nuts which were entered at the ports of Buffalo and Niagara Falls, NY. Samples were adulterated with violative levels of aflatoxin ranging from 35 ppb to 153 ppb (check analysis). The samples were representative of the three referenced Canadian shippers.
Guidance:
For Shelled Brazil Nuts:
Districts may detain, without physical examination, all shipments of Brazil nuts from the above named Canadian shippers. Increased sampling from other shippers is indicated.
For In-Shell Brazil Nuts:
Review all entries of imported Brazil nuts. Determine if the lot has been tested by USDA. If it has, release or detain the shipment based on USDA findings; if it has not, collect a sample for analysis by your designated servicing laboratory.
Sampling instructions are provided in IOM Chapter 4, Chart 6. When informing the importer of the results of analysis, remind the importer of the existence of the MOU and the voluntary testing program for aflatoxin in Brazil nuts.
Districts may detain, without physical examination, all shipments of Brazil nuts from the above named Canadian shippers. Increased sampling from other shippers is indicated.
For In-Shell Brazil Nuts:
Review all entries of imported Brazil nuts. Determine if the lot has been tested by USDA. If it has, release or detain the shipment based on USDA findings; if it has not, collect a sample for analysis by your designated servicing laboratory.
Sampling instructions are provided in IOM Chapter 4, Chart 6. When informing the importer of the results of analysis, remind the importer of the existence of the MOU and the voluntary testing program for aflatoxin in Brazil nuts.
Product Description:
In Shell and Shelled Brazil Nuts
Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain aflatoxin, a poisonous or deleterious substance [Adulteration, Section 402(a)(1)]."
OASIS charge code - AFLATOXIN
OASIS charge code - AFLATOXIN
Countries
(CA) CANADA
(23 B - - 02) Brazil Nut, Shelled
(99) MULTIPLE COUNTRIES (PODS ONLY)
(23 A - - 02) Brazil Nut, In Shell
(3003066524) Ciex-Comercio,Ind E Exportacao Ltda
Date Published : 03/11/2010
Av. Leopoldo Peres,243 , Educandos Manaus/Am, (BR) BRAZIL
23 A - - 02 Brazil Nut, In Shell
Date Published: 03/11/2010
Desc:In shell Brazil Nuts
23 B - - 02 Brazil Nut, Shelled
Date Published: 03/11/2010
Desc:In shell Brazil Nuts
(1000209406) Krispak Ltd
Date Published : 09/16/2009
490 Midwest Rd , Scarborough, ON (CA) CANADA
23 B - - 02 Brazil Nut, Shelled
Date Published: 09/16/2009
Problems:
AFLATOXIN B1;
AFLATOXIN B2;
AFLATOXIN M2;
AFLATOXIN G2;
AFLATOXIN M1;
AFLATOXIN G1;
(1000312206) Trophy Foods Inc
Date Published : 09/16/2009
6555 Kestrel Road , Mississauga, ON (CA) CANADA
23 B - - 02 Brazil Nut, Shelled
Date Published: 09/16/2009
Problems:
AFLATOXIN B1;
AFLATOXIN B2;
AFLATOXIN M2;
AFLATOXIN G2;
AFLATOXIN M1;
AFLATOXIN G1;
(13658) Watt & Scott Inc
Date Published : 09/16/2009
5470 Ferrier St , Montreal, QC (CA) CANADA
23 B - - 02 Brazil Nut, Shelled
Date Published: 09/16/2009
Problems:
AFLATOXIN B1;
AFLATOXIN B2;
AFLATOXIN M2;
AFLATOXIN G2;
AFLATOXIN M1;
AFLATOXIN G1;
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