Import Alert 28-02
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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 # 28-02
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Indian Pepper"
Reason for Alert:
From December 1, 1986, through May 31, 1987, 20 out of 60 shipments of black pepper (peppercorns) that were sampled, or 33 percent, were detained for filth. The 20 detentions represented 11 different shippers. These findings resulted in black pepper from India being placed under automatic detention in July 1987.
During April 1988, discussions between FDA and the Government of India resulted in a certification program being implemented by the Export Inspection Council (EIC) of the Indian Ministry of Commerce. Under this program the EIC is committed to: sample and test each lot of black pepper exported to the United states; only permit those lots that comply with FDA's requirements for Salmonella, filth, mold and foreign matter to be exported to the United States; and supply a certificate, to be attached to the shipping manifest of each lot found acceptable for export to the United States.
On March 9, 1989, a field assignment issued to NYK-DO and BLT-DO for the collection of Indian black pepper samples from entries with EIC certificates. The objective of the assignment was to determine the effectiveness of the certification program. Results from 23 samples collected during the period of March 1989 through September 1989 did not reveal any violative certified entries.
Because of the apparently successful certification program initiated by the Government of India, detention without physical examination of Indian black pepper shipments will not be invoked when such shipments are accompanied by certificates.
During April 1988, discussions between FDA and the Government of India resulted in a certification program being implemented by the Export Inspection Council (EIC) of the Indian Ministry of Commerce. Under this program the EIC is committed to: sample and test each lot of black pepper exported to the United states; only permit those lots that comply with FDA's requirements for Salmonella, filth, mold and foreign matter to be exported to the United States; and supply a certificate, to be attached to the shipping manifest of each lot found acceptable for export to the United States.
On March 9, 1989, a field assignment issued to NYK-DO and BLT-DO for the collection of Indian black pepper samples from entries with EIC certificates. The objective of the assignment was to determine the effectiveness of the certification program. Results from 23 samples collected during the period of March 1989 through September 1989 did not reveal any violative certified entries.
Because of the apparently successful certification program initiated by the Government of India, detention without physical examination of Indian black pepper shipments will not be invoked when such shipments are accompanied by certificates.
Guidance:
Districts may detain all shipments of black pepper *** (including whole peppercorns, ground, crushed, etc)*** from India not accompanied by a certificate from the Indian EIC. EIC certificates should contain the following information:
a. Lot identification number;
b. Number and size of containers in the lot;
c. Analytical methodology used to determine levels of adulterants/ contaminants;
d. Analytical results of tests for Salmonella, filth, mold and foreign matter;
e. Date of certificate; and,
f. Name and stamp or seal of authorizing official.
Audit sampling of shipments accompanied by certificates is at the discretion of District Offices. However, please alert ***CFSAN's Division of Enforcement (HFS-605), Division of Field Programs and Guidance,*** when entries accompanied by certificates are found violative.
***For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-5992.***
a. Lot identification number;
b. Number and size of containers in the lot;
c. Analytical methodology used to determine levels of adulterants/ contaminants;
d. Analytical results of tests for Salmonella, filth, mold and foreign matter;
e. Date of certificate; and,
f. Name and stamp or seal of authorizing official.
Audit sampling of shipments accompanied by certificates is at the discretion of District Offices. However, please alert ***CFSAN's Division of Enforcement (HFS-605), Division of Field Programs and Guidance,*** when entries accompanied by certificates are found violative.
***For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-5992.***
Product Description:
Black Pepper ***(All)***
Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to contain Salmonella, a poisonous or deleterious substance which may render it injurious to health [adulteration, section 402(a)(1)]."
OASIS charge code - SALMONELLA
or
"...the article appears to contain filth or is otherwise unfit for food (mold, foreign matter)."
OASIS charge code - FILTHY
or
"...the article appears to contain foreign objects [adulteration, section 402(a)(3)]."
OASIS charge code - FOREIGN OB
OASIS charge code - SALMONELLA
or
"...the article appears to contain filth or is otherwise unfit for food (mold, foreign matter)."
OASIS charge code - FILTHY
or
"...the article appears to contain foreign objects [adulteration, section 402(a)(3)]."
OASIS charge code - FOREIGN OB
Countries
INDIA
(28 A - - 54) Pepper,Black, Whole (Spice)
Problems:
SALMONELLA;
(28 B - - 54) Pepper, Black, Ground, Cracked (Spice)
Problems:
SALMONELLA;
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