IA #28-02 - REVISION - 8/11/98, IMPORT ALERT #28-02 ***DETENTION WITHOUT PHYSICAL
EXAMINATION***OF INDIAN PEPPER
(NOTE: This import alert represents the Agency's current guidance to FDA field
personnel regarding Indian pepper offered for import. It does not create
or confer any rights for or on any person, and does not operate to bind
FDA or the public.)
TYPE OF ALERT : Audit Sampling/***Detention Without Physical Examination***
NOTE: This alert is being revised to provide changes to format and/or terminology
and are bracketed by asterisks (***).
PRODUCT : Black Pepper ***(All)***
PRODUCT CODE : ***28A__54; 28B__54***
***OASIS
VIOLATION
CHARGE*** : SALMONELLA
FILTH
FOREIGN OB
PAF (Problem
Area Flag) : MIC (Microbiological Hazard)
FIL (Filth)
PAC FOR
COLLECTION : 03819 (A and/or C)
COUNTRY : India (455, IN)
MANUFACTURER
: All
SHIPPER
: 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)];
or the article appears to contain filth or is otherwise unfit
for food (mold, foreign matter); or the article appears to
contain foreign objects [adulteration, section 402(a)(3)]."
RECOMMENDING
OFFICE : DIOP
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.
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-606), Office of Field
Programs,*** 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) 443-
3320 or 3007.***
PRIORITY : I
FOI : No purging is required.
KEYWORDS : Pepper, Black Pepper, Bird Filth, Salmonella, Mold.
PREPARED BY : Jack Geltman, SDWG, DIOP, HFC-172, (301)443-6553
DATE LOADED
INTO FIARS : August 11, 1998
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