IA #28-10 - 9/19/00, IMPORT ALERT #28-10 "Detention Without Physical Examination of
Basil and Other Aromatic Herbs from Calidad Natural S.P.R. de R.I., Morelos, Mexico
Due to the Presence of Cyclorspora Cayetanensis"
TYPE OF ALERT : Detention without Physical Examination (DWPE)
(NOTE: This import alert represents the Agency's current guidance to FDA field
personnel regarding the manufacturer(s) and/or product(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.)
PRODUCTS : Basil and Other Aromatic Herbs such as Rosemary, Oregano,
Tarragon, Chives, Marjoram, Arugula, Thyme, Mint, and Sage
PRODUCT CODES : 28A( )B 04 - Basil
28A( )C 04
28A( )B 53 - Rosemary
28A( )C 53
28A( )B 27 - Oregano, Marjoram
28A( )C 27
28A( )B 47 - Tarragon
28A( )C 47
28A( )B 28 - Mint
28A( )C 28
28A( )B 48 - Thyme
28A( )C 48
28A( )B 41 - Sage
28A( )C 41
28A( )B 99 - n.e.c.
28A( )C 99
PROBLEM : Cyclospora cayetanensis
PAF : FIL
PAC FOR
COLLECTION : 03819A
COUNTRY : Mexico (MX)
MANUFACTURER
: Calidad Natural S.P.R. De R.I.
Panama S/N Sequin Altamirano, C.P. 62790
Xochitepec, Morelos, Mexico
FEI# 3001147126
CHARGE : "The article is subject to refusal of admission pursuant to Section
801(a)(1) of the Act in that it appears to have been manufactured,
processed, or packed under insanitary conditions [Adulteration,
Section 402(a)(4)]." (OASIS Charge Code: MFR INSAN)
RECOMMENDING
OFFICE : CFSAN/Office of Field Programs, Import Branch, HFS-606
REASON FOR
ALERT : Two cases of foodborne illness episodes occurring in Missouri
during July 1999 were traced back to Calidad Natural. The agent in
the outbreak was determined to be Cyclospora cayetanensis and the
implicated food was basil. FDA sent a team to Calidad during
December 1999 to inspect the farm. Well water samples from the
farm were positive for Eimeria spp. which is closely related to
Cyclospora but does not cause illness in humans. However, the team
was unable to visit and/or inspect the well. FDA sent a sampling
kit to the Mexican Government to collect a sample from the well.
Recently, the sampling kit was returned and the well water was
found positive for Cyclospora.
GUIDANCE : Detain without physical examination basil and other similar
aromatic herbs from this firm.
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.
Because of the difficulty in detecting Cyclospora contamination in
fresh products, testing of the product upon entry to the U.S. will
not be sufficient. However, the Agency may consider evidence to
establish that the cause of Cyclospora contamination in herbs
produced by the subject grower has been identified and appropriate
corrective action has been taken.
PRIORITIZATION
GUIDANCE : I
FOI : No purging is required.
KEYWORDS : Basil, rosemary, oregano, tarragon, chives, marjoram, thyme
mint, sage, herbs, Cyclospora
PREPARED BY : Linda Wisniowski, Division of Import Operations and Policy,
HFC-170, 301-443-6553
DATE LOADED
INTO FIARS : September 19, 2000
|