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