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