Skip page top navigation FDA Logo--links to FDA home
page Logo of and Link to start page of Office of Regulatory Affairs, 
U.S. Food and Drug Administration U.S. Food and Drug Administration Office of Regulatory Affairs HHS Logo and link to Department of Health and Human Services website

FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search

IA #24-21 - 12/18/98, IMPORT ALERT #24-21, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF PARSLEY AND CILANTRO FROM AGRICOLA HERENDIRA, MEXICO DUE TO
SHIGELLA SONNEI"

TYPE OF ALERT: DETENTION WITHOUT PHYSICAL EXAMINATION

               (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).

PRODUCT:       Fresh Parsley and Fresh Cilantro

PRODUCT CODE:  24T[][]21 - Parsley
               24T[][]99 - Cilantro

PROBLEM:       Shigella sonnei

PAF:           MIC

PAC FOR
COLLECTION:         03819C

COUNTRY:       Mexico (MX, 595)

MANUFACTURER/
SHIPPER:       Agricola Herendira S. de R.L. de C.V.
               San Marcos No. 198 Fracc Buenaventura
               Ensenada, Baja CFA, Mexico C.P. 22880

MANUFACTURER/
SHIPPER FEI#:  3001295709

CHARGE:        "The article is subject to refusal of admission pursuant to
               Section 801(a)(3) of the Act in that it appears to bear or
               contain a poisonous or deleterious substance which may
               render it injurious to health [adulteration, 402(a)1].

RECOMMENDING
OFFICE:        Division of Import Operations and Policy, Division of
               Emergency & Investigational Operations, and CFSAN/Office of
               Field Programs, Imports Branch

REASON FOR
ALERT:         In August 1998, there were numerous outbreaks of Shigella
               sonnei in the United States and Canada.  In many of the
               reported cases, subsequent traceback investigations and
               epidemiological data implicated fresh parsley from Agricola
               Herendira S. de R.L. de C.V., Mexico as the cause of the
               outbreaks.

               On September 9 and 10, 1998, FDA received reports of an
               additional outbreak of Shigella sonnei. Subsequent traceback
               investigation and epidemiological data implicated fresh
               cilantro from Agricola Herendira, Mexico as the cause of the
               outbreak.

               Due to the non-uniform nature of contaminant such as
               Shigella sonnei in foods of this type, any submission of
               private laboratory testing results indicating a non-
               violative product should be discussed with CFSAN, Office of
               Field Programs Import Branch, before they are determined to
               be sufficient to remove the appearance of the violation.

GUIDANCE:      Districts may detain fresh parsley and fresh cilantro from
               Agricola Herendira, Mexico without physical examination.

PRIORITIZATION
GUIDANCE:      I

FOI:           No purging is required

KEYWORDS:      Parsley, Cilantro, Shigella sonnei, Agricola Herendira

PREPARED BY:   George N. Butler, DIOP, 301-443-6553

DATE LOADED
                    INTO FIARS:         12/18/98