IA #71-04 - 1/23/04, "IMPORT ALERT #71-04, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF ANIMAL FEEDS, OTHER THAN PET TREATS, DUE TO THE PRESENCE OF
SALMONELLA"


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 products(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:       See Attachment

PRODUCT
CODE:               See Attachment

PROBLEM:       Salmonella

PAF:           MIC (Microbiological Contamination)

PAC FOR
COLLECTION:         71003E

COUNTRY:       See Attachment

MANUFACTURER/
SHIPPER FEI#:  See Attachment

CHARGE:        The article is subject to refusal of admission pursuant to
               Section 801(a)(3) in that it appears to bear or contain
               Salmonella, a poisonous or deleterious substance, which may
               render it injurious to health, [Adulteration, Section
               402(a)(1)]
               (OASIS CHARGE CODE: SALMONELLA)

RECOMMENDING
OFFICE:        SWID-DO, HFR-SW640 and CVM/HFV-232

REASON FOR
ALERT:         In March, 2003, the Southwest Import District collected a sample
               of ovine (sheep) meat and bone meal from an Australian
               manufacturer in domestic status.  Subsequently, the sample was
               analyzed and found to be contaminated with Salmonella. Although
               traced back to an imported shipment, it was difficult to assess
               whether the source of adulteration had occurred at the foreign
               manufacturer or at the domestic manufacturer.  Subsequently,
               samples of feeds from other foreign manufacturers collected at
               entry by SWID have been found positive for Salmonella.

               This import alert provides for manufacturers and shippers,
               from multiple countries, to be placed on detention without
               physical examination for animal feeds, other than pet
               treats, found to contain Salmonella.  Pet treats are
               covered by Import Alert #72-03.

GUIDANCE:      Districts may detain without physical examination, products
               offered for importation from manufacturers and shippers
               listed in the Attachment to this alert.

               Report animal feed samples found positive for Salmonella to
               Jack Geltman, CVM, Division of Compliance, HFV-232, at
               (301)827-6591. Refer to Compliance Program 71003, Feed
               Contaminants Program, for further guidance. Recommendations
               for detention without physical examination should be
               forwarded to DIOP.

               For questions or issues concerning science, science policy,
               sample collection, analysis, preparation, or analytical
               methodology, contact the Division of Field Science at (301)
               827-7605.

               To enable the agency to assess whether the firm has
               identified the source of the problem, and has taken the
               appropriate steps to correct and prevent future
               occurrences, FDA recommends that the firm provide the
               following information:

               a.   Results of the firm's investigation(s) into the
                    problem of Salmonella contamination

               b.   Documentation showing corrective action(s), such as:

                    i.   a description of the process(es) being used
                    ii.  verification that the process is adequate
                    iii. measures that have been taken to prevent
                         recontamination

               c.   Copies of three (3) production records showing the
                    process, quantities processed, lot numbers and dates
                    of processing.

               FDA personnel should assess the adequacy of the firm's
               corrective process by reviewing third party analytical
               results for five (5) consecutive shipments, where the
               removal request relates to a single product, or twelve (12)
               consecutive shipments, where the removal request relates to
               multiple products.

               All requests for removal from DWPE should be forwarded to
               DIOP (HFC-170).

PRIORITIZATION
GUIDANCE:      I

FOI:           No purging is necessary

KEYWORDS:      Feed, ovine, meat, bone, meal

PREPARED BY:        Jack Geltman, HFV-232, 301-827-6591
               Linda Wisniowski, DIOP, 301-442-6553

DATE LOADED
INTO FIARS:         January 23, 2004


                Attachment for Import Alert #71-04

FIRMS AND PRODUCTS ON DETETNION WITHOUT PHYSICAL EXAMINATION

                           MEXICO (MX)

FIRM                     PRODUCT        DATE      PRODUCT CODE
                                        DWPE



Cerverceria Cuahtemoc SA de CV     Brewers Dried  11/15/04  70Y--99
Km. 149.5                     Yeast
Carretera Mochis-Navoja            (animal feed)
Navojoa, Sonora Mexico
FEI# 3003347502


Maz Industrial S.A.de C.V.    Fish meal      1/23/04   71D[][]03
Estero De Urias S/N
Mazatlan, Sin., Mexico
FEI# 3003737848