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" ATTACHMENT REVISED 10/10/07
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, 240 276-9203
Linda Wisniowski, DIOP, 301-442-6553
DATE LOADED
INTO FIARS: January 23, 2004
Attachment for Import Alert #71-04 Revised 10/10/07
FIRMS AND PRODUCTS ON DETENTION WITHOUT PHYSICAL EXAMINATION
AUSTRALIA (AU)
Firm: Product: Date Product
DWPE code:
Southern Meats Ovine meat and 7/20/05 71A[][]99
100 Mazamet Road bone meal 71A[][]06
Goulburn, Australia
FEI# 3001664932
CANADA (CA)
FIRM PRODUCT DATE PRODUCT CODE
DWPE
Lilydale CO-OP, Feed Grade 8/8/07 71B[][]99
Wynyard Rendering Div. Poultry Blend 71B[][]06
502 Bosworth Street Meal 71E[][]01
Wynyard
Saskatchewan, Canada
FEI# 3004405917
Oakhill Feeds Dried Egg 9/27/06 71Y[][]99
90 Adams Blvd. Powder
Brantford
Ontario, Canada N3S7V2
FEI# 3004598636
(Office)
Oakhill Feeds
aka Fraser Commodities
42 Willow Dr.
Brantford
Ontario, Canada N3R2W4
FEI# 3002714758
(Manufacturer)
Soya Excel Inc. Bulk Soyplus 6/28/06 70A[][]09
380 boul. L'Heureux Feed
Beloeil
Quebec, Canada J3G 2C9
FEI# 3003003002
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
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