IA #71-02, 1/21/04, IMPORT ALERT #71-02, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF ANIMAL FEEDS AND FEED INGREDIENTS THAT MAY CONTAIN ***
INGREDIENTS OF ANIMAL ORIGIN***", ATTACHMENT 9/24/08
NOTE: Revisions of this Import Alert include modification of the alert title
and charge, and clarification of the reason for this alert, and of the
guidance section. Changes are highlighted by asterisks (***)
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: Animal feeds and feed ingredients that may contain
ingredients of animal origin [See Attachment]
PRODUCT CODE: 69[][][][][] - medicated animal feeds
70[][][][][] - non-medicated animal feeds
71[][][][][] - by products for animal food
72[][][][][] - pet and laboratory animal food
PROBLEM: Bovine Spongiform Encephalopathy (BSE) Certain animal
feeds and feed ingredients from BSE-affected or BSE-at-risk
countries that may contain ingredients of animal origin.
PAF: FIL
PAC: 71R844
COUNTRY: See Attachment
MANUFACTURERS/
SHIPPERS: See Attachment
CHARGE: *** "The article is subject to refusal of admission
pursuant to Section 801(a)(1)in that it appears that such
article has been manufactured, processed, or packed under
insanitary conditions." *** (OASIS Charge Code: MFR INSAN)
RECOMMENDING
OFFICE: Center for Veterinary Medicine, HFV-230, and ORO/Division of
Import Operations and Policy, HFC-170
REASON FOR
ALERT: *** The United States Department of Agriculture (USDA),
Animal and Plant Health Inspection Service (APHIS),
Veterinary Services (VS) regulates the importation of
animals and animal-derived materials. More specifically,
under 9 CFR 95.4, the USDA does not allow the importation of
animal feeds or feed ingredients that contain or consist of
processed animal protein (e.g. meat and bone meal) and other
animal waste and by product materials that have been derived
from animals that have been in specified BSE-affected and
BSE-at-risk countries. The USDA may, however, allow for the
importation of specific non-ruminant animal-derived
products, provided the product is the subject of a valid
USDA import permit (VS Form 16-6)
BSE is the bovine form of a group of uniformly fatal
Neurological diseases known as TSEs (Transmissible
Spongiform Encephalopathies). BSE appears to be spread in
part through feeding of infected material to cattle. At
this time, the causative agent is unknown and there is no
test for the presence of the agent in animal derived
products. There appears to be a link between the bovine
TSE, BSE, and a human form of TSE known as vCJD (new variant
Creutzfeldt-Jakob Disease).
In support of the USDA/APHIS import prohibitions, the FDA
instituted Import Alert #99-25, "Detention Without Physical
examination of Animal Feed, Animal Feed Ingredients and
Other Products For Animal Use Consisting or Containing
Ingredients of Animal Origin and NOT the subject of a valid
USDA permit."
To ensure compliance with Import Alert #99-25, the FDA has a
sampling program to conduct random sampling and analysis of
feed and feed ingredients for the presence of animal tissues
offered for entry into the U.S. The firms listed in the
Attachment of this Import Alert #71-02 have offered feed
and/or feed ingredients into the U.S. that have been found
to contain animal protein upon sampling and analysis. ***
GUIDANCE: *** Districts may detain without physical examination
products offered for import from those firms that are listed
on the attachment. In order to fully evaluate whether such
products contain ingredients of animal origin subject to
detention under Import Alert #99-25 and, if so, whether this
problem has been corrected, FDA recommends that firms
provide the following information:
1. Evidence that the firm has determined that the
products it is importing are no longer subject to
detention under Import Alert 99-25, because it has
taken appropriate steps to prevent the presence of
animal material in feed and feed ingredients.
This should be documented by:
a. Results of the firm's investigation(s) into the
problem of animal protein contamination.
b. Documentation showing corrective action(s).
This should include at a minimum:
1) a description of the current processes
being used to prevent contamination and
2) verification that the processes are
adequate
c. Documentation, based on current feed microscopy
analytical methodology, that a minimum of five
(5) consecutive import entries have been
released by FDA based on private laboratory
analyses that show the shipments contain no
material of animal origin. Requests to remove
from the DWPE list multiple products from a
manufacturer should include a minimum of twelve
(12) import entries representative of products
covered by detention without physical
examination.
OR
2. Evidence that the product is the subject of a valid
USDA import permit (VS Form 16-6).
All requests for removal from DWPE should be forwarded
to(HFC-170)at the address below. Requests will be
forwarded to CVM for evaluation.
Food And Drug Administration
Division, Import Operations and Policy
(HFC-170), Room 12-38
5600 Fishers Lane
Rockville, MD 20857 ***
PRIORITIZATION
GUIDANCE: I
FOI: No purging is required
KEYWORDS: feeds, mammalian protein, animal, BSE, TSE
PREPARED BY: Dave Krawetz, DIOP, (HFC-170) 301-594-3872
Linda Wisniowski, DIOP, (HFC-170) 301-443-6553
CVM contact: Neal Bataller, HFV-230, 301-827-0163
DATE LOADED
INTO FIARS: January 21, 2004
ATTACHMENT 9/24/08
Firms/Products on Detention without Physical Examination:
CANADA (CA)
Firm name and address: Product/product code: Reason:
Agricore United Medicated animal feeds Muscle tissue
P.O. Box 420 69[][][][][] blood material
Carseland Non-medicated animal feeds
Alberta, Canada T0L 070 70[][][][][]
FEI# 3004318200 5/10/04
Aliments Breton Inc. Poultry Feed Avian and mammalian
1312 St.George Street 70M[][]03 bones, hairs, soft
St. Bernard, Quebec, Canada 6/2/05 tissue and feathers
FEI# 3004346002
Cereales D.L. Ltee Medicated animal feeds Blood, Bone
25 Avenue Du Pont 69[][][][][] material present
Saint-Louis De Gonzague Non-medicated animal feeds
Quebec, Canada J0S 1T0 70[][][][][]
FEI# 3003447727 4/6/04
Dawn Foods Products Medicated animal feeds Muscle tissue
75 33rd St. E 69[][][][][] feather barbule
Saskatoon, Canada S7K3K7 Non-medicated animal feeds material
FEI# 1000344064 70[][][][][]
12/30/03
Excel Feeds Ltd. Medicated feeds Blood material, bovine
3007 Turner St. 69[][][][][] hair, and mammalian
Abbotsford, B.C., Non-medicated feeds bone material
Canada V2S7T9 70[][][][][]
FEI #3004316870 9/15/06
Landmark Feeds Inc. Macintosh Beef Calf Grower Contains
1950 Brier Park Rd. NW with corn suspect
Medicine Hat 70M--01 muscle and
Alberta Canada T1C 1V3 8/24/04 blood tissue
FEI# 3001400728
Land O Lakes Feeds Bagged medicated Blood and
90540 London Rd., RR#2 animal feeds blood meal
Wingham, Ontario, Canada 69[][][][][]
N0G 2W0 Bagged non-medicated
FEI# 3004318728 animal feeds
70[][][][][]
6/2/05
Louis Dreyfus Canada Ltd. Medicated animal feeds Muscle tissue
(Brass Facility) 69[][][][][]
P.O. Box 689 Non-medicated animal feeds
Wilkie, Saskatchewan 70[][][][]
Canada SOK 4WO 12/30/03
FEI #3004283114
Masterfeeds Medicated animal feeds Blood material
11 Jamieson Ave. 69[][][][][]
Picture Butte, AB Non-medicated animal feeds
T0K 1VO, Canada 70[][][][][]
FEI #3003541855 10/3/03
Oleet Processing Ltd Medicated feeds Mammalian muscle
Box 26011 69[][][][][] and mammalian bone
Regina, SK, Canada Non-medicated feeds material
S4R8R7 70[][][][][]
FEI #3003334575 9/15/06
Ritchie Smith Feeds Inc. Medicated animal feeds Blood, muscle
33777 Enterprise Avenue 69[][][][][] tissue, and
Abbotsford, BC, V2S 4N9 Non-medicated animal feeds feather barbule
Canada 70[][][][][]
FEI #1000501066 10/3/03
Unifeed Limited dba Mixed ration for cattle Suspect muscle
Sure Crop Feeds 69[][][][][]/70[][][][][] tissue and bone
1150 Industrial Dr. 9/30/05 mammalian material
Armstrong, B.C. Canada
FEI #3003110241 Address Change
3/29/06
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