IA #99-25, 5/20/03, REVISION OF IMPORT ALERT #99-25, "REVISION OF THE ATTACHMENT TO
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
IMPORT PERMIT***"
NOTE: REVISION OF THIS IMPORT ALERT EXPANDS THE TITLE AND TEXT OF THE IMPORT ALERT
TO REFERENCE THE USDA IMPORT PERMIT. INDUSTRY CODE 54, ANIMAL
VITAMINS/MINERALS IS DELETED FROM ATTACHMENT A PER USDA GUIDELINES FOR
IMPORTATION DOCUMENT #1122 (http://www.aphis.usda.gov/vs/ncie/ifeed.html).
NEW INFORMATION IS HIGHLIGHTED BY ASTERISKS (***).
TYPE OF ALERT: DETENTION WITHOUT PHYSICAL EXAMINATION
(Note: This Import Alert contains 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: ALL ANIMAL FEED (INCLUDING PET FOOD), ANIMAL FEED
INGREDIENTS,AND OTHER PRODUCTS FOR ANIMAL USE CONSISTING
OF OR CONTAINING INGREDIENTS OF ANIMAL ORIGIN (SEE ATTACHMENT
A)
PRODUCT CODES: SEE ATTACHMENT A
PROBLEM: POSSIBLE CONTAMINATION WITH THE INFECTIOUS AGENT FOR BOVINE
SPONGIFORM ENCEPHALOPATHY (BSE)
PAC: 71R844
PAF: MIC
COUNTRIES: ALBANIA (AL), ANDORRA (AD), AUSTRIA (AT), BELGIUM (BE), BOSNIA-
HERZEGOVINA (BA), BULGARIA (BG), CANADA (CA), CROATIA (HR), the
CZECH REPUBLIC (CS), DENMARK (DK), the FEDERAL REPUBLIC OF
YUGOSLAVIA (YU), FINLAND (FI), FRANCE (FR), GERMANY (DE), GREECE
(GR), HUNGARY (HU), IRELAND, REPUBLIC of (IE), ISRAEL (IL), ITALY (IT),
JAPAN (JP), LEICHSTENSTEIN (LI), LUXEMBOURG (LU), the former YUGOSLAV
REPUBLIC OF MACEDONIA (MK), MONACO (MC), NETHERLANDS (NL),
NORWAY (NO), OMAN (OM), POLAND (PL), PORTUGAL (PT), ROMANIA (RO),
SAN MARINO (SM), the SLOVAK REPUBLIC (SLOVAKIA) (SK), SLOVENIA (SI),
SPAIN (ES), SWEDEN (SE), SWITZERLAND (CH) UNITED KINGDOM (Great
Britain & Northern Ireland, and Falkland Islands) (GB)
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: CVM, Division of Compliance (HFV-230)
REASON FOR
ALERT: On December 7, 2000, USDA/APHIS enacted an immediate prohibition on the importation into
the United States of all meat and bone meal (MBM), meat meal, bone meal, blood meal, tankage,
offal, or any product containing such, which originated directly from Europe or was
rendered/processed in European plants processing animal materials, regardless of species of
origin, including poultry and fish meal. This prohibition was deemed necessary by APHIS
because of the possibility of cross contamination with the BSE agent.
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).
***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).***
GUIDANCE: Districts may detain without physical examination shipments of animal feeds (including
pet food), animal feed ingredients, and other products for animal use consisting of, or
containing, ingredients of animal origin as listed in Attachment A from the designated
countries ***if the product is not the subject of a valid USDA import permit (VS Form
16-6).***
OASIS Screening Criteria have been loaded to ensure that entries of products that
contain or may contain animal protein or by-products will be selected for review by the
entry reviewer. As part of the review process, the entry reviewer should contact the
filer/importer, request paper entry documents ***(USDA import permit, VS Form 16-
6)),*** and remind the filer/importer of their requirement to hold the shipment intact
pending FDA release. Additionally, the entry reviewer should determine the intended
use of the product, the ingredients, and the name and address of the ultimate consignee.
If the filer/importer does not agree to hold the product intact pending FDA release,
contact the local office of US Customs and ask that they detain the product.
Products which (from labeling or other documentation) appear to contain animal protein
or by-products *** and which are not the subject of a valid USDA import permit (VS
Form 16-6)***should either be detained by FDA or recommended to USDA/APHIS for
appropriate action. (The location of the APHIS/Plant Protection and Quarantine office
can be determined by calling USDA's Veterinary Medical Office at (301) 734-7633).
Products detained and refused under the above reference charge may not be
reconditioned or converted to non-FDA regulated use. They must be either destroyed or
exported.
Please note that APHIS has received information that shipments of animal-derived
products may be offered for entry under descriptions that may be misleading or appear to
not be subject to their prohibition, such as fertilizer, adhesive, supplement, nutritional
supplement, additive, feed/food additive.
PRIORITIZATION
GUIDANCE: I
FOI: No purging is required
PREPARED BY: Gloria J. Dunnavan, CVM, Division of Compliance, HFV-230 (301-827-1168) and Dr.
Neal Bataller (301-827-0163) and Linda Wisniowski, DIOP, (301-443-6553)
KEYWORDS: MBM, Feed, Meal, Animal, European Union, EU, BSE, TSE
DATE LOADED
INTO FIARS: October 1, 2003
ATTACHMENT A
Products Subject to Detention Without Physical Examination
(NOTE: This list is subject to revision as additional information is received.)
69 - Medicated Animal Feeds
69 [ ][ ][ ][ ][ ] All products
70 - Non-Medicated Animal Feeds
70 [ ][ ][ ][ ][ ] All products
71 - By-products for Animal Food
71[ ][ ][ ] [ ] [ ] All products EXCEPT:
71F[ ] [ ] [ ] - Brewery and Distillery
71G[ ] [ ] [ ] - Corn Products
71H [ ] [ ] [ ] - Flour Mill
71I [ ] [ ] [ ] - Rice Mill
71J[ ] [ ] [ ] - Fruit
71K[ ] [ ] [ ] - Vegetable
71L[ ] [ ] [ ] - Oilseed
72 - Pet and Laboratory Animal Food
72 [ ] [ ] [ ] [ ] [ ] All products
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