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From: TSS ()
Subject: UNITED STATES NEW IMPORT REQUIREMENTS FOR BSE
Date: July 21, 2005 at 1:33 pm PST


Government of Canada
Factsheet

Exporting Cattle, Bison, Sheep and Goats to the United States
Following the detection of bovine spongiform encephalopathy (BSE) in May 2003, the United States Department of Agriculture (USDA) restricted the importation of Canadian ruminant livestock. The USDA is now implementing a new Rule - Bovine Spongiform Encephalopathy; Minimal Risk Regions and Importation of Commodities - to re-open the U.S. border to cattle, bison, sheep and goats, under certain conditions. The Rule also removes all BSE-related import restrictions for elk, deer, llamas and alpacas.

Specifically, the Rule permits the importation of cattle and bison less than 30 months of age and sheep and goats less than 12 months of age. These animals may be imported for immediate slaughter and feeding prior to slaughter in the U.S. Cattle, bison, sheep and goats for breeding purposes remain prohibited. This document provides information for Canadian exporters.

Export Certificates
Official Canadian export certificates must be obtained for exports of cattle, bison, sheep and goats for immediate slaughter and feeding. Primary inspection and certification procedures will be conducted by private veterinary practitioners who are accredited by the Canadian Food Inspection Agency (CFIA) to certify for the export of these commodities to the U.S. Veterinarians who wish to become accredited should contact the CFIA.

Accredited veterinarians must use an export certificate supplied by the CFIA and follow the inspection process prescribed by the U.S. Rule. Once an export certificate has been completed, the accredited veterinarian must have it endorsed by the CFIA. The endorsed certificate will then be returned to the accredited veterinarian to accompany the shipment of animals. Unless the health status of the animals to be exported changes, the certificate is valid for 30 days from the inspection date.

The export certificate must confirm that the following U.S. animal health and identification requirements have been met:

Animal Health Requirements
Cattle and bison must be less than 30 months of age when exported to the U.S. Age may be determined from birth records or by an examination of each animal’s dentition.
Sheep and goats must be less than 12 months of age when exported to the U.S. Age may be determined from birth records or by an examination of each animal’s dentition.
All animals must have been born in the U.S. or Canada, or kept in the U.S. or Canada during the last 60 days before shipment to the U.S.
Veterinary inspections must verify all animals are not pregnant and are free from any communicable diseases. All animals must not have been exposed to any such diseases during the 60 days previous to the inspection, must not be in quaratine and must be from brucellosis and tuberculosis free regions.
All animals must be subject to the feed ban.
Sheep and goats must not have tested positive for a transmissible spongiform encephalopathy, such as scrapie, or be considered to pose a risk of such diseases.
Identification Requirements
All animals must be identified with official Canadian ear tags, which can only be removed by U.S. officials at the port of entry or destination slaughter establishment.
Cattle and bison for feeding must be permanently and humanely identified before entering the U.S. with a distinct and legible “CN” mark. This mark must be easily visible on live animals and on the carcass. It must be at least two inches high, readable at the time of export and applied to each animal’s right hip.*
Sheep and goats for feeding must be permanently and humanely identified before entering the U.S. with a distinct and legible “C” mark. This mark must be easily visible on live animals and on the carcass. It must be at least one inch high, readable at the time of export and applied to each animal’s right hip.*
*Marks may be applied by hot or freeze branding, or any other means approved by the USDA. Tattooing is not accepted.

Transporting Animals
Once animals have been certified and loaded, vehicles must be sealed by the accredited veterinarian using official federal seals. The numbers from these seals must be recorded on the Canadian health certificate. If these seals are missing, broken or do not match the numbers on the export certificate, the shipment will be refused entry into the U.S. American border officials may remove seals to inspect the animals in the shipment. If this happens, U.S. seals will be applied.

Shipments must be accompanied by the official Canadian export certificate. Shipments must also be accompanied by VS Form 17-29 “Declaration of Importation.” This form, which is generally prepared by a customs broker, is available on the USDA’s Animal and Plant Health Inspection Service Website at http://www.aphis.usda.gov/library/forms.

Sealed vehicles must move directly from the exporting premises to port of entry and from the port of entry to the designated slaughter establishment or feedlot.

Be Prepared
Exporters should be prepared to provide the following information, which is required to complete the Canadian health certificate:

Exporter’s name and address;
Description of each animal in the shipment;

Species, breed and total number of animals;
Age, colour, markings (including any brands on the animal);
Identification information (ear tag and any other registration numbers);
Addresses of the premises that the animals resided on immediately before export (if different that that of the exporter);
Name and address of importer;
Address of slaughter establishment (including USDA/FSIS number) or feedlot location;
Port of embarkation in Canada and port of entry in the U.S.; and
Mode of transportation and travel route.
Additional Requirements
Unrelated to the requirements of the U.S. rule, the U.S. Food and Drug Administration (FDA) requires exporters of live animals intended for food use (i.e., slaughter) to provide prior notice before animals enter the U.S. As well, Canadian commercial feedlots exporting live animals to the U.S. are required to be registered with the FDA. Prior notice must be received and confirmed electronically by the FDA no more than five days before arrival and no fewer than two hours by land for animals arriving by road.

Information about the registration and prior notice requirements can be found on the Agriculture and Agri-Food Canada Website at http://ats.agr.ca/us/bioterrorism_e.htm. Information can also be obtained by calling a customs broker.

For More Information
Please contact a CFIA district office (listed in the blue pages of the telephone book). Also, see the attached chart for a list of animals, animal products and by-products, including meat products, eligible for export to the U.S.

http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/americ/factfiche.shtml

Canadian Food Inspection Agency
BSE in North America

UNITED STATES NEW IMPORT REQUIREMENTS FOR BSE
Printer friendly PDF version

This is not a regulatory instrument or a regulatory proposal; it is provided as an information guide. The applicable regulatory requirements are those established by the United States.

U.S. Food & Drug Administration
Prior notice of shipments of live food animals, animal feed (including pet food) and feed ingredients and additives must be provided electronically to the U.S. Food and Drug Administration prior to arrival at the border.
Feed lots for live animals and animal feed (pet food) processors of products destined to the United States must be registered with the Food and Drug Administration prior to exporting.
Further information concerning Prior Notice and Registration is available on the U.S. Food and Drug Administration Web Site (www.fda.gov./).
U.S. Department of Agriculture
BSE; MINIMAL RISK REGIONS AND COMMODITIES FOR IMPORTATION

U.S. Final Rule December 29, 2004 to be implemented March 7, 2005

(temporarily delayed by legal proceedings)

COMMODITIES
CONDITIONS

Live ruminants for immediate slaughter or for feeding for slaughter Cattle/bison under 30 months and sheep/goats less than 12 months allowed for immediate slaughter or for feeding and subsequent slaughter; Extensive export certification and sealing of vehicles required.
(See Appendix A)

Live ruminants for breeding purposes No ruminants other than camelids and cervids allowed for breeding purposes.
Ruminant Semen Not restricted.
Ruminant embryos Not in Rule (current policy continues to apply -bovines unrestricted; caprine and ovine prohibited)
Live cervids (deer, elk etc.) and Camelids (llamas, alpacas etc.) No longer prohibited - no import restrictions relative to BSE. Standard sanitary requirements applicable for other diseases
Export Certificate required.

Live ruminants for temporary stay (e.g. fairs, rodeos) Canadian ruminants other than cervids and camelids prohibited.
Live ruminants imported for medical use, scientific research or zoological collections No provision in Rule - prohibited
Live ruminants carrying an animal pathogen for research and testing No provision in Rule - prohibited

COMMODITIES
CONDITIONS

Animal Products and By-Products (includes meat and meat products)

Edible meat from bovines of Canadian origin for human consumption Allows imports of bovine meat products (bone-in/boneless) derived from bovines under 30 months and meeting establishment segregation requirements1
Beef livers Allows edible and inedible beef livers from animals of all ages
Processed meat products containing ruminant meat imported from Canada and/or from CFIA recognized BSE free countries Processed meat products are included in the definition of meat food products and are allowed with the same certification as for the relative ruminant meat1 (derived from bovines under 30 months and meeting establishment segregation requirements)
Inedible meat from bovine animals for manufacture of pet food and pharmaceuticals Is defined as offal and is allowed under the same conditions as for edible meat from bovines1 (derived from bovines under 30 months and meeting establishment segregation requirements)
Edible meat from sheep and goats for human consumption Allowed provided that:
animals subjected to feed ban
slaughtered at facility dedicated to slaughter of sheep and /or goats less than 12 months of age or complies with a segregation program approved by authority of the exporting country
animals did not test positive for and were not suspect for TSE
animals not from a flock diagnosed positive for BSE
animal not subject to movement restrictions due to TSE

Commercial shipments of edible meat from arctic ruminants for human consumption (derived from caribou, reindeer or musk ox) Exempted from BSE related restrictions in the case of cervid. Clarification of status of meat derived from musk ox under discussion with USDA.
Inedible meat from sheep and goats for manufacture of pet food and pharmaceuticals Is allowed as inedible offal, under the same conditions as for edible meat from sheep and goats
Meat from cervids No restrictions (certificate for inedible cervid offal that states cervids have not been in a BSE region)
Trans-shipment of ruminant meat and meat products imported from third countries to Canada via USA No changes in Rule. Meat & meat products from third country may transit at air or sea ports. It may only transit overland if eligible to enter U.S. Transit permit required.
Food containing insignificant amount of Bovidae (sheep, goat, beef) meat Under discussion with FDA. Not in Rule.
Same requirements apply as for meat (soup mixes, products less than 3%, 2% meat)1 (derived from bovines under 30 months and meeting establishment segregation requirements)

Bovidae meat and meat (sheep, goat, beef) products carried by travelers for personal consumption Not allowed.
Meat products delivered just in time and directly to cruise ships in Canadian ports No change, not in Rule
Specific requirements are under discussion with USDA

Meat products kept on a ship as ship’s stores No change, not in Rule.
Natural salted sheep casings Allowed provided derived from sheep less that 12 months of age and were subject to feed ban
Animal food and ingredients for animal food (includes blood) No change in Rule - ruminant ingredients not permitted.
Commercially prepared pet food No change in Rule
Fertilizers and ingredients for fertilizers No change in Rule
Manure No change in Rule - prohibited unless by policy change, e. g. cervid/camelid manure.
Specified risk materials Specified risk materials as defined under USDA-FSIS requirements are prohibited.
Products of a rendering plant No change in Rule- Ruminant product prohibited.
Milk and milk derivatives No change in Rule - not prohibited
Tallow and derivatives Protein free tallow now allowed according to OIE standards plus minor other certification1 (derived from bovines under 30 months and meeting establishment segregation requirements). Under discussion with USDA.
Finished pet chews No change in Rule - ruminant products prohibited.
Things from bones and tissues subjected to rigorous processes of extraction and purification No provision in Rule for this specialized commodity - remains prohibited.
Hides, skins, wool and derivatives No provision in Rule - hides and skins exempted. Hide derived gelatin remains eligible with import permit and certification.
Household garbage, aircraft garbage and ship’s refuse No provision in Rule -exempted since May 2003
Things carrying an animal pathogen No provision in Rule for this specialized commodity.
Things for medical use, scientific research or zoological collection No provision in Rule - no exemptions for ruminants of this nature.
Commercially prepared pet food destined for the importer’s pets own consumption No provision in Rule. Pet food for personal use will not be exempted by policy.
Bone derived gelatin Rule allows gelatin from bovine bones with restrictions and certification1 (derived from bovines under 30 months and meeting establishment segregation requirements)
Animal food for sled dog races (includes inedible ruminant meat scraps and pet food) Allowed under a ‘’Research import permit’‘

--------------------------------------------------------------------------------

Federal Register, Vol 70, No. 47, March 11, 2005, derived from bovines under 30 months (UTM) if:
air-injected stunning is not used
SRM removed at slaughter (small intestine and lingual tonsils from bovines less than 30 months
animals subjected to feed ban
Establishments exporting under thirty month (UTM) beef may now process over thirty month (OTM) beef in the same establishment provided they meet appropriate segregation requirements

This is not a regulatory instrument.

Final Version: 19 July 2005

http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/exp/export_bseesb_e.shtml

USA BSE GBR RAISED TO BSE GBR III

Working Group Report on the Assessment of the Geographical BSE-Risk (GBR
III) of USA 2004 ''extremely/very unstable BSE/cattle system''

USA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/574/sr03_biohaz02_usa_report_annex_en1.pdf>

CANADA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_report_annex_en1.pdf

MEXICO

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/566/sr04_biohaz02_mexico_report_annex_en1.pdf


Canada and the United States have been raised to level III (presence of BSE likely but not confirmed, or confirmed at a lower level) following a new assessment taking into account the most recent evidence. EFSAs Scientific Expert Working Group on geographic BSE risk assessment also evaluated the status of Mexico and South Africa which were classified as level III.

http://www.efsa.eu.int/press_room/press_release/575_en.html

From: Terry S. Singeltary Sr. [flounder@wt.net]
Sent: Tuesday, July 29, 2003 1:03 PM
To: fdadockets@oc.fda.gov
Cc: ggraber@cvm.fda.gov; Linda.Grassie@fda.gov; BSE-L
Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]

Greetings FDA,

snip...

PLUS, if the USA continues to flagrantly ignore the _documented_ science to date about the known TSEs in the USA (let alone the undocumented TSEs in cattle), it is my opinion, every other Country that is dealing with BSE/TSE should boycott the USA and demand that the SSC reclassify the USA BSE GBR II risk assessment to BSE/TSE GBR III 'IMMEDIATELY'. for the SSC to _flounder_ any longer on this issue, should also be regarded with great suspicion as well. NOT to leave out the OIE and it's terribly flawed system of disease surveillance. the OIE should make a move on CWD in the USA, and make a risk assessment on this as a threat to human health. the OIE should also change the mathematical formula for testing of disease. this (in my opinion and others) is terribly flawed as well. to think that a sample survey of 400 or so cattle in a population of 100 million, to think this will find anything, especially after seeing how many TSE tests it took Italy and other Countries to find 1 case of BSE (1 million rapid TSE test in less than 2 years, to find 102 BSE cases), should be proof enough to make drastic changes of this system. the OIE criteria for BSE Country classification and it's interpretation is very problematic. a text that is suppose to give guidelines, but is not understandable, cannot be considered satisfactory. the OIE told me 2 years ago that they were concerned with CWD, but said any changes might take years. well, two years have come and gone, and no change in relations with CWD as a human health risk. if we wait for politics and science to finally make this connection, we very well may die before any decisions
or changes are made. this is not acceptable. we must take the politics and the industry out of any final decisions of the Scientific community. this has been the problem from day one with this environmental man made death sentence. some of you may think i am exaggerating, but you only have to see it once, you only have to watch a loved one die from this one time, and you will never forget, OR forgive...yes, i am still very angry... but the transmission studies DO NOT lie, only the politicians and the industry do... and they are still lying to this day...TSS


http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt


Terry S. Singeltary Sr. P.O. BOX 42 Bacliff, TEXAS USA


From: TSS ()
Subject: MAD COW FEED BAN WARNING LETTER USA June 9, 2005
Date: July 5, 2005 at 8:46 am PST

Department of Health and Human Services Public Health Service
Food and Drug Administration

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7119
FAX: (612) 334-4142

June 9, 2005

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 05-15

Michael J. Langenhorst
President
Anamax Corporation
P.O. Box 10067
Green Bay, WI 54307

Dear Mr. Langenhorst:

Our inspection of your rendering plant located at 505 Hardman Avenue South, South St. Paul, Minnesota, from January 12-20, 2005, revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations , Part 589 .2000 (21 CFR 589 .2000), Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to follow the requirements of this regulation, products being manufactured and distributed by your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)], and misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)].

Our investigation found that you failed to provide for measures to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] in that:

1. You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.

2. You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.

Our investigation also found that you failed to label products that may contain protein derived from mammalian tissues with the statement, "Do not feed to cattle or other ruminants." For example, your Feather Meal and Stabilized Poultry By-Product Meal lack this statement, even though the absence of sufficient measures to avoid commingling or cross-contamination may result in these products containing protein derived from mammalian tissues. Because your products do not bear this caution statement, they are misbranded under Section 403(a)(1) of the Act [21 U.S .C. 343(a)(1)).

The above is not intended as an all-inclusive list of violations. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring that your overall operation and the products you manufacture and distribute are in compliance with the law.

You should acknowledge this letter within 15 working days of receiving and include any additional corrective actions concerning your facility. We have received your letter dated January 31, 2005, which replies to the Form FDA-483 issued on January 20, 2005, and your letter dated February 25, 2005, that states all corrections have been implemented. The corrections you have reported appear to be adequate but will be evaluated further during our follow-up inspection.

Your response should be directed to Compliance Officer Jane E . Nelson at the address on the letterhead. If you have any questions regarding this letter, you may phone Ms. Nelson at (612) 758-7119.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District


http://www.fda.gov/foi/warning_letters/g5373d.pdf


well, at least they got the title right;

UNITED STATES NEW IMPORT REQUIREMENTS FOR BSE

that is exactly what they will now do with GW/OIE et als MRR policy of trading BSE/TSEs globally. nothing like junk science...TSS

TSS




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