Final Rule on BSE and Minimal-Risk Regions

December 2004

Veterinary Services

On Jan. 4, 2005, after a careful and thorough science-based risk assessment and a comprehensive rulemaking process, the U.S. Department of Agriculture (USDA) published a final rule amending its regulations to provide for the importation of certain ruminants, ruminant products and byproducts from regions that pose a minimal risk of introducing bovine spongiform encephalopathy (BSE) into the United States. The rule establishes criteria for regions to be recognized as presenting minimal risk of introducing BSE into the United States. This rule ensures the continued protection of the U.S. food and feed supply from BSE, while removing unnecessary prohibitions on the importation of certain commodities from minimal-risk regions.

A minimal-risk region could include:
• A region in which BSE-infected animals have been diagnosed, but sufficient regulatory measures have been put in place that would make the introduction of BSE into the United State unlikely; or
• A region that has taken effective regulatory measures to prevent BSE, has never detected the disease, but cannot be considered BSE free.

By establishing criteria for minimal-risk regions, the United States has taken a leadership role in fostering trade of low-risk products with countries that have a low incidence of BSE and historically strong risk mitigation measures. Such a move is consistent with the World Organization for Animal Health (OIE) recommendations for the trade in animals and animal products from BSE-affected countries.

Classification of Canada as Minimal-Risk Region

In addition to defining the standards for minimal-risk regions, this rule places Canada in the minimal-risk category and defines the requirements that must be met to allow the import of certain ruminants and ruminant products from Canada.

USDA conducted a thorough risk analysis to evaluate the risk of resuming the importation of Canadian ruminants and ruminant products in view of the two BSE cases of Canadian origin. This risk analysis included careful consideration of the risk mitigation measures Canada has in place to detect and prevent BSE within Canadian cattle and also the risk mitigation measures imposed in this final rule. USDA determined that allowing the importation of certain Canadian ruminants and ruminant products under the conditions imposed by the rule will continue to protect against introducing additional cases of BSE into the United States.

USDA has determined that Canada meets the requirements for a minimal-risk region. The minimal-risk standards that Canada has met include, among other things:
• Import restrictions sufficient to minimize exposure to BSE. Since 1990, Canada has maintained stringent import restrictions preventing the entry of live ruminants and ruminant products, including rendered protein products, from countries that have found BSE in native cattle or that are considered to be at significant risk for BSE.
• Surveillance for BSE at levels that meet or exceed international guidelines. Canada has conducted active surveillance for BSE since 1992 and exceeded the level recommended in international guidelines for at least the past seven years.
• Ruminant-to-ruminant feed ban in place and effectively enforced. Canada has had a ban on the feeding of ruminant proteins to ruminants since August 1997, with compliance monitored through routine inspections.
• Appropriate epidemiological investigations, risk assessment, and risk mitigation measures imposed as necessary. Canada has conducted extensive investigations of BSE cases and has taken additional risk mitigation measures in response to these cases. These risk mitigation measures include among others, prohibiting specified risk materials in human food.

Commodities Eligible for Import from Canada

The final rule is effective March 7, 2005. Certain live ruminants and ruminant products and byproducts are eligible for importation from Canada as of that date under specified conditions. The following commodities are allowed to be imported as long as they meet applicable criteria specified in the regulations:
• Bovines, for feeding or immediate slaughter, as long as they are slaughtered at less than 30 months;
• Sheep and goats (ovines and caprines), for feeding or immediate slaughter, as long as they are slaughtered at less than 12 months of age;
• Meat from bovines, ovines, caprines and cervids (deer, elk, caribou, moose, and reindeer); and
• Certain other products and byproducts, including bovine livers and tongues, gelatin, and tallow.

USDA is also specifying that there are no import restrictions because of BSE for live cervids or camelids (i.e., llamas, alpacas, guanacos and vicunas) from a BSE-minimal risk region.

Additional Requirements for Canadian Imports

USDA is confident that the animal and public health measures that Canada has in place to prevent BSE, combined with existing U.S. domestic safeguards and additional safeguards provided in the final rule provide the utmost protections to U.S. consumers and livestock. The final rule provides the following additional requirements for live Canadian feeder cattle designed to ensure they are slaughtered before they reach 30 months of age:
• Feeder cattle must be permanently marked with a brand to identify the BSE minimal-risk region of origin before entering the United States. Feeder cattle exported from Canada will be branded with "C/\N;"
• Cattle must be individually identified with an ear tag before entering the United States. This ear tag allows the animal to be traced back to the premises of origin (birth herd);
• Information must be included on the cattle's animal health certification, relating to animal identification, origin, destination, and responsible parties;
• Cattle must be moved to feedlots in sealed containers and cannot go to more than one feedlot; and
• SRM's will be removed from Canadian cattle slaughtered in the United States in accordance with FSIS regulations.

The final rule provides the following additional requirements for live Canadian sheep and goats designed to ensure they are slaughtered before they reach 12 months of age:
• Sheep and goats must be permanently marked with a brand to identify the BSE minimal-risk region of origin before entering the United States. Sheep and goats exported from Canada will be branded with a "C;"
• Sheep and goats must be individually identified with an ear tag before entering the United States. This ear tag allows the animal to be traced back to the premises of origin;
• Information must be included on the sheep's and goat's animal health certification, relating to animal identification, origin, destination, and responsible parties;
• Sheep and goats must be moved to feedlots in sealed containers and cannot go to more than one feedlot.

USDA first proposed changes to its regulations regarding establishing minimal-risk regions and conditions for safely importing live ruminants and ruminant products from such regions on November 4, 2003, and the comment period was still under way when the United States announced its first case of BSE on December 23, 2003. To allow additional time for commenters to evaluate the proposal in the context of the first U.S. finding of the disease, USDA reopened the comment period and accepted comments until April 7, 2004.

Other countries or regions that meet the minimal-risk conditions will be considered in the future. The designation of any future countries as minimal-risk regions will be accomplished through rulemaking procedures following completion of an appropriate risk assessment.

Economic Impact

Prior to detection of BSE in Canada in May 2003, the United States and Canada engaged in significant trade in feeder cattle and slaughter cattle. This rule will reestablish mutually beneficial trade in live animals between the two countries. Because the United States has permitted imports from Canada of boneless beef from animals less than 30 months of age since mid-2003, this rule is expected to have little impact on U.S. beef imports.

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