Questions and 

Answers for MinimalRisk (Canada) Rule

Q. What does the final rule on bovine spongiform 

encephalopathy (BSE) and minimal-risk regions 

change?

A. The rule amends regulations regarding the importation of ruminants and ruminant products and 

byproducts. It establishes a set of conditions whereby a country can be recognized as presenting minimal risk of introducing BSE into the United States. 

The new rule will continue to protect the United 

States from the introduction of BSE, while removing 

unnecessary prohibitions on the importation of certain commodities from minimal-risk regions.

Q. What is a minimal-risk region?

A. A minimal-risk region must meet the standards 

described in the rule and includes

• 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 States 

unlikely; or

• A region that has taken effective regulatory measures to prevent BSE, has never detected the 

disease, but cannot be considered BSE-free.

 A minimal-risk region must have had in place, 

prior to the detection of BSE, risk-mitigation measures—such as import restrictions, a ruminant-toruminant feed ban, and surveillance—adequate to 

prevent widespread establishment of the disease. 

The region also should conduct epidemiologic investigations and risk assessments when cases are identified and impose additional risk-mitigation measures 

as necessary. 

Q. Has any country met the conditions and been 

listed as a minimal-risk region?

A. Canada has provided information for an evaluation and has been determined to meet the conditions 

of a minimal-risk region. The U.S. Department of 

Agriculture (USDA) conducted a thorough, scientific 

assessment 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 assessment included careful consideration of the risk-mitigation measures Canada 

has in place, the risk-mitigation measures in the 

United States, and also the risk-mitigation measures 

imposed in this final rule. The assessment confirms 

that allowing the importation of certain Canadian 

ruminants and ruminant products under the conditions imposed by the rule will continue to protect 

against introduction of BSE into the United States. 

Q. What types of mitigation measures does 

Canada have in place to qualify as a minimal-risk 

region?

A. The minimal-risk standards that Canada has met 

include

• 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 7 

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 epidemiologic investigations, risk 

assessments, and risk-mitigation measures 

imposed as necessary: Canada has conducted 

extensive investigations in response to any BSE 

finding and has taken additional mitigation measures in response. These risk-mitigation measures include, among others, prohibiting specified risk materials in human food.

Q. Why is Canada in a different category from 

other countries where BSE has been discovered?

A. USDA has determined through a scientific risk 

assessment that the risk presented by opening the 

borders to certain Canadian ruminants and ruminant products is minimal. We have used international recommendations—as defined by the World 

Organisation for Animal Health (OIE)—as a reference 

in developing these regulations. The OIE recomFactsheet

Veterinary Services July 2005

APHIS
mendation, based on current scientific understanding, recognizes that there are different levels of risk 

in countries or regions, and provides guidelines for 

trade according to these levels of risk. Canada has 

had a stringent set of risk-mitigation measures in 

place for several years prior to the diagnosis of a 

case of BSE. Thus, the first case doesn’t represent 

the front edge of a rapidly increasing outbreak situation. It represents a limited exposure that occurred 

years ago that has not continued to circulate or 

amplify. This creates a very different risk scenario as 

compared to a country that diagnoses the first case 

of BSE and then begins to institute risk-management 

measures. In this latter scenario, the disease would 

have continued to amplify, and the first case may 

have indicated the beginning of a significant outbreak 

curve.

 Other countries may seek minimal-risk status 

if they meet the necessary conditions. USDA will 

determine the eligibility of future countries in the 

same manner it used with Canada-risk analysis and 

appropriate rulemaking procedures.

Q. What types of products will be eligible for 

importation from Canada?

A. The commodities that will be allowed to be imported from Canada under specified conditions under 

this final rule can be summarized as

• 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 due to BSE for live cervids or camelids 

(i.e., llamas, alpacas, guanacos, and vicunas) from a 

BSE minimal-risk region.

Q. When will cattle start crossing the border from 

Canada?

A. The rule is effective immediately–July 15, 2005–

due to the order from the Circuit Court, and the live 

animals and products addressed in the rule are eligible for importation as of that date. However, to 

ensure appropriate certification procedures and policies are in place, USDA does not expect any movement to occur until Monday, July 18, 2005. 

Q. Under the new rule, can live ruminants from 

Canada enter the United States through any port?

A. The final rule requires that live ruminants from 

Canada enter the United States through specified ports-of-entry. These 20 entry points have the 

facilities available to ensure the requirements of 

the final rule are being met: Eastport, ID; Houlton, 

and Jackman, ME; Detroit, Port Huron, and Sault 

Ste. Marie, MI; Baudette, MN; Opheim, Raymond, 

and Sweetgrass, MT; Alexandria Bay, Buffalo, and 

Champlain, NY; Dunseith, Pembina, and Portal, ND; 

Derby Line and Highgate Springs, VT; Oroville and 

Sumas, WA.

Q. Can ruminant products come through the same 

entry ports as live ruminants?

A. No, all ruminant products entering the United 

States from Canada must, if arriving at a land border 

port, arrive at one of the following ports: Eastport, 

ID; Calais and Houlton, ME; Detroit (Ambassador 

Bridge), Port Huron, and Sault St. Marie, MI; 

International Falls, MN; Raymond, Roosville, and 

Sweetgrass, MT; Alexandria Bay, Buffalo (Lewiston 

Bridge and Peace Bridge), and Champlain, NY; 

Pembina and Portal, ND; Derby Line and Highgate 

Springs, VT; and Blaine (Pacific Highway and Cargo 

Ops), Lynden, Oroville, and Sumas (Cargo), WA.

Q. Will feeder cattle and feeder sheep and goats 

imported from minimal-risk regions require identification before they cross the border?

A. Yes. 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 must be branded with 

“C/\N” and feeder sheep and goats from Canada will 

be branded with “C.” 

 In addition, all feeder cattle and feeder sheep 

and goats imported from minimal-risk regions must 

be individually identified by an official eartag of the 

country of origin. The eartag must be applied before 

the animal’s arrival at the port-of-entry into the United 

States, meet U.S. eartag standards, and be traceable to the animal’s premises of origin. No person 

may alter, deface, remove, or otherwise tamper with 

the individual identification while the animal is in the 

United States or moving through the United States. 

Q. Will Canadian products be labeled with their 

country of origin?

A. All Canadian ruminant products and byproducts 

will need to have the proper import documentation 

when they cross the border into the United States. 

However, these products won’t be labeled with their 

country of origin when they reach the consumer.

 It is important to remember that imported meat 

products are subject to the same stringent food 

safety standards as domestic products. Foreign 

countries must undergo a stringent review process 

before they become eligible to export meat, poultry, 

or egg products to the United States. 
The 2002 Farm Bill provided for country-of-origin

labeling for beef, lamb, pork, fish, perishable agricultural commodities, and peanuts. However, 

Public Law 108–199 (the FY 2004 Consolidated 

Appropriations Act) delayed the implementation of 

mandatory country of origin labeling (COOL) for all 

covered commodities, except wild and farm-raised 

fish and shellfish, until September 30, 2006. When 

mandatory COOL goes into effect for beef, it will 

apply to all appropriate Canadian ruminant products 

and byproducts.

Q. What safeguarding measures does the rule 

require for the importation of live Canadian cattle 

for immediate slaughter?

A. Canadian cattle imported for immediate slaughter 

must be less than 30 months of age when imported. 

They must be accompanied by a health certificate, 

attesting to their age and relating to animal identification, origin, destination, and responsible parties. 

 Cattle for immediate slaughter must move directly 

as a group from the port of entry to a recognized 

slaughtering establishment in sealed containers. They 

must be slaughtered as a group, and all appropriate specified risk materials as defined by USDA’s 

Food Safety and Inspection Service (FSIS) must be 

removed. 

Q: What happens if a bovine animal over 30 

months of age enters the United States from 

Canada?

A: USDA thinks such a scenario is very unlikely due 

to the fact that each animal presented at slaughter 

comes in under sealed containers and with a veterinary health certificate attesting to the age and health 

condition of the animal. If the animal is determined 

to be over 30 months of age, it will be properly disposed of and will not enter the human or animal food 

chains.

 As noted in the March 2004 notice reopening the 

comment period on the proposed minimal-risk region 

rule, APHIS is currently evaluating the appropriate 

approach regarding live cattle 30 months of age and 

older and intends to address that issue in a separate 

rulemaking proceeding in the Federal Register. 

Q. Will Canadian cattle be tested for BSE in the 

United States?

A. BSE testing in the United States is conducted for 

animal health surveillance purposes. The current 

enhanced surveillance program focuses on obtaining 

samples from the targeted population of cattle where 

the disease is most likely to be found—in adult animals that have some type of clinical abnormality that 

could be consistent with BSE. Because of the nature 

of the disease and limitations of current BSE testing 

technology, testing clinically normal animals does not 

provide any significantly meaningful information for 

surveillance purposes. In addition, the BSE test cannot be considered a food safety test.

 If any Canadian cattle fit our targeted population 

as described, they will be subject to sampling under 

the enhanced BSE surveillance program. This would 

include any cattle condemned by FSIS at antemortem examination. 

Q. If Canada discovers additional cases of BSE, 

will the border be closed again?

A. Should another case of BSE be discovered, any 

actions taken by USDA will depend on the facts and 

circumstances of the situation, an analysis of these 

facts and circumstances, and Canada’s subsequent 

response to the detection. 

Q. How will the amended regulations affect transshipment of domestic ruminants and ruminant 

products through Canada to Alaska?

A. This regulation will not affect the transshipment of 

domestic ruminants and ruminant products through 

Canada to Alaska. Earlier this year, the Canadian 

Food Inspection Agency (CFIA) began allowing the 

temporary entry of live cattle under conditions that 

included the USDA’s assurance that the animals 

would return to the United States. Accordingly, all 

BSE-based restrictions that prohibited the transshipment of ruminant livestock from the lower 48 States 

to Alaska via Canada were lifted. However, CFIA’s 

regulations pertaining to the humane transport of 

livestock continue to preclude the transshipment of 

livestock by land via Canada. 

Q. What process did USDA use to amend these 

regulations?

A. USDA amended the regulations through the 

Federal rulemaking process. USDA first proposed 

changes to its regulations regarding establishing 

minimal-risk regions and conditions for safely importing certain 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, in a cow imported from Canada. 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. 

Q. Is USDA confident that the final rule will continue to safeguard U.S. public and animal health?

A. USDA conducted a thorough, scientific assessment of the risk of certain types of Canadian ruminants and ruminant products introducing BSE into 
United States Department of Agriculture • Animal and Plant Health Inspection Service • Safeguarding American Agriculture

the United States. This risk assessment included 

consideration of the risk-mitigation measures Canada 

has in place, the risk-mitigation measures in the 

United States, and also the risk-mitigation measures 

imposed in this final rule. USDA determined that 

allowing the importation of Canadian ruminants and 

ruminant products under the conditions imposed by 

the rule will continue to protect against the introduction of BSE into the United States and protect human 

and animal health.

Q. Is USDA working with any other agencies to 

implement these regulations? How will USDA 

implement this rule?

A. USDA’s Animal and Plant Health Inspection 

Service (APHIS) is finalizing preparations to implement the rule and will have these in place by Monday, 

July 18, 2005. 

 APHIS and FSIS have worked closely together 

throughout the rulemaking process and have agreed 

on certification language for ruminant products 

and prepared importer information. These will be 

posted to the APHIS Web site on July 15, 2005. 

Stakeholders can find out more about importing animal products by going to <http://www.aphis.usda.

gov/lpa/issues/bse/trade/Dear_Product_importer.

pdf>.

 USDA has also coordinated these regulations 

with the U.S. Department of Health and Human 

Services’ (HHS) Food and Drug Administration. In 

addition, APHIS will be working closely with the U.S. 

Department of Homeland Security’s Customs and 

Border Protection to ensure that the regulations and 

policies are clear to those performing inspections at 

the border. 

Q. Will other countries be categorized as minimalrisk regions in the future?

A. Other countries that meet the conditions necessary to be recognized as a minimal-risk region will 

be considered in the future. The designation of any 

future countries as minimal risk will be accomplished 

in the same manner as Canada—through risk analysis and appropriate rulemaking.

Q. What is the risk of allowing cattle to enter from 

Canada?

A. The risk of BSE being introduced and spread 

through cattle imported under the provisions of this 

rule is absolutely minimal. The risk analysis conducted demonstrates that Canada has taken appropriate 

risk mitigation measures and that the possible prevalence of BSE circulating in Canada is extremely low. 

The risk of introduction is further lessened by the 

specific import restrictions imposed on animals and 

animal products imported under this rule. In addition 

to these measures, there are measures in place in the 

United States, such as the ruminant-to-ruminant feed 

ban, that prevent the disease from spreading into the 

U.S. domestic cattle population in the highly unlikely 

even that it is introduced.

 The risk is further mitigated by five interlocking, 

overlapping, and sequential risk barriers applied at 

critical control points. For an infected Canadian animal to transmit infection to a U.S. cow, five barriers 

must be crossed: (1) U.S. import restrictions; 

(2) slaughter controls; (3) rendering inactivation; 

(4) feed manufacturing controls; and (5) dose limitations. Since the risk of infectivity circulating in 

Canada is already minimal, each of these barriers 

will further reduce that risk, leading to a very small 

residual risk.

Q. Where can the public view a copy of the final 

rule?

A. The final rule is available online at <http://www.

aphis.usda.gov/lpa/issues/bse/bse.html>.

Q. Where can the public view a copy of the risk 

assessment?

A. The risk assessment is available online at <http://

www.aphis.usda.gov/lpa/issues/bse/bse.html>.

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