53314 Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Parts 93, 94, 95, and 96 

[Docket No. APHIS–2006–0041] 

RIN 0579–AC01 

Bovine Spongiform Encephalopathy; 

Minimal-Risk Regions; Importation of 

Live Bovines and Products Derived 

From Bovines 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Final rule. 

SUMMARY: We are amending the 

regulations regarding the importation of 

animals and animal products to 

establish conditions for the importation 

of the following commodities from 

regions that present a minimal risk of 

introducing bovine spongiform 

encephalopathy into the United States: 

Live bovines for any use born on or after 

a date determined by the Animal and 

Plant Health Inspection Service to be 

the date of effective enforcement of a 

ruminant-to-ruminant feed ban in the 

region of export; blood and blood 

products derived from bovines; and 

casings and part of the small intestine 

derived from bovines. We are making 

these amendments after conducting a 

risk assessment and comprehensive 

evaluation of the issues and concluding 

that such bovines and bovine products 

can be safely imported under the 

conditions described in this rule. This 

document also removes the delay in 

applicability of certain provisions of a 

final rule published in January 2005. 

DATES: Effective Date: November 19, 

2007. 

FOR FURTHER INFORMATION CONTACT: For 

information regarding ruminant 

products, contact Dr. Karen JamesPreston, Director, Technical Trade 

Services, Animal Products, National 

Center for Import and Export, VS, 

APHIS, 4700 River Road Unit 38, 

Riverdale, MD 20737–1231; (301) 734– 

4356. 

For information concerning live 

ruminants, contact Dr. Lee Ann Thomas, 

Director, Technical Trade Services, 

Animals, Organisms and Vectors, and 

Select Agents, National Center for 

Import and Export, VS, APHIS, 4700 

River Road Unit 38, Riverdale, MD 

20737–1231; (301) 734–4935. 

For other information concerning this 

proposed rule, contact Dr. Lisa 

Ferguson, Senior Staff Veterinarian, 

National Center for Animal Health 

Programs, VS, APHIS, 4700 River Road 

Unit 43, Riverdale, MD 20737–1231; 

(301) 734–6954. 

SUPPLEMENTARY INFORMATION: 

Purpose 

This document makes final a 

proposed rule that the Animal and Plant 

Health Inspection Service (APHIS) of 

the U.S. Department of Agriculture 

(USDA or the Department) published in 

the Federal Register on January 9, 2007 

(72 FR 1101–1129, Docket No. APHIS– 

2006–0041). Additionally, it removes 

the delay of applicability of certain 

provisions of a final rule APHIS 

published in January 2005. The removal 

of delay is discussed below under the 

heading ‘‘Removal of Partial Delay of 

Applicability of Provisions of January 

2005 Final Rule.’’ 

In our January 2007 proposed rule, we 

proposed to amend the regulations in 9 

CFR parts 93, 94, 95, and 96 to establish 

conditions for the importation of the 

following commodities from regions 

that present a minimal risk of 

introducing bovine spongiform 

encephalopathy (BSE) into the United 

States: Live bovines for any use born on 

or after a date determined by APHIS to 

be the date of effective enforcement of 

a ruminant-to-ruminant feed ban in the 

region of export; blood and blood 

products derived from bovines; and 

casings and part of the small intestine 

derived from bovines. 

In this document, we respond to 

public comments received on the 

proposed rule and its underlying risk 

assessment and other supporting 

analyses. Additionally, we discuss 

below the history of APHIS rulemaking 

related to BSE minimal-risk regions. 

Background 

APHIS regulates the importation of 

animals and animal products into the 

United States to guard against the 

introduction of animal diseases. The 

regulations in 9 CFR parts 93, 94, 95, 

and 96 (referred to below as the 

regulations) govern the importation of 

certain animals, birds, poultry, meat, 

other animal products and byproducts, 

hay, and straw into the United States in 

order to prevent the introduction of 

various animal diseases, including BSE, 

a chronic degenerative disease affecting 

the central nervous system of cattle. 

With some exceptions, APHIS’ 

regulations prohibit or restrict the 

importation of live ruminants and 

certain ruminant products and 

byproducts from the following three 

categories of regions with regard to BSE: 

(1) Those regions in which BSE is 

known to exist (listed in § 94.18(a)(1) of 

the regulations); (2) those regions that 

present an undue risk of introducing 

BSE into the United States because their 

import requirements are less restrictive 

than those that would be acceptable for 

import into the United States and/or 

because the regions have inadequate 

surveillance (listed in § 94.18(a)(2) of 

the regulations); and (3) those regions 

that present a minimal risk of 

introducing BSE into the United States 

via live ruminants and ruminant 

products and byproducts (listed in 

§ 94.18(a)(3) of the regulations). 

Chronology of Federal Register 

Publications Regarding BSE MinimalRisk Regions 

We added the § 94.18(a)(3) category 

(BSE minimal-risk regions) to the 

regulations in a final rule published in 

the Federal Register on January 4, 2005 

(70 FR 459–553, Docket No. 03–080–3). 

In the final rule, we specified which 

commodities may be imported from BSE 

minimal-risk regions and under what 

conditions, and recognized Canada as a 

BSE minimal-risk region. (At this time, 

Canada is the only recognized BSE 

minimal-risk region.) 

The January 2005 final rule was based 

on a proposed rule we published in the 

Federal Register on November 4, 2003 

(68 FR 62386–62405, Docket No. 03– 

080–1). On December 25, 2003, less than 

2 weeks before the close of the comment 

period for our proposed rule, a case of 

BSE in a dairy cow of Canadian origin 

in Washington State was verified by an 

international reference laboratory. 

In response to comments from the 

public requesting an extension of the 

comment period and in order to give the 

public an additional opportunity to 

comment on the proposed rule in light 

of this development, on March 8, 2004, 

we published a document in the Federal 

Register (69 FR 10633–10636, Docket 

No. 03–080–2) reopening the comment 

period. 

On January 4, 2005, along with the 

final rule, we published in the Federal 

Register a notice (70 FR 554, Docket No. 

03–080–4) announcing the availability 

of, and requesting comments on, a final 

environmental assessment (EA) 

regarding the potential impact on the 

quality of the human environment due 

to the importation of ruminants and 

ruminant products and byproducts from 

Canada under the conditions specified 

in the final rule. On January 21, 2005, 

we published in the Federal Register a 

notice (70 FR 3183–3184, Docket No. 

03–080–5) announcing the availability 

of a corrected version of the EA for 

public review and comment. On April 8, 

2005, we published in the Federal 

Register a finding (70 FR 18252–18262, 

Docket No. 03–080–7) that the 

provisions of the final rule would not 


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Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 53315 

1The regulations regarding BSE minimal-risk 

regions apply to bison as well as cattle. In 

§§ 93.400, 94.0, and 95.1 of the regulations, bovine 

is defined as Bos taurus, Bos indicus, and Bison 

bison. Although the research and other data cited 

in this rulemaking refer to bovines other than bison 

(i.e., to ‘‘cattle’’), there is no evidence to indicate 

that the BSE susceptibility of bison differs from that 

of cattle. We therefore assume that our conclusions 

based on cattle-specific evidence discussed in this 

rulemaking are also applicable to bison. Given that 

no cases of BSE have been detected in bison, this 

is likely a conservative assumption. The provisions 

of this rule apply to bovines as defined in the 

regulations, which include bison. 

have a significant impact on the quality 

of the human environment. 

On March 11, 2005, we published a 

document in the Federal Register that 

gave notice that the Secretary of 

Agriculture was delaying until further 

notice the implementation of certain 

provisions of the final rule with regard 

to certain commodities (70 FR 12112–

12113, Docket No. 03–080–6). 

On November 28, 2005, we published 

in the Federal Register an interim rule 

(70 FR 71213–71218, Docket No. 03–

080–8) that amended certain provisions 

established by the January 2005 final 

rule. The interim rule broadened the list 

of who is authorized to break seals on 

conveyances and allows transloading 

under supervision of products transiting 

the United States. 

On March 14, 2006, we published in 

the Federal Register a technical 

amendment (71 FR 12994–12998, 

Docket No. 03–080–9) that clarified our 

intent with regard to certain provisions 

in the January 2005 final rule and 

corrected several inconsistencies within 

the rule. 

On August 9, 2006, we published in 

the Federal Register a proposed rule (71 

FR 45439–45444, Docket No. APHIS–

2006–0026) that proposed to amend the 

provisions established by the January 

2005 final rule by removing several 

restrictions regarding the identification 

of animals and the processing of 

ruminant materials from BSE minimalrisk regions, and by relieving BSE-based 

restrictions on hide-derived gelatin from 

BSE minimal-risk regions. We solicited 

comments concerning our proposal for 

60 days ending October 10, 2006. On 

November 9, 2006, we published a 

document in the Federal Register (71 

FR 65758–65759, Docket No. APHIS–

2006–0026) reopening and extended the 

comment period until November 24, 

2006. We received a total of 10 

comments by that date. We are 

considering the issues raised by the 

commenters and will address them in a 

separate rulemaking document. 

Scope of the January 2005 Final Rule 

The regulations established by the 

January 2005 final rule and subsequent 

amendments have allowed the 

importation from BSE minimal-risk 

regions of live bovines that are under 30 

months of age when imported and when 

slaughtered and that have been subject 

to a ruminant feed ban equivalent to 

that in place in the United States. 

We did not attempt, for that 

rulemaking, to assess the BSE risk 

associated with the importation of live 

bovines 30 months of age or older from 

a BSE minimal-risk region. Our March 

8, 2004, document that reopened the 

comment period on the November 2003 

proposed rule stated that APHIS was 

evaluating the appropriate approach 

with regard to the importation of live 

animals 30 months of age or older from 

BSE minimal-risk regions, and would 

address that issue in a supplemental 

rulemaking proposal in the Federal 

Register. The provisions in our January 

9, 2007, proposed rule regarding live 

bovines were the result of that 

evaluation. 

The regulations established by the 

January 2005 final rule also provided for 

the importation of the following 

commodities derived from bovines of 

any age: (1) Meat, meat food products, 

and meat byproducts; (2) whole or half 

carcasses; (3) offal; (4) tallow composed 

of less than 0.15 percent insoluble 

impurities that are not otherwise 

eligible for importation under 

§ 95.4(a)(1)(i) of the regulations; and (5) 

gelatin derived from bones of bovines 

that is not otherwise eligible for 

importation under § 94.18(c) of the 

regulations. 

The January 2005 final rule and 

subsequent amendments did not change 

the regulations concerning the 

importation of blood and blood 

products from regions listed in 

§ 94.18(a); the requirements for the 

importation of blood and blood 

products from BSE minimal-risk regions 

remain the same as the requirements for 

importation of blood and blood 

products from other regions listed in 

§ 94.18(a)—only serum and serum 

albumin have been eligible for 

importation. The January 2005 final rule 

also did not change the regulations 

concerning the importation of bovine 

casings (defined as intestines, stomachs, 

esophagi, and urinary bladders) from 

regions listed in § 94.18(a); the 

requirements for the importation of 

bovine casings from BSE minimal-risk 

regions remain the same as the 

requirements for importation of bovine 

casings from other regions listed in 

§ 94.18(a)—only bovine stomachs are 

eligible for importation. 

The January 2005 final rule and 

subsequent amendments allowed trade 

to resume in many, but not all, of the 

commodities that had been prohibited 

importation from Canada following 

detection of a BSE-infected cow in 

Canada in May 2003. Following our 

January 2005 final rule, we continued to 

consider the BSE risk associated with 

older bovines and other bovine products 

from BSE minimal-risk regions—and 

Canada in particular—including bovine 

blood and blood products, bovine small 

intestine other than the distal ileum, 

and bovine casings, and included 

provisions in our January 2007 

proposed rule for the importation of 

those commodities.1

Peer Review of APHIS’ Risk 

Assessment 

As part of this rulemaking, APHIS 

conducted an assessment that evaluated 

the animal health risk to the United 

States of BSE—i.e., the likelihood of 

establishment and the potential impacts 

of cases that may occur even without 

establishment—as a result of importing 

the bovine commodities considered in 

this rule (APHIS 2006b). Our assessment 

concluded that, over the 20 years of the 

analysis, the BSE risk to the United 

States is negligible. We made the risk 

assessment available for public review 

and comment at the time the proposed 

rule was published. 

In addition to making the risk 

assessment available for review and 

comment by the general public, we 

requested an external, formal, 

independent peer review of the 

assessment by recognized experts in the 

field, consistent with guidelines of the 

U.S. Office of Management and Budget 

(OMB 2004). The objective of the peer 

review was to determine whether the 

risk assessment was scientifically 

sound, transparent, and consistent with 

international standards (e.g., those by 

the OIE); the application of external 

assessments or models was appropriate; 

and the assumptions were justified, 

supported and reasonable. Comments 

submitted by the public on the proposed 

rule were submitted to the peer 

reviewers for their consideration. The 

peer review process was coordinated by 

an independent private contractor. 

The full peer review report may be 

viewed at http://www.aphis.usda.gov/ 

peer_review/peer_review_agenda.shtml. 

Additionally, we have included below, 

under the heading ‘‘Final Report from 

Peer Review of APHIS’ Risk Assessment 

and Responses to Peer Reviewer 

Questions and Recommendations,’’

APHIS’ responses to reviewer comments 

that we consider representative of the 

content-related questions and 

recommendations of the report, and our 

response to those questions and 

recommendations. In summary, the 


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reviewers found that the methods used 

in the risk assessment were 

scientifically rigorous in terms of using 

existing literature and models 

appropriately and making sound 

assumptions and that the risk 

assessment itself adhered to 

international risk assessment standards. 

The reviewers also agreed with the 

conclusion that the likelihood of 

establishment of BSE in the U.S. cattle 

population is negligible. 

In addition to being supportive of the 

methods, evidence, and conclusions 

presented by APHIS in the risk 

assessment, the reviewers made several 

useful suggestions for its improvement. 

We made several clarifications and 

updates in consideration of these 

comments. While we expect that the 

changes improve the transparency and 

accuracy of the document, they do not 

alter our conclusion that the risk to the 

United States of BSE—i.e., the 

likelihood of establishment and the 

potential impacts of cases that may 

occur even without establishment—

resulting from the changes outlined in 

the proposed rule is negligible. 

Removal of Partial Delay of 

Applicability of Provisions of January 

2005 Final Rule 

Our January 2005 final rule made 

eligible for importation from Canada 

meat that is derived from bovines 

slaughtered in BSE minimal-risk 

regions, as well as certain other 

specified commodities derived from 

such bovines, provided certain specified 

risk-mitigating conditions have been 

met. The risk analysis we conducted for 

that rulemaking indicated a low BSE 

risk from such commodities derived 

from bovines of any age if certain 

conditions are met (APHIS 2004). These 

conditions include the removal of those 

tissues considered at particular risk of 

containing the BSE agent in infected 

animals (specified risk materials, or 

SRMs). In that rulemaking, we 

discussed regulatory requirements 

implemented by FSIS in 2004 that 

banned SRMs from the human food 

supply in the United States, and we 

stated that the Canadian Government 

had established similar safeguards in 

Canada. 

Consequently, we provided that meat, 

meat byproducts, meat food products, 

and offal derived from bovines are 

eligible for importation from BSE 

minimal-risk regions if the following 

conditions, as well as all other 

applicable requirements of the 

regulations, are met: 

• The commodity is derived from 

bovines that have been subject to a 

ruminant feed ban equivalent to the 

requirements established by the U.S. 

Food and Drug Administration at 21 

CFR 589.2000; 

• The commodity is derived from 

bovines for which an air-injected 

stunning process was not used at 

slaughter; and 

• The SRMs and small intestine of the 

bovines from which the commodity was 

derived were removed at slaughter. 

Additionally we provided that tallow 

composed of less than 0.15 percent 

insoluble impurities that is not 

otherwise eligible for importation under 

9 CFR 95.4(a)(1)(i), and gelatin derived 

from bones of bovines that is not 

otherwise eligible for importation under 

9 CFR 94.18(c) are eligible for 

importation from BSE minimal-risk 

regions, provided certain specified 

conditions are met. 

In the economic analysis we 

conducted for the January 2005 final 

rule, we evaluated the potential 

economic effects of implementing that 

rulemaking, including implementation 

of the provisions allowing the 

importation of meat and other 

commodities derived from bovines 

slaughtered in BSE minimal-risk regions 

(APHIS 2004a). 

In March 2005, APHIS published a 

document in the Federal Register that, 

pursuant to an announcement by the 

Secretary of Agriculture on February 9, 

2005, delayed the applicability of the 

provisions in our January 2005 final rule 

as they apply to the importation from 

Canada of the following commodities 

when derived from bovines 30 months 

of age or older when slaughtered: (1) 

Meat, meat food products, and meat 

byproducts other than liver; (2) whole or 

half carcasses; (3) offal; (4) tallow 

composed of less than 0.15 percent 

insoluble impurities that is not 

otherwise eligible for importation under 

9 CFR 95.4(a)(1)(i); and (5) gelatin 

derived from bones of bovines that is 

not otherwise eligible for importation 

under 9 CFR 94.18(c). 

In his February 9, 2005, 

announcement, the Secretary stated that 

because ongoing investigations into 

recent finds of BSE in Canada in 

animals over 30 months of age were not 

complete, he felt it prudent to delay the 

effective date for allowing imports of 

meat from bovines 30 months of age and 

over. He also indicated that the delay of 

applicability would address concerns 

that the January 2005 final rule allowed 

the importation of beef from bovines 30 

months of age or older, while 

continuing to prohibit the importation 

of live cattle 30 months of age or older 

for processing in the United States. The 

Secretary stated that the Department 

would consider and develop a plan—

based on the latest scientific 

information and with the protection of 

public and animal health as the highest 

priority—to allow imports of live 

bovines 30 months of age or older as 

well as beef from animals 30 months of 

age and older. 

Since the date of the partial delay of 

applicability of our January 2005 final 

rule, we have obtained additional 

information regarding all aspects of the 

issues that prompted the delay of 

applicability and have conducted 

additional analyses in line with the plan 

as described. The risk assessment for 

this final rule demonstrates the 

negligible BSE risk from the importation 

of additional classes of live cattle, 

including those 30 months of age or 

older. This includes acknowledging the 

potential risk pathway that could be 

available if the SRMs from infected 

imported cattle entered the ruminant 

feed supply in contravention of current 

feed regulations. The negligible risk 

from the importation of live older cattle 

therefore gives further support to the 

conclusion of the risk analysis 

conducted for our January 2005 final 

rule regarding meat and meat products 

derived from bovines of any age in BSE 

minimal-risk regions. Specifically, the 

risk is even lower for the importation of 

meat and meat products, as the SRMs 

will be removed in accordance with the 

regulations, than for live bovines. 

Therefore, this document will remove 

the partial delay of applicability of the 

January 2005 final rule. The removal of 

the partial delay of applicability will 

become effective on the date that the 

other provisions of this document 

become applicable. Including the 

removal of the partial delay of 

applicability in this final rule and 

making it effective along with the other 

provisions of this rule will enable 

APHIS to more efficiently communicate 

the necessary implementation 

instructions to U.S. Customs and Border 

Protection and to APHIS field 

personnel. Additionally, it will provide 

commercial entities more flexibility in 

carrying out import planning based on 

the relative economic merits of 

importing live bovines or meat and 

other products derived from bovines. 

Because, for reasons of efficiency for 

APHIS and the regulated community, 

the Secretary has decided to remove the 

delay in applicability as part of this 

document, we looked at the economic 

effects of doing so in combination with 

allowing the importation of bovines 

born on or after March 1, 1999. 

Although we previously analyzed the 

economic effects of allowing the 

importation of meat and other products 

derived from bovines 30 months of age 


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Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 53317 

or older, the economic analysis for this 

rule provides an updated analysis. 

Public Comments on the January 2007 

Proposed Rule 

We solicited comments concerning 

our January 2007 proposal for 60 days 

ending March 12, 2007. We received 

close to 400 comments by that date. The 

commenters included cattle industry 

and farm bureau associations, consumer 

groups, representatives of the Canadian 

Government and other foreign countries, 

State Departments of Agriculture, food 

processing companies, individual cattle 

producers, and other members of the 

public. 

Subjects of Comments Received 

A number of commenters supported 

the rule and recommended no changes 

to the proposed provisions. Other 

commenters supported the rule in 

general but recommended certain 

changes or actions. Other comments 

consisted only of recommended 

changes, objections to the rule in 

general or to specific provisions, or 

requests for clarification. We discuss 

below by topic the issues raised by 

commenters and our response to those 

comments. 

General Opposition to Imports 

Issue: A number of commenters 

expressed general opposition to the 

importation of any bovines or bovine 

products from BSE minimal-risk 

regions. 

Response: It appears to us that these 

commenters are not addressing just our 

January 2007 proposed rule, but, rather, 

also the January 2005 final rule that 

recognized the category of BSE minimalrisk regions and established conditions 

for the importation of certain ruminants 

and ruminant products from such 

regions. 

As we discussed in the January 2005 

final rule, the comprehensive analysis 

and evaluation we conducted for that 

rulemaking led to the conclusion that 

the conditions specified in that rule for 

the importation of ruminants and 

ruminant products from BSE minimalrisk regions would be effective and 

would therefore protect against the 

introduction of BSE into the United 

States. Our January 2007 proposed rule 

considered expansion of the types of 

commodities allowed importation from 

BSE minimal-risk regions, based on an 

evaluation of the risk (i.e., the 

likelihood of establishment and the 

potential impacts of cases that may 

occur even without establishment) of 

importing from Canada live animals, 

blood and blood products, and the small 

intestine excluding distal ileum.) Given 

the determination of negligible BSE risk 

associated with the provisions of this 

final rule, and the findings associated 

with our 2005 final rule, there is no 

scientific basis for increasing 

restrictions from those already in effect 

or being established in this rule. 

Issue: A number of commenters 

expressed opposition, without further 

explanation, to the importation from 

BSE minimal-risk regions of live 

bovines 30 months of age or older and 

to the importation of products derived 

from such bovines. 

Response: We discussed in our 

January 2007 proposed rule the 

rationale for our proposal to allow the 

importation, under certain conditions, 

of live bovines 30 months or older from 

BSE minimal-risk regions. We discussed 

further the assessment of the disease 

risk of allowing such imports that we 

conducted before issuing our proposal. 

It is not clear to us which factors in our 

risk assessment or discussion of 

rationale were being addressed by those 

commenters who expressed general 

opposition to the importation of live 

bovines 30 months of age or older. We 

continue to consider the BSE risk from 

importing live bovines under the 

conditions specified in this rule to be 

negligible. 

Issue: Several commenters who 

expressed opposition to the proposed 

rule expressed concern that the agent 

that causes BSE has yet to be fully 

characterized. The commenters stated 

that what we know about BSE is mostly 

supposition, which should be a 

compelling reason not to allow the 

importation of cattle from a region of 

known BSE outbreaks. One commenter 

stated that research recently conducted 

at Yale University suggests that one of 

the agents that activates BSE may be 

viral, which, according to the 

commenter, implies that a feed ban is 

effective only when the virus is not 

present or active. 

Response: As one of the commenters 

noted, some researchers (Manuelidis et 

al., 2007) suggest that diseases 

characterized as transmissible 

spongiform encephalopathies (TSEs), 

such as BSE, may be caused by viruses, 

although, at this point, no infectionspecific nucleic acids have been 

identified. 

Experimental data and 

epidemiological studies strongly suggest 

that contaminated feed containing 

ruminant proteins derived from infected 

animals was the source of the epidemic, 

and that the epidemic was perpetuated 

through the use of these materials in 

ruminant feed. APHIS considers that 

regardless of the characteristics of the 

BSE causal agent, it is clear that the 

epidemic was sustained and amplified 

by the recycling of BSE infected cattle 

into cattle feed. Despite the difficulty in 

definitively determining the causal 

agent of BSE, risk factors for 

transmission of the agent have been 

identified. The identification and 

characterization of these risk factors 

through epidemiological and 

experimental study have allowed the 

development of effective mitigations to 

prevent BSE spread. The development 

and demonstrated effectiveness of those 

mitigations does not require 

identification of the agent itself. We 

consider mitigation measures that 

address the risk factors for BSE to be 

effective regardless of the precise nature 

of the BSE agent. 

Prevalence of BSE in Canada 

Although the provisions of this rule 

apply to any region recognized by 

APHIS as a BSE minimal-risk region, at 

present APHIS recognizes only one 

country, Canada, as such a region. 

Therefore, in evaluating the BSE risk of 

implementing this rule, we conducted 

an assessment of the risk of importing 

bovines and bovine products from 

Canada under the provisions of our 

proposed rule (APHIS 2006b). In our 

risk assessment, we laid out the likely 

risk pathway (i.e., a series of 

occurrences or steps necessary for 

disease to enter and become 

established). 

In conducting our risk assessment, 

one of the factors we took into account 

was the prevalence of BSE in Canada, 

since prevalence is one factor that 

affects the likelihood of a BSE-infected 

bovine being imported into the United 

States. We received a number of 

comments from the public that 

addressed our estimate of the 

prevalence of BSE in Canada. Although 

some of the comments supported our 

estimate of BSE prevalence in Canada, 

in general the commenters maintained 

that such prevalence is either higher 

than we estimated, may be increasing, 

or is uncertain, or that our methods of 

estimating it were flawed. The 

methodology we used to arrive at such 

estimates is discussed in detail in our 

risk assessment. However, to provide 

some context for the issues raised by 

commenters and discussed below, we 

summarize here the models that we 

used in conducting our assessment. 

The number of BSE cases detected 

through surveillance understates the 

disease prevalence because exposed 

animals may be incubating disease and 

carrying infectious material in their 

tissues without presenting clinical 

symptoms. Like many transmissible 

spongiform encephalopathies (TSEs), 


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2The power of a statistical test is the probability 

of rejecting the null hypothesis when it is false. The 

power depends on the test level of significance, the 

magnitude of effect under the alternative 

hypothesis, sample size, and variability in the 

population. Rice (1988, pp.361–364) describes the 

calculation of statistical power for comparing two 

independent samples. 

3A confidence interval is a statistical range with 

a specified probability that a given parameter lies 

within the range. For example, the 90 percent 

confidence interval of a distribution indicates the 

range of values that we are 90 percent certain 

include the parameter value of interest. It extends 

from the 5th percentile, or 5 percent confidence 

level, at the low end of the distribution of the 95th 

percentile, or 95 percent confidence level at the 

high end of the distribution. Similarly, a 95 percent 

confidence interval would extend from the2.5 

percent confidence level to the 97.5 percent 

confidence level. 

BSE has an incubation period of several 

years. Therefore, the disease is not 

detectable in its early stages with 

current technology. Moreover, 

surveillance will miss a proportion of 

detectable cases. Therefore, we applied 

statistical methods to the available 

epidemiologic and surveillance data to 

estimate, with attendant uncertainty, the 

prevalence of BSE in Canada. 

We used two related, but distinct, 

methods to estimate BSE prevalence in 

Canada: the BSurvE model and the 

Bayesian Birth Cohort (BBC) model. 

Given its international prominence, we 

used the European Union (EU) BSurvE 

model (Wilesmith et al., 2004, 2005), 

recently developed for the purpose of 

estimating BSE prevalence in national 

herds. The BSurvE model is noteworthy 

for its sound epidemiologic structure, 

including stratifying cattle by age and 

cause of death (i.e., healthy slaughter, 

fallen stock, casualty slaughter, or 

clinical suspect) and accounting for the 

relative likelihood of detecting BSE in 

various strata (EFSA 2004). The BSurvE 

model structure calculates BSE 

surveillance point values (random 

sample size equivalents) represented by 

targeted Canadian sampling of certain 

groups of cattle in which BSE cases are 

more likely to be detected. This 

approach allows for the inclusion of 

infected, but undetected, cases (such as 

young animals in the early stages of 

incubation) in the estimate, which 

would be ignored by conventional 

methods. 

The other prevalence estimation 

model that we used is the BBC model. 

This model uses the BSurvE model 

structure and incorporates additional 

information. Unlike BSurvE, the BBC 

model adopts a Bayesian statistical 

framework to incorporate prior 

information about the decreased 

incidence of BSE observed in animals 

born after a feed ban equivalent to the 

initial ruminant-to-ruminant feed ban 

introduced in the United Kingdom in 

1988. 

Issue: One commenter stated that BSE 

has become ‘‘firmly established’’ in 

Canada. 

Response: We disagree with the 

comment, which we consider to 

erroneously equate disease presence, 

which may be transient, with disease 

establishment. In epidemiology, an 

infectious disease has become 

established in a population when the 

disease is perpetuated in the population 

without the need for reintroduction 

from an external source. For example, 

OIE’s sister agency, the international 

Commission on Phytosanitary Measures 

(CPM) defines plant pest establishment 

as ‘‘the perpetuation, for the foreseeable 

future, of a nonindigenous biological 

agent within an area after entry’’ (CPM 

2001). With the implementation and 

continuation of a feed ban in Canada, all 

evidence points toward eventual 

eradication, rather than perpetuation of 

BSE in that country. 

Issue: One commenter stated that, 

since the time APHIS published its 

January 2005 final rule classifying 

Canada as a BSE minimal-risk region, 

the Agency has presented no new 

evidence that would support allowing 

the importation from Canada of the 

additional commodities discussed in the 

proposed rule. In fact, stated the 

commenter, evidence points to Canada 

having a higher prevalence of BSE than 

APHIS had previously determined. 

Response: As discussed in our 

January 2007 proposed rule, we 

revisited our earlier conclusions and 

policies by conducting a rigorous risk 

assessment based on current available 

scientific knowledge of the disease. We 

used peer reviewed risk assessment 

models in our analysis to estimate the 

prevalence of the disease in Canada and 

to analyze the likelihood of BSE 

establishment in the United States and 

the potential impacts of cases that may 

occur even without establishment as a 

result of the importation into the United 

States of the bovine commodities 

considered in this rule. The risk 

assessment itself was peer reviewed by 

experts in the field. As noted above, the 

reviewers agreed with the conclusion 

that the risk of establishment of BSE in 

the U.S. cattle population is negligible 

and noted that several assumptions in 

the risk assessment actually overestimate the risk, so the overall finding 

that the BSE risk is negligible is 

reasonable. Based on the results of the 

risk assessment, we concluded that we 

could safely import Canadian cattle 

born on or after March 1, 1999, blood 

and blood products, and small 

intestines, excluding the distal ileum. 

Issue: Several commenters raised 

questions about the ability to 

statistically determine BSE prevalence 

‘‘trends’’ in Canada, but reached 

different conclusions. Some 

commenters stated that the trajectory of 

BSE prevalence in Canada cannot be 

determined by available surveillance 

data and that, therefore, BSE prevalence 

in Canada may be increasing. On the 

other hand, another commenter 

requested that APHIS make clear that, 

despite the Agency’s use of the BSurvE 

Prevalence B estimate, prevalence 

should not be assumed constant over 

time. The commenter requested that 

APHIS emphasize that lack of statistical 

evidence that prevalence varies from 

cohort to cohort is likely the result of 

inadequate statistical power,2 and that, 

nevertheless, BSE prevalence in Canada 

is most likely decreasing. 

Response: In our risk assessment for 

this rule, we acknowledge that, given 

the rarity of BSE cases in Canada, the 

surveillance data are unlikely to provide 

adequate statistical power to detect any 

trend. However, as discussed in the risk 

assessment, we consider it likely that 

the prevalence of BSE in Canada will 

decrease over time. With so few total 

BSE cases observed in Canada, the 

statistical power to detect differences in 

prevalence between cohorts is low. The 

peer reviewers of our risk assessment 

concur with our conclusion. (RTI 2007, 

pp. 6–26, 6–27). 

Issue: One commenter estimated the 

Canadian BSE prevalence to be 6.4 cases 

per million cattle. Further, the 

commenter stated that this prevalence 

estimate is smaller than the risk 

estimate provided by one of APHIS’

own risk assessments for a more 

pessimistic value of the misfeeding rate. 

The commenter suggested that this 

discrepancy reflects optimistic 

modeling assumptions in APHIS’ risk 

assessment. 

Response: We disagree with the 

commenter’s analysis. Although the 

commenter’s alternative prevalence 

estimate, based on a simple 

extrapolation method, falls within the 

90 percent confidence interval 3 of 

APHIS’ BSurvE Prevalence B estimate 

(2.4 to 6.8 cases per million adult cattle) 

with an expected value of 3.9 per 

million case per million adult cattle 

(APHIS 2006c, table 5), it is based on 

different assumptions. Based on an 

analysis of BSE testing in the EU in 

2001 and 2002, the commenter’s 

prevalence estimate assumes that 

targeted ‘‘risk cattle’’ are only 10 times 

more likely to test positive for BSE than 

non-targeted routinely slaughtered 

cattle. Considering the BSE testing 

conducted in the EU during 2001–2004 

(EC 2005a, table 3, p. 23), cattle in the 


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4 In the BsurveE model, specific ‘‘point values’’

are assigned to each test sample, based on the 

surveillance stream or subpopulation of animals 

from which it was collected, as well as the 

likelihood of detecting infected cattle in that 

subpopulation. A sample from the specific 

surveillance subpopulation where BSE is most 

likely to be detected—i.e., a middle adult clinical 

suspect—provides the most surveillance points. 

Conversely, a sample from the subpopulation where 

BSE is least likely to be detected—generally routine 

slaughter—provides the least points. 

5The BBC model provides a more precise 

estimate of BSE prevalence in Canada by combining 

the epidemiologic theory and application of 

surveillance data underlying the BSurvE model 

with additional information about the effect of the 

feed ban on prevalence. 

European BSE risk animals category 

(emergency slaughter, clinical suspects, 

and fallen stock) are 22 times more 

likely to test BSE positive than cattle in 

the healthy slaughter category. Using 

the commenter’s simple extrapolation 

method and these more up-to-date data 

on BSE test positive ratio, the resulting 

BSE prevalence estimate would be 2.9 

per million cattle. Although actually 

lower than the expected value for the 

BSurvE estimate, this value also falls 

within the 90 percent confidence 

interval of the Agency’s BSurvE 

Prevalence B estimate, described above. 

APHIS calculated both the BSurvE 

Prevalence B estimate and the Bayesian 

Birth Cohort (BBC) prevalence estimate, 

but judged the latter to better 

characterize the BSE prevalence in 

Canada over the next 20 years, due to 

the expected downward pressure 

exerted on the disease by a feed ban. 

With regard to the commenter’s 

suggestion of a discrepancy, the 

commenter provides no specific 

reference to ‘‘the risk estimate provided 

by one of APHIS’ own risk 

assessments,’’ but appears to refer to the 

main body of the 2005 report of Cohen 

and Gray (available at http:// 

www.fsis.usda.gov/PDF/ 

BSE_Risk_Assess_Report_2005.pdf), 

which was prepared for the USDA’s 

Food Safety and Inspection Service 

(FSIS). Cohen and Gray (2005) do not 

estimate Canadian BSE prevalence, but 

rather the effect of introducing 500 BSEinfected cattle into the United States, 

and the pessimistic misfeeding 

assumption estimates that introduction 

would result in an expected 2,600 new 

cases over 20 years. There is no 

discrepancy because this aspect of the 

Cohen and Gray 2005 report is not 

relevant to our estimate of Canadian 

BSE prevalence. 

Issue: Based on APHIS’’ statements 

that animals are infected within their 

first year, and that feed produced prior 

to the feed ban would not be available 

for longer than a year, one commenter 

stated that additional undetected 

infected animals must have existed and 

been rendered in order to provide 

infectivity to detected cases. Therefore, 

stated the commenter, adding in these 

‘‘undetected’’ animals raises the number 

of Canada’s known and measurable BSE 

cases rises from 10 to 14, and APHIS’

estimate of BSE prevalence in Canada 

based on 10 animals is low. 

Response: We disagree with the 

commenter’s analysis and conclusion, 

which assumes that we did not take into 

account the possibility of undetected 

cases of BSE in arriving at our 

prevalence estimate. APHIS’ estimate of 

the prevalence of BSE in Canada was 

adjusted to account for cases that would 

not be tested and for false negative test 

results. Also, although the bulk of feed 

will be consumed within a year after it 

is produced, residual infectivity may 

remain in the feed supply chain for an 

extended period. For example, 

examination of BSE cases in animals 

born in the United Kingdom after the 

1996 ‘‘reinforced feed ban’’ suggests that 

these animals may have been infected 

from the persistence of the BSE agent in 

residual feed in storage bins (SEAC 

2005). 

Issue: One commenter suggested that 

it is likely that Canada has numerous 

cattle over 30 months of age that are 

presently incubating the BSE disease, 

rather than just a few (4.1) as suggested 

by APHIS. 

Response: The estimate of 4.1 BSEinfected animals in the standing 

Canadian adult cattle population was 

based on the expected BSE prevalence 

in Canada under the BBC model. Using 

the estimated prevalence under BSurvE 

Prevalence B resulted in an estimate of 

23.2 BSE-infected animals in the 

standing Canadian adult cattle 

population. Although, quantitatively, 

our risk assessment did not assume a 

decline in BSE prevalence over the next 

20 years, we qualitatively consider such 

a decline to be likely because of 

continued compliance with the feed 

ban. Therefore, in assessing the BSE risk 

associated with imports from Canada 

over the next 20 years, we consider the 

result of the BBC model to be the more 

applicable prevalence estimate for use 

in our quantitative exposure model. 

Issue: One commenter indicated that 

although it is unclear whether the 

APHIS estimates of Canadian BSE 

prevalence included the BSE case 

confirmed on August 23, 2006, the 

APHIS estimates certainly do not take 

into account the case confirmed on 

February 7, 2007. 

Response: We estimated Canadian 

BSE prevalence based on a 7-year 

surveillance period through August 15, 

2006. This surveillance period included 

the detection of nine BSE cases of 

Canadian origin reported through 

August 2006. Through surveillance 

conducted from August 16, 2006, 

through April 2007, Canada detected 

one BSE case born in 2000 and another 

born in 2001 (CFIA 2007). The BSE 

prevalence estimation methods used by 

APHIS (2006a) require detailed data to 

stratify tested cattle by age and cause of 

death (healthy slaughter, fallen stock, 

casualty slaughter, or clinical suspect) 

that are unavailable for the more recent 

surveillance period. However, we can 

assess the sensitivity of our previous 

Canadian BSE prevalence estimates by 

adding the two additional cases without 

changing the BSE surveillance points 

accumulated by Canada during the 7- 

year surveillance period through August 

15, 2006 (APHIS 2006a, table 4). 4 This 

approach results in a revised table of 

BSurvE points and BSE cases by birth 

year cohort that reflects a total of 11 BSE 

cases of Canadian origin reported 

through April 2007 (APHIS 2007, table 

i). 

Using the same methods described in 

USDA’s estimate of BSE prevalence in 

Canada (APHIS 2006c), we obtain 

updated Canadian BSE prevalence 

estimates: 

• BSurvE Prevalence B: 90 percent 

confidence interval = 3.0–8.0 cases per 

million adult cattle 

• Bayesian Birth Cohort (BBC, 

Winbugs): 90 percent confidence 

interval = 0.47–1.2 cases per million 

adult cattle 

Because the updated confidence 

intervals contain the previous expected 

value estimates of 0.68 per million 

(BBC) and 3.9 per million (BSurvE 

Prevalence B) (APHIS 2006c), we 

conclude that the prevalence estimate is 

not sensitive to the addition of the two 

additional BSE cases discovered in 

Canada in August 2006 and February 

2007. 

Issue: One commenter stated that 

APHIS’ expectation that the prevalence 

of BSE in Canada will continue to 

decline from its present minimal level 

does not acknowledge that the 

prevalence of BSE in Canada right now 

is very uncertain. The commenter’s 

independent estimate of the current 

Canadian BSE prevalence is ‘‘on the 

order of 4–6 per million.’’

Response: APHIS’ risk assessment 

addresses the uncertainty in the 

prevalence of BSE in Canada by 

considering estimates that differ by 

more than a factor of five (APHIS 

2006b). The BBC prevalence estimate 

has an expected value of 0.68 cases per 

million adult cattle.5 The BSurvE 

Prevalence B estimate has an expected 

value of 3.9 per million. The 


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6The OIE Terrestrial Animal Code (Chapter 

1.1.1., Article 1.1.1.1) defines incidence as ‘‘the 

number of new cases or outbreaks of a disease that 

occur in a population at risk in a particular 

geographical area within a defined time interval 

(OIE 2006b).’’

commenter’s own method of 

estimation—‘‘on the order of 4–6 per 

million——provides an estimate on the 

same order of magnitude as the BSurvE 

Prevalence B estimate of current 

prevalence. In either case, prevalence is 

extremely low. 

Issue: One commenter stated that, 

although APHIS estimates that BSE 

prevalence in Canada is about 6.8 or 

more times greater than in the United 

States (0.68 vs. 0.1 per million), this 

does not adjust for the important fact 

that the first BSE case in the United 

States was imported from Canada. 

Response: The APHIS October 2006 

estimate of BSE prevalence in Canada is 

based on the nine BSE cases of 

Canadian origin that had been 

confirmed in North America as of 

August 23, 2006. This total includes a 

case of BSE that was confirmed in 

Washington State on December 25, 2003 

(APHIS 2006c, p. 1). The estimate of 

BSE prevalence in the United States 

excludes this case. 

Issue: One commenter stated that the 

calculation of BSE prevalence in Canada 

used in APHIS’ risk assessment 

excluded the European-born case 

detected in 1993. 

Response: The 1993 Canadian BSE 

case of European origin was likely part 

of the original exogenous source of BSE 

infectivity introduced into Canada that 

caused the subsequent generation of 

indigenous cases. Imported cases of BSE 

reflect an exposure to the disease that 

occurred elsewhere, and, therefore, are 

not generally included in estimates of 

prevalence that reflect native exposure. 

Similarly, when APHIS estimated the 

prevalence of BSE in the United States, 

the BSE-infected cow of Canadian origin 

that was detected in Washington State 

in December 2003 was excluded from 

the analysis, because it was an imported 

animal. In addition, as noted in APHIS’

estimation of BSE prevalence in Canada 

(APHIS 2006c, p. 5), in accordance with 

OIE guidelines (which indicate that 

surveillance points totals taken into 

account in assessing a country’s BSE 

risk be accumulated over a maximum of 

7 consecutive years), the estimated 

prevalence of BSE in Canada is based on 

surveillance data accumulated over a 7- 

year period beginning August 16, 1999. 

The 1993 case predates the OIE 7-year 

period. 

Issue: One commenter indicated that 

APHIS should not take action on the 

proposal until real surveillance data 

(not model-based predictions) show that 

the BSE problem has abated. The 

commenter stated further that denying 

Canada’s BSE problem, or assuming it 

away with unvalidated and incorrect 

risk modeling assumptions, does not 

responsibly manage BSE risks to the 

United States. 

Response: We disagree with the 

commenter. In low BSE prevalence 

populations such as Canada, 

surveillance at levels that meet or even 

greatly exceed OIE guidelines provide 

insufficient statistical power to reliably 

detect changes in BSE prevalence over 

time. In other words, starting with a 

very low number of infected animals 

makes it very difficult to statistically 

demonstrate decreases in that number, 

even when testing a relatively large 

number of animals. 

The OIE Guidelines for BSE 

Surveillance (Type A) call for countries 

to accumulate 300,000 BSE surveillance 

points over 7 consecutive years in order 

to detect with 95 percent confidence a 

prevalence level of at least one case of 

BSE per 100,000 animals (OIE 2006, 

Appendix 3.8.4). 

To illustrate the comparative 

difficulty in demonstrating trends in 

low versus high prevalence populations, 

consider two hypothetical countries that 

have accumulated 1 million BSE 

surveillance points for each of two 

cohorts: Animals born before and 

animals born after the introduction of a 

ruminant-to-ruminant feed ban. Under 

this scenario, sampling levels in both 

countries far exceed the OIE guidelines. 

Assume, however, that the two 

countries differ with respect to their 

initial prevalence—i.e., the initial 

prevalence in ‘‘Country A’’ is 1 infected 

animal per 10,000 animals, while that in 

‘‘Country B’’ is 1 infected animal per 

100,000 animals. 

For a given surveillance level, the 

statistical power of a hypothesis test can 

be evaluated as a function of the 

supposed change in BSE prevalence 

between cohort 1 (pre-feed ban) and 

cohort 2 (post-feed ban). The 

conventional minimum statistical power 

criterion is 80 percent. In other words, 

the probability that a statistical analysis 

will detect a true difference across 

groups should be at least 80 percent. 

The conventional significance level is 5 

percent, meaning that we would 

conclude that a result was nonrandom 

if it were 5 percent or less likely to 

occur by chance alone. In our 

hypothetical scenario, the power of the 

surveillance in the country with higher 

prevalence, Country A, to detect a 50 

percent decline in BSE prevalence is 98 

percent. In comparison, the power of the 

surveillance in the lower prevalence 

Country B to detect a 50 percent decline 

in BSE prevalence is only 25 percent. In 

other words, if the Country B feed ban 

actually led to a 50 percent decline in 

BSE prevalence and the equivalent of 2 

million random samples were collected 

(6.7 times the level under the OIE 

guidelines), there would still be a 75 

percent chance of concluding that the 

prevalence was unchanged from its 

initial level of 1 infected animal per 

100,000 animals. 

An important implication of the low 

statistical power of sampling in low 

prevalence populations is that BSE 

surveillance data are unlikely to provide 

a purely statistical basis for making a 

determination about the date when a 

specific intervention (e.g., a ruminantto-ruminant feed ban) becomes effective, 

even when large amounts of 

surveillance data are available. For 

example, according to the OIE (2007a), 

the annual incidence of reported BSE 

cases in the Netherlands dropped from 

13.2 to 0.8 per million adult cattle from 

2001–2005.6 Despite the EU BSE 

surveillance requirements for testing all 

risk animals over 24 months of age and 

all healthy slaughter cattle over 30 

months of age, Figure 1 shows that 

application of the BSurvE (Prevalence 

A) model to Netherlands BSE 

surveillance data does not yield 

sufficient statistical power to draw clear 

distinctions among birth year cohorts as 

prevalence declines (Figure 1). 


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Note that, in figure 1, there is a 

decrease in estimated prevalence 

between 1998 birth-year cohorts and 

1999 birth-year cohorts, while, at the 

same time, there is an increase in the 

upper confidence limit. This apparent 

paradox is indicative of another 

shortcoming of relying on surveillance 

data alone to determine whether BSE 

prevalence has been reduced. Because 

fewer animals from the most recent 

birth year cohorts are tested when sent 

to slaughter, uncertainty about the 

prevalence in the most recent cohorts is 

much greater than in older cohorts. 

Furthermore, the lower likelihood of 

detecting BSE in young infected animals 

means that the young animals that are 

tested contribute relatively little to 

reducing uncertainty in the true (as 

opposed to apparent) BSE prevalence. 

These two sources of uncertainty in 

young birth cohorts (low numbers of 

animals tested, and little value in the 

surveillance data that are gathered from 

them) cause an asymmetrical increase in 

the upper limit of the confidence 

interval compared to the lower 

confidence limit. This effect on the 

upper confidence limit on BSE 

prevalence is most pronounced for the 

most recent birth year cohorts which are 

less likely to be tested and will not have 

lived long enough to manifest BSE, even 

if they have been infected. Wilesmith et 

al. (2004, figure 3) further illustrates this 

same concept. 

Consequently, if the effectiveness of a 

country’s safeguards against BSE 

amplification were determined strictly 

by setting a tolerance for the upper 

confidence limit on BSE prevalence 

associated with the ‘‘real surveillance 

data,’’ one might reach the incorrect 

conclusion that prevalence is 

increasing, when in actuality, the result 

is simply due to testing fewer and 

younger animals in the most recent birth 

year cohorts. Finally, relying solely on 

surveillance data fails to account for 

under reporting of disease due to the 

lack of diagnostic sensitivity to detect 

BSE at an early stage of disease. By 

accounting for the possibility of false 

negative test results, epidemiologic 

models such as BSurvE are recognized 

as providing a more accurate estimate of 

true BSE prevalence than the apparent 

prevalence measured by surveillance 

data alone. 

Issue: One commenter stated that the 

output from the BSurvE model used by 

Canada in 2005 grossly underestimated 

Canada’s 2006 and 2007 BSE prevalence 

and, therefore, the BSurvE model is 

unreliable for estimating Canada’s BSE 

prevalence. The commenter stated 

further that, at the minimum, APHIS 

should determine the erroneous inputs 

that resulted in the failed prediction in 

2005 and correct them. 

Response: In the risk assessment 

conducted for this rulemaking, APHIS 

used its own prevalence estimate, not 

that of the Canadian Food Inspection 

Agency’s (CFIA’s) 2006 prevalence 

estimate, which was not based on 

BSurvE, but on a modified version that 

appears similar to the APHIS BBC 

model. The commenter cites CFIA’s 

Assessment of the North American BSE 

Cases Diagnosed from 2003–2005 (Part 

II), which states that ‘‘when the BSurvE 

model was recently applied to Canada’s 

statistics and adjusted to account for the 

effectiveness of the 1997 feed ban (based 

on experiences with the 1988 feed ban 

in the United Kingdom), the resulting 

prediction was that it could be expected 

that three infected animals remain 

within the national herd’’ (CFIA 2006, 

p. 13). 

APHIS’ estimation of BSE prevalence 

in Canada (APHIS 2006c) is that the 

expected prevalence values under the 

BBC and BSurvE Prevalence B models 

correspond to an expected number of 

BSE-infected animals in the standing 

Canadian adult cattle population of 4.1 

and 23.2, respectively. APHIS further 

explains that it is important to note that 

this range of prevalence estimates 

represents uncertainty and not 

variability. BSE-infected animals are 

recruited into and exit from the adult 

cattle population over time, but at a 

given point in time, the number of 

infected animals in the population is a 

fixed but uncertain value. 

Assuming the overall probability of 

infection remains constant over time, 

the actual number of infected cattle in 

the population at any given point in 

time would still vary randomly about 

the mean. This variability is 

incorporated in the model supporting 

the exposure assessment for live bovines 

by means of the Poisson variability 

distribution. Assuming a fixed mean 

prevalence of 4.1 and 23.2 BSE infected 

animals in the standing adult cattle 

population in Canada, the 95th 

percentile of the Poisson distribution 

are 7 and 31 BSE-infected animals in 

any given year, respectively. We note 

that these numbers are greater than the 


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five BSE cases detected in Canada in 

2006, which means that the greatest 

number of Canadian BSE cases 

identified in a single surveillance year 

is lower than even the 95th percentile 

of distribution. 

Issue: One commenter stated that, if 

the United States were finding BSE 

cases at the same rate as in Canada, this 

would translate into roughly 40 BSE 

cases detected in the United States since 

January 2006, which would be regarded 

as a large number. The commenter 

stated further that, at this time, the BSE 

situation in Canada does not appear to 

be improving. 

Response: We do not agree with the 

commenter. The commenter’s 

conclusion appears to be based on a 

cursory estimate and does not provide 

an accurate comparison of BSE cases 

detected in Canada with a comparable 

number that would have been detected 

in the United States, given the larger 

U.S. cattle population. The commenter’s 

comparison fails to take into account 

other years of surveillance, as well as 

the age and surveillance stream of tested 

animals. These data are extremely 

important for estimating BSE 

prevalence. A comparison based solely 

on the number of detected cases ignores 

infected animals with unapparent or 

undetected infections. 

Table 1 provides a direct comparison 

of the estimated BSE prevalence in the 

current standing adult cattle population 

of the United States and Canada, 

respectively, using identical estimation 

methods (APHIS 2006a; 2006c). 

TABLE 1.—COMPARISON OF ESTIMATED BSE PREVALENCE IN THE

CURRENT STANDING ADULT CATTLE

POPULATION OF U.S. AND CANADA

Country 

BSE Prevalence Estimation 

Method 

BSurvE 

prevalence B BBC 

Expected value 

US .................. 0.18 × 10¥6 0.10 × 10¥6

Canada .......... 3.9 × 10¥6 ... 0.68 × 10¥6

Despite the higher estimated BSE 

prevalence in the current standing adult 

cattle population in Canada compared 

to the prevalence of BSE in the standing 

adult cattle population in the United 

States, APHIS finds that, because of the 

extremely low BSE prevalence in 

Canada and the high levels of BSE 

controls in both Canada and the United 

States, the risk to the United States (i.e., 

the likelihood of establishment of BSE 

in the United States and the potential 

impacts of cases that may occur even 

without establishment) as a result of 

importing from Canada the bovine 

commodities considered in this rule is 

negligible (APHIS 2006b). Furthermore, 

as stated in our risk assessment, we 

expect that the prevalence of BSE in 

Canada will decrease continuously over 

the next several years. Peer reviewers of 

our risk assessment agreed (RTI 2007). 

Issue: One commenter stated that 

Canada’s ratio of positive cases per 

10,000 cattle tested exceeds the ratio of 

22 of the 25 EU-member countries; that 

only the ratios for the United Kingdom, 

Portugal, and Spain exceed Canada’s 

2006 ratio. The commenter noted 

further that even the countries of 

Ireland, Germany, and France, each of 

which are considered to have had 

widespread BSE exposure, have a lower 

ratio for positive cases detected per 

10,000 head tested than does Canada. 

Another commenter stated that Canada’s 

BSE prevalence is higher than that for 

Denmark, Belgium, and Austria, and is 

comparable to the rate in Germany. This 

commenter, who estimated the 

Canadian BSE prevalence to be 6.4 cases 

per million cattle, stated further that no 

one considers countries with a reported 

BSE rate of 1 to 2 cases per million 

animals (e.g., Denmark, Belgium and 

Austria) to have a minimal BSE risk, 

and that Canada is not a BSE minimalrisk region in any ordinary sense. 

Response: The commenters’

statements ignore important differences 

in BSE surveillance and cattle 

populations among countries, and a 

comparison based simply on the 

proportion of positive cases per number 

of cattle tested is inconsistent with the 

prevalence estimate approach taken by 

one of the commenters, as well as the 

prevalence estimate used by APHIS. 

Although calculating the proportion of 

infected animals detected per number of 

tested animals can serve as a useful tool, 

depending on the purpose for the 

calculation, it is not an estimate of 

prevalence. Rather, prevalence is 

defined as the number of infected 

animals in the total population at a 

given point in time. On the other hand, 

the calculation conducted by the 

commenter who referred to the ratio of 

positive cases per 10,000 cattle tested is 

similar to that conducted by the U.S. 

Department of Health and Human 

Services, Centers for Disease Control 

and Prevention (CDC). In May 2007, 

using data similar to that analyzed by 

APHIS for this rulemaking, CDC 

calculated the proportion of Canadianborn BSE cases identified by Canadian 

authorities in relation to the total 

number of animals tested in that 

country. CDC then made a like 

calculation regarding BSE cases in U.S.- 

born cattle and compared the Canadian 

and U.S. results (CDC 2007). Unlike the 

estimate used by APHIS in the risk 

assessment for this rule, the CDC 

calculation is not an estimate of the 

prevalence of BSE in Canada, nor of the 

prevalence in the United States. 

Although the type of calculations 

conducted by CDC can be useful in 

comparing relative proportions of BSE 

detections per number of cattle tested, 

they do not, as noted above, constitute 

an estimate of prevalence. 

The number of disease detections per 

total number of animals tested can be 

influenced by the criteria used for 

choosing animals for testing. For 

instance, Canada, like the United States, 

conducts targeted BSE surveillance, 

sampling those animals where disease is 

most likely to be detected if present. In 

contrast, EU countries routinely test 

large numbers of healthy animals at 

slaughter. Approximately 80 percent of 

cattle tested for BSE in the EU during 

2001–2004 were healthy slaughtered 

animals, but ‘‘risk animals’’ were 22 

times more likely to test positive (EC 

2005a). One study (Giovannini et al., 

2005) estimates the true prevalence of 

BSE infection in several EU countries. 

Based on BSE testing in 2001, although 

Denmark, Finland, and the Netherlands 

had a lower proportion of positives per 

test than Canada, the estimated 

prevalences from this study for those 

three countries were higher than the 

expected values of our Canadian BSE 

prevalence estimates using the BBC 

estimation method (0.68 cases per 

million adult cattle) or BSurveE 

Prevalence B (3.9 cases per million 

adult cattle). Giovannini et al. (2005) 

estimated the following 90 percent 

confidence intervals for the prevalence 

of BSE infection: Denmark, 9 to 38 cases 

per million animals; Finland, 29 to 110 

cases per million animals; and 

Netherlands, 8 to 34 cases per million 

animals. The methods used by APHIS to 

estimate Canada’s BSE prevalence, 

including the BSurvE model developed 

by the EU Transmissible Spongiform 

Encephalopathies Community Reference 

Laboratory, account for the cattle 

population demographics, the age and 

surveillance category of animals tested, 

and the insensitivity of BSE diagnostics 

with regard to detection of the disease 

at an early stage of development. 

The comments are based on an 

inappropriate comparison of a statistical 

estimate of the true BSE prevalence in 

Canada to the crude rate. Table 2 below 

compares the crude reported BSE rates 

in all five countries in 2005. Comparing 

the reported BSE rate of Canada to those 

of the countries listed by the 

commenters shows that Canada’s 


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reported rate is at least an order of 

magnitude below that of the others. 

TABLE 2.—REPORTED BSE RATES IN

5 COUNTRIES

Country 

Reported BSE 

cases per 

million adult 

cattle—2005 

Canada ............................... 0.145 

Denmark ............................. 1.289 

Belgium ............................... 1.448 

Austria ................................. 2.114 

Germany ............................. 4.965 

Source: OIE (2007a). 

The problem with comparing the 

crude reported rate of BSE detection to 

the estimated true BSE prevalence is 

illustrated by the situation in Belgium. 

The reported rate of BSE in Belgium 

peaked in the 2001 surveillance year at 

28.22 cases detected per million adult 

cattle (OIE 2007a). In comparison, 

Saegerman et al. (2004) applied the 

BSurvE model to the Belgian BSE 

surveillance data and estimated that the 

actual BSE prevalence in Belgium 

peaked at approximately 400 cases per 

million adult cattle in the 1995 birth 

year cohort. (The lag between the 1995 

birth year and the 2001 surveillance 

year is consistent with the long BSE 

incubation period.) 

With regard to the comment that 

countries with 1 to 2 cases per million 

animals are not considered to present 

minimal risk, APHIS notes that, prior to 

the 2005 revisions in the OIE guidelines 

on BSE, countries with a reported BSE 

rate of 1 to 2 cases per million animals 

could satisfy the prevalence criterion for 

the pre-2005 OIE BSE minimal-risk 

classification. Under the 2004 OIE 

Terrestrial Animal Health Code (Article 

2.3.13.5), the criteria for a BSE minimalrisk country included a reported rate of 

less than two cases per million during 

each of the last four consecutive 12- 

month periods within the cattle 

population over 24 months of age. The 

OIE Code was modified in 2005 to 

include a revised country categorization 

system which more accurately reflected 

current scientific understanding of BSE. 

These modifications streamlined the 

number of country categories to three 

(negligible, controlled, or undetermined 

BSE risk) and also eliminated the 

numeric prevalence criteria for 

classifying the BSE risk status. The 

previous OIE minimal-risk category is 

now incorporated into the controlled 

risk category. We note that in 2007, the 

OIE recognized Switzerland as a BSE 

controlled risk region. Switzerland had 

a reported rate of 5.4 BSE cases per 

million adult animals in 2006 (OIE 

2007a), greater than the 1 to 2 cases per 

million animals cited by the 

commenters. 

APHIS disagrees with the 

commenter’s statement that Canada 

does not qualify as a BSE minimal-risk 

region. APHIS regulations at § 94.0 

define the standards for a region to be 

designated as a minimal-risk region. 

These include the standard that the 

region maintain ‘‘risk mitigation 

measures adequate to prevent 

widespread exposure and/or 

establishment of the disease.’’ Canada 

continues to meet this standard. The 

commenters provided no specific 

evidence to document how or why 

Canada does not meet the APHIS 

standards. 

Issue: One commenter stated that the 

prior information [information using 

data from the United Kingdom feed ban] 

incorporated into the Bayesian models 

used to estimate prevalence of BSEinfected cattle in Canada may have 

resulted in estimates that are biased 

downward (to a limited degree) from the 

true burden. However, stated the 

commenter, the Bayesian models used 

to estimate prevalence in Canada (as of 

August 2006) are basically sound and a 

better approach than relying on the 

BSurvE Prevalence B estimate. Further, 

said the commenter, given the proviso 

that the models could overestimate the 

effectiveness of the feed ban, it is most 

likely that the actual prevalence of 

infected animals is between 0.68 and 3.9 

animals per million adult cattle. The 

commenter stated that because it is 

likely that the Canadian feed ban was at 

least as effective as the initial United 

Kingdom feed ban, and based on 

available data, the true BSE prevalence 

in Canada is probably substantially 

closer to 0.68 cases per million animals 

than to 3.9 cases per million animals. 

Conversely, several commenters 

suggested that APHIS rejected the 

higher prevalence estimate of the 

BSurvE model for the lower prevalence 

estimate of the BBC model, and that the 

BBC model prevalence estimate is not 

realistic in light of recent data. 

Response: Although APHIS 

considered the results of both the 

BSurvE and the BBC prevalence 

estimation models, we consider the 

result of the BBC model as the more 

likely prevalence estimate to apply to 

the assessment of BSE risks associated 

with imports from Canada over the next 

20 years in our quantitative exposure 

model, for the following reasons. APHIS 

estimated Canadian BSE prevalence 

based on surveillance conducted 

through August 15, 2006. (Note: This 

time period includes all cases of 

Canadian origin reported through 

August 2006 (APHIS 2006c).) From 

August 16, 2006, through April 2007, 

Canada accumulated approximately 

44,980 additional BSE samples and 

detected two BSE cases (one confirmed 

on February 7, 2007, and another 

confirmed on May 2, 2007). Based on 

the negative binomial likelihood ratio, 

which considers the number of negative 

tests prior to one or more positives, the 

BSurvE Prevalence B estimate (with 

expected value of 3.9 cases per million 

animals) is indeed far more likely to be 

true than is the BBC prevalence estimate 

(with an expected value of 0.68 cases 

per million animals) for the current 

standing Canadian cattle population. 

However, the primary purpose of 

characterizing BSE prevalence in 

Canada’s current standing herd (APHIS 

2006c) was not to discuss or assume its 

implications for the present, but rather, 

to estimate prevalence for use as an 

input for the Harvard exposure model 

used in the Exposure Assessment of the 

analysis. Because BSE has a long 

amplification cycle (it takes an average 

of 7 years from the time that one animal 

is exposed, to the time that another 

might be exposed from infectivity 

produced by the first animal), the 

Harvard model is typically run with 20- 

year simulations to include roughly 3 

amplification cycles. The prevalence 

estimates contained in APHIS’

estimation of BSE prevalence in Canada 

(APHIS 2006c) are applied, unchanged, 

to the cattle imports projected over the 

next 20 years (2007–2026). Since we 

expect that the true prevalence will 

drop from its current level (whatever 

that may be), we anticipate that the 

lower, BBC estimate is a more realistic 

prediction (or even an overestimate) of 

average prevalence levels over this time 

frame. Consequently, APHIS considers 

the result of the BBC model, which 

incorporates the effect of a feed ban, to 

be better for application to the 

quantitative assessment of BSE risks 

associated with imports from Canada 

over this time period. In order to 

determine the impact of this assumption 

on the results, we applied the BSurvE 

estimate to the exposure model. We note 

that the likelihood of BSE establishment 

remained negligible (R0 of 0.079, which 

is far less than 1), as did the potential 

impact of cases even without 

establishment (less than 4 clinical cases) 

over the 20 years of the analysis. 

Issue: One commenter suggested that 

the APHIS risk model is not trustworthy 

because it has not been shown to have 

predictive validity and does not explain 

or predict a sustained flow of BSE cases 

from one geographic area (the Alberta 

region in Canada). 


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Response: It is not clear to us from the 

comment which model the commenter 

is referring to. Consequently, in this 

response, we discuss the Harvard model 

and the prevalence models used by 

APHIS. In either case, we disagree with 

the commenter’s conclusion that the 

APHIS risk model is not trustworthy. 

The plausibility of the Harvard model 

was established by comparing its 

predictions for Switzerland against the 

observed progression of BSE within that 

country’s cattle herd (Cohen et al., 

2003). It is not clear from the comment 

how the predictive validity of an 

infectious disease model is to be 

demonstrated over a 20-year time 

horizon, or how the model has failed to 

explain or predict the observed data. 

Regarding a sustained flow of BSE cases 

from one geographic area, assuming a 

constant proportion of BSE infected 

cattle in the herd, more BSE cases are 

found where large cattle populations 

exist. 

As we discuss above in response to 

another issue raised by commenters, 

APHIS’ estimation of BSE prevalence in 

Canada (APHIS 2006c) concludes that 

the expected prevalence values under 

the BBC and BSurvE Prevalence B 

models correspond to an expected 

number of BSE-infected animals in the 

standing Canadian adult cattle 

population of 4.1 and 23.2, respectively. 

Further, the prevalence estimates 

represent uncertainty and not 

variability. At any given point in time, 

the number of infected animals in the 

population is a fixed (although 

uncertain) value, although over time the 

actual number of infected cattle in the 

population would vary randomly about 

the mean of the probability distribution, 

as BSE-infected animals are recruited 

into and exit from the adult cattle 

population (i.e., some are newly 

infected and some die). Even assuming 

that the probability of infection remains 

constant, over time the actual number of 

infected cattle in the population would 

vary. This variability is incorporated in 

the model supporting our exposure 

assessment for live bovines by means of 

the Poisson variability distribution. 

Assuming a fixed mean prevalence of 

4.1 and 23.2 BSE-infected animals in the 

standing adult cattle population in 

Canada, the 95th percentile of the 

Poisson distribution is respectively 7 

and 31 BSE-infected animals in any 

given year. As we noted above, these 

numbers are greater than the five BSE 

cases detected in Canada in 2006, which 

means that the greatest number of 

Canadian BSE cases identified in a 

single surveillance year is lower than 

even the 95th percentile of distribution. 

While this observation does not 

statistically validate (confirm) the 

APHIS estimates of Canadian BSE 

prevalence, neither does it invalidate 

them, as the commenter seems to 

suggest. Furthermore, the prevalence 

estimates are applied not only to the 

current standing population, but also to 

the next 20 years. 

BSE Data From the United Kingdom 

In our January 2007 proposed rule 

and its supporting risk assessment, we 

discussed data associated with a 

ruminant-to-ruminant feed ban in the 

United Kingdom and indicated that 

experience in the United Kingdom 

demonstrates that implementation of a 

ruminant-to-ruminant feed ban causes 

BSE prevalence to decrease. We noted 

that animal feed restrictions were 

implemented in the United Kingdom in 

1988, when the use of ruminant MBM 

in ruminant animal feed was banned. In 

September 1990, the use of specified 

bovine offals was banned for use in any 

animal feed. This ban prohibited the use 

in any animal feed of bovine tissues 

with the highest potential concentration 

of infectivity. In 1994, the use of 

mammalian protein—not just ruminant 

protein—was banned from ruminant 

feed. In 1996, feeding of any farmed 

livestock, including fish and horses, 

with mammalian MBM was completely 

banned. As a result of reducing the 

recycling of infectivity, the annual 

incidence of BSE fell by 99.4 percent, 

from 36,680 in 1992 to 203 in 2005 

(DEFRA 2006b). There is, therefore, 

every reason to expect downward 

pressure on the prevalence of BSE in 

any country that implements a feed ban. 

Issue: One commenter stated that, of 

180,986 confirmed cases of BSE in Great 

Britain, the year of birth of the infected 

animal is unknown in 43,342 cases, and 

the large percentage of animals whose 

birth year is unknown casts doubt on 

the ability to determine the timeframe of 

an effective feed ban and, and further, 

makes it doubtful that all BSE-infected 

cattle in Canada are going to show 

clinical signs of the disease only if they 

were born before March 1, 1999. The 

commenter also stated that Japan has 

reported cattle as young as possibly 20 

months of age or younger as testing 

positive for BSE. 

Response: It is not clear to us how the 

information presented by the 

commenter supports the conclusions the 

commenter reached. However, we 

consider it useful to provide some 

clarification regarding the information 

presented. With regard to the proportion 

of BSE cases in Great Britain for which 

the date of birth is unknown, our risk 

assessment included a sensitivity 

analysis that takes into account that 

general source of uncertainty. 

(Sensitivity analysis evaluates the 

degree to which changes in the 

assumptions used in a model affect the 

model’s results.) We made no 

assumptions as to whether Great 

Britain’s feed ban is or has been 

effective, but applied the same 

proportional drop in cases observed in 

the United Kingdom to the Bayesian 

analysis that was performed to estimate 

BSE prevalence in Canada’s standing 

cattle herd. 

The commenter’s statement that it is 

doubtful that only animals born before 

March 1, 1999, would show clinical 

signs of BSE indicates a potential 

confusion between the likelihood of 

exposure as expressed in terms of the 

date of the effectively enforced feed ban 

(and, thus, the potential for exposure) 

and the likelihood of an exposed animal 

developing clinical signs (which is 

based on age and amount of exposure, 

and the amount of time that has elapsed 

since exposure). In neither our risk 

assessment nor our proposed rule do we 

conclude that only infected animals 

born before March 1, 1999, would show 

clinical signs of the disease. Based on 

Canada’s system of regulations, 

compliance and enforcement, and the 

length of time we expect pre-feed ban 

feed to persist in the system, we 

conclude that animals born on or after 

March 1, 1999, have an extremely low 

likelihood of exposure to BSE. Any 

animal, however, exposed to an 

infectious dose of the BSE agent and 

allowed to live to the end of its 

incubation period, would likely exhibit 

clinical signs. 

Regarding the age of cattle diagnosed 

with BSE in Japan, the comment did not 

contain sufficient information for us to 

determine and respond to the relevance 

of the statement to the remainder of the 

comment. 

Issue: One commenter questioned the 

effectiveness of APHIS’ use of United 

Kingdom surveillance numerators to 

estimate Canada’s BSE prevalence. 

Specifically, the commenter stated that 

‘‘Nowhere * * * is incidence reported. 

Cases (without reference to a population 

at risk) are used. This may be important 

because the manner in which BSE cases 

were counted changed over time in the 

[United Kingdom].’’

Response: We acknowledge that 

changes over time in BSE surveillance 

and in the size and demographics of the 

cattle population do contribute to the 

uncertainty about the efficacy of the 

initial, ruminant-to-ruminant feed ban 

introduced in the United Kingdom in 

1998. However, the United Kingdom’s 

Department for Environment, Food, and 


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Rural Affairs (DEFRA) does not report 

BSE surveillance results by birth year 

and surveillance class (e.g., active or 

passive surveillance, animal health 

status). Ideally, such data could be 

entered into BSurvE or a similar model 

to estimate true BSE prevalence for all 

United Kingdom birth year cohorts 

since the onset of the epidemic. This 

process would permit not only an 

improved estimate of the effect of the 

initial feed ban but also of the 

incremental impact of additional 

measures that were subsequently 

introduced. DEFRA has reported backcalculation model estimates of true BSE 

prevalence in cohorts born after 1995 to 

assess the effects of the ‘‘reinforced feed 

ban’’ introduced by the United Kingdom 

in August 1996 (DEFRA 2005, 2006b). 

However, we are unaware of any 

published estimates of true BSE 

prevalence in the United Kingdom for 

the 1987–1995 birth year cohorts based 

on up-to-date surveillance results. 

Issue: One commenter stated that 

APHIS is wrong to assume that the 

United Kingdom data regarding the 

effectiveness of the feed ban can be 

applied directly to the situation in 

Canada. 

Response: We acknowledge that the 

applicability to Canada of the data from 

the initial United Kingdom ruminant-toruminant feed ban is uncertain. 

Nonetheless, the United Kingdom’s 

experience and data are important and 

useful to our risk assessment and 

analyses. In addition, the Peer Review 

Report (RTI 2007, p. ES–2) noted that 

‘‘[all reviewers] agreed that the evidence 

from the United Kingdom * * * and 

Europe that the feed ban is effective is 

reasonable to consider in the case of 

Canada.’’

Issue: Several commenters noted the 

differences in the feed bans in the 

United Kingdom and Canada in stating 

that it is not valid to draw conclusions 

about the likely prevalence of BSE in 

Canada by extrapolating from the rate of 

decline in BSE cases in the United 

Kingdom following implementation of a 

feed ban there. The commenters noted 

that (until expanded this July) the feed 

ban in Canada prohibited the feeding of 

ruminant material to ruminants. In 

contrast, said one commenter, 

significant declines in the number of 

confirmed BSE cases in the United 

Kingdom did not occur until the United 

Kingdom took stronger measures, 

ultimately banning the feeding of all 

mammalian protein to food animals in 

2001. The commenter suggested that the 

United Kingdom’s experience in 

particular clearly shows that ruminantto-ruminant feed bans do not drastically 

curtail the number of confirmed BSE 

cases and that much stronger measures 

are needed to eradicate the disease. 

Response: The comments appear to 

confuse the absolute level of BSE in the 

United Kingdom with its rate of decline. 

The comments also ignore the BSE 

incubation period and the effects of 

other concurrent measures, trends, and 

events in the United Kingdom. The 

number of BSE cases in United 

Kingdom birth year cohorts (all cattle 

born in a given year) has continued to 

decline since peaking in 1987. With the 

exception of the 1996 birth year cohort, 

it is not readily apparent that there has 

been any significant change in the rate 

of decline in birth year cohort 

prevalence after the United Kingdom 

introduced the initial ruminant-toruminant feed ban in 1988 (figure 2). As 

of March 1, 2007, the United Kingdom 

had confirmed two BSE cases in animals 

born after 2001, but due to the long BSE 

incubation period, it is reasonable to 

expect that ongoing surveillance may 

detect additional cases in animals born 

after 1998. 


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Shortly after the emergence of vCJD 

was publicly recognized in March 1996, 

the United Kingdom introduced several 

BSE-related measures, including the ban 

on the use of mammalian MBM in feed 

for all farm animals (the ‘‘reinforced 

feed ban’’), a selective cull, and the 

over-30-month rule limiting the age of 

animals that could be slaughtered for 

food. As shown in figure 3, the size of 

the United Kingdom cattle population 

began a marked decline in 1996, 

punctuated by a drop associated with 

the foot and mouth disease (FMD) 

outbreak in 2001. 

In addition to the declining cattle 

population size, other confounding 

variables, such as changes in cattle 

population demographics and BSE 

surveillance practices, make it difficult 

to ascertain the independent or marginal 

effect of any single measure on the 

decline of BSE in United Kingdom birth 

year cohorts. At this time, it appears 

that the confluence of events and 

measures of 1996 may have hastened 

the waning of BSE in the United 

Kingdom, but the decline was underway 

in 1988. 

Issue: One commenter indicated that 

scientific studies in France and Britain 

have found that, after a ruminant-toruminant feed ban was put into place, 

the subsequent incidence of BSE was 

correlated to pig density, and that the 

new Canadian BSE feed rule, to be 

implemented in July 2007, is, according 

to the commenter, similar to, but weaker 

than, the September 1990 United 

Kingdom SBO [Specified Bovine Offals] 

ban. The commenter stated that, by not 

following the lead of the United 

Kingdom [and banning the feeding of all 

mammalian protein to food animals], 

the proposed CFIA SRM ban may 

reduce but will not eliminate the risk of 

BSE in Canada. 

Response: Two studies—Abrial et al. 

(2005) and Stevenson et al. (2005)—

indicate a correlation between cases of 

BSE born after a ruminant-to-ruminant 

feed ban was implemented and areas of 

higher pig density in France and Britain. 

These studies indicate the potential for 

cross-contamination of livestock feeds 

after ruminant-derived protein was 

excluded from ruminant feed. 

Eventually, each country and the EU 

adopted regulations prohibiting the 

inclusion of any animal protein in 

livestock feed. At this time, however, it 

is not possible to ascertain the extent, if 

any, to which establishment of a more 

restrictive feed ban had any impact on 

the rate of BSE decline in EU Member 

States beyond the feed controls already 

in effect. 

As discussed previously, the number 

of BSE cases in United Kingdom birth 

year cohorts began to decline in 1988, 

the year the initial ruminant-toruminant feed ban was introduced. 

Although France initially introduced a 

ban on mammalian MBM in cattle feed 

in July 1990—not a ruminant-toruminant feed ban—the European 

Commission Scientific Steering 

Committee concluded that the French 

feed ban adopted in 1990 ‘‘was likely 

not effectively enforced until 1994/ 

1995.’’ (ECSSC 2000, p. 30). Based on 

testing in 2001–2002, Bonnardiere et al. 

(2004) found a significant increase in 

French BSE prevalence between the July 

1993–June 1994 and July 1994–June 

1995 cohorts, followed by a significant 

decrease in BSE prevalence in birth 

cohorts born in France after June 1995. 

More recently, active surveillance 

during 2001–2005 also indicates that the 

number of BSE cases per cohort peaked 

in France in the 1995 birth year cohort 

and declined thereafter (EC 2006, table 

B20). 

In Europe more generally, based on 

active surveillance during 2001–2005, 

the number of BSE cases per birth year 

cohort in the original EU Member States 

(EU 15), excluding the United Kingdom, 

was on the decline after the 1995 birth 

year cohort. In June 1994, the EU 

banned the feeding of mammalian MBM 

to ruminants. However, among EU 

members, only Belgium, Germany, 

Greece, Italy, Luxembourg, and Spain 

had no feed ban in place prior to the 

1994 EU-wide measure (Court of 

Auditors 2001). In June 2005, the 

European Commission issued the 

‘‘Report on the Monitoring and Testing 

of Ruminants for the Presence of 

Transmissible Spongiform 

Encephalopathy in the EU in 2004’’ and 

observed that the impact of the 2001 

‘‘total feed ban’’ (EU Regulation 999/ 

2001) cannot yet be assessed due to the 

long BSE incubation period. As noted in 

the discussion of the decline of BSE in 

the United Kingdom, it is reasonable to 

expect that ongoing surveillance may 

detect additional cases in animals born 

after 1998. 


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The conclusion of our risk assessment 

that, over the 20 years of the analysis, 

the risk to the United States (i.e., the 

likelihood of establishment and the 

potential impacts of cases that may 

occur even without establishment of 

BSE) as a result of importing from 

Canada the bovine commodities 

considered in this rule is negligible, is 

not predicated on the eradication of BSE 

in Canada. 

Issue: One commenter indicated that 

year-of-birth data collected by the EU 

shows that, based on the number of BSE 

cases detected in the United Kingdom 

since 2001, there was a steady increase 

in the number of BSE-positive cattle 

born in the United Kingdom after its 

1988 feed ban, beginning with cattle 

born in the year 1990. 

Response: We disagree with the 

commenter. Since July 2001, when the 

EU-wide active BSE surveillance 

program commenced, an increasing 

proportion of the total BSE cases in the 

United Kingdom have been detected as 

a result of targeted (active) surveillance 

(DEFRA 2006b, figure 4.3). However, as 

shown by the EC (EC 2006, chart B1), 

the vast majority of BSE cases in the 

United Kingdom were detected by 

surveillance prior to 2001. Based on all 

available United Kingdom BSE 

surveillance data (DEFRA 2007), the 

number of BSE cases in United 

Kingdom birth year cohorts began to 

decline in 1988, the year the initial 

ruminant-to-ruminant feed ban was 

introduced. 

For the reasons discussed above, we 

continue to consider it appropriate to 

apply our estimates of BSE prevalence 

in Canada to our risk assessment. As 

noted above, we used two related, but 

distinct, methods to estimate BSE 

prevalence in Canada, and addressed 

the uncertainty in the prevalence of BSE 

in Canada by considering prevalence 

estimates that differ by more than a 

factor of five. Although we consider the 

BSurvE Prevalence B estimate to be far 

more likely to be true than is the BBC 

estimate for the current standing 

Canadian cattle population, we consider 

the result of the BBC model as the more 

likely prevalence estimate to apply to 

the assessment of BSE risks associated 

with imports from Canada over the next 

20 years. 

Feed Ban in Canada 

As discussed above, in our January 

2007 proposed rule, we proposed to 

allow the importation of live bovines 

from BSE minimal-risk regions if the 

animals were born on or after a date 

determined by APHIS to be the date on 

and after which a ruminant-to-ruminant 

feed ban in the region of export has been 

effectively enforced. We noted that 

experience around the world in 

countries with BSE has demonstrated 

that feed bans are effective control 

measures, and that the incidence of BSE 

worldwide continues to decline because 

of these measures (OIE 2007a). 

We indicated that, because of the 

demonstrated efficacy of an effectively 

enforced feed ban in reducing the 

possibility of exposure of cattle to the 

BSE agent, the OIE provides guidelines 

for trade in live cattle from regions that 

have reported BSE if such regions have 

an effective feed ban in place, provided 

the cattle were born after the date when 

the feed ban was effectively enforced 

(OIE Terrestrial Animal Health Code, 

Chapter 2.3.13). We proposed to 

consider March 1, 1999, as the date on 

and after which a feed ban has been 

effectively enforced in Canada. A 

number of commenters addressed 

Canadian enforcement of its feed ban, 

and also addressed the date we 

proposed to consider as the date of 

effective enforcement of a feed ban in 

Canada. Although some commenters 

specifically supported March 1, 1999, as 

the date of effective enforcement of a 

ruminant-to-ruminant feed ban in 

Canada, a number of other commenters 

disagreed that Canada was effectively 

enforcing a feed ban as of that date. 

Some commenters suggested alternative 

dates or time frames. 

Issue: Several commenters stated that 

APHIS’ determinations of the level of 

compliance with the Canadian feed ban 

and the time at which compliance was 

achieved are arbitrary and scientifically 

indeterminable. 

Response: We disagree with the 

commenters. In January 2005, USDA 

sent a team to Canada to assess Canada’s 

feed ban and its feed inspection 

program to determine whether the 

control measures put in place by the 

Canadian Government were achieving 

compliance with that country’s 

regulations. APHIS conducted an 

extensive review of the feed ban in 

Canada. As part of its review, APHIS 


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analyzed CFIA’s description of past 

cases of BSE in Canada, as well as 

historical inspection and compliance 

data related to the feed ban for the 

previous 3 years, educational materials, 

published notices, and the report of the 

International Review Team that was 

submitted to the U.S. Secretary of 

Agriculture in February 2004. 

Additionally, the U.S. team 

accompanied the CFIA inspection staff 

on inspections of randomly selected 

commercial feed mills and rendering 

facilities. At the facilities, the U.S. team 

observed the application of the 

inspection standards, observed 

manufacturing techniques, and 

discussed processes with facility 

personnel involved in various steps of 

feed manufacturing. In its report, the 

team concluded that Canada has a 

robust inspection program, that overall 

compliance with the feed ban in Canada 

is good, and that the feed ban is 

reducing the risk of transmission of BSE 

in the Canadian cattle population 

(USDA 2005). The team’s findings 

support our conclusions regarding the 

level of compliance with the feed ban in 

Canada. 

Issue: In our January 2007 proposed 

rule, in discussing our rationale for 

considering March 1, 1999, to be the 

date of effective enforcement of a feed 

ban in Canada, we stated that a 12- 

month period would generally be 

sufficient to allow purchased feed 

products that may contain MBM to be 

completely used. One commenter 

expressed uncertainty about that 

estimation and suggested that it might 

be advisable for APHIS to conduct a 

quantitative assessment of compliance 

with the feed ban to determine the date 

of its effective enforcement. 

Response: We recognize uncertainty 

regarding the precise date on which 

Canada achieved effective enforcement 

of its feed ban, but we note that, given 

the extremely low prevalence of BSE in 

Canada along with the safeguards in the 

United States, the impact on the overall 

risk of a slightly earlier or later date 

would be minimal. Although reducing 

uncertainty can, at times, be achieved 

by performing more rigorous 

quantitative analyses, before attempting 

to reduce the uncertainty regarding any 

given factor or parameter—such as the 

precise date on which Canada achieved 

effective enforcement of its feed ban—

it is important to examine the 

significance of the parameter to the 

overall risk result. 

Issue: Several commenters stated that 

APHIS’ calculation of the amount of 

time necessary for ruminant feed to 

cycle through the Canadian feeding 

system is irrelevant in the absence of 

effective enforcement of feed-ban 

regulations in Canada. The commenters 

stated that it was not until between 2000 

and 2002 that Canada implemented 

inspections of feed and rendering 

facilities. 

Response: The commenters’ statement 

is not accurate. Inspections of rendering 

facilities and feed mills in Canada began 

immediately with the implementation of 

the feed ban in that country in August 

1997. Rendering facilities were required 

to obtain an annual permit to operate, 

and issuance of a permit required an 

inspection of the facility. In addition, 

CFIA immediately began a program for 

inspection of commercial feed mills. All 

commercial feed mills were inspected in 

the first year after the implementation of 

the feed ban, with none of the feed mills 

found to be including prohibited 

material in ruminant feed. Thereafter, 

feed mills were on a 3-year inspection 

interval until 2002, when annual 

inspection of commercial feed mills was 

initiated. 

Issue: A number of commenters stated 

that the diagnosis of BSE in cattle born 

after the establishment of a feed ban in 

Canada demonstrates that Canada’s feed 

ban is either ineffective or not 

effectively enforced. 

Response: We disagree with the 

commenters’ conclusion. The 

commenters suggest that, in order for 

the Canadian feed ban to be considered 

effective, BSE surveillance data would 

have to demonstrate that the likelihood 

of BSE transmission in that country has 

been eliminated. However, as noted in 

our risk assessment, Canadian BSE 

surveillance data do not provide a 

statistical basis for distinguishing BSE 

prevalence among birth year cohorts 

(APHIS 2006b, p. 12); the overall 

prevalence is so low that distinguishing 

any difference is nearly impossible. In 

other words, the data cannot distinguish 

any significant difference in prevalence 

among animals born in different years, 

which would have been one way to 

demonstrate the effect of a feed ban 

(e.g., if the feed ban were implemented 

at the beginning of 1997, surveillance 

data showing a higher BSE prevalence 

in animals born in 1996 than in animals 

born in 1997 would support the 

effectiveness of the feed ban). However, 

in the absence of a feed ban that 

reduced exposure to BSE, we would 

expect the prevalence of the disease to 

increase over time. We have no 

evidence that such an increase has 

occurred, but we do have data that the 

feed ban is being enforced. 

Furthermore, as we discussed in our 

risk assessment, detection of BSE in an 

animal born after the date a feed ban 

was implemented does not indicate an 

overall failure of the measures in place 

to stem transmission of the disease in 

that country. Most other countries that 

have experienced cases of BSE, have 

reported similar cases. Of 25 countries 

that have reported indigenous BSE 

cases, only 4 reported no cases in 2005–

06 (OIE 2007). Human error is expected, 

which is why the feed ban is comprised 

of a number of interrelated measures 

that have a cumulative effect. Our risk 

assessment does not assume 100 percent 

compliance with all measures all of the 

time. We discussed factors related to the 

feed ban in Canada since before its 

implementation in 1997. We considered 

activities related to inspection and 

compliance with the feed ban, the 

rendering industry, the risk of crosscontamination, education activities and 

industry awareness, and on-farm 

practices that might contribute to the 

efficacy of the feed ban. In addition, we 

highlighted the fact that since the 

implementation of the feed ban on 

August 4, 1997, CFIA has continued to 

revise and strengthen its processes and 

procedures to further enhance the 

effectiveness of the feed ban. Canada’s 

July 2007 modification of its feed ban to 

remove SRMs from all animal feeds, pet 

food, and fertilizer is a good example of 

such enhancements. We concluded that 

compliance with the feed ban measures 

in Canada continues to increase as the 

program evolves and that all of these 

factors have resulted in a cumulative 

reduction in the risk that Canadian 

cattle will be exposed to the BSE agent. 

Issue: Several commenters stated that 

Canada cannot demonstrate that it has 

effectively prevented the feeding of 

ruminant material to cattle over the past 

8 years. Commenters stated that eight or 

nine Canadian feedlots were discovered 

to still be feeding banned bone meal 

products, and that, because of their 

violations of the feed ban, 30,000 

Canadian cattle were under quarantine. 

Additionally, one commenter stated that 

in March 2007, nine farms in 

Saskatchewan and as many as 8,000 

cattle, deer, and other ruminants were 

quarantined after ruminant MBM was 

accidentally shipped to those farms 

from a Saskatoon feed mill. Another 

commenter stated that, in December 

2006, Canada’s Minister of Agriculture 

and Agri-Food acknowledged that up to 

10,000 head of Canadian cattle on 113 

different farms in the Provinces of 

Ottawa and Quebec had recently been 

fed feed contaminated with ruminant 

material. 

Response: APHIS is aware of the 

incidents reported in late 2006 and in 

March 2007 and considered such 

incidences very carefully in its 

evaluation of the effectiveness of the 


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7 In the rulemaking for our 2005 final rule 

establishing criteria for recognition of a region as a 

BSE minimal-risk region, we discussed in detail our 

evaluation of Canada’s veterinary infrastructure; 

disease history; practices for preventing widespread 

introduction, exposure, and/or establishment of 

BSE; and measures taken following detection of the 

disease (APHIS 2005). 

feed ban. However, it is not clear to us 

what the commenters are referring to 

regarding 30,000 Canadian cattle under 

quarantine. 

It should be noted that the use of the 

term ‘‘contaminated’’ above refers to the 

potential inclusion in ruminant feed of 

MBM derived from ruminants, but not 

to the feeding of known BSEcontaminated material to ruminants. 

Feed control systems, including those in 

the United States, are inherently subject 

to human error such as occurred in 

these incidents. These compliance 

errors require follow up and correction 

by CFIA, just as in the United States 

such incidents would necessitate 

follow-up by the U.S. Human Health 

and Services, Food and Drug 

Administration (FDA). Following 

detection of these occurrences, CFIA 

conducted a detailed investigation and 

traced all potentially contaminated feed. 

CFIA accounted for and disposed of all 

feed that did not enter the distribution 

channels, and feed already distributed 

to farms was removed, disposed of, and 

replaced. CFIA conducted risk 

assessments to help evaluate the 

possibility that new cases of BSE would 

occur due to the contamination of feed 

with prohibited material, and concluded 

that the overall risk was negligible. Even 

though this finding indicated that it was 

highly unlikely that animals exposed to 

the involved feed would develop BSE in 

the coming years, in those instances 

where exposure to the feed could not be 

ruled out, the CFIA has excluded these 

animals and their meat and byproducts 

from export eligibility. This measure 

was established to meet the technical 

requirements of various trading partners 

and does not affect the movement or 

marketing of these animals within 

Canada. These findings, together with 

Canada’s rapid and comprehensive 

response to the incidents, reinforces our 

confidence in the effective enforcement 

of Canada’s ruminant feed ban.7

Issue: Some commenters questioned 

the effectiveness of Canada’s feed ban, 

given evidence of contamination of 

ruminant feed with MBM derived from 

ruminants. One commenter stated that, 

in the five cases of cattle born after 

March 1, 1999, where investigations of 

BSE in Canadian cattle have been 

completed, the reported cause of BSE 

infectivity centered on ruminant MBM 

used in non-ruminant feeds crosscontaminating ruminant feeds, either 

during processing at the feed mill or 

during transport. Given that four 

animals were born after March 1, 1999, 

the commenters indicated that great care 

must be given to the analysis of these 

animals in the risk assessment and did 

not feel that APHIS thoroughly 

examined the cases. 

Response: We agree with the 

commenters that the investigations of 

BSE in animals born in Canada in 2000 

and 2002 suggest that these animals 

were most likely exposed during their 

first year of life to feed contaminated 

during processing (CFIA 2006a). Reports 

of the investigations identified incidents 

of concern in which ruminant feed was 

processed or transported immediately 

following the handling of nonruminant 

feed containing prohibited material. 

Such incidents were in contravention of 

Canadian regulations, which require 

flushing and/or clean-out between 

batches if ruminant feed is processed on 

the same lines as feed containing 

prohibited material. 

We considered the issue of crosscontamination and concluded that 

Canada has implemented measures to 

prevent cross-contamination of 

ruminant feed with prohibited materials 

in the rendering and feed manufacturing 

industries are essential for 

implementation of an effective feed ban. 

We also considered other factors—

including the regulatory actions taken to 

implement the feed ban, education and 

industry awareness efforts, inspection 

and compliance activities, and on-farm 

feeding practices—in our overall 

evaluation to determine the date the 

feed ban was effectively enforced in 

Canada and, based on those factors, 

identified March 1, 1999 as the date of 

effective enforcement of the feed ban. 

APHIS did not specifically address 

each individual case of BSE in Canada 

in the risk assessment, as the available 

details of each epidemiological 

investigation did not contribute to the 

overall risk estimation. The risk 

estimation was based on consideration 

of all factors relevant in the risk 

pathway. These included consideration 

of the current Canadian feed ban, with 

explicit recognition that cases born after 

the feed ban was implemented in 

August 1997, or after the March 1, 1999 

date have occurred and could continue 

to occur. The prevalence estimate 

acknowledges that BSE is present in 

Canada, albeit at a very low level. The 

risk reduction factors in the United 

States, including feed ban regulatory 

activities similar to those in Canada, 

were considered in the exposure 

assessment. The combination of all of 

these factors, including recognition that 

human error can occur in any step of the 

pathway, supported the conclusion that 

the risk to the United States of BSE—i.e, 

the likelihood of establishment and the 

potential impact of cases that may occur 

even without establishment—as a result 

of importing from Canada the bovine 

commodities considered in this rule is 

negligible. 

Issue: One commenter stated that 

Canada has experienced an increase in 

the number of BSE cases since it 

instituted a feed ban in 1997. 

Response: It appears that the 

commenter is equating the number of 

detected cases of BSE with the number 

of infected animals in a national herd. 

However, an increased number of 

detections of BSE does not necessarily 

mean an increase in prevalence. A BSE 

detection rate is dependent not only on 

prevalence, but also on intensity of 

surveillance. An increased number of 

BSE cases have been detected in Canada 

as that country has increased 

surveillance for the disease. As noted 

above, an APHIS analysis of the 

Canadian BSE surveillance data did not 

find a statistical basis for distinguishing 

BSE prevalence among birth year 

cohorts. 

Issue: A number of commenters 

referred to the number of BSE cases in 

cattle born in Canada after March 1, 

1999, as evidence that the date should 

not be accepted as the date of an 

effectively enforced feed ban. 

Commenters requested that APHIS 

reassess the proposed rule in light of 

recent diagnoses of such cattle. 

Response: In the assessment of 

potential BSE risk we conducted for this 

rulemaking, we concluded that there is 

an extremely low likelihood that cattle 

born in Canada on or after March 1, 

1999, will have been exposed to BSE. 

This conclusion does not mean that 

effective enforcement necessarily equals 

no instances of contravention of the feed 

ban, either accidentally or intentionally, 

just as isolated transgressions of U.S. 

laws do not necessarily constitute 

ineffective enforcement of those laws. 

While specific incidents of crosscontamination can, and most likely will, 

happen, since no regulatory effort can 

ensure 100 percent compliance, the 

detection of BSE in several bovines in 

Canada born after March 1, 1999 does 

not negate the overall effect of the feed 

ban in decreasing the opportunities for 

transmission of disease. Empirical 

evidence from the United Kingdom has 

demonstrated, and simulation studies 

have reinforced, that implementation of 

a ruminant-to-ruminant feed ban leads 

to continued decrease in prevalence 

over time (Cohen, et al., 2001; 2003; 

DEFRA 2006, EC 2003; 2005). Similar 


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effects of a feed ban have been seen in 

other countries in the EU, where there 

have been continued detections of BSE 

in cattle born after a feed ban is initially 

implemented. At the same time, 

however, the apparent number of cases 

of BSE identified in the EU–15 Member 

States has decreased every year since 

2001. The available evidence leads 

firmly to the conclusion that animals 

born after the date of implementation of 

a ruminant-to-ruminant feed ban are far 

less likely to be exposed to the BSE 

agent (Heim and Kihm, 2003). 

Issue: A number of commenters 

recommended various alternative dates 

or timeframes for consideration as the 

date of effective enforcement of a feed 

ban in Canada. Most of the commenters 

who recommended an alternative date 

expressed concern regarding the 

detection of BSE in bovines born in 

Canada after March 1, 1999. 

The recommended alternative dates or 

timeframes included the following: July 

1, 2007; the date of birth of the youngest 

bovine in Canada that has been 

determined to be BSE-positive; May 1, 

2002; 5 to 7 years after the most recently 

diagnosed case of BSE in Canada; 

whenever Canada can verify 100 percent 

compliance with its ruminant-toruminant feed ban; a staggered system of 

dates that would increase the allowable 

age of bovines intended for importation 

from Canada as time progressed with no 

additional diagnoses of BSE in Canada. 

Some of the commenters who 

suggested July 2007 as the date of 

effective enforcement based their 

recommendation on the fact that on July 

12, 2007, Canada expanded its feed ban 

to prohibit the inclusion of SRMs in any 

animal feeds, pet foods, or fertilizers. 

One commenter asked how APHIS can 

be satisfied that the United States would 

be importing a safe product if Canada 

itself was not satisfied with the 

safeguards in place at the time the 

proposed rule was published, and 

subsequently took additional measures 

to strengthen its feed ban. A number of 

commenters recommended that the 

provisions of the proposed rule not be 

implemented until Canada bans all 

feeding of animal material to food 

animals. One commenter stated that July 

2007 would be an appropriate point to 

begin the importation of breeding 

animals that have had exposure to 

processed animal feed, and that March 

1, 1999 would be an acceptable date for 

bovines that have not been exposed to 

processed animal feeds—such as bison 

maintained by Parks Canada. 

Several commenters, who expressed 

no animal health concerns with 

identifying March 1, 1999 as the date of 

effective enforcement of a feed ban in 

Canada, recommended that APHIS 

consider harmonizing the date chosen 

with the date Canada has identified as 

the effective date of a ruminant-toruminant feed ban in the United States, 

January 1, 1999. 

Response: In prior rulemaking (APHIS 

2005), we evaluated evidence 

(regulations in place based on statutory 

authority, adequate infrastructure to 

implement the regulations, and 

evidence of implementation and 

monitoring) in making the 

determination that compliance with the 

feed ban in Canada is good and 

concluded that the feed ban was 

effectively enforced. In our process of 

identifying the date of effective 

enforcement of a ruminant-to-ruminant 

feed ban in Canada, we considered 

Canada’s implementation guidance and 

policies. For example, we considered 

the allowance of grace periods for 

certain aspects of the industry, in 

determining the practical 

implementation period for the feed 

regulations. Then we considered a 

sufficient time period subsequent to this 

implementation period to allow most 

feed products to cycle through the 

system, given the management practices 

in the country. We concluded, based on 

the above evaluations, that cattle born in 

Canada on or after March 1, 1999, can 

be imported into the United States with 

an extremely low likelihood that they 

have been exposed to the BSE agent. 

As noted, a number of commenters 

recommended that APHIS consider July 

2007, when Canada expanded its feed 

ban, as the date of effective enforcement 

of the Canadian feed ban. We consider 

the July 2007 expansion of the Canadian 

feed ban to be an enhancement of an 

already effective ban. CFIA, in 

explaining its rationale for the enhanced 

ban, emphasizes that, although 

surveillance results and investigations 

of BSE cases indicate that the feed ban 

in Canada has effectively reduced the 

spread of BSE since being implemented 

in 1997, even compliance with the ban’s 

requirements left limited opportunities 

for contamination during manufacture, 

transportation, and storage that CFIA 

considered worth eliminating. In 

addition, the accidental misuse of feed 

on farms with multiple species could 

not be discounted. With the enhanced 

ban, CFIA projects that the eradication 

of BSE in Canada will be accelerated. 

Following such a regulatory path does 

not indicate that the feed ban in Canada 

prior to July 2007 was not effective or 

effectively enforced. 

With regard to the recommendation 

that the date of effective enforcement of 

the Canadian feed ban be identified as 

the date of birth of the youngest bovine 

in Canada that has been determined to 

be BSE-positive, we do not consider 

such a change to be necessary or 

justified. The risk assessment we 

conducted for this rulemaking 

acknowledged that BSE exists in Canada 

and that there would likely be 

additional cases detected. March 1, 1999 

was never intended to be an absolute 

cut-off point after which no new cases 

of BSE would be acceptable. The risk 

assessment concluded that, despite the 

likelihood of additional diagnoses of 

BSE in Canadian cattle, the proposed 

amendments would pose negligible risk 

to animal health and food safety in the 

United States. If an infected cow were 

to be imported into the United States, a 

series of strong safeguards would have 

to fail—in sequence—for that animal to 

pose any risk. 

With regard to the recommendation 

that APHIS harmonize its identification 

of the effective enforcement date of a 

Canadian feed ban with the date 

identified by Canada as the date of 

effective enforcement in the United 

States, we do not agree that such a 

change would be appropriate or 

necessary. APHIS arrived at the March 

1, 1999 date for effective enforcement of 

the feed ban in Canada by considering 

not only the date the feed ban was 

established in that country but also 

information provided by Canada 

regarding its implementation timetable, 

as well as feeding practices in that 

country. It does not necessarily follow 

that implementation events in the 

United States followed precisely the 

same track as those in Canada. 

Issue: In our January 2007 proposed 

rule, we discussed the diagnosis of BSE 

in cattle in Canada born after March 1, 

1999, and stated that ‘‘such isolated 

incidents are not epidemiologically 

significant and do not contribute to 

further spread of BSE, especially when 

considered in light of the entire risk 

pathway and its attendant risk 

mitigations.’’

Several commenters took issue with 

APHIS’ description of the cases as 

‘‘isolated.’’ Some commenters stated 

that ‘‘isolated’’ implies a solitary or 

separated condition, which cannot be 

said of the BSE cases recently confirmed 

in Canada. Further, other commenters 

stated the cases are linked by a trend in 

geographic location, with the last three 

cases occurring in the Province of 

Alberta. One commenter stated that of 

the nine cases of BSE detected in 

Canada, four occurred in cattle born 

after March 1, 1999, and that four of 

nine cases—or 44 percent—do not 

represent isolated cases and strongly 

disagreed that this date corresponds to 


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when Canada’s feed ban became 

effectively enforced. 

Response: We disagree with the 

comments, although we acknowledge 

that the term ‘‘isolated’’ could be 

interpreted in several ways. The use of 

the term in our proposed rule was not 

intended to imply that the cases were 

‘‘solitary or separated.’’ Our use of the 

term ‘‘isolated’’ was intended to 

characterize the cases as being small in 

number and not indicative of a systemic 

failure of the feed ban in Canada, but 

rather the result of individual instances 

of error in contravention of the feed ban 

(e.g., inadequate cleaning between 

handling of feed for non-ruminants and 

feed for ruminants). 

For the reasons discussed above, we 

consider our determination that March 

1, 1999 be deemed the date of effective 

enforcement of the feed ban in Canada 

to be reasonable, grounded firmly in the 

regulatory basis and operations of the 

ban in Canada, and entirely consistent 

with the science and with OIE 

guidelines. Accordingly, we are making 

no changes based on the comments. 

Likelihood of Exposure of Cattle in the 

United States to BSE 

The assessment is designed to 

estimate the likelihood of each of the 

multiple steps. Although we analyzed 

the likelihood of each individual step in 

the process occurring, we interpreted its 

significance in the context of the entire 

process. 

As part of the risk assessment we 

conducted for our January 2007 

proposed rule, we evaluated both the 

likelihood of ‘‘release’’ of the BSE agent 

into the United States and the 

likelihood of susceptible animals being 

exposed, given such release. We 

evaluated the pathways by which 

infected Canadian cattle, if imported, 

might expose U.S. cattle to BSE, and the 

likelihood that these pathways might 

lead to the establishment of the disease 

in the U.S. cattle population. 

Several steps must take place for BSE 

to be transmitted to cattle in the United 

States from a bovine imported live from 

another country. A BSE-infected bovine 

must be imported into the United States; 

the infected bovine must die or be 

slaughtered; tissues from that animal 

that contain the infectious agent must be 

sent to a rendering facility; the 

infectivity present in these tissues must 

survive inactivation in the rendering 

process; the resulting meat-and-bone 

meal (MBM) containing the abnormal 

prion protein must be incorporated into 

feed; and this feed must be fed to cattle 

at a level adequate to infect the cattle. 

(The amount of infectious material 

required in feed for cattle to become 

infected is dependent on the age of the 

cattle; younger cattle are more 

susceptible to BSE and require less BSEcontaminated feed to become infected 

(Arnold and Wilesmith, 2004). We 

indicated in our risk assessment that the 

nature and likelihood of these pathways 

depend in large part on mitigations 

acting in series and in parallel that 

reduce the likelihood that BSE will be 

established in the United States. 

A number of commenters addressed 

the issues of the likelihood of release of 

the BSE agent into the United States and 

the likelihood of exposure of U.S. cattle 

to BSE due to the importation of bovines 

from Canada. In general, the 

commenters said that we had 

underestimated the likelihood of release 

and/or exposure, or questioned one or 

more elements of our assessment. 

Issue: One commenter, whose 

statements were referenced and 

supported by a second commenter, 

discussed the geographic distribution of 

BSE cases in Canada and expressed 

concern that Canada’s experience 

demonstrates that certain locations in 

the United States might be more 

susceptible to BSE establishment than 

others. The commenter stated that 

events in Canada indicate that an 

average risk estimate is meaningless for 

BSE and demonstrates how ‘‘hot spots’’

(i.e., locations that are more susceptible 

to spread of disease and, therefore, that 

have a localized higher BSE prevalence) 

allow BSE to propagate and spread. The 

commenter stated that the model-based 

predictions in APHIS’ risk assessment 

are useless because the models do not 

account for geographic and other 

sources of heterogeneity and pointed to 

Alberta as a BSE hot spot. Further, the 

commenter indicated that the APHIS 

risk assessment has not provided any 

real data or relevant analyses related to 

BSE hot spot development and that 

APHIS has not quantified the risks that 

imports will create localized BSE hot 

spots in the United States. The 

commenter calculated that, if 5 percent 

of U.S. locations are potential hot spots, 

and 1 million animals are imported each 

year with six of them BSE-positive, the 

expected probability of at least one hot 

spot being activated in the United States 

is at least 77.7 percent. 

Response: We disagree with the 

commenters. The available evidence 

provides no basis for distinguishing BSE 

prevalence among Canadian provinces. 

The commenter who singled out Alberta 

provides no analysis to support the 

hypothesis that the BSE prevalence in 

Alberta is higher than in other 

provinces. Through May 2007, reported 

BSE cases have originated in three 

western Provinces: Alberta (8 cases), 

British Columbia (2 cases), and 

Manitoba (1 case). No cases have been 

reported through May 2007 in the 

eastern Provinces. Intuition might 

suggest that the BSE prevalence is 

higher in Alberta. However, Alberta 

contains approximately 40 percent of 

the Canadian cattle herd. Other factors 

being equal, BSE is more likely to be 

detected in regions with large cattle 

populations. 

Apart from the detected cases, 

geographically disaggregated data on 

BSE surveillance and Canadian cattle 

population demographics are not 

available. However, assuming that the 

total BSurvE points accumulated 

through August 15, 2006 (APHIS 2006c, 

table 4) were collected proportionally to 

the cattle population size in each 

province, table 3 presents the allocation 

of the random sample size equivalents 

(BSurvE points). 

TABLE 3.—ALLOCATION OF BSURVE POINTS AMONG PROVINCES PROPORTIONAL TO HERD SIZE

Province Cattle 

(000)* Percent BSurvE points 

BSE 

cases** 

Alberta .......................................................................................................................... 6,300.0 38.8 594,858.4 7 

Manitoba ...................................................................................................................... 1,720.0 10.6 162,405.8 1 

British Columbia ........................................................................................................... 830.0 5.1 78,370.2 1 

Saskatchewan .............................................................................................................. 3,450.0 21.2 325,755.8 0+ 

Ontario ......................................................................................................................... 2,203.9 13.6 208,096.6 0 

Quebec ........................................................................................................................ 1,455.0 9.0 137,384.0 0 

Nova Scotia ................................................................................................................. 107.0 0.7 10,103.2 0 

New Brunswick ............................................................................................................ 90.5 0.6 8,545.2 0 

Prince Edward Island ................................................................................................... 84.5 0.5 7,978.7 0 

Newfoundland .............................................................................................................. 9.1 0.1 .................... ........................


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TABLE 3.—ALLOCATION OF BSURVE POINTS AMONG PROVINCES PROPORTIONAL TO HERD SIZE—Continued 

Province Cattle 

(000)* Percent BSurvE points 

BSE 

cases** 

Labrador ....................................................................................................................... .................... .................... 859.2 ........................

Total ...................................................................................................................... 16,250.0 .................... 1,534,357 9 

*Source: Statistics Canada (2007). 

**BSE cases reported through August 2006 were included in APHIS (2006c). 

+The BSE case confirmed in May 2003 was born in Saskatchewan but reported in Alberta. 

Based on this allocation of evidence, 

a binomial likelihood ratio test (Fleiss et 

al., 2003) fails to reject the hypothesis 

that the provinces have the same BSE 

prevalence. That is, the result provides 

no basis for concluding that BSE 

prevalence varies among provinces. 

Depending on the method used to 

estimate provincial BSE prevalence, the 

test indicates that 11 to 20 BSE cases 

would have to have been observed in 

Alberta (or 4 to 7 cases in British 

Columbia) before rejection of the 

hypothesis. 

The commenters provide no data or 

analysis related to BSE hot-spot 

development. APHIS’ risk assessment 

discusses the apparent geographic 

clustering of Canadian BSE cases 

reported through August 2006 in three 

western provinces: Alberta, British 

Columbia, and Manitoba (APHIS 2006b, 

pp. 12–13). (In addition, the May 2003 

case reported in Alberta was born in 

Saskatchewan.) However, APHIS also 

noted that the Manitoba BSE case was 

phenotypically different than the 

previously detected BSE cases of 

Canadian origin (APHIS 2006b). In 

addition, in its risk assessment, APHIS 

considered the CFIA report (CFIA 2006) 

that discusses geographic and temporal 

BSE clustering theories. APHIS 

concluded that the detection of further 

clusters (i.e., linked cases) that might be 

defined in the future cannot be ruled 

out and did not assume that any 

Canadian provinces are BSE-free. While 

BSE case investigations may reveal 

associations among individual cases, 

such as a common feed source, the 

question of clustering is scale 

dependent. At a local scale, there may 

be associations between individual 

cases, but at a regional or national scale, 

the clusters themselves may be 

geographically dispersed. In addition, 

the geographic disease dispersal pattern 

may change over time due to the 

movement of cattle. 

Further, the commenter provides no 

evidence or analysis to support the 

hypothesized sources of heterogeneity. 

On the contrary, disaggregating the 

available surveillance data into 

numerous strata to account for 

hypothetical sources of heterogeneity 

(geography, market class, etc.) generates 

substantial uncertainty within strata by 

diluting the sample size. One 

consequence of this practice (commonly 

called over-stratification) would be to 

inflate the upper confidence level risk 

estimates within putative strata (e.g., 

Alberta beef cattle). 

With regard to quantifying the 

likelihood of imports creating localized 

hot spots in the United States, the 

commenter provides no data or analysis, 

and cites no existing scientific 

literature, in support of the hypothesis 

that some U.S. cattle-producing areas 

are—on average—more susceptible than 

others to the establishment of BSE. 

While such spatial heterogeneity is 

theoretically plausible, APHIS is 

unaware of any empirical data that 

would provide a statistical basis for 

distinguishing BSE susceptibility among 

U.S. cattle-producing locations. 

Although the commenter claims that the 

APHIS analysis represents an average 

risk estimate, the assessment does 

consider random variability on the 

national scale in the BSE reproductive 

rate (R0) and the number of infected 

animals under each scenario or set of 

assumptions (APHIS 2006b). In essence, 

the commenter argues for a more 

disaggregated risk model that has 

random variability at the local level (in 

which regions are assumed to vary 

significantly from one another) rather 

than at the national level, but the 

comment does not provide any evidence 

in support of the hypothesis that such 

local differences (spatial heterogeneity) 

either exist, can be distinguished from 

a random distribution, or are of 

sufficient magnitude that they need to 

be accounted for by the model. 

Finally, the commenter’s calculation 

of a 77.7 percent probability of at least 

one U.S. hot spot being activated rests 

on two assumptions. First, the 

commenter assumes that the prevalence 

of BSE in Canada exceeds the APHIS 

prevalence estimate by a factor of 10. 

There is no evidence to support this 

assumption. Second, the commenter 

assumes that there is a 5 percent 

probability that Canadian cattle would 

be introduced into pockets within the 

United States where R0 exceeds unity. 

(If R0 exceeds unity (one), the disease 

will tend to spread. Conversely, if R0 is 

less than unity, the number of cases will 

tend to decline over time, and 

ultimately the disease will die out.) 

Other than asserting the existence of 

such pockets and that 5 percent of U.S. 

locations may be hot spots, the 

commenter provides no evidence to 

support this contention. Even if the 

comment did provide such evidence, it 

would have to show that in such 

pockets the value of R0 substantially 

exceeds 1 in order for there to be 

evidence that a substantial impact is 

likely. For example, if R0 = 1.1 and each 

generation of the disease (i.e., the time 

between infection of an animal and that 

animal’s subsequent infection of another 

animal) lasts just 2 years, it would take 

40 years for the disease prevalence to 

climb from 1 animal to 7. Finally, the 

commenter’s suggestion supposes that 

no action would be taken to address 

vulnerabilities in a susceptible pocket if 

BSE did materialize. This assumption is 

inconsistent with APHIS’ policy and 

record. 

Issue: One commenter asked whether 

the expected number of imported 

animals by class (i.e., the intended use 

of the animal, such as for breeding, 

immediate slaughter, or feeding and 

then slaughter) needed to be validated 

or explored in the sensitivity analysis. 

Response: We projected the expected 

number of imported animals by class 

because an animal’s usage will govern at 

what age it goes to slaughter. How long 

a bovine lives will, in turn, have an 

effect on the animal’s likelihood of 

developing detectable levels of BSE 

infectivity. The projected numbers of 

imports by age and use class used in our 

risk assessment were prepared for 

APHIS by USDA ERS. These values are 

based on USDA baseline projections, 

with specific factors considered based 

on the regulatory changes proposed. 

Additional details are provided in 

Appendix 1 of the Regulatory Impact 

Analysis and Final Regulatory 

Flexibility Analysis. 


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8As discussed in the regulatory impact analysis 

APHIS conducted for this rule, most steers and 

heifers are ready for slaughter between 16 and 24 

months of age, feeders are generally ready between 

9 and 15 months of age, and vealers and light calves 

are slaughtered between less than 3 months and 8 

months of age. In our analysis, we project that the 

total number of projected imports from Canada for 

these three categories of cattle in 2008 will be 

987,000. This represents about 88 percent of the 

overall number of cattle projected to be imported 

from Canada in 2008. This percentage does not 

include imported replacement heifers and other 

breeding stock younger than 2 years of age. 

Although these estimates cannot be 

entirely certain, they are based on the 

input of experts in the fields of 

commodity projection and cattle 

markets iteratively refined with 

estimates from widely accepted models. 

Therefore, alternative plausible 

assumptions for the number of imported 

animals by class would not likely vary 

substantially from those based on the 

most current inputs. Hence, the import 

projections do not contribute 

significantly to uncertainty in the total 

estimated rate at which BSE may be 

introduced into the United States from 

Canada. In any case, new economic 

information based on market forces and 

age verification described above 

indicates that, compared to those used 

in the published risk assessment, the 

import projections should be revised 

downwards, especially estimates for the 

projected number of older cull animals. 

As a result, any potential release of BSEinfected animals should be lower than 

previously estimated. In addition, the 

key determinant of the impact of an 

introduction of BSE into the United 

States is its propensity to spread within 

the cattle herd. The risk assessment 

results indicate that, because the 

reproductive constant, R0, remains 

consistently less than one, prevalence in 

the United States will tend to fall over 

time. (In order for the disease to spread, 

R0 must exceed unity (one).) 

Issue: One commenter stated that the 

incidence rate among just the older 

cattle covered by the proposed rule 

would be expected to be even higher 

than the overall incidence for all 

Canadian cattle slaughtered, thereby 

making the likely risk even greater. 

Response: We are not certain what the 

commenter is referencing as ‘‘overall 

incidence for all Canadian cattle 

slaughtered.’’ We note that APHIS 

estimated the prevalence of BSE in the 

standing adult cattle population in 

Canada, not the BSE incidence in all 

Canadian cattle slaughtered. The 

Canadian BSE surveillance data provide 

no statistical basis for concluding that 

one birth-year cohort has a higher or 

lower BSE prevalence than another. 

Therefore, we assumed for our risk 

assessment that all animals in the 

current standing Canadian cattle 

population, including animals 30 

months of age and older that are eligible 

for importation under this rule (as well 

animals that are not eligible for 

importation under this rule due to the 

birth-date requirement) have the same 

probability of BSE infection. However, it 

would not be surprising if animals born 

at an earlier date (i.e., either before or 

around the time the feed ban was 

implemented) have a greater likelihood 

of exposure to contaminated feed, and 

therefore could have a higher 

prevalence of BSE than animals born in 

later years. For this reason, we are 

restricting imports of live bovines from 

Canada to those born after the date 

when the country had an effectively 

enforced feed ban—which we have 

determined to be March 1, 1999. 

Additionally, of the live bovines we 

project will be imported following the 

effective date of this rule, greater than 

80 percent of the animals are expected 

to be younger than 2 years of age at the 

time of importation.8 Therefore, even if 

older animals had some significantly 

higher level of BSE prevalence (which is 

already reflected in the standing herd 

estimates), the fact that this rule 

excludes the importation from Canada 

of bovines born before March 1, 1999, 

along with the fact that the large 

majority of animals are expected to be 

young, would tend to decrease, rather 

than increase the overall risk from that 

which we have estimated. 

Issue: One commenter indicated that 

Canada’s BSE prevalence rate 

essentially guarantees (probability 

greater than 98 percent) that some BSEpositive cattle will enter the United 

States. Another commenter suggested 

that there is a 99.75 percent chance that 

one or more cattle that would test 

positive for BSE will be imported into 

the United States among the first 

million cattle that would be imported 

after adoption of the proposed rule. 

Response: We note that prevalence 

refers to the proportion of BSE-infected 

animals, not the proportion of animals 

that would test positive for BSE. BSEinfected cattle are unlikely to test 

positive unless they are tested at a late 

stage of disease incubation. 

Nevertheless, the commenter’s 

estimated likelihood of entry of BSEinfected cattle is consistent with the 

APHIS risk assessment. The risk 

assessment clearly acknowledged the 

possibility of importing infected 

animals. Given the estimated current 

prevalence in Canada, table 7 in the risk 

assessment presents the projections for 

imports in the first year of 

implementation, including infected 

animals. 

Issue: One commenter expressed 

doubt regarding the conclusion reached 

by the APHIS risk assessment that—

because Canada’s BSE prevalence will 

likely decrease over time, and because 

of the barriers to BSE transmission in 

the United States—the likelihood of BSE 

exposure and establishment in the U.S. 

cattle population as a consequence of 

the proposed rule is negligible. The 

commenter stated that the overlapping 

safeguarding measures described in the 

risk assessment have not prevented the 

continued spread of BSE in other 

countries (including Canada) that have 

relied on similar measures. The 

commenter further suggested that the 

measures have not been empirically 

tested or validated and cited the four 

Canadian BSE cases born in the years 

2000 and 2002 as evidence that the 

measures are, in fact, ineffective to 

either reduce or prevent BSE infection. 

Response: We disagree with the 

commenter’s statements. Various data—

epidemiological, modeling, and 

experimental—clearly demonstrate that 

the barriers discussed in the risk 

assessment and the proposed rule will 

decrease the risk of the introduction of 

BSE and its amplification. These 

barriers have been used internationally 

as strategies for the control and 

prevention of BSE. Furthermore, the 

barriers have demonstrated a striking 

effect in curtailing the epidemic and are 

responsible for the downward pressure 

on the prevalence of BSE observed in 

the United Kingdom and Europe. As 

described in the risk assessment: (1) 

Slaughter controls prevent the recycling 

of infectivity into human food and cattle 

feed; (2) rendering processes contribute 

to the inactivation of the BSE agent; and 

(3) feed controls prevent the recycling 

into cattle feed. In addition, there is 

epidemiological evidence of an agerelated susceptibility to infection, which 

implies that the animal not only needs 

to be exposed to the BSE agent to 

become infected, but needs to be 

exposed with a sufficient dose at the 

time in its life that it is susceptible. For 

disease transmission to occur, the 

following events must happen in 

sequence: An infected animal dies or is 

slaughtered at a sufficiently late point in 

the incubation period to have significant 

infectivity present in certain tissues; 

those tissues go into the rendering 

system; some level of infectivity 

remains after the rendering process; the 

resulting protein is included in feed; 

and feed is fed to a ruminant in a 

sufficient amount at an age when it is 

susceptible. Although this could occur, 

the likelihood of it happening 


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repeatedly is negligible. This fact is 

demonstrated in the quantitative 

exposure model used in our risk 

assessment—i.e., transmission can 

occur, but it is not sufficient to sustain 

the disease (R0 remains far less than 

one). 

We reviewed Canada’s feed 

production process (e.g., regulations in 

place based on statutory authority, 

infrastructure to implement the 

regulations, and compliance with the 

regulations). We used a peer-reviewed 

model to estimate the prevalence and 

determined that the prevalence in 

Canada is extremely low. We also used 

a peer-reviewed exposure model in our 

assessment of the risk (Cohen et al., 

2001; 2003). This model takes into 

consideration several parameter values 

that are based on experimental and 

epidemiological information related to 

BSE. These parameters represent key 

epidemiological elements related to the 

mechanisms by which BSE is 

transmitted. As we indicate in the 

exposure assessment, that assessment 

demonstrated that, because we expect 

Canada’s prevalence to decrease over 

time, and because of the barriers to BSE 

transmission in the United States, the 

likelihood of BSE establishment in the 

U.S. cattle population is negligible. We 

reach the same conclusion even without 

assuming a drop in Canada’s BSE 

prevalence over the next 20 years. 

Issue: One commenter, in addressing 

risk mitigation measures in place in the 

United States, stated that several 

loopholes remain in the U.S. feed ban 

through which BSE infectivity could be 

introduced to cattle, despite 

recommendations from an APHIS TSE 

Working Group. 

Response: APHIS has proceeded in a 

thorough and deliberative manner, in 

cooperation with FSIS and FDA, to 

determine the steps necessary to 

continue to protect animal and public 

health. APHIS has used a peer-reviewed 

model to assess the likelihood of 

exposure of cattle to BSE as a result of 

importing live cattle from Canada under 

the proposed rule (Cohen et al., 2001; 

2003). This model takes into 

consideration several parameter values 

relevant to the cattle production 

process, including what the commenter 

refers to as loopholes in the feed ban 

regulations. Even after considering these 

features of the U.S. system, the results 

indicate that the likelihood of BSE 

exposure and establishment in the U.S. 

cattle population as a consequence of 

infectivity introduced via imports from 

Canada is negligible. 

Issue: One commenter stated that the 

models that Canada and the United 

States used in estimating BSE risk are 

not validated and have no predictive 

value. The commenter stated further 

that the predicted risks from the 

Harvard model would increase almost 

15-fold if compliance is less than 

assumed in the base case. 

Response: We disagree with the 

commenter’s assessment of the 

quantitative exposure model we used in 

developing our risk assessment. As 

noted earlier, the plausibility of the 

model was established by comparing its 

predictions for Switzerland against the 

observed progression of BSE within that 

country’s cattle herd (Cohen et al., 

2003). Although the model’s 

performance in the United States has 

not been empirically evaluated (because 

there have been too few cases in the 

United States to do so), the use of 

models to characterize future risks is 

well-accepted in the scientific 

community. 

The commenter cites an FSIS risk 

assessment (Cohen and Gray, 2005), 

which uses a version of the Harvard 

model, to argue that, if the misfeeding 

rate parameter is highly uncertain, the 

resulting range of results generated by 

the simulation model is likewise wide. 

As explained in the APHIS risk 

assessment, new information indicates 

that the original range of estimates for 

the misfeeding rate in the Harvard 

model as originally developed in 2001 

were overly pessimistic. APHIS 

obtained new data and, using these new 

data in the Harvard model, reduced the 

range of the original estimates. 

Therefore, in APHIS’ evaluation, the 

impact of misfeeding on the output of 

the model is much more modest. 

Issue: One commenter asserted that 

APHIS’ risk assessment model predicts 

low or ‘‘negligible’’ risks only if 

optimistic assumptions are made. 

Response: APHIS disagrees with the 

commenter. The commenter simply 

cites the results of APHIS’ own 

sensitivity analysis using ‘‘pessimistic’’

assumptions and provides no evidence 

or analysis demonstrating that the 

APHIS ‘‘base case scenario’’

assumptions are optimistic. APHIS 

combined qualitative and quantitative 

methods in its assessment of risk from 

live cattle. We qualitatively evaluated 

what we expect as the most likely 

scenario—prevalence drops in Canada 

over the next 20 years, resulting in 

decreases in potential release and 

exposure. While the commenter may 

consider this expectation an optimistic 

assumption, we do not and we note that 

this assumption is based on evidence 

from countries around the world that a 

feed ban provides continuous 

downward pressure on prevalence. 

However, APHIS also considered 

other less likely (more pessimistic) 

scenarios, for which we assumed that 

the prevalence in Canada remained 

constant over the next 20 years, using a 

quantitative exposure model. The 

quantitative exposure model simulates 

the cattle management system in the 

United States, with assumptions made 

for certain variables, or parameters as 

input to this system. These parameters 

include BSE prevalence in Canada, 

which is an exogenous variable (and 

therefore, external to the U.S. system of 

mitigations), and many endogenous, or 

internal parameters. The endogenous 

parameters include various aspects of 

compliance with the FDA feed ban, how 

many carcasses enter the rendering 

system, what rendering processes are 

used, how rendered protein is 

incorporated into feed, and many other 

factors that can contribute to the spread 

of BSE. The values for each of these 

parameters basic assumptions that are 

meant to represent the most plausible 

and realistic representation of the U.S. 

system are reflected in the ‘‘base case 

scenario.’’

Assumptions regarding those 

parameters for which we have the least 

information (or the most uncertainty) 

were changed to more pessimistic, but 

still plausible, values in the sensitivity 

analysis, to evaluate the degree to which 

these changes would affect the results as 

compared to the base case. Given that at 

least one significant parameter—the 

constant prevalence of disease in 

Canada—was pessimistic even in the 

base case, we do not agree with the 

commenter’s assertion that the 

quantitative model predicts low or 

negligible risk only if optimistic 

assumptions are used. Moreover, even 

under the more pessimistic scenario 

examined in the senstivity analysis, the 

reproductive rate of BSE (R0) remains far 

below 1, indicating that the disease 

would not become established in the 

United States. 

Issue: Several commenters stated that 

APHIS has not adequately considered 

the risk that imperfect compliance with 

U.S. SRM removal policies would have 

once we allow the importation of cattle 

over 30 months of age from Canada. One 

of the commenters stated further that 

APHIS provided no data or analysis in 

the proposed rule to address this series 

of known incidences of noncompliance. 

Response: We disagree with the 

commenters. As noted in our risk 

assessment, the quantitative exposure 

model assumes that SRMs are 

effectively removed 99 percent of the 

time. This assumption is based on FSIS 

summaries of Noncompliance Records 

(NRs) performed from January 2004 to 


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May 2005 in about 6,000 federally 

inspected meat and poultry 

establishments. Based on these records, 

FSIS estimated that noncompliance 

with respect to SRM-related regulations 

had a frequency of less than 1 percent. 

To explore the possible impact of 

assuming an arbitrary decrease 

(compared to the results of our exposure 

model) in SRM removal compliance on 

the availability of infectivity for human 

consumption, we can discuss the 

significance of an order of magnitude 

increase in available infectivity 

compared to our model’s findings. First, 

we consider the results of that model, 

which used the unlikely assumption 

that prevalence in Canada (and thus the 

proportion of infected animals imported 

from Canada) remained constant over 

the next 20 years. In the model’s 

scenario, the total amount of infectivity 

potentially available for human 

consumption over the 20 years of the 

analysis is 45 cattle oral infectious dose50 units (ID50s). (BSE infectivity is 

expressed in terms of cattle oral ID50s. 

A cattle oral ID50 is defined as the 

amount of infectivity required to cause 

infection in 50 percent of an exposed 

cattle population (APHIS 2006)). The 

significance of cattle oral ID50 units to 

human exposure and susceptibility is 

not known; however, various studies 

suggest that the infectious agent may be 

10 to 10,000 times less pathogenic in 

humans than in cattle because of a 

species barrier (EC SSC, 2000). Thus, if 

the cattle—human species barrier were 

100, it would mean that 100 times more 

infective material would be required in 

order to have a similar probability of 

infecting a human as a bovine. Comer 

and Huntly (2003) estimated, after an 

evaluation of available literature, that 54 

million bovine oral ID50 units were 

available for human consumption in 

Great Britain from 1980 to 2003. This 

extremely large amount of available 

infectivity has resulted in 165 cases of 

vCJD identified in the United Kingdom 

through April 2007, plus a few 

additional cases identified in other 

countries but attributed to exposure in 

the United Kingdom. When compared to 

the United Kingdom’s BSE experience 

and the associated estimate of available 

bovine oral ID50 units, the expected, or 

average value of 45 cattle oral ID50

indicates that only a miniscule amount 

of the BSE infective agent that could 

possibly be available for potential 

human exposure in the United States 

over a 20-year period (APHIS 2006). 

(The potential for human exposure 

under this scenario is estimated at 

1,200,000 times less in the United States 

than what the United Kingdom 

experienced during its BSE epidemic.) 

Even if compliance with the SRM ban 

were not as high as the 99 percent 

estimated in our exposure model, and 

we were to assume that the infectivity 

available for human consumption were 

increased by an order of magnitude 

(10x), it would still be far less than that 

estimated to have circulated in the 

United Kingdom and, we conclude, not 

to be of significance to human health. 

Issue: One commenter stated that, 

although APHIS assumes that removal 

of SRMs from a bovine carcass will 

effectively shield consumers from 

exposure to BSE, numerous studies have 

demonstrated limitations on mitigating 

the risk of BSE exposure via SRM 

removal. In particular, the commenter 

stated that APHIS did not appropriately 

consider several studies (Buschmann, 

2005; Iwamaru et al., 2005; Hoffman, 

2006) related to the distribution of 

SRMs, and that APHIS failed to explain 

why these uncertainties and concerns 

do not undermine its almost exclusive 

reliance on SRM removal requirements 

to protect American public health from 

potentially hazardous Canadian 

imports. 

Response: We are aware of the studies 

cited by the commenter and do not 

agree that they question the efficacy of 

SRM removal. We acknowledge that 

studies using new methods that provide 

increased sensitivity will probably 

demonstrate the presence of PrPBSE (the 

abnormal form of the prion protein) in 

various tissues. However, demonstrating 

the presence of PrPBSE does not 

necessarily indicate the presence of BSE 

infectivity, especially if no infectivity is 

demonstrated via the most sensitive 

method available: Cattle-to-cattle 

exposure via intracerebral transmission. 

Therefore, one cannot automatically 

assume that a finding of PrPBSE in a 

tissue means the tissue should be 

defined as an SRM. The OIE made this 

particular point in the Terrestrial 

Animal Health Standards Commission 

Report, October 2006—Supporting 

Document for Chapter 2.3.13. Of the 

Terrestrial Animal Health Code on 

Bovine Spongiform Encephalopathy, as 

follows: 

The availability of experimental infectivity 

data has significantly increased in recent 

years. During the same interval, extremely 

sensitive tests have been developed, 

including those employing highly sensitive 

transgenic mice strains and potentially more 

sensitive laboratory PrP detection methods. 

With the development of such highly 

sensitive methods, the probability of 

detection of PrPBSE in tissues that are not 

currently listed as infectious is increasing. 

However, such findings need to be 

considered in context, and their relevance to 

establishing risk to consumers evaluated 

carefully when the quantity of PrPBSE

detected is potentially below the limit of 

detection of intracerebral (i.c.) cattle to cattle 

bioassay. By April 2007, 165 variant 

Creutzfeldt-Jakob Disease (vCJD) cases had 

been detected in the United Kingdom, a 

country where most probably the majority of 

the population was exposed to the BSE-agent. 

The latest models of the vCJD epidemic 

estimate that the potential scale of the 

clinical epidemic arising from food-borne 

exposure is unlikely to exceed 400 future 

cases in the United Kingdom (Clarke and 

Ghani, 2005). The relatively low number of 

predicted vCJD cases in relation to the 

massive exposure to the BSE agent is 

suggested to be due mainly to a significant 

species barrier between cattle and humans 

(Comer and Huntley, 2004; Bishop et al., 

2006). 

APHIS is familiar with the results of 

the study (Buschmann, 2005) cited by 

the commenter in which tissues from a 

BSE-diseased cow were inoculated into 

genetically engineered (transgenic) mice 

that are highly susceptible to BSE and 

which over-express the bovine prion 

protein. Using this extremely sensitive 

mouse assay, this study demonstrated 

low levels of infectivity in the 

peripheral nervous system (e.g., facial 

and sciatic nerves) of the infected cow. 

APHIS discussed these findings in its 

risk assessment and concluded that 

‘‘[g]iven all these factors there is not 

sufficient information to alter our 

understanding of the epidemiologically 

significant distribution of BSE 

infectivity in cattle.’’ APHIS also 

acknowledges the results of Japanese 

studies in which PrPBSE has been 

reported in the peripheral nerves of a 

case of BSE (Iwamaru et al., 2005) and 

in some peripheral nerves of cattle 

slaughtered at abattoirs in Japan (Iwata 

et al., 2006) by Western blot analyses. 

APHIS has also reviewed the German 

study in which infectivity was detected 

in the brainstem of an animal at 24 

months post-infection (Hoffman, 2006). 

We have carefully considered all of 

these findings. USDA reviews and takes 

into consideration all BSE research for 

the definitions of SRMs, as does Canada 

and other countries internationally. As 

noted in the quote above, international 

policies regarding SRM removal have 

not changed based on the results of the 

studies discussed. Both the U.S. and 

Canadian policies regarding SRM 

removal are consistent with 

international standards. 

Issue: One commenter referenced an 

FSIS study that found that the removal 

of SRMs can reduce human exposure to 

BSE by about 80 percent. The 

commenter stated that this level of 

protection is clearly inadequate to 

protect the United States from risks 

associated with the importation of older 


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cattle from Canada that represent an 

inherently higher risk for BSE. The 

commenter then referred to the 

sensitivity analysis APHIS conducted as 

part of its risk assessment, which 

incorporated a higher value for Canada’s 

BSE prevalence than in the more likely 

base-case scenario. The commenter 

expressed concern that the sensitivity 

analysis revealed that 108 BSE infected 

cattle could be imported into the United 

States over the next 20 years and result 

in 12 new BSE cases in the United 

States. 

Response: We disagree with the 

commenter regarding the significance 

and applicability of the cited study. In 

this response, we present a more 

appropriate study from which to draw 

useful inferences regarding the impacts 

of SRM removal. 

The 2004 FSIS document referred to 

by the commenter—Preliminary 

Analysis of Interim Final Rules and An 

Interpretive Rule to Prevent the BSE 

Agent From Entering the U.S. Food 

Supply’’—is an analysis intended to 

evaluate the major impacts of measures 

contained in the FSIS interim final rules 

published and implemented in January 

2004. FSIS used the Harvard model in 

this analysis to estimate the benefits of 

these measures, specifically ‘‘those 

[benefits] resulting from the reduction 

in human exposure to BSE infectivity.’’

FSIS used this model to create a 

baseline estimate of potential human 

exposure and then evaluated three 

scenarios of risk mitigation options (e.g., 

SRM removal) for comparison to the 

baseline. In each simulation, FSIS 

assumed that five infected animals were 

introduced into the United States in 

2003, and then simulated the spread of 

BSE infectivity until 2020. The 

simulations of the risk mitigation 

measures were run assuming that the 

mitigations were implemented in 2004, 

i.e., approximately 12 months after the 

introduction of infected animals. While 

the commenter is correct that this 

analysis demonstrated a reduction in 

potential human exposure of 80 percent, 

the comment does not accurately 

portray the context of this result. Given 

the assumptions used in the simulation 

(i.e., the risk mitigation measures, 

including SRM removal, were not 

implemented until 12 months after 

introduction of infectivity), a certain 

amount of infectivity would have 

become available for human exposure 

before the mitigations measures were 

implemented in the model scenario. 

Therefore, the mitigation measures 

could never eliminate all of the 

infectivity available. Since all scenarios 

included at least some time in which 

the mitigations were not implemented, 

under the simulations, a certain amount 

of potential infectivity was allowed into 

inappropriate channels, such as human 

food. Because none of these scenarios 

incorporated the more realistic 

assumption that the mitigations were 

implemented (even imperfectly) 

throughout the simulation period, it is 

inappropriate to use this analysis as a 

citation for the level of public health 

protection provided by risk mitigation 

measures in place in the United States. 

A more appropriate analysis for 

understanding the role of SRM removal 

in potential human exposure to BSE 

infectivity would be the FSIS update of 

the same Harvard simulation model that 

was available for public comment in 

2006. APHIS cites the analysis in the 

risk assessment conducted for this 

rulemaking as Cohen and Gray (2005). 

This updated model used the ‘‘base 

case’’ as the circumstances in the United 

States prior to December 2003, and 

simulated the response of the U.S. 

system for 20 years following the import 

of BSE-infected cattle. FSIS’ updated 

model estimated the impact of various 

risk management measures, including 

measures that were adopted, 

considered, or proposed by various 

agencies and groups. These simulations, 

where the risk mitigation was applied 

during the entire simulation, as opposed 

to the simulation in the analysis cited 

by the commenter (in which it was not), 

indicated that removing SRMs, as 

currently defined by FSIS, reduced 

potential human exposure by more than 

99 percent, on average. This report also 

stated that ‘‘[i]t is worth noting that 

these measures reduce what is already 

a small exposure in absolute terms.’’

Issue: One commenter stated that 

SRM removal requirements have not 

been in place long enough for an effect 

to be determined, due to the 

exceedingly long incubation periods 

assumed for humans. The commenter 

stated further that the experience of 

other countries in which BSE has been 

detected (except for Canada) cannot be 

used to demonstrate that SRM removal 

is highly effective, because other 

countries have more stringent SRM 

removal requirements than do Canada 

and the United States and their 

experience is not applicable for 

predicting risk in the United States. 

Response: The commenter appears to 

be questioning two points—first, 

whether SRM removal is actually highly 

effective in protecting public health, 

and second, whether experience in 

Europe can be used as a comparison for 

expectations in North America. 

The commenter is correct in that there 

has been no specific controlled study 

that clearly and unequivocally 

demonstrates the effectiveness of SRM 

restrictions on protecting public health. 

The absence of such a study does not 

negate the fact, however, that 

substantial epidemiological and case 

evidence clearly indicate the success of 

such control measures. It is widely and 

generally accepted internationally, 

including by such international bodies 

such as the World Health Organization 

(WHO) and the OIE, that the primary 

public health protective measure 

regarding BSE is the removal of SRMs 

from the human food supply (WHO, 

2002). 

The OIE Scientific Revue notes the 

following: ‘‘Excluding SRM from the 

human food chain effectively minimizes 

the risk of human exposure and is the 

most important measure taken to protect 

consumers. Failure to remove SRMs 

would probably expose a large number 

of consumers to an unnecessary risk.’’

(Heim and Kihm, 2003). This point is 

also widely acknowledged in scientific 

literature, including articles cited by the 

commenter. For example, Bradley and 

Liberski (2004) conclude that ‘‘risks to 

humans from infected cattle are now 

remote so long as the [bans on the use 

of SRMs in human food] are rigorously 

enforced.’’ Fox and Peterson (2004) 

conclude that ‘‘[a]doption of the human 

[specified bovine offal] ban in the 

United Kingdom in 1989 is probably the 

only example in the BSE story of a 

government going beyond expert 

opinion in taking a precautionary 

measure. It turned out to be the correct 

decision, and likely saved thousands of 

people from exposure to the disease.’’

Simulation models and analysis 

conducted in the United Kingdom 

support the assumption that primary 

exposure sources for people were SRMs 

in the food supply prior to imposed 

restrictions. These models have been 

updated and revised repeatedly since 

the original identification of vCJD and 

the link to BSE in cattle (Ghani and 

others, 1998, 2000, 2001, 2003, 2005). 

They incorporate assumptions for all the 

parameters that could influence the 

course of vCJD in the United Kingdom—

including assumptions about primary 

exposure from dietary sources, 

calculations about how many infected 

cattle may have been slaughtered at 

different points in time, what tissues 

from those animals were available for 

consumption, and what restrictions 

were imposed on the tissues and types 

of products available for consumption. 

The models are updated routinely to 

incorporate new information about vCJD 

cases as they are reported. 

These models have been used to 

predict the course of the vCJD epidemic 

in the United Kingdom. Initially, the 


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projections were fairly high with 

considerable uncertainty. As more 

information is incorporated into the 

models, these projections continue to 

decline and the uncertainty levels also 

decrease. The number of clinical cases 

of vCJD in the United Kingdom has 

continued to decline since an apparent 

peak in 2000 (Andrews, 2007). This 

decline is consistent with projections 

made from the models, thus validating 

some of the assumptions used in the 

models. As an example, Cooper and 

Bird (2003) assume that the primary 

sources of exposure are the 

consumption of meat products—

including mechanically separated meat 

and head meat—that were most likely 

contaminated with SRMs such as spinal 

cord, dorsal root ganglia, and brain. 

Restrictions on the inclusion of spinal 

cord and brain, among other tissues, 

were initially imposed in the United 

Kingdom in 1989. Restrictions on the 

production of mechanically separated 

meat, which included a significant level 

of infectivity from dorsal root ganglia, 

were imposed in the United Kingdom in 

1995. Cooper and Bird (2003) concluded 

that ‘‘[t]here is remarkable similarity 

between the age distribution and gender 

of simulated and observed vCJD 

patients, which supports (but does not 

prove) our assumption about the 

primary sources of exposure to BSE.’’

The commenter notes the 

‘‘exceedingly long incubation periods 

assumed for humans.’’ More recent 

updates of the models described 

previously have included estimates of 

the mean incubation period for vCJD 

(Ghani et al., 2003) and estimated the 

mean incubation period for vCJD at 12.6 

years when using the accumulated case 

data from confirmed vCJD cases. When 

additional information was added from 

results of a screening study performed 

on appendix and tonsil tissues, the 

mean incubation period was 16.7 years 

when fitted to this data. From this 

evidence, we can conclude that even the 

longer mean incubation period of 16.7 

years would allow sufficient time to 

demonstrate the effect of SRM 

restrictions on the outbreak, since the 

initial SRM restrictions were imposed in 

1989. We note that all vCJD cases that 

have been genotyped to date, with one 

exception, have been of the homozygous 

methionine (MM) genotype at codon 

129 of the human prion protein gene. It 

is estimated that approximately 40 

percent of the Caucasian population is 

homozygous methionine, with 

approximately 10 percent valine 

homozygous, and the remaining 50 

percent heterozygous. While the effect 

of genotype on vCJD is still unknown, 

we can evaluate scenarios in the MM 

genotype as an example of epidemic 

progression, because this genotype may 

be the most susceptible and/or have 

shorter incubation periods than other 

genotypes. 

The second point the commenter 

raises is whether there would be 

significant differences in potential 

public health exposure due to the 

different definitions of SRMs in Europe 

and North America (Canada and the 

United States). While these definitions 

identify essentially the same tissues, 

European regulations define tissues 

such as brain and spinal cord as SRMs 

in animals greater than 12 months of 

age, where North American regulations 

define these tissues as SRMs in animals 

greater than 30 months of age. 

In the past few years, significant 

consideration has been given to the age 

limits on SRMs and their 

appropriateness. Additional information 

obtained from new research findings has 

contributed to these evaluations. 

Scientists in Europe have specifically 

examined these findings as part of their 

consideration on the age limit in cattle 

for the removal of SRMs (EFSA, 2005; 

2007). In each of these opinions, they 

conclude that any likely detectable 

infectivity in the central nervous system 

(CNS)—including the SRMs in 

question—appears at about 75 percent 

of the incubation time. These opinions 

also note that the experimental low-dose 

scenarios are more likely to resemble 

the actual field exposure. The low-dose 

research scenarios are those in which 

calves were exposed orally to 1 gram of 

highly infective brain tissue, rather than 

the 100 grams used in the high-dose 

scenario. Experimental attack rate 

studies indicate that the incubation 

period for the low-dose scenario has a 

mean of 60 months, with a range of 45 

to 73 months (Wells et al., 2007). Using 

the low end of this range of incubation 

period, and assuming that infectivity is 

present in the CNS at 75 percent of the 

incubation period, they predict that 

infectivity would be sub-detectable or 

still absent in CNS in cattle aged 33 

months. 

In the United Kingdom, even 

including cases from the height of the 

BSE epidemic there, which are believed 

to have had shorter incubation periods 

than more recent cases, the peak age at 

onset of clinical signs was 5 to 6 years. 

This age of clinical onset is consistent 

with an assumption that the average 

incubation period in the United 

Kingdom has been about 60 months. 

The average age of animals identified 

with disease in the EU is higher than 

this—the average was 86 months in 

2001 and has increased since then. This 

evidence indicates that considering 

certain tissues in bovines 30 months of 

age or older to be SRMs, and removing 

and disposing of those tissues, would 

eliminate the majority of infectivity 

present, and removing and disposing of 

these same tissues from bovines 

between 12 and 30 months of age would 

not provide any significant additional 

protection. 

This same point is illustrated in 

various models. Comer and Huntly 

(2003) modeled the potential human 

exposure available in the United 

Kingdom from 1980 through 2002. They 

concluded that an estimated total of 54 

million bovine oral ID50 units could 

have been consumed in that timeframe. 

This period included both the beginning 

of the epidemic in cattle, before the 

disease was recognized and public 

health control measures were 

established, and later in the epidemic 

when control measures were developed 

and instituted. Comer and Huntly also 

concluded that 99.4 percent of this 

estimated exposure was from animals 

older than 30 months of age. Therefore, 

SRM restrictions from animals greater 

than 30 months would reduce the vast 

majority of potential exposure. 

In summary, we are in agreement with 

the conclusion that has been widely 

reached and that has generally been 

accepted internationally, that the 

primary public health protective 

measure regarding BSE is the removal of 

SRMs from the human food supply. 

Issue: One commenter stated that 

APHIS’ assertion that the rendering 

process is important in the inactivation 

of the BSE agent is overstated. 

Response: As we stated in our January 

2007 proposed rule, we recognize that 

standard rendering processes do not 

completely inactivate the BSE agent, 

and that rendered protein such as MBM 

derived from infected animals may 

remain contaminated. However, the 

rendering process is an important factor 

in BSE risk reduction for two reasons. 

First, standard rendering processes 

will inactivate significant levels of any 

BSE infectivity that might remain in 

materials sent to rendering by subjecting 

the material to intense heat and 

pressure. The risk assessment 

conducted for this rulemaking noted 

that the rendering process has proven to 

be effective in reducing the level of 

infectivity. This is based on data 

regarding inactivation by various 

rendering methods (Taylor et al., 1995; 

Taylor et al., 1997). The assumptions on 

this point used in the quantitative 

exposure model have been previously 

explained (Cohen et al., 2002, 2003) and 

include a range from 0 logs reduction in 

infectivity in a vacuum rendering 


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9The original and the revised FSIS assessments 

may be viewed at http://www.fsis.usda.gov/Science/ 

Risk_Assessments/index.asp. 

system to 3.1 logs reduction in a batch 

system. The proportions of cattle 

rendered in the various systems were 

also explained, with the majority of 

rendering (90 percent) done in either a 

continuous/fat-added system (providing 

a 2.0 log or 99 percent reduction) or a 

continuous/no-fat-added system 

(providing a 1.0 log or a 90 percent 

reduction). On average, the rendering 

process inactivates 1.4 logs of 

infectivity, or greater than 97 percent. 

Additionally, rendering serves as a 

critical control point in redirecting 

ruminant proteins away from cattle 

feed. In the risk assessment we 

conducted for this rulemaking, we 

explained that the rendering process 

will contribute to the prevention of BSE 

as part of a series of sequential barriers, 

rather than as an independent barrier. 

Issue: One commenter expressed 

concerns about plate waste as a 

potential pathway for BSE infection of 

U.S. cattle, because the proposed rule 

did not prohibit the feeding of plate 

waste, including beef, to cattle. The 

commenter referred to APHIS’ risk 

analysis that accompanied the 

rulemaking related to the importation of 

boneless beef from Japan (70 FR 73905–

73919, Docket No. 05–004–2), which 

concluded that the plate-waste pathway 

did not present a significant BSE risk, 

and stated that the conclusion reached 

in that risk assessment would not be 

applicable regarding beef from Canada, 

because the expected amount of product 

from Canada would be much greater 

than that projected for importation from 

Japan. 

Response: We do not agree with the 

commenter that plate waste is a 

potentially significant BSE pathway due 

to this rule. In the risk analysis we 

conducted for the rule related to the 

importation of boneless beef from Japan, 

we discussed direct and indirect 

exposure pathways by which such beef 

might expose U.S. cattle to BSE if the 

product contained the BSE agent. In 

addition, we stated in unequivocal 

terms that the primary factors limiting 

the likelihood that whole cuts of 

boneless beef imported from Japan 

would expose the U.S. cattle population 

to BSE are (1) the inherently low risk of 

the product, (2) measures to prevent 

contamination, which would be the 

same for any beef from cattle from 

Canada that might become plate waste, 

and (3) the fact that the product is 

unlikely to be fed to cattle. 

Although we recognized in our 

rulemaking for boneless beef from Japan 

that the product (inherently low-risk 

boneless beef) is not intended for animal 

consumption, we evaluated pathways 

by which some small fraction of the 

product might inadvertently be fed to 

cattle. We considered the possible 

pathways to include restaurant 

trimmings and plate waste, and the 

direct feeding of human food waste to 

cattle. We further evaluated pathways 

by which home food waste and plate 

waste can be fed directly to cattle, and 

we did not identify any 

epidemiologically significant pathways 

for exposure of the U.S. cattle 

population. Specifically for plate waste, 

which is allowed to be incorporated into 

ruminant feed, we considered that the 

amount of meat in the plate waste 

would be insignificant (Cohen et al., 

2001; 2003). Furthermore, because FDA 

requires that the plate waste be further 

heat processed for feed, it may be 

subject to rendering processes that will 

inactivate significant levels of the agent, 

further reducing the level of infectivity 

in the rendered product. (Cohen et al., 

2001; 2003). 

The inherent (low risk) characteristic 

of the product imported under the Japan 

rule, coupled with the measures to 

prevent contamination of the product 

and the fact that the product is unlikely 

to be fed to cattle, were the primary 

factors in our evaluation. We did not 

dismiss any risk based on quantity. We 

considered the level of imports 

specifically under that rule as an 

additional limiting factor for any 

infectious material, if present, in the 

product. 

Canadian cattle imported under this 

final rule will be slaughtered for edible 

meat production at slaughter plants 

within the United States and would be 

subject to FSIS’ slaughter restrictions. 

These restrictions include ante-mortem 

inspection and prohibition of the 

slaughter of downer animals. In 

addition, FSIS requires the removal of 

SRMs, which is a critical risk measure 

preventing contamination of edible meat 

with BSE infectivity. We consider these 

measures, combined with the fact the 

edible meat is inherently low risk for 

the BSE agent, to be sufficient to 

mitigate the risk of exposing U.S. cattle 

to the BSE agent, if present, via plate 

waste. 

Issue: One commenter noted that a 

peer reviewer of the 2005 Harvard Risk 

Assessment of Bovine Spongiform 

Encephalopathy Update: Phase IA 

suggested lowering the estimate that, at 

ante-mortem inspection, a Federal 

inspector will identify BSE symptoms in 

infected animals 90 percent of the time. 

The commenter stated further that the 

Canadian BSE cases have not been 

clinical suspects. 

Response: The FSIS revision of the 

ante-mortem assumptions demonstrates 

that the assumed ante-mortem detection 

rate does not strongly influence the 

results of the analysis. The commenter 

noted that cutting the detection rates to 

50 percent (ambulatory animals) and 25 

percent (non-ambulatory animals) 

increases the projected number of 

infected animals by approximately 5 

percent. Importantly from the 

perspective of APHIS, this revision had 

a limited impact on R0. The revised 

FSIS assessment (dated December 26, 

2006) included several changes relative 

to the original FSIS assessment (dated 

October 31, 2005).9 The mean value of 

R0 increased from 0.24 in the original 

FSIS assessment to a mean value of 0.27 

in the revised FSIS assessment. The 

95th percentile estimate for R0 

increased from 0.45 in the original FSIS 

analysis to 0.48 in the revised FSIS 

analysis. In conclusion, the FSIS 

analysis indicates that changing the 

ante-mortem assumptions does not 

appreciably alter the projected spread of 

BSE. On the basis of the FSIS finding, 

APHIS concludes that a change in the 

ante-mortem detection rate of this 

magnitude does not qualitatively alter 

APHIS’ conclusions, and therefore does 

not merit revision to the simulation 

model. 

Issue: One commenter cited published 

literature described in the risk 

assessment to point out the levels (in 

grams) of highly infective brain tissue 

that resulted in infection of calves 

following experimental oral exposure. 

The commenter then asked if, after 

gauging what dosage is necessary to 

transmit BSE orally, the risk to each 

animal should be calculated based on 

the number of times it has a feeding. 

Response: There is no need to revise 

the model in response to this comment 

for the following reasons. First, the 

model does not assume any threshold 

below which exposure to BSE would 

pose zero risk of infection. Second, and 

as a result of the first point, the model 

assumes that every exposure event 

incrementally contributes to the risk of 

infection. 

Issue: One commenter noted that the 

number of infected animals that survive 

sufficiently long enough to develop 

clinical disease is always small in the 

exposure assessment (even under very 

pessimistic assumptions), and that, 

presumably, clinical animals will come 

primarily from those animals 

characterized as ‘‘beef repro’’ and 

‘‘dairy’’ (APHIS 2006b, table 5). The 

commenter questioned whether the 

estimates of animals imported in these 

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Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 53339 

dependent removal (death, slaughter, 

and cull) rates from the population 

before clinical signs develop were 

realistic and validated. 

Response: This comment appears to 

consist of two parts. In the first, the 

commenter asks if the estimates of 

numbers of imported breeding animals 

are realistic and valid, and in the 

second, the commenter asks if the timedependent removal of these animals is 

realistic and valid. Because different 

sources of evidence support these two 

components of the question, we address 

them individually in the following 

discussion. 

As we explained in response to 

another comment, our estimates of 

imports of all cattle classes, including 

breeding animals, were developed by 

USDA, ERS. They are based on a wellaccepted, iterative method involving 

expert opinion and country-commodity 

specific modeling. Based on the above 

description of this process, we expect 

that alternative plausible assumptions 

for the number of imported breeding 

animals would not likely vary 

substantially from those based on the 

most current inputs. 

With regard to the commenter’s 

questions about time-dependent 

removal of these animals (i.e., at what 

point animals are removed from the 

cattle population by, e.g., slaughter) 

APHIS notes that imported animals are 

integrated into the U.S. herd and thus 

are removed (slaughtered) using the 

same distribution used for native-born 

U.S. cattle. The slaughter parameter 

used in the Harvard model (Cohen et al., 

2003) ‘‘represents the probability that 

cattle will be sent to slaughter. This 

probability depends on the [animal’s] 

type of production, age, and gender 

(e.g., steers and heifers are sent to 

slaughter earlier than dairy cows or 

reproductive beef animals).’’ The 

developers of the model based the 

associated assumptions for the 

parameter on the following sources, 

listed in Cohen et al. 2003: USDA (U.S. 

Department of Agriculture 1998a), 

Radostits et al., 1994, and several 

personal communications (Clay 2001; 

Crandall 2001; Pinter 2001). The model 

and its parameters have been subject to 

previous peer review and have been 

found to be realistic. 

Issue: One commenter expressed 

concern that, if an undetected BSEinfected cow were imported into a 

family herd and, upon becoming 

incapacitated, were sent to a local small 

rural facility to be processed into beef 

for the cow’s owners, BSE could enter 

the food chain. 

Response: The commenter seems to be 

concerned about the possibility of BSE 

entering the human food chain after a 

cow is slaughtered for personal use at a 

custom slaughter facility. However, 

such usage would be in contravention of 

FSIS regulations. FSIS prohibitions on 

the use of SRMs for human food apply 

to cattle slaughtered for personal use at 

custom facilities, as does FSIS’

prohibition of the use of all nonambulatory disabled cattle in the human 

food chain (FSIS 2007). 

Issue: A number of commenters 

recommended that the provisions of the 

proposed rule not be implemented 

unless focused testing for BSE of cattle 

imported from a BSE minimal-risk 

region is carried out at slaughter. A 

number of commenters recommended 

that any bovine 30 months of age or 

older imported into the United States 

from a BSE minimal-risk region be 

tested for BSE before being used for 

food. Several commenters 

recommended that USDA require testing 

for BSE of all cattle imported to the 

United States from countries in which 

BSE has been diagnosed, such as 

Canada. One commenter recommended 

that the proposed rule not be 

implemented until rapid-test technology 

for BSE is provided to all U.S. 

slaughtering facilities. Another 

commenter recommended that USDA 

allow slaughter establishments to 

conduct additional tests to satisfy 

consumer demands. 

Response: Our peer-reviewed risk 

assessment concluded that the 

likelihood of BSE release from cattle 

imported from Canada is likely to be 

extremely low because (1) the 

prevalence of BSE in Canada is 

extremely low, and (2) measures 

requiring imported animals to be born 

on or after March 1, 1999, will further 

decrease the likelihood that those 

animals had been exposed to infectious 

material. Moreover, the exposure 

assessment for live animals qualitatively 

indicates that because of the barriers to 

BSE transmission in the United States, 

the likelihood of BSE exposure and 

establishment in the U.S. cattle 

population as a consequence of 

infectivity introduced via imports from 

Canada is negligible. 

Further, although we understand the 

interest expressed by some commenters 

in testing certain cattle for slaughter, 

such comprehensive testing would not 

necessarily yield accurate or useful 

results. Current testing methodology can 

detect a positive case of BSE only a few 

months before the animal begins to 

demonstrate clinical signs. The 

incubation period for BSE—the time 

between initial infection and the 

manifestation of clinical signs—is 

generally very long—on average about 5 

years, which means that there is a long 

period during which testing an infected 

animal would produce negative but 

incorrect results, especially if the 

animal is clinically normal. The import 

projections anticipate that the majority 

of animals imported for immediate 

slaughter and/or for feeding and 

subsequent slaughter are young animals, 

generally slaughtered at less than 30 

months of age. Since current tests only 

determine the presence of BSE shortly 

before the likely onset of symptoms, 

testing young, apparently normal 

animals is not an effective use of the 

tests. In addition, since SRM removal 

requirements are in place, testing 

apparently normal animals at slaughter 

does not provide any significant 

additional public health protective 

measure. Heim and Kihm (2003) note 

that it is questionable whether testing 

all animals at slaughter provides any 

measurable increase in consumer safety. 

Additionally, they note that such testing 

can be counter-productive since 

measures such as SRM removal may not 

be sufficiently emphasized due to the 

perceived total reliability of the testing. 

Given that testing of clinically normal, 

apparently healthy cattle does not 

provide meaningful data, combined 

with the conclusions of the risk 

assessment concerning the extremely 

low likelihood of release and negligible 

likelihood of exposure and 

establishment in the U.S. cattle 

population, testing these animals at 

slaughter as commenters suggest is not 

appropriate at this time. 

Issue: A number of commenters stated 

that APHIS should not expand the types 

of bovines allowed importation from a 

BSE minimal-risk region until it can be 

shown that the current U.S. regulations 

are being adequately enforced. Several 

commenters cited as an example of 

inadequate enforcement an incident 

involving the importation and 

movement to slaughter in the United 

States of Canadian cattle over 30 months 

of age. Of those commenters, some 

expressed concern regarding the time it 

took to trace the animals back. 

Several commenters stated that 

records from Washington State suggest 

that Washington and several other 

States are having difficulty tracking 

hundreds of cattle that arrive from 

Canada each week. Other commenters 

stated that a number of cows entered the 

United States from Canada without ear 

tag identification or certificates of 

health, or had eartag identification that 

did not match the accompanying health 

certificate. 

Response: The commenters referenced 

an alleged violation of the regulations in 

which imported Canadian feeder cattle 


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were reportedly sold through an auction 

market in the United States. A detailed 

investigation into the incident 

demonstrated that the animals in 

question were legally imported for 

immediate slaughter. 

Commenters also referenced issues 

that State authorities identified in 

tracking imported animals. Certain 

States instituted policies or regulations 

that required additional movement 

controls and verification beyond the 

APHIS import requirements. In these 

instances, it is the responsibility of the 

State authorities to monitor compliance 

with their regulations and to follow up 

on any reported violations. APHIS can 

assist in resolving issues if requested. 

APHIS port veterinarians inspect all 

live animal shipments entering the 

United States. These inspections 

include careful review of the health 

certificate accompanying the animals 

and a visual inspection of the animals. 

Live cattle presented at the port of entry 

with no accompanying valid health 

certificate are denied entry. We are not 

aware of any instances where shipments 

of cattle have entered through a 

designated port of entry without a 

health certificate. We recognize that 

animals can lose eartags at various 

points in the process and have 

established procedures to reapply 

eartags with appropriate documentation. 

In addition, apparent transposition of 

digits or similar errors in recording 

eartag numbers can often be addressed 

during consultation with CFIA and/or 

the private veterinarian involved. 

APHIS is not aware of significant or 

repeated violations of the existing 

APHIS import regulations, and no 

evidence of such violations has been 

provided by the commenters concerned. 

Individual instances of errors or 

violations can, and have, occurred. 

These are investigated and dealt with 

appropriately. At no time have any of 

these errors presented a significant 

threat to animal or public health. 

Issue: One commenter stated that the 

animal health risk assessment does not 

address the risks to the U.S. cattle 

industry, or to human health, of having 

additional BSE cases discovered in the 

United States. 

Response: We disagree with the 

commenter. In our risk assessment, we 

addressed both the likelihood and the 

consequences of the adverse event of 

concern. We examined the likelihood of 

BSE becoming established in the United 

States, as well as the incremental 

consequences that may occur for every 

additional case that might be detected as 

a result of implementing the proposed 

rule. As discussed in the consequences 

section of the risk assessment, based on 

the responses to cases discovered in the 

United States since the initial finding of 

BSE in Canada in 2003, we do not 

expect additional costs (such as further 

closure of export markets or reduction 

in domestic consumption). When 

combined with the expected number of 

clinical cases, the resulting risk 

estimation is negligible, as discussed in 

the risk estimation section of the risk 

assessment. Determining what portion 

of the finding of negligible risk might be 

borne by the U.S. cattle industry, as the 

commenter requests, is unnecessary for 

the purposes of our risk assessment. 

Because we have determined the overall 

risk to be negligible, we do not consider 

it warranted to subdivide what is 

already a negligible risk in assessing its 

potential impact on various sectors. 

The overall economic consequences 

of the proposed rule on trade were 

addressed by the Preliminary Regulatory 

Impact Analysis that was conducted for 

the proposed rule. That document 

concluded that, although larger net 

welfare benefits may be realized under 

the scenario of no restriction by date of 

birth on live bovine imports, the 

proposed rule is preferable because it 

would pose a lower risk of BSE 

infectivity entering the United States via 

imports of live bovines from Canada. In 

response to public comments, the 

revision of this analysis published with 

the final rule has further examined the 

welfare effects on certain sub-categories 

of the cattle industry. 

As noted, the risk assessment 

specifically examines animal health, not 

human health. However, there would be 

no impact of detected cases on human 

health, because such animals would be 

removed from the human food supply. 

The risk assessment did, however, note 

the following and indicated that 

additional discussion of the human 

health aspects were included in the 

environmental assessment. ‘‘Thus, 

although human health is not the focus 

of this assessment, we note that, even 

our quantitative model, which includes 

multiple sources of risk over-estimation, 

indicates that, over the 20 years of the 

analysis, only 45 cattle oral infectious 

dose-50 (ID50) units will be available for 

human exposure.’’ In comparison, as 

discussed above, Comer and Huntly 

(2003) estimated that 54 million bovine 

oral ID50 units were available for human 

consumption in Great Britain from 1980 

to 2003. This extremely large amount of 

available infectivity has resulted in 165 

cases of vCJD identified in the United 

Kingdom through April 2007, plus a few 

additional cases identified in other 

countries but attributed to exposure in 

the United Kingdom. When compared to 

the United Kingdom’s BSE experience 

and the associated estimate of available 

bovine oral ID50 units, the expected, or 

average value of 45 cattle oral ID50

would result in a miniscule amount of 

the BSE infective agent that could 

possibly be available for potential 

human exposure in the United States 

over a 20-year period (APHIS 2006). The 

potential for human exposure under this 

scenario is estimated at 1,200,000 times 

less in the United States than what the 

United Kingdom experienced during its 

BSE epidemic. Whereas potential 

human exposure to infectivity is 

expected to be miniscule and 

epidemiologically insignificant, 

exposure (and hence potential human 

health impacts) due to detected cases 

would be nonexistent; detected cases of 

BSE are removed from the food supply. 

OIE Guidelines 

The OIE is recognized by the World 

Trade Organization (WTO) as the 

international organization responsible 

for development and periodic review of 

standards, guidelines, and 

recommendations with respect to 

animal health and zoonoses (diseases 

that are transmissible from animals to 

humans). The OIE guidelines provide a 

science-based reference document for 

international trade in animals and 

animal products. The OIE guidelines for 

trade in terrestrial animals (mammals, 

birds, and bees) are detailed in the 

Terrestrial Animal Health Code (OIE, 

2006a). The OIE guidelines on BSE are 

contained in Chapter 2.3.13 of the 

Terrestrial Animal Health Code and are 

supplemented by Appendix 3.8.4 of the 

Code. 

Some commenters stated that our 

proposed rule was inconsistent with 

OIE guidelines. We discuss below those 

areas addressed by the commenters. 

Issue: Several commenters stated that 

the proposed rule is inconsistent with 

OIE guidelines because it did not 

require’as the commenters stated OIE 

guidelines recommend—that for 

countries that do not have an effectively 

enforced feed ban that is reducing the 

incidence of BSE, the vertebrae and all 

other SRMs be removed from cattle over 

12 months of age. 

Response: The OIE-recommended 

guidelines regarding BSE contain 

criteria for categorizing the risk of a 

country as either negligible risk, 

controlled risk, or undetermined risk. 

The basis for categorization 

encompasses several factors, including a 

risk assessment, surveillance efforts, 

regulatory structure for notifiable 

diseases, and education and awareness 

efforts. Canada has an effectively 

enforced feed ban. Further, Canada has 

been categorized by the OIE as 


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controlled risk (OIE 2007b), rather than 

as undetermined risk as implied by the 

commenters. The OIE guidelines 

recommend that certain SRMs be 

removed from cattle over 30 months of 

age for exports from countries that are 

considered controlled risk, and cattle 

over 12 months of age for exports from 

countries that are considered 

undetermined risk. 

Issue: Several commenters stated that 

the proposed rule did not comply with 

OIE guidelines for either controlled risk 

or undetermined risk countries 

regarding the birth date of cattle in 

relation to the date of effective 

enforcement of a feed ban. The 

commenters stated that the OIE 

recommends that cattle not be exported 

from a country of undetermined risk for 

BSE, which the commenters stated 

Canada qualifies as, unless the cattle 

were born at least 2 years after the feed 

ban was effectively enforced. Nor, said 

the commenters, did the proposed rule 

meet the OIE guidelines that cattle not 

be exported from a controlled risk 

country until after the date a feed ban 

was effectively enforced. 

Response: We disagree with the 

commenters. As noted previously, the 

OIE has categorized Canada as 

controlled risk. Our proposed changes 

are consistent with the OIE guidelines 

for trade in live animals from a 

controlled risk region. As part of the risk 

analysis that APHIS conducted in 

conjunction with its January 2005 final 

rule that recognized Canada as a BSE 

minimal-risk region, APHIS evaluated a 

series of measures introduced in Canada 

to prevent the feeding of ruminant 

proteins to ruminant animals. USDA 

considered the compliance activities 

reported by CFIA as well as 

epidemiological information in 

concluding that compliance with the 

feed ban was good, and that the feed ban 

was effectively enforced. 

The OIE guidelines do not define how 

to determine the date the feed ban was 

effectively enforced. APHIS identified 

March 1, 1999, as the date of effective 

enforcement of the feed ban in Canada 

based on a careful evaluation of the full 

panoply of features employed by the 

feed ban and consideration of regulatory 

enforcement actions (i.e., a practical 

implementation period) and sufficient 

additional time to allow previously 

manufactured feed to cycle through the 

system. 

Issue: Several commenters stated that 

APHIS published the proposed rule 

despite the fact that Canada does not 

meet OIE guidelines for testing for BSE, 

and requested that APHIS withdraw or 

delay this rulemaking until Canada 

significantly increases its BSE testing. 

One commenter stated that, to meet OIE 

testing guidelines, Canada needs to test 

with negative results 187,000 

consecutively targeted cattle with a BSE 

risk equal to that in the casualty 

slaughter age between 4 and 7 years, in 

order to be confident that the BSE 

prevalence in Canada is not more than 

1 in 100,000. However, said the 

commenter, Canada tested only 143,528 

total cattle in the period from 2004 

through February 12, 2007, with 8 

positive cases found during that period. 

Response: We disagree with the 

conclusions and assertions of the 

commenters. The OIE Terrestrial 

Animal Health Code, 2006, Appendix 

3.8.4, contains guidelines for BSE 

surveillance. These guidelines describe 

a weighted points system for BSE 

surveillance samples and suggest total 

points targets for what is considered as 

either Type A or Type B surveillance. 

As noted in the Code, ‘‘The application 

of Type A surveillance will allow the 

detection of BSE around a design 

prevalence of at least one case per 

100,000 in the adult cattle population in 

the country, zone or compartment of 

concern, at a confidence level of 95 

percent.’’ Based on this definition, we 

assume the comments described above 

refer to Type A surveillance. The points 

target for Type A surveillance in a 

country such as Canada with an adult 

cattle population of more than 1,000,000 

is 300,000 points, to be obtained over a 

7-year period. 

Under the OIE guidelines, specific 

‘‘point values’’ are assigned to each 

sample, based on the surveillance 

stream or subpopulation of animals 

from which it was collected, as well as 

the likelihood of detecting infected 

cattle in that subpopulation. Table 4, 

below, outlines the point values for 

samples obtained from the different 

surveillance streams: 

SURVEILLANCE POINT VALUES FOR SAMPLES COLLECTED FROM ANIMALS IN THE GIVEN SUBPOPULATION AND AGE

CATEGORY

Surveillance subpopulation 

Routine slaughter Fallen stock Casualty slaughter Clinical suspect 

Age >1 year and <2 years 

0.01 0.2 0.4 N/A 

Age >2 years and <4 years (young adult) 

0.1 0.2 0.4 260 

Age >4 years and <7 years (middle adult) 

0.2 0.9 1.6 750 

Age >7 years and <9 years (older adult) 

0.1 0.4 0.7 220 

Age >9 years (aged) 

0.0 0.1 0.2 45 

As demonstrated in table 4, a sample 

from the specific surveillance 

subpopulation where BSE is most likely 

to be detected—i.e., a middle adult 

clinical suspect—provides the most 

surveillance points. Conversely, a 

sample from the subpopulation where 

BSE is least likely to be detected—


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generally routine slaughter—provides 

the least points. 

It appears that the commenter 

calculated the number of samples 

necessary from an assumed surveillance 

subpopulation. That is, if a country 

samples only middle adult casualty 

slaughter animals at 1.6 points per 

sample, it would need to sample 

187,000 cattle in this specific 

subpopulation to obtain 300,000 points. 

However, it is inaccurate to compare 

such a calculation to Canada’s 

surveillance efforts. The commenter 

referred to surveillance conducted in 

Canada from 2004 through February 

2007—a period of slightly more than 3 

years. However, as noted, the OIE 

guidelines provide for points targets to 

be met over a 7-year period. Therefore, 

a valid comparison of the OIE 

guidelines and the testing conducted in 

Canada would need to be based on 

surveillance totals from, e.g., January 

2000 through December 2006. 

More significantly, the commenter 

appeared to assume that Canada is 

sampling only one specific surveillance 

stream—casualty slaughter animals from 

4 to 7 years of age. Attachment 1 of the 

risk assessment conducted for this 

rulemaking—‘‘Estimation of BSE 

Prevalence in Canada (APHIS 2006c)’’—

contains tables that allocate Canadian 

surveillance samples into the different 

surveillance streams. In every year from 

1999 through August 2006, animals 

from three different surveillance 

streams—fallen stock, casualty 

slaughter, and clinical suspect—of all 

ages were sampled. Therefore, the 

points value for each sample will vary 

in line with the previously provided 

table. A summary of OIE points can be 

calculated from the information 

provided. For example, data from 

surveillance conducted in Canada in 

2005 for only one surveillance stream—

clinical suspect—show that, in that 

year, 2 clinical suspects less than 2 

years old were sampled (0 points), 43 

clinical suspects 2 to 3 years of age were 

sampled (11,180 points), 120 clinical 

suspects 4 to 6 years of age were 

sampled (90,000 points), 68 clinical 

suspects 7 to 8 years of age were 

sampled (14,960 points), and 194 

clinical suspects greater than 9 years of 

age were sampled (8,730 points). 

Testing of the 194 clinical suspects 

sampled in 2005 provided a total of 

124,870 points for this 1 surveillance 

stream in 1 year. The total number of 

OIE points accumulated by Canadian 

surveillance over the 7-year period 

ending at August 2006 is 922,176. This 

far exceeds the OIE point target of 

300,000 points for Type A surveillance. 

Issue: Several commenters stated that 

the proposed rule did not comply with 

the OIE guidelines with regard to the 

importation of SRMs. The commenters 

stated that the OIE recommends that 

SRMs not be imported for feed or 

fertilizer and the proposed rule would 

allow SRMs to be used for non-ruminant 

feed and fertilizer. 

Response: The commenters are correct 

that the OIE guidelines recommend that 

certain tissues—SRMs—should not be 

traded. Specifically, the guidelines 

recommend that SRMs ‘‘should not be 

traded for the preparation of food, feed, 

fertilizers, cosmetics, pharmaceuticals 

including biologicals, or medical 

devices.’’ It also states that ‘‘protein 

products, food, feed, fertilizers, 

cosmetics, pharmaceuticals or medical 

devices prepared using these 

commodities (unless covered by other 

Articles in this Chapter) should also not 

be traded.’’ However, the Code also 

includes guidelines for trade in live 

cattle—from which such materials could 

be derived after export to the recipient 

country—from countries of any risk 

status, thus creating an apparent 

contradiction in recommendations. 

We recognized in our risk assessment 

that SRMs from live cattle imported 

under these conditions could enter the 

U.S. system, similar to SRMs from U.S. 

cattle. The assessment acknowledges 

that SRMs from imported animals—just 

as those from domestic animals—can 

enter the rendering system in the United 

States, and the quantitative exposure 

model in the risk assessment 

specifically simulates this situation. 

Certain rendered protein products—

bone meal, for example—can be 

included in fertilizer. However, this is 

not a common practice in the United 

States, as the vast majority of rendered 

protein products are sold for use in 

animal feed. Raw or untreated tissues 

are not generally used as fertilizer, and 

in fact are often prohibited from being 

spread on land. Therefore, any 

consideration of risk from fertilizer 

would be an evaluation of the risk of 

cattle exposure to oral consumption of 

fertilizer that contains in part rendered 

protein. 

Our quantitative exposure model 

evaluates the potential oral exposure of 

cattle to feed containing infected 

rendered protein products. It does not 

specifically model potential exposure 

through fertilizer. However, it assumes 

that all rendered ruminant protein 

products are sold for feed use. 

Therefore, any of the infectivity 

contained in rendered ruminant protein 

is simulated through the potential for 

direct feed exposure—either through 

misfeeding, cross-contamination, or 

poultry litter. Feed constitutes a more 

significant pathway than potential 

consumption of a component of a 

fertilizer product after it is spread on a 

pasture. Therefore, any potential 

exposure through fertilizer would be 

assumed to be far less than exposure 

through feed, which is modeled in the 

risk assessment. 

For the reasons discussed above, we 

disagree that this rule is inconsistent 

with OIE guidelines. In those cases 

where one might see in the OIE 

guidelines an internal contradiction, 

that contradiction is much more 

apparent then real, and we consider this 

rule to be consistent with the intent and 

objectives of the guidelines. Therefore, 

we are making no changes based on the 

comments. 

International BSE Classification of 

Canada and the United States 

Issue: At the time APHIS was 

accepting public comments on its 

January 2007 proposed rule, the OIE 

was in the process of completing its 

evaluation of countries internationally 

to determine which BSE risk category 

would be appropriate to each country 

evaluated. Several commenters 

recommended that our proposed rule be 

delayed until the OIE released its 

determinations. Commenters stated that 

waiting for release of the OIE 

designations would allow the U.S. 

categorization of BSE minimal-risk 

regions to be made consistent with OIE 

guidelines. Additionally, stated some 

commenters, the proposed rule could 

negatively influence the OIE’s BSE risk 

categorization of the United States. One 

commenter recommended that the 

rulemaking be postponed until the 

European Food Safety Authority (EFSA) 

announced its BSE risk categorization of 

various countries, including Canada. 

Response: Under the OIE risk 

classification system, a country can be 

considered to be ‘‘negligible risk,’’

‘‘controlled risk,’’ or ‘‘undetermined 

risk’’ with regard to BSE. Based on the 

risk classification of a country, the OIE 

provides guidelines for the safe trade of 

cattle and cattle products. As noted 

above, at the May 2007 annual General 

Session of the OIE International 

Committee, a list of countries 

recognized as being BSE controlled risk 

or negligible risk was confirmed. Both 

the United States and Canada were 

confirmed as BSE controlled risk 

countries (OIE 2007b). 

Request To Allow Imports From the 

European Union 

Issue: One commenter requested that 

APHIS implement OIE import 

guidelines regarding BSE or, 


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10We proposed (71 FR 45439–45444, Docket No. 

APHIS–2006–0026) to allow the individual 

identification to be provided with some form of 

identification other than an eartag. We solicited 

comments concerning our proposal for 60 days 

ending October 10, 2006. On November 9, 2006, we 

published a document in the Federal Register (71 

Continued 

alternatively, recognize the European 

Union as a BSE minimal-risk region. 

Response: As noted above, it is 

APHIS’ intent to develop rulemaking 

that would incorporate OIE guidelines. 

Commodities Eligible for Importation 

Under This Rule 

We proposed to allow the 

importation, under certain conditions, 

of live bovines for any use born on or 

after a date determined by APHIS to be 

the date of effective enforcement of a 

ruminant-to-ruminant feed ban in the 

region of export; blood and blood 

products derived from bovines; and 

casings and part of the small intestine 

derived from bovines. 

Although commenters addressed the 

provisions of our proposed rule 

regarding each of these commodities, 

the great majority of commenters 

focused on the potential importation of 

live bovines. We discuss below first the 

issues raised concerning live bovines, 

then the commenter issues regarding 

bovine blood and blood products and 

then those regarding the small intestine, 

including casings derived from the 

small intestine. 

Those commenters who addressed the 

importation of live bovines discussed 

which bovines should be eligible for 

importation with regard to usage and 

date of birth, identification of the 

animals, verification that the animals 

are imported in compliance with the 

regulations, sealing of means of 

conveyance carrying the animals, and 

monitoring of imported cattle once in 

the United States. 

Live Bovines 

Date of Birth Eligibility 

Issue: A number of commenters 

questioned how it will be determined 

whether a bovine intended for 

importation from Canada was born on or 

after March 1, 1999. The commenters 

stated that it will not be feasible to use 

dentition to determine the age of 

imported bovines, particularly in 

animals over 4 years of age. In many 

cases, said the commenters, Canadian 

veterinarians would have to accept 

producers’ statements as the only source 

of verification of the age of the cattle. 

The commenters stated that the 

Canadian national cattle identification 

program was not made mandatory until 

2002, and that it is still not mandatory 

in Canada to enter the entire birth date 

information into the database. Several 

commenters stated that it is nearly 

impossible to verify the actual age of 

older Canadian cattle, because the 

Canadian animal identification 

requirement applies only to cattle that 

leave the farm. 

Response: The provisions in 

§ 93.436(a)(3) and (b)(4) of this rule 

provide that bovines are not eligible for 

importation from a BSE minimal-risk 

region unless they are accompanied by 

certification that, among other things, 

the animals were born on or after March 

1, 1999. As provided in § 93.405(a), 

such certification must be issued by a 

full-time salaried veterinary officer of 

the national government of the region of 

origin, or by a veterinarian designated 

by the national government of the region 

of origin and endorsed by a full-time 

salaried veterinary officer of the 

national government of the region of 

origin, representing that the veterinarian 

issuing the certificate was authorized to 

do so. It is incumbent upon the 

individual issuing or endorsing the 

certificate to ascertain whether an 

animal’s date of birth can be determined 

with the accuracy necessary for such 

certification. As the commenters imply, 

dentition can be used to adequately 

determine the birth date of animals 

below about 4 years of age. Specifically, 

if an animal does not have all of its 

permanent teeth erupted, it is less than 

4–5 years of age and therefore was born 

after March 1, 1999. However, if all 

permanent teeth are present and in 

wear, dentition does not provide an 

estimate of birth date specific enough to 

support certification that the animal was 

born on or after March 1, 1999. 

We recognize that Canada’s 

mandatory identification requirements 

did not take effect until 2002, and also 

that these requirements do not mandate 

that birth date information be entered 

into the database. However, we also 

note that provisions have been 

established for birth date information to 

be entered at any time, with appropriate 

documentation available to support 

such information. The number of these 

age-verification entries continues to 

increase, with over 3.5 million birth 

dates submitted to the Canadian Cattle 

Identification Agency (CCIA) database 

by late 2006 (CCIA, 2006). We recognize 

that it is likely that owners of some 

bovines may not be able to provide the 

documentation regarding an animal’s 

birth date that is necessary for the 

required certification. In those cases, 

even if an animal was born on or after 

March 1, 1999, the animal would not be 

eligible for importation into the United 

States. 

Permanent Identification of Country of 

Origin 

Issue: Under the provisions of the 

proposed rule, cattle imported from 

Canada for other than immediate 

slaughter would have to be permanently 

and humanely identified before arrival 

at the port of entry with a distinct and 

legible mark identifying the exporting 

country. As proposed, acceptable means 

of permanent identification would 

include a mark applied with a freeze 

brand, hot iron, or other method; a 

tattoo applied to the inside of one ear 

of the animal, or other means of 

permanent identification if deemed 

adequate by the Administrator. For 

bovines imported from Canada, a brand 

would have to read ‘‘CLN’’ and a tattoo 

would have to read ‘‘CAN.’’

A number of commenters addressed 

the issue of permanent identification of 

bovines as to the country of export. 

Several commenters recommended that 

the regulations require that such 

identification be applied with a hot-iron 

brand, and that a ‘‘hair brand’’ not be 

considered acceptable means of 

identification. 

Response: A hair brand would not 

meet the requirements of the 

regulations, in that it could not be 

depended upon to provide permanent 

identification of the animal’s country of 

export. However, we do not consider it 

necessary to list in the regulations all 

the forms of identification that would 

not be considered adequate to meet the 

intent of the regulations. 

Issue: Several commenters addressed 

the requirement for permanent 

identification of the country of export as 

it would apply to bison. The 

commenters stated that a brand on the 

right hip or an ear tattoo are not the 

preferred alternatives, because of 

unnecessary stress on the animals and 

handlers. The commenters stated that a 

more humane means of bison 

identification, such as electronic tags 

(dual tags if necessary), could readily 

meet the need of tracking the origin of 

the bison and the movement patterns in 

Canada and the United States. 

Response: The type of identification 

recommended by the commenters 

would provide the individual unique 

identification required by the 

regulations to facilitate traceback of the 

animal. Although the current 

regulations in § 93.436 require that such 

identification be provided by an official 

eartag of the country of origin, in August 

2006 we have proposed to allow for 

forms of individual identification other 

than eartags.10


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FR 65758–65759, Docket No. APHIS–2006–0026) 

reopening and extended the comment period until 

November 24, 2006. We received a total of 10 

comments by that date. We are considering the 

issues raised by the commenters and will address 

them in a separate rulemaking document. 

However, we consider it necessary 

that the animal also be marked in some 

permanent and easily visible way as 

having been imported from a BSE 

minimal-risk region. In the case of bison 

from Canada, this would be a brand or 

other permanent ‘‘CLN’’ mark on the 

right hip, an ear tattoo with the letters 

CAN, or some other means of permanent 

identification if deemed adequate by the 

Administrator to humanely identify the 

animal in a distinct and legible way as 

having been imported from the BSE 

minimal-risk exporting region. The type 

of identification recommended by the 

commenters would not allow for easily 

visible identification of the country of 

origin. 

Issue: A number of commenters 

disagreed that an ear tattoo would be an 

effective permanent means of 

identifying the country of origin of a 

bovine. The commenters stated that 

tattoos applied inside an animal’s ear 

frequently become illegible after a 

period of time, and further, that tattoos 

may not be visible without catching the 

animal and examining it in a chute or 

other restraint system. The commenters 

recommended that, if tattoos are 

allowed, the regulations require that 

animals so identified be restrained and 

examined in the country of export to 

confirm that the tattoo is legible and 

permanent, and that such confirmation 

be indicated on signed documentation 

accompanying the animals to the United 

States. 

Response: As discussed in our 

proposed rule, we agree that tattoos 

might not be the most readily visible 

means of identification of live animals 

in groups of animals. However, the 

purpose of requiring permanent 

identification of the animal’s country of 

export is to expedite initial 

identification of an animal’s country of 

export in the event the animal is 

diagnosed with BSE. Such a diagnosis 

cannot be confirmed on a live animal. 

Once the animal has been euthanized or 

has otherwise died, an ear tattoo will be 

an effective means of identification. 

Issue: Several commenters stated that 

the APHIS Administrator should be 

required, upon request, to evaluate 

alternative means of permanent 

identification and, if they are 

functionally equivalent to the existing 

methods, be required to approve them. 

Response: Paragraph (b)(2)(iii) of 

§ 93.436 (of this rule provides for such 

approval by the Administrator of 

alternative means of permanent 

identification. 

Issue: Several commenters 

recommended that a hot-iron brand on 

the right hip be required on all cattle 

crossing the U.S. border. 

Response: As noted above, we 

proposed to require a permanent mark 

identifying the animal’s country of 

origin only for cattle imported from a 

BSE minimal-risk region for other than 

immediate slaughter. We do not 

consider it necessary for cattle imported 

from a BSE minimal-risk region for 

immediate slaughter to be permanently 

identified as to country of export. Such 

animals will be moved to the 

slaughtering establishment in a group 

and the movement documentation 

accompanying such animals will be 

sufficient to provide ready identification 

of the animals’ country of origin. 

Issue: One commenter recommended 

that the regulations require that each 

animal entering the United States have 

permanent identification by which the 

animal could be traced back to its farm 

of origin. 

Response: The commenter’s 

recommendation refers to two types of 

identification that are already addressed 

by this rule. In this rule, paragraphs 

(a)(2) and (b)(3) of § 93.436 already 

require each bovine imported into the 

United States from a BSE minimal-risk 

region to be officially identified with an 

official eartag that provides unique 

individual identification that is 

traceable to the premises of origin of the 

animal. (As noted above, we have 

proposed to allow for forms of 

individual identification other than 

eartags). This rule requires, further, that 

no person may alter, deface, remove, or 

otherwise tamper with the official 

identification while the animal is in the 

United States or moving into or through 

the United States, except that the 

identification may be removed at the 

time of slaughter. 

In addition to the individual 

identification that allows for traceback 

to the animal’s premises of origin, the 

regulations also require that all cattle 

imported from a BSE minimal-risk 

region be permanently identified as to 

country of origin as described above. As 

discussed above, we do not consider it 

necessary for bovines imported for 

immediate slaughter to have this 

additional permanent identification as 

to country of origin. 

Issue: One commenter requested that 

APHIS provide details of its protocol 

and criteria for ensuring that all live 

cattle imported from Canada have 

permanent identification maintainable 

until harvest. 

Response: In § 93.436(b) of this rule, 

we give examples of means of 

permanent identification that would be 

considered acceptable. Acceptable types 

of permanent identification include a 

mark applied with a freeze brand, hot 

iron, or other method, or a tattoo 

applied to the inside of one ear of the 

animal. Any other types of permanent 

identification approved by the 

Administrator would have to be as 

effective as the examples cited in 

providing a permanent, distinct, and 

legible mark. 

Individual Identification of Bovines 

Issue: One commenter recommended 

that all cattle imported from Canada that 

are not moved directly to slaughter be 

required to be identified by a low 

frequency ISO compliant radio 

frequency tag placed in the left ear. 

Response: As noted above, we have 

proposed to provide for forms of 

individual identification other than 

eartags, provided the identification can 

be used to trace the animal back to its 

premises of origin. We do not consider 

it necessary to mandate the use of any 

particular technology for meeting that 

criterion. 

Issue: One commenter recommended 

that the regulations require that animals 

intended for importation into the United 

States from a country with a verified 

case of BSE be enrolled in a third-party 

source and age identification program 

that uses individual electronic 

identification devices. 

Response: With regard to bovines 

intended for importation into the United 

States from a BSE minimal-risk region, 

the regulations already require that such 

animals be individually identified with 

unique identification that enables 

traceback to the premises of origin of the 

animal. Additionally, under this rule, 

bovines imported from Canada must be 

accompanied by certification issued or 

endorsed by the Canadian Government 

that the animals were born on or after 

March 1, 1999. After having evaluated 

the veterinary infrastructure of countries 

wishing to import animals and animal 

products into the United States, APHIS 

accepts official certification from those 

countries that commodities intended for 

export to the United States are in 

compliance with U.S. import 

regulations, just as U.S. trading partners 

rely on official U.S. certification that 

products exported from the United 

States meet the recipient country’s 

requirements. 

Sealing of Means of Conveyance 

Issue: The regulations for importing 

live bovines from BSE minimal-risk 

regions have required that the bovines 


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Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 53345 

be imported in a means of conveyance 

sealed in the region of origin with seals 

of the national government of the region 

of origin. In our proposed rule, we 

proposed to remove the requirement 

that bovines imported into the United 

States from BSE minimal-risk regions 

for other than immediate slaughter enter 

the country in sealed conveyances. We 

additionally proposed to remove the 

requirement that means of conveyance 

carrying bovines into the United States 

from minimal-risk regions for 

immediate slaughter be sealed in the 

region of export and to require instead 

that means of conveyance carrying 

bovines into the United States from 

Canada be sealed at the U.S. port of 

entry with seals of the U.S. Government. 

Several commenters specifically 

supported the proposed change to 

require sealing of means of conveyance 

at the port of entry, rather than in the 

country of export. 

One commenter stated that the 

proposed change to require sealing at 

the port of entry would allow APHIS 

less oversight of shipments and less 

opportunity to ensure that each animal 

in the shipment is accurately identified 

and of the appropriate age. 

Several commenters recommended 

that APHIS specify which country or 

agency will be responsible for sealing a 

means of conveyance at the port of 

entry. 

Response: We disagree that requiring 

sealing of means of conveyance at the 

port of entry will allow APHIS less 

oversight of shipments or cause 

decreased ability to ensure that the 

animals are being shipped in 

compliance with the regulations. The 

primary verification that the animals 

meet the requirements of the regulations 

will remain as it has been—i.e., 

certification by the country of export 

that the requirements of the regulations 

have been met. 

However, we believe it is necessary to 

continue to require sealing of means of 

conveyance transporting bovines from 

Canada to immediate slaughter as a 

mitigative measure against diseases 

other than BSE. Cattle imported from 

Canada for immediate slaughter are not 

subject to tuberculosis and brucellosis 

testing requirements that would 

otherwise be applied to animals 

imported into the United States. 

Therefore, we would continue to require 

that such cattle be moved directly to 

slaughter in a sealed means of 

conveyance. (APHIS had been requiring 

such sealing at the port of entry even 

before our November 2003 proposal 

regarding BSE. However, the 

requirement for sealing was being done 

as APHIS policy, and was not specified 

in the regulations.) 

As the commenters noted, this rule 

will remove the requirement that the 

sealing of the means of conveyance be 

done in the region of export. That 

requirement was included in the 

January 2005 final rule in response to 

comments from members of the public 

who expressed concern that requiring 

sealing at the port of entry could be 

harmful to the welfare and quality of the 

animals, due to delays at the port of 

entry. Under the provisions of this 

proposed rule, however, we do not 

expect undue delays of shipments at the 

port of entry. When a means of 

conveyance carrying bovines for 

immediate slaughter arrives at the U.S. 

port of entry, APHIS inspectors would 

confirm that the animals are as 

described on the certificate that must 

accompany the animals being imported, 

but generally would not require that the 

animals be offloaded from the means of 

conveyance. Therefore, requiring that 

the sealing of the means of conveyance 

take place at the port of entry would not 

cause measurable delay of the shipment. 

Further, sealing at the port of entry 

rather than in the region of export will 

reduce the time the animals will need 

to be contained in a sealed means of 

conveyance and reduce the likelihood 

that a seal will need to be broken 

between the time it is applied and the 

arrival of the animals at a slaughtering 

establishment. 

We do not consider it necessary to 

specify which agency will seal means of 

conveyance at the port of entry with 

seals of the U.S. Government. In each 

case, the means of conveyance will be 

sealed by an APHIS employee. 

Movement of Cattle for Other Than 

Immediate Slaughter 

Issue: Some commenters who 

opposed allowing the importation from 

Canada of bovines 30 months of age or 

older urged the continuation of the 

current restrictions on movement in the 

United States of cattle moved to a 

feedlot, as well as continuation of the 

current requirements regarding sealing 

of conveyances carrying such animals 

and the requirement that the animals be 

accompanied by an APHIS-issued 

movement permit. 

Response: The sealing and movement 

restrictions referred to by the 

commenters were included in our 

January 2005 final rule to ensure that 

live bovines from BSE minimal-risk 

regions were imported and slaughtered 

before the age of 30 months. At the time 

we published that final rule, we had not 

formally assessed the disease risk of 

allowing the importation of live bovines 

30 months of age or older from BSE 

minimal-risk regions. Since that time, 

we have conducted an assessment of the 

risk of such importations, which we 

discussed in our January 2007 proposed 

rule and made available with that 

proposed rule. Our risk assessment 

indicates that there is a negligible 

likelihood of U.S. cattle being exposed 

to BSE and of BSE becoming established 

in the U.S. cattle population as a 

consequence of this rule. 

Under this final rule, bovines from a 

BSE minimal-risk region will not have 

to be imported and slaughtered before 

they are 30 months of age. Therefore, it 

is not necessary to retain provisions in 

the regulations that were designed to 

help ensure that bovines imported from 

a BSE minimal-risk region are moved 

directly to a feedlot and then to 

slaughter as an easily identifiable group. 

Request To Exempt Cattle for Immediate 

Slaughter From Birth Date Requirement 

We proposed to require that live 

bovines imported from BSE minimalrisk regions have been born on or after 

the date recognized by APHIS as the 

date of effective implementation of a 

ruminant-to-ruminant feed ban in the 

region of export. We proposed to apply 

this requirement to all bovines imported 

from a BSE minimal-risk region, 

whether they are imported for 

immediate slaughter or for some other 

usage. 

Issue: A number of commenters stated 

that the eligibility of cattle to be 

imported for immediate slaughter 

should not be dependent on when the 

animals were born. The commenters 

stated that such animals do not present 

a BSE risk justifying such a condition, 

and that APHIS has not demonstrated 

such a risk. Several commenters stated 

that the risk assessment APHIS 

conducted for the proposed rule is 

based on the premise that slaughter 

cattle will be eligible for importation 

from Canada no matter what their date 

of birth. 

Additionally, commenters argued that 

requiring cattle moving directly to 

slaughter to have been born on or after 

March 1, 1999, would be inconsistent 

with the January 2005 final rule, which 

provided for the importation of beef 

derived from cattle of any age if 

requirements for the removal of SRMs 

are met. The commenters stated that 

allowing the importation of beef from 

cattle of any age while prohibiting the 

importation of cattle born before March 

1, 1999, suggests that SRM removal can 

be accomplished more effectively in a 

foreign country than in the United 

States. 


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Commenters stated further that 

scientific evidence overwhelmingly 

demonstrates that the safety of food 

products derived from cattle is not 

dependent on the age of the animal, but 

on whether SRMs have been removed 

and disposed of. The commenters stated 

that complete control of cattle imported 

from BSE minimal-risk regions can be 

assured by requiring movement under 

Government seal, as we proposed. As an 

additional safeguard, stated the 

commenters, USDA regulations require 

that if an animal showing clinical signs 

of BSE risk is tested for the disease at 

slaughter, the carcass and parts derived 

from the animal cannot enter the food 

supply unless the animal tests negative 

for BSE. 

Response: The commenters who 

recommended allowing the importation 

of cattle of any age from BSE minimalrisk regions, regardless of date of birth, 

raised several distinct issues in support 

of their recommendations. We agree 

with the commenters who stated that 

the removal and disposal of SRMs is the 

key factor in the food safety of products 

from bovines used for human 

consumption. However, the risk 

assessment conducted for the proposed 

rule specifically addressed the risk to 

animal health. The risk of transmission 

to U.S. cattle occurs when infectious 

tissues—most likely SRMs—

inadvertently and/or in contradiction to 

U.S. feed regulations are rendered and 

included in ruminant feed and fed back 

to cattle. The risk of BSE-infected SRMs 

being present in the United States, 

while minimal, might be increased to 

some extent if cattle from BSE minimalrisk regions were allowed to be 

imported for immediate slaughter 

regardless of date of birth. The 

commenters are incorrect that our risk 

assessment did not take into account the 

date of birth of slaughter cattle. As 

described in the risk assessment, the 

requirement that animals for import be 

born after a certain date is one 

mitigation step that helps reduce the 

risk that infected animals will be 

imported, and therefore helps reduce 

the possibility that their SRMs will be 

incorporated into the ruminant feed 

chain in the United States. 

Request for Restrictions on Use of 

Imported Cattle 

Issue: As discussed above, we 

proposed to allow the importation of 

bovines from BSE minimal-risk regions 

for any use, provided the animals were 

born on or after the date recognized by 

APHIS as the date of effective 

implementation of a ruminant-toruminant feed ban in the region of 

export. This provision allows bovines to 

be imported for immediate slaughter or 

for some other usage, such as breeding 

or feeding and then slaughter. It differs 

from the regulations, that have been in 

place, which have limited the 

importation of bovines from BSE 

minimal-risk regions according to both 

the age of the animal and the intended 

usage of the animal in the United States 

(only those animals moved to 

immediate slaughter, or to one feedlot 

and then directly to slaughter, have 

been eligible for importation). 

A number of commenters opposed the 

proposed removal of restrictions on how 

cattle imported from BSE minimal-risk 

regions may be used. Although most of 

these commenters did not object to the 

importation of cattle born on or after the 

date of effective implementation of a 

feed ban if the cattle were moved in a 

sealed means of conveyance directly to 

immediate slaughter, or to a single 

feedlot and then to slaughter, they 

expressed concern regarding the 

potential importation of cattle intended 

for breeding or as replacement animals 

in dairy herds. 

Some of the commenters stated that 

BSE-infected cattle imported from BSE 

minimal-risk regions for breeding or 

herd replacement may not show clinical 

symptoms of BSE infection for many 

years, allowing BSE to incubate in U.S. 

cattle herds, and that an outbreak of BSE 

in the United States due to such 

imported cattle would be devastating to 

the U.S. dairy industry. 

A commenter stated that, at the 95th 

percentile confidence for model 

simulations of Canadian BSE prevalence 

in the APHIS risk assessment, 180 new 

BSE cases occur over 20 years, and that 

90 percent of these new cases would be 

expected to be in animals already 

infected with BSE when imported from 

Canada. Therefore, stated the 

commenter, almost all new cases of BSE 

expected in the United States will be 

from BSE-infected cattle imported from 

Canada and that any U.S.-born cases 

will be the result of importing breeding 

animals. Commenters stated further 

that, according to USDA, younger cattle 

are more susceptible to BSE and require 

less BSE-contaminated feed to become 

infected, and that since it is likely that 

younger cattle will be the ones imported 

for breeding or replacement purposes, 

the chance of introducing BSE into the 

United States from Canada is magnified. 

Commenters stated that, although a 

series of risk mitigations are in place, 

these are different when it comes to 

animals imported for breeding versus 

those going directly to slaughter. 

Response: The risk of BSE 

transmission to U.S. cattle occurs when 

infectious tissues—most likely SRMs—

inadvertently and/or in contravention of 

U.S. feed regulations are rendered and 

included in ruminant feed and fed back 

to cattle. This risk is the same whether 

the animals were imported for 

immediate slaughter or were imported 

for breeding and are slaughtered later, 

and the series of risk mitigations or 

steps that prevent the transmission of 

BSE are the same, regardless of the 

purpose of the imported animal. While 

it is true that the level of infectivity in 

a BSE-infected bovine has been shown 

to increase as an animal ages, the 

amount of infectivity in, for example, a 

7-year-old cow infected at 1 year of age 

would be the same at slaughter whether 

it was imported as a 1-year-old infected 

cow and used for breeding in the United 

States until it was 7 years old, or 

whether it was imported as a 7-year-old 

cull cow for immediate slaughter. 

The U.S. feed ban prohibits the use of 

most mammalian protein in ruminant 

feed. The mammalian protein 

referenced could be derived from 

slaughterhouse offal—including SRMs—

from animals imported for immediate 

slaughter, or from slaughterhouse offal 

derived from animals imported for 

breeding that have reached the end of 

their useful life in the United States. 

The protein could also be derived from 

the carcass of an animal imported for 

breeding that died other than by 

slaughter. The feed restrictions on the 

use of rendered protein derived from 

any of those scenarios would be exactly 

the same. 

The commenters are correct that BSEinfected cattle may not show clinical 

signs for many years, due to the long 

incubation period for this disease as 

explained in the risk assessment. 

However, as long as the animals were 

born on or after March 1, 1999, the 

likelihood of any individual animal 

having been exposed to and infected 

with BSE, and subsequently releasing 

BSE infectivity into the United States, is 

negligible. There is no expected 

difference in the likelihood of BSE 

infection in two animals born on or after 

March 1, 1999, and raised in Canada, 

one imported into the United States as 

a young animal for breeding purposes 

and slaughtered at the end of its 

productive period, and one used as a 

breeding animal in Canada, and 

exported for immediate slaughter in the 

United States at the end of its 

productive period. Furthermore, BSE is 

not a contagious disease and does not 

spread by casual animal contact. 

Therefore, while an individual animal 

in a herd may be infected, that does not 

mean that other animals in that herd are 

at risk of becoming infected via spread 

from that animal. 


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Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 53347 

11Note that this estimate for the 95th percentile 

for imported cases (105) is approximate. The 95th 

percentile values for the total number of infected 

animals (180) and the number of endogenous cases 

(75) are estimated independently. In particular, all 

of the trials are first ranked according to the total 

number of endogenous cases, allowing 

identification of the 95th percentile value. The 

same is then done in order to identify the 95th 

percentile value for the total number of BSE cases. 

As a result, the 95th percentile values may be 

selected from different simulation trials. Because 

the number of endogenous cases influences the 

number of total cases, these two quantities are 

(imperfectly) correlated, however. That is, 

simulation trials that project a large number of 

endogenous cases also project a large total number 

of BSE cases. Hence, the actual 95th percentile 

value for the total number of imported BSE cases 

is likely to be similar to 105. 

Regarding the commenter’s reference 

to our model simulation, we believe the 

commenter did not correctly interpret 

the results from the simulation. For 

sensitivity analysis 5 (pessimistic value 

for assumed BSE prevalence in Canada), 

the 95th percentile value for total 

infected cattle in the United States over 

a 20-year period amounts to 180 

animals. The 95th percentile value for 

endogenous BSE-infected cattle over 

that period is 75, suggesting that 

180¥75 = 105 BSE cases are imported 

over that period, not 160 animals, as 

suggested by the commenter.11

Also, although our quantitative 

exposure models project that new cases 

of BSE in the United States would be 

transmissions secondary to the 

importation of infected cattle from 

Canada, we note that the United States 

has identified two indigenous cases of 

BSE. Given this fact, one cannot 

categorically state that any such cases 

identified ‘‘will be from BSE-infected 

cattle directly imported from Canada.’’

We explained in the risk assessment 

that there is an apparent agesusceptibility in regard to BSE, 

specifically noting that susceptibility in 

cattle declines with age. However, we 

disagree with the commenter’s 

conclusion that, based on this fact, 

importing younger animals—

specifically breeding animals as they are 

generally imported at less than 2 years 

of age—presents a magnified risk. 

Susceptibility is not the same as 

likelihood of being infected. As an 

example, the commenter’s conclusion 

means that any animal born within the 

past 2 years would have a higher 

likelihood of being infected than an 

animal born 6 years ago. Given equal 

exposure a younger animal may be more 

susceptible to infection. However, as 

noted in the risk assessment, the overall 

prevalence in Canada is extremely low 

and BSE controls such as the feed ban 

are effectively enforced, so the chance 

that a given animal of any age had been 

exposed to an adequate amount of 

infectivity at a susceptible age i.e., the 

likelihood of being infected) is 

extremely small. 

Monitoring of Imported Cattle 

Issue: A number of commenters 

expressed concern that the proposed 

rule did not explicitly provide for a 

system to monitor the movement in the 

United States of cattle imported from 

BSE minimal-risk regions, specifically 

Canada. Some commenters limited their 

discussion to cattle 30 months of age or 

older. Commenters recommended that 

the regulations include an accounting 

procedure capable of monitoring the 

movement of imported animals from 

entry into the United States until 

slaughter, including changes in 

ownership of the animals. 

Response: The regulations currently 

include movement conditions for 

bovines from BSE minimal-risk regions 

imported for other than immediate 

slaughter. Such bovines must be 

imported in a sealed conveyance and be 

moved directly from the port of entry to 

a feedlot identified on APHIS Form VS 

17–130 or other movement 

documentation required by the 

regulations. The APHIS Form VS 17–

130 or other movement documentation 

must identify the physical location of 

the feedlot, the individual responsible 

for the movement of the animals, and 

the individual identification of each 

animal. The bovines must remain at the 

feedlot until transported from the 

feedlot in sealed conveyances to a 

recognized slaughtering establishment 

for slaughter. While being moved to 

slaughter, the bovines must be 

accompanied by APHIS Form VS 1–27 

or other movement documentation 

deemed acceptable by the 

Administrator, which must identify the 

physical location of the recognized 

slaughtering establishment, the 

individual responsible for the 

movement of the animals, the 

individual identification of each animal. 

In our January 2007 proposed rule, 

however, we proposed to remove each 

of the above requirements from the 

regulations. The requirements described 

above were implemented solely to help 

ensure that cattle imported from BSE 

minimal-risk regions were slaughtered 

at less than 30 months of age—i.e., to 

preclude any diversion of the bovines to 

other uses in the United States that 

would result in a slaughter at some age 

30 months or older. 

We did not attempt, for that 

rulemaking, to assess the BSE risk 

associated with the importation of live 

bovines 30 months of age or older from 

a BSE minimal-risk region. However, as 

discussed in our January 2007 proposed 

rule and in this final rule, for this 

rulemaking we did assess the BSE risk 

associated with the importation of such 

animals, and concluded that the 

resulting BSE risk from the importation 

from Canada of bovines born on or after 

March 1, 1999—whether or not the 

bovines are 30 months of age or older 

when imported and slaughtered—would 

be negligible. Therefore, in our January 

2007 proposed rule, we proposed to 

remove the requirement in § 93.436(a)(1) 

of the current regulations that live 

bovines imported from BSE minimalrisk regions be less than 30 months of 

age when ported into the United States 

and when slaughtered. 

With the removal of the less-than-30- 

month age restriction on the importation 

of bovines from BSE minimal-risk 

region, any cattle imported from 

Canada—once certification has been 

presented to APHIS that the animals 

were born on or after March 1, 1999—

will be able to be moved and handled 

in the United States in the same way as 

U.S.-born cattle. 

Scientific evidence strongly indicates 

that BSE, unlike most transmissible 

diseases of cattle, is not transmitted 

from live animal to live animal. BSE is 

not a contagious disease and, therefore, 

is not spread through casual contact 

between animals. Scientists believe that 

the primary route of transmission 

requires that cattle ingest feed that has 

been contaminated with a sufficient 

amount of tissue from an infected 

animal. Therefore, even a BSE-infected 

bovine poses no BSE risk to other 

bovines unless those other bovines are 

fed BSE-contaminated materials from 

the infected animal. This route of 

transmission can be prevented by 

excluding potentially contaminated 

materials from ruminant feed, as is 

required in the United States. 

If a bovine imported from a BSE 

minimal-risk region were diagnosed as 

being infected with the disease, from a 

biosecurity standpoint, it would not be 

necessary to know its record of 

movement while in the United States. 

However, we would proceed to trace the 

bovine back to its herd of origin, in 

order to identify birth cohorts of the 

animal. Traceback to the animal’s 

premises of origin would be facilitated 

by the animal’s unique individual 

identification, which is required under 

the current regulations and continues to 

be required by this rule, and which 

must be traceable to the premises of 

origin of the animal. 

Issue: Several commenters stated that 

imports of bovines under the proposed 

rule should not be allowed until a 

mandatory cattle and premises 

identification program is implemented 


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53348 Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 

throughout the United States. At the 

minimum, stated one commenter, USDA 

should amend the National Animal 

Identification System policy to allow for 

and integrate with mandatory 

identification when required for animal 

health programs. 

Response: As discussed in the 

preceding response, one of the 

requirements for the importation of 

bovines from BSE minimal-risk regions 

is that each animal have unique 

individual identification that is not 

removed from the animal, except at 

slaughter. Such identification is in 

addition to any cattle or premises 

identification that might be carried out 

under the U.S. national animal 

identification system, and would 

facilitate tracing an imported bovine 

that is determined to be infected with 

BSE to its herd of origin. 

For the reasons discussed above, we 

are making no changes based on the 

comments regarding the monitoring and 

identification of cattle imported into the 

United States from a BSE minimal-risk 

region. 

Feed Cohorts of BSE-Infected Animals 

Issue: Several commenters stated that 

the regulations should specifically 

prohibit the importation from BSE 

minimal-risk regions of feed cohorts of 

BSE-infected cattle. 

Response: We do not consider it 

necessary to add such a provision to the 

regulations and are making no changes 

based on the comments. Our definition 

of a BSE minimal-risk region in § 94.0 

of the regulations includes a 

requirement that such regions conduct 

an epidemiological investigation 

following detection of BSE sufficient to 

confirm the adequacy of measures to 

prevent the further introduction or 

spread of BSE, and continue to take 

such measures. We described such 

investigations in our January 2005 final 

rule, as well as in the proposed rule and 

the risk analysis for that rulemaking. 

This description noted that CFIA 

conducts comprehensive 

epidemiological investigations, and one 

component of these investigations is to 

trace feed cohorts of confirmed BSEpositive cattle, in accordance with OIE 

guidelines. As a result of these traces, 

feed cohorts that remain alive are 

euthanized and tested for BSE. 

Therefore, since such animals would be 

euthanized, there is no need to 

specifically prohibit their importation. 

Maternal Transmission of BSE 

Issue: One commenter stated that 

APHIS’ policy of destroying progeny of 

BSE-positive cows, in accordance with 

OIE guidelines, demonstrates that 

APHIS acknowledges there is some risk 

of maternal transmission of BSE. The 

commenter expressed the opinion that 

APHIS’ conclusion expressed in the 

proposed rule that infectivity is unlikely 

to localize to the fetal blood is based on 

scant scientific evidence that remains 

equivocal. The commenter stated that 

APHIS does not prescribe any action to 

mitigate the additional risk pathway of 

the importation of pregnant cattle and 

fetuses from pregnant cattle. 

Response: We disagree with the 

commenter and are making no changes 

based on the comment. In the proposed 

rule, we pointed out that, based on 

scientific and epidemiological data, 

maternal transmission of BSE is 

unlikely to occur at any appreciable 

level. In fact, maternal transmission can 

be ruled out in the majority of the cases 

born after the 1996 ban in the United 

Kingdom of all animal protein from 

livestock feed (DEFRA 2007b). 

Additionally, modeling studies using 

data obtained from the United Kingdom 

epidemic show that even if maternal 

transmission occurred at very small 

levels, it could not sustain an epidemic. 

The commenter states that the OIE 

continues to recognize the risk of 

maternal transmission. However, we 

note that the 2006 OIE guidelines 

contain no specific recommendations 

regarding the destruction of offspring of 

infected animals as part of an 

epidemiological investigation. These 

recommendations were removed after 

recognition that the possibility of 

maternal transmission is very low. In 

addition, the 2006 guidelines with 

regard to trade from controlled risk 

regions for BSE contain no specific 

restrictions regarding progeny of 

positive animals. While the 2006 

guidelines did contain a restriction for 

progeny of positive animals with regard 

to trade with undetermined risk regions 

(i.e., ‘‘cattle selected for export * * * 

are not the progeny of BSE suspect or 

confirmed females’’), this reference was 

removed in the 2007 OIE general 

session. Therefore, all restrictions on the 

trade in progeny of BSE-positive 

animals have been removed from the 

current OIE guidelines. APHIS believes 

the weight of the scientific information 

and scientific consensus reflected in the 

OIE international guidelines support the 

conclusion that maternal transmission 

of BSE is unlikely to occur at any 

appreciable level, and that specific 

regulatory measures are not necessary or 

warranted. 

SRM Removal 

Issue: One commenter stated that 

USDA regulations should require the 

removal of all SRMs from cattle 

imported from Canada at 30 months of 

age or older. 

Response: FSIS regulations require 

the removal of all SRMs from cattle 

slaughtered in the United States, 

regardless of the country of origin of the 

cattle. Therefore, the action requested 

by the commenter is already included as 

a requirement in USDA regulations for 

any cattle 30 months of age or older that 

would be imported from Canada. 

Ports of Entry 

Some commenters addressed the 

regulations that have required that live 

bovines imported from Canada enter the 

United States only through ports of 

entries listed as authorized ports in 

§ 93.403 of the regulations. Some 

commenters expressed concern about 

the ability of the ports to handle 

shipments from Canada, while other 

commenters requested that the list of 

authorized ports be expanded. 

Authorized Ports of Entry 

Issue: Several commenters stated that 

the proposed rule should not be 

implemented until sufficient personnel, 

quarantine facilities, and testing 

capabilities are available at the U.S.- 

Canadian border to monitor imports and 

detect suspect animals. 

Response: APHIS regulations require 

that live ruminants imported into the 

United States from Canada come 

through the border ports listed in 

§ 93.403(b) (except as provided in 

special cases in § 93.403(f)). APHIS lists 

ports in § 93.403(b) only after 

determining that they have sufficient 

personnel and facilities to accommodate 

importations of live animals from 

Canada. 

Border Ports in Alaska 

Issue: Several commenters noted that 

none of the border ports listed in 

§ 93.403(b) are on the border of Alaska 

and Canada and requested that the 

regulations provide for such a border 

port. 

Response: The volume and frequency 

of live animal imports through the ports 

listed in § 93.403(b) justifies making 

Federal inspectors available on a regular 

basis. As noted above, § 93.403(f) of the 

regulations provides for the designation 

by the Administrator of other ports in 

special cases as necessary. 

Historically, the volume and 

frequency of imports of ruminants from 

Canada directly into Alaska has not 

made it resource-effective to provide the 

Federal inspectors for such importations 

on a regular basis. Imports of bovines 

from Canada into Alaska under this rule 

will continue to be handled by special 

arrangements on an as-needed basis. 


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For the reasons discussed above, we 

are making no changes based on the 

comments. 

Blood and Blood Products 

Paragraph (a) of § 94.18 lists regions 

from which imports of ruminants and 

ruminant products are prohibited or 

restricted because of BSE. Those regions 

in which BSE is known to exist are 

listed in § 94.18(a)(1); those regions that 

present an undue risk of introducing 

BSE into the United States because their 

import requirements are less restrictive 

than those that would be acceptable for 

import into the United States and/or 

because the regions have inadequate 

surveillance are listed in § 94.18(a)(2); 

those regions that present a minimal 

risk of introducing BSE into the United 

States via live ruminants and ruminant 

products and byproducts are listed in 

§ 94.18(a)(3). 

The requirements for the importation 

of blood and blood products from BSE 

minimal-risk regions have been the 

same as the requirements for 

importation of blood and blood 

products from other regions listed in 

§ 94.18(a)—only serum and serum 

albumin have been eligible for 

importation. In our January 2007 

proposal, we proposed to allow the 

importation of blood and additional 

blood products from BSE minimal-risk 

regions provided certain conditions 

were met regarding the health of the 

animal from which the blood or blood 

products were derived, or—in the case 

of blood collected from a fetal calf—the 

health of the dam; the method of 

slaughter; the process of collection of 

blood; and certification of compliance 

with the regulations. 

We received comments regarding the 

importation of bovine blood and blood 

products from BSE minimal-risk 

regions. Most of the commenters 

addressing this topic expressed concern 

regarding such importation, while 

others sought clarification as to 

allowable methods of collection of 

bovine blood intended for importation 

as blood or blood products into the 

United States. 

Issue: Several commenters stated that 

the regulations should not allow the 

importation of cattle blood for use as 

animal feed. One commenter stated that 

a number of studies have shown prion 

transmission through blood, that there is 

evidence that TSE diseases are capable 

of crossing the species barrier, that the 

EU has banned all animal protein except 

meat and eggs from use in feed for any 

animal that enters the human food chain 

and the United States should do the 

same, and that what the commenter 

referred to as the EC report on the 

assessment of BSE risk in the United 

States specifically condemned the 

practice of intraspecies recycling of 

ruminant blood and blood products. 

Some commenters specifically 

expressed concern about the potential 

use of blood protein as a milk 

replacement or as animal feed, and the 

production of spray-dried blood plasma 

or blood meal for use in feed. 

Response: As we discussed in detail 

in our risk assessment, in experiments 

examining tissues from BSE-infected 

cattle, no BSE infectivity was 

demonstrated in cattle blood or any 

tested derivatives (EC SSC 2002). Also 

as discussed in our risk assessment, the 

Scientific Steering Committee of the 

European Commission concluded that 

the finding of BSE infectivity in the 

blood of sheep could not be 

extrapolated to BSE in cattle (EC SSC 

2002a). Further, the available evidence 

indicates that TSEs in other species, 

when found in the blood, are localized 

primarily to the cellular fractions. 

Although BSE has never been detected 

in any bovine blood or blood product, 

we expect even further risk reduction 

after removal of cellular fractions in the 

preparation of the most commonly 

imported bovine blood commodities. In 

addition, the mitigations included in 

this rule help prevent contamination of 

bovine blood and blood products with 

infectious tissues such as SRMs. Thus, 

there is no reason to prohibit the 

importation of cattle blood for use in 

animal feed. (We note that FDA has 

responsibility for determining which 

materials may be used in animal feed.) 

Finally, as discussed in our risk 

assessment, infection with BSE via the 

oral route is less efficient than by 

subcutaneous or intramuscular 

injection. Given that we have concluded 

that there is a negligible risk for 

exposure to bovine blood and blood 

products via the injectable route, the 

same conclusion holds for exposure via 

the oral route. 

Issue: One commenter cited a report 

(Castilla et al., 2005) regarding the first 

detection of scrapie prions in hamster 

blood, using a biochemical technique 

called protein misfolding cyclic 

amplification (PMCA). 

Response: APHIS is making no 

changes in response to this comment. 

The study cited by the commenter does 

not present evidence about BSE 

infectivity in bovine blood. The cited 

study presents a technique for the rapid 

amplification and detection of scrapie 

prions in hamster blood. The study is 

notable because the novel detection 

method could be useful in the 

development of diagnostic methods. 

Previously, only the prion concentration 

in the brain and some lymphoid tissues 

was high enough for detection by 

routine biochemical detection. 

However, APHIS does not assume that 

finding the presence of abnormal prion 

protein in a given tissue, especially at 

low levels, is equivalent to 

demonstrating infectivity of the tissue. 

APHIS notes that there are very 

sensitive bioassays in live animals for 

determining the infectivity of various 

tissues, such as that for BSE using 

intracerebral inoculation of transgenic 

mice expressing the bovine PrP. These 

methods, recently used by authors of the 

cited study and others (Espinosa et al., 

2007; EC SSC 2002) have reliably 

determined that, unlike sheep, mouse, 

and hamster blood, bovine blood from 

BSE-infected animals does not have 

demonstrable infectivity. 

Issue: One commenter stated that the 

reference APHIS used in its risk 

assessment in discussing the lack of TSE 

infectivity in bovine blood—the 

European Commission Scientific 

Steering Committee report, 2002—is 

dated. 

Response: We note that, in addition to 

the 2002 European Commission 

Scientific Steering Committee report the 

commenter refers to, a more recently 

published study (Espinosa et al., 2007) 

provides evidence of lack of TSE 

infectivity in cattle blood. The 2007 

study found that orally inoculating 

asymptomatic cattle with BSE resulted 

in BSE infectivity restricted to the 

nervous system, Peyer’s patches, and 

tonsils, as had been reported previously 

for clinically affected cattle. The study 

involved collection of tissue at 20, 24, 

27, 30, and 33 months post-challenge. 

Infectivity in brainstem and sciatic 

nerve was detectable only after 27 

months, whereas Peyer’s patches and 

tonsils were positive at every time point 

tested. Blood, urine, spleen, and skeletal 

muscle were negative for detectable 

infectivity throughout the study, using 

the very sensitive bioassay, intracerebral 

inoculation of transgenic mice 

expressing the bovine PrP, to assess 

infectivity. 

Issue: In order to guard against BSE 

contamination of blood intended for 

importation into the United States from 

BSE minimal-risk regions—or blood 

products derived from such blood—we 

proposed to require that the blood be 

collected in a closed system (in which 

the blood is conveyed directly from the 

animal in a closed conduit to a closed 

receptacle) or in an otherwise hygienic 

manner that prevents contamination of 

the blood with SRMs. 

Several commenters stated that, 

because of current line speeds in beef 

slaughter facilities, a closed collection 


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system is not practical and would be 

cost prohibitive for production of spraydried blood plasma or blood meal. The 

commenters stated that industry 

associations of both renderers and 

spray-dried blood and plasma producers 

in the United States and Canada have 

developed and implemented guidelines 

and a code of practice designed to 

minimize the risk of contamination. One 

of the commenters stated that the 

manufacture of spray-dried blood 

products involves concentration of the 

liquid plasma with reverse osmosis or 

ultra-filtration, followed by atomization 

of the concentrated liquid in a heated 

drying container. According to the 

commenter, because the filtration and 

spray drying equipment will operate 

inefficiently if the feed liquid contains 

particulate material, a number of prefiltration steps to remove particulate 

contamination are included in the 

production of spray-dried blood 

products. The commenter stated that the 

combination of the filtration system 

with manufacturing standards results in 

a system that meets the requirements of 

the regulations for collection ‘‘in an 

otherwise hygienic manner that 

prevents contamination of the blood 

with SRMs.’’

Several other commenters 

recommended that the regulations 

specifically provide for the adoption of 

alternative, less restrictive mitigation 

measures should the Administrator 

determine they are scientifically 

justified. 

Response: As noted above, our 

proposed rule provided for collection in 

an otherwise hygienic manner that 

prevents contamination of the blood 

with SRMs, in lieu of using a closed 

system for the collection of blood. 

APHIS will determine whether an 

alternative process collects blood in a 

hygienic manner that prevents 

contamination of the blood with SRMs 

upon request by a party that such a 

determination be made. The request for 

determination must include a 

description of the proposed alternative 

method of collection. 

Based on information received from 

the industry and an evaluation of 

industry capabilities, APHIS would 

consider the following to be an example 

of an acceptable alternative collection 

process at a slaughter facility: After the 

animal has passed ante-mortem 

inspection and is stunned, a long 

midline cut is made in the skin on the 

ventral part of the neck. A specially 

designed bucket—with two barbs that 

allow it to hang on the hide and that has 

been treated with anticoagulant prior to 

use—is inserted into the cut, so that the 

opening of the bucket, an oval-shaped 

area that conforms to the shape of the 

cut, is essentially inside the skin. As the 

animal moves down the line, another 

cut is made with a clean knife inside the 

skin opening, cutting the arteries and 

veins through the thoracic inlet for 

exsanguinations. The carcass travels 

down the rail while the blood drains. 

The bucket is mechanically removed by 

a conveyor at the end of this line. The 

conveyor carries the bucket into a 

separate room (separate from the kill 

floor), and empties the bucket into a vat 

with a screen to pick out any clots. The 

blood in the vat is then centrifuged, and 

the cells are piped to a dryer in another 

part of the plant, while the plasma is 

held in large refrigerated vats prior to 

transfer to another processing facility. 

The empty bucket travels through a prewash that removes any remaining blood, 

then through a disinfectant wash. Before 

reentering the collection process, the 

cleaned and disinfected bucket is 

treated with a measured amount of 

anticoagulant. 

For the reasons discussed above, we 

are making no changes based on these 

comments to the proposed requirements 

for importing blood or blood products. 

Small Intestine 

The regulations in § 94.19 have 

required that meat, meat byproducts, 

and meat food products derived from 

bovines that have been in a BSE 

minimal-risk region be derived from 

bovines from which the SRMs and the 

small intestine were removed at 

slaughter. The regulations at § 95.4(g) 

have applied this same requirement to 

offal derived from bovines from BSE 

minimal-risk regions. Section 94.0 

defines SRMs as ‘‘those bovine parts 

considered to be at particular risk of 

containing the bovine spongiform 

encephalopathy (BSE) agent in infected 

animals, as listed in the FSIS 

regulations at 9 CFR 310.22(a).’’

The regulations require removal of the 

entire small intestine, even though only 

part of the small intestine (the distal 

ileum) has been determined to be an 

SRM, to ensure removal of the distal 

ileum. 

In our January 2007 proposed rule, we 

proposed to remove the requirements 

for removal of the entire small intestine. 

We proposed, instead, to require 

removal of 80 inches of the uncoiled 

and trimmed small intestine, as 

measured from the cecocolic junction, 

unless the processing establishment has 

demonstrated that an alternative method 

is effective in ensuring complete 

removal of the distal ileum. We 

explained that this proposed change is 

consistent with the definition of SRMs 

in the FSIS regulations at 9 CFR 

310.22(a). 

Some commenters who addressed the 

topic of the removal of the distal ileum 

and other parts of the small intestine 

requested that the regulations be made 

more stringent than at present, while 

others expressed the view that our 

proposed regulations were too 

restrictive. 

Issue: Several commenters addressed 

our proposed change regarding removal 

of the small intestine. One commenter 

recommended not only that the 

regulations continue to require the 

removal of the small intestine, but that 

we require that the large intestine be 

removed as well. The commenter stated 

that the European Commission 

Scientific Steering Committee stated 

that, because slaughterhouse 

contamination of other intestinal areas 

with matter from the distal ileum cannot 

be avoided, it is prudent to remove the 

entire small and large intestines. 

Additionally, stated the commenter, the 

International Review Team (IRT) that 

issued a report to the U.S. Secretary of 

Agriculture in February 2004 called for 

the banning the entire intestine—from 

anus to pylorus—from human and 

animal food, from cattle of any age. 

Response: The issue of how much of 

the intestines should be removed to 

ensure removal of the distal ileum to 

prevent contamination with the BSE 

agent was also raised in response to 

rulemaking documents published in the 

Federal Register by FSIS and FDA. The 

agencies’ responses to those comments 

were published in interim final rules 

published in the Federal Register on 

September 7, 2005. (FSIS Docket No., 

03–025IFA, 70 FR 53043–53050, and 

FDA Docket No. 2004N–0081, 70 FR 

53063–53069). We concur with FSIS 

and FDA that, although the EU prohibits 

the entire intestine from use in food, the 

data we are aware of indicating BSE 

infectivity along the entire intestine is 

from other species, and may not 

represent the distribution of infectivity 

in cattle infected with BSE, as 

evidenced by studies with bovine 

tissues. 

In cattle, infectivity has been found in 

the distal ileum in tissue assay from 

cattle experimentally given BSE (Wells 

et al., 1994). In such cattle, positive 

Peyer’s patches were found by 

immunohistochemistry only in the 

distal ileum, and in cattle with naturally 

occurring and experimental BSE, 

positive myenteric plexus neurons were 

found only in the distal ileum (Terry et 

al., 2003). The duodenum of cattle 

experimentally given BSE has not 

demonstrated infectivity when tested by 

mouse bioassay and has been negative 


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for the presence of abnormal prions 

when examined by 

immunohistochemistry during all stages 

of the pathogenesis of the disease 

(Wells, 1994). Few samples of jejunum 

have been tested, but those that have 

been tested were negative for the 

presence of abnormal prions when 

examined by immunohistochemistry 

(Terry et al., 2003). In a bioassay of 

tissues from cattle with naturally 

occurring BSE, no infectivity was found 

in the splanchnic nerve, rumen, 

omasum, abomasum, proximal small 

intestine, proximal colon, distal colon, 

and rectum, or in the distal small 

intestine (EU SSC 2002). 

The study by Terry and others 

indicated that the myenteric plexus of 

the distal ileum contained some 

abnormal prion protein in neurons 

(Terry et al., 2003). Since the myenteric 

plexus extends throughout the small 

intestine, we acknowledge the 

possibility that infectivity might exist in 

the myenteric plexus of the jejunum or 

the duodenum. However, if infectivity 

in intestinal tissues (other than distal 

ileum) exists, it is below the level of 

detection by both mouse and cattle 

bioassay. Given the relative efficacies of 

these experimental modes of 

transmission compared to oral exposure 

at doses estimated to have occurred in 

the field, we conclude that intestine 

other than the distal ileum is highly 

unlikely to contain epidemiologically 

significant levels of infectivity, if any 

infectivity is present at all. 

We do not agree that slaughterhouse 

contamination of other intestinal areas 

with matter from the distal ileum cannot 

be avoided. FSIS is responsible for 

ensuring the adequacy and effectiveness 

of procedures for removing the distal 

ileum in slaughterhouses. The FSIS 

regulations require that establishments 

develop, implement, and maintain 

written procedures for the removal, 

segregation, and disposition of SRMs, 

and that they incorporate these 

procedures into their HACCP (Hazard 

Analysis and Critical Control Point) 

plans, sanitation standard operating 

procedures, or other required programs 

(9 CFR 310.22(d)(1)). These procedures 

must ensure that SRMs, including the 

distal ileum, are completely removed 

from the carcass, segregated from edible 

products, and disposed of in an 

appropriate manner as prescribed by 9 

CFR 314.1 and 9 CFR 314.3 (i.e., used 

for inedible rendering, incinerated, or 

denatured). Regions wishing to export 

meat and meat products to the United 

States must follow processing practices 

equivalent to those of FSIS. 

With regard to the IRT report 

referenced by the commenter, the 

recommendation for removal of the 

entire intestine, from anus to pylorus, 

was meant to apply in the United States 

only if the risk of BSE had not been 

determined to be minimal, based on 

aggressive surveillance. Aggressive 

surveillance conducted in both the 

United States and Canada indicate a 

very low prevalence of BSE. Therefore, 

the recommendation of the IRT for 

removal of the entire intestine of all 

cattle does not apply. As discussed 

above, scientific evidence does not 

support the designation of the entire 

intestine as an SRM. 

Issue: Several commenters stated that 

the regulations should require that only 

the distal ileum be removed, rather than 

an additional 80 inches of small 

intestine. The commenters stated that 

APHIS has not established that it is 

necessary to excise so much additional 

intestine. At a minimum, stated the 

commenters, the regulations should 

allow the Administrator to approve 

effective alternatives in ensuring 

complete removal of the distal ileum. 

Response: As discussed in our 

proposed rule, removal of the distal 

ileum as well as an additional portion 

of the small intestine is consistent with 

FSIS and FDA requirements to ensure 

removal of the distal ileum. APHIS 

concurs with FSIS and FDA that, unless 

demonstrated otherwise, to ensure 

complete removal of the distal ileum, it 

is prudent to require removal of 80 

inches of the uncoiled and trimmed 

small intestine as measured from the 

cecocolic junction. We concur that this 

standard will ensure removal of the 

distal ileum despite differences in 

length of the intestinal tract or its 

segments between breeds or variations 

from animal to animal of the same 

breed. However, we recognize, as do 

FSIS and FDA, that alternative means of 

ensuring removal of the distal ileum 

may exist, and current APHIS 

regulations provide for such alternative 

means. 

For the reasons discussed above, we 

are making no changes based on these 

comments to the proposed requirements 

regarding removal of part of the small 

intestine. 

Bovine Tongue 

Issue: One commenter stated that 

USDA’s assumption that removal of a 

fraction of the small intestine and the 

tonsils removes any potential for 

transmission to humans is unjustified, 

given that APHIS has not evaluated the 

potential for contamination of tongue 

with tonsil tissue. The commenter also 

stated that APHIS claims this possibility 

is eliminated by current slaughter 

techniques, and stated further that such 

an assumption is contradicted by facts 

(i.e., scientists who examined over 250 

bovine tongues intended for human 

consumption found tonsillar tissue in 

the vast majority—in some cases, ‘‘even 

after the most rigorous trimming of the 

root of the tongue’’ (Wells et al., 2005). 

The commenter stated that APHIS 

cannot simply assume this risk away by 

stating, without record support, that it is 

eliminated. 

Response: We are making no changes 

based on the comment. Wells et al. 

(2005) state the following: 

However, the trace level of infectivity so 

far detected in tonsillar tissue and the 

localization of the lingual tonsillar lymphoid 

tissue, together with the current SRM 

legislation for the removal of tonsil from 

cattle carcasses and the low and diminishing 

prevalence of BSE in the UK suggest that the 

risk of human exposure to infected tonsil is 

now remote. It seems likely that under these 

circumstances any additional trimming of the 

tongue would result in an immeasurable 

reduction in the risk. * * * 

In other words, the study cited by the 

commenter does not present a strong 

case for additional risk measures. The 

study, in fact, indicates the opposite 

conclusion. 

Moreover, even before the SRM 

requirements were implemented in 

January 2004, FSIS did not consider 

tonsil to be edible tissue—it was 

previously required to be removed. As 

noted in FSIS Notice 50–04: 

In the preamble to 9 CFR 310.22, FSIS 

stated that tonsils of all livestock species, 

including cattle, were already required to be 

removed and were prohibited for use as 

ingredients in meat food products under 9 

CFR 318.6(b)(6). The accepted practice for 

removing the tonsils from livestock has been 

to remove all visible tonsils. In cattle, this 

includes separation of the palatine tonsils 

and lingual tonsils from the tongue (in 

establishments that harvest the tongue for 

human food) by a transverse cut caudal (just 

behind) the last vallate papillae. * * * FSIS 

expected that establishments would continue 

to remove tonsils from cattle in accordance 

with the procedures that they had 

implemented to comply with 9 CFR 

318.6(b)(6) * * *. Establishments that 

slaughter cattle should have been following 

these practices before tonsils were designated 

as SRMs. (FSIS, 2004). 

APHIS’ quantitative exposure model 

included an update that acknowledged 

the potential infectivity in tonsils and 

clearly added these as an SRM, with the 

acknowledgment that they could still be 

potentially available for human 

consumption. In fact, the output tables 

from the model runs show the potential 

ID50s derived from tonsils and available 

for human consumption over the 20- 

year period of the analysis. These values 

are obviously very low, ranging from 


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0.026 ID50s in the base case scenario to 

0.16 ID50s in sensitivity analysis 6 (in 

which all uncertain parameters were 

simultaneously set to their 

corresponding pessimistic level). Such 

very small values are not surprising 

given the low likelihood of infectivity in 

the tissue itself. These possible 

exposure routes were therefore 

explicitly modeled and not ‘‘assumed 

away.’’ Moreover, although our model 

predicts a vanishingly low level of 

possible human exposure via tonsils, we 

have not stated that the risk is 

‘‘eliminated,’’ as was suggested in the 

comment. 

Issue: A number of commenters urged 

that, before this rule is implemented, a 

plan should be in place for the removal 

and mitigation of any potential risk 

factors that might arise from the 

introduction of the BSE agent into the 

United States because of the importation 

of a BSE-infected cow. 

Response: We are making no changes 

based on the comments. The safeguards 

in the United States regarding any BSEinfected cow that might be imported 

from a BSE minimal-risk region are the 

same that are in place to deal with a 

BSE-infected cow of any source, 

including any of U.S. origin that might 

be detected. These mitigations are 

simulated in the quantitative exposure 

model used in the risk assessment for 

this rule. 

The primary animal-health mitigation 

measure is the feed ban implemented by 

the FDA in 1997. This feed ban is the 

most important measure to prevent the 

transmission of disease to cattle. In 

addition to the regulatory restrictions 

imposed by the feed ban, other industry 

practices—such as rendering processes 

that inactivate a significant proportion 

of BSE infectious agent present in raw 

material—and biological processes—

such as age susceptibility to infection—

also help to mitigate the transmission of 

disease to animals. 

Public or human health protective 

measures are maintained by both the 

FSIS and the FDA. The most important 

public health protective measure is the 

removal from the human food supply of 

SRMs. Other controls include 

prohibiting air-injection stunning of 

slaughter cattle; requiring additional 

process controls in advanced meatrecovery systems; forbidding the use of 

mechanically separated meat in human 

food; and prohibiting nonambulatory 

disabled cattle from the human food 

chain. Additionally, protection from 

BSE and other disease is achieved 

through ante-mortem inspection of 

slaughter cattle and the exclusion of 

animals with any clinical signs of 

neurological disease or other 

abnormalities. 

If a BSE-positive bovine were 

identified in the United States, APHIS 

would lead an epidemiological 

investigation that would include the 

tracing of birth cohorts of the infected 

animal. Birth cohorts are those animals 

that could have been exposed to the 

same feed as the infected animal, and 

include those bovines that were born on 

the same premises as the infected 

animal during the 12-month period 

immediately before the birth of the 

infected animal or during the 12-month 

period immediately after the birth of the 

infected animal. They would also 

include other bovines raised on the 

premises at the time the infected animal 

was there. Any birth cohorts located 

would be prevented from entering the 

human or animal feed chains. In 

addition to the APHIS epidemiological 

investigation, FDA would conduct an 

extensive feed investigation to help 

determine the potential source of the 

infection. 

With regard to commodities eligible 

for importation from BSE minimal-risk 

regions under this rule, we have 

concluded that such commodities can 

be imported with a negligible BSE risk 

to the United States. 

The Role of States 

Several commenters discussed the 

role U.S. States should play regarding 

bovines imported from BSE minimalrisk regions. 

Issue: Commenters stated that CFIA 

and APHIS should provide the State 

veterinarian in the U.S. State that is 

receiving such bovines with all animal 

health and identification documentation 

before the animal is imported. 

Commenters requested further that the 

regulations require all importers of 

cattle over 30 months of age from BSE 

minimal-risk regions to report all 

movements of the animal to the 

department of agriculture of the 

recipient State before the animal is 

moved into or through the State. 

Response: As noted above, the 

purpose of the current APHIS 

regulations with regard to BSE, and 

those in this rule, is to allow the 

importation into the United States of 

commodities that can be imported with 

a negligible likelihood of the BSE 

exposure and establishment in the U.S. 

cattle population as a consequence of 

eligible imports from Canada. We do not 

consider the extensive recordkeeping 

and paperwork requirements suggested 

by the commenters to be warranted or 

justified by science and are making no 

changes in response to the comments. 

Issue: Commenters recommended that 

APHIS authorize each State Veterinarian 

to ensure that the animal health and 

identification requirements of the 

APHIS regulations are met, and 

recommended further that, in the event 

the State determines noncompliance 

with the APHIS regulations, USDA 

support the enforcement actions of the 

State officials. 

Response: APHIS has a historical and 

ongoing working relationship with State 

animal health officials to protect 

livestock in the United States from both 

foreign diseases and diseases endemic 

to the United States. This ongoing 

cooperation has enabled the United 

States to protect this country’s livestock 

from a variety of diseases, including 

BSE. It has not been necessary to specify 

this working relationship in the APHIS 

regulations, and we do not consider it 

warranted to do so for any one disease. 

However, APHIS emphasizes that it 

values highly its cooperative efforts 

with State animal health officials and 

welcomes a continuing exchange of 

information and support in carrying out 

our mutual missions. 

Potential Economic Effects of the 

Proposed Rule 

A large number of commenters 

addressed the potential economic effects 

of the proposed rule. Most of these 

commenters expressed concern that the 

proposed rule would have an 

unacceptable negative impact on U.S. 

entities. Some of the commenters took 

issue with the economic analysis we 

conducted for our proposed rule. 

Issue: Many commenters 

recommended that APHIS withdraw or 

restrict implementation of this rule 

because of its potential negative 

economic effects on the U.S. livestock 

and livestock product industry, due to 

the potential significant influx of cattle 

from Canada over a short period of time. 

A number of commenters requested that 

the rule not take effect until USDA has 

developed and implemented an orderly 

market transition plan to reduce the 

negative effect of the rule on U.S. cattle 

producers. One commenter stated that 

such a plan should include gradually 

accepting imports, so as not to overload 

the U.S. cattle supply and crash those 

markets. Further, commenters 

recommended that APHIS delay 

implementation of the rule until all U.S. 

export markets that were closed due to 

the December 2003 detection in an 

imported cow in Washington State are 

reopened. 

Response: APHIS does not have the 

statutory authority to restrict trade 

based purely on its potential economic 

impact, market access effects, or 


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12Arnade, C.,and K. Jones. ‘‘Modeling the Cattle 

Replacement Decision.’’ Paper prepared for 

presentation at the American Agricultural 

Economics Association Meeting, Montreal, Canada, 

July 27–30, 2003. 

Brester, G.W., J.M. Marsh, and V.H. Smith. ‘‘The 

Impacts on U.S. and Canadian Slaughter and Feeder 

Cattle Prices of a U.S. Import Tariff on Canadian 

Slaughter Cattle.’’ Can. J. Agr. Econ. 50(March 

2002), pp. 51–66. 

Brester, G.W. ‘‘Estimation of the U.S. Import 

Demand Elasticity for Beef: The Importance of 

Disaggregation.’’ Rev. Agr. Econ. 18(January 1996), 

pp. 31–42. 

Brester, G.W., and M.K. Wohlgenant. ‘‘Estimating 

Interrelated Demands for Meats Using New 

Measures for Ground and Table Cut Beef.’’ Amer. 

J. Agr. Econ. 73(November 1991), pp. 1182–94. 

Marsh, J.M. ‘‘Impacts of Declining U.S. Retail 

Beef Demand on Farm-Level Beef Prices and 

Production.’’ Amer. J. Agr. Econ. 85(November 

2003), pp. 902–13. 

Marsh, J.M. ‘‘Estimating Intertemporal Supply 

Response in the Fed Beef Market.’’ Amer. J. Agr. 

Econ. 76(August 1994), pp. 444–53. 

Marsh, J.M. ‘‘USDA Data Revisions of Choice Beef 

Prices and Price Spreads: Implications for 

Estimating Demand Responses.’’ J. Agr. and Res. 

Econ. 17(December 1992), pp. 323–34. 

Wohlgenant, M.K. ‘‘Demand for Farm Output in 

a Complete System of Demand Functions.’’ Amer. 

J. Agr. Econ. 71(May 1989), pp. 241–52. 

quantity of products expected to be 

imported. Under the Animal Health 

Protection Act, the Secretary of 

Agriculture may prohibit or restrict the 

importation or entry of any animal or 

article when the Secretary determines it 

is necessary to prevent the introduction 

or dissemination of a pest or disease of 

livestock. This authority has been 

delegated to APHIS. 

We note that this rule, and our 

January 2005 final rule, do not make any 

commodities eligible for importation 

from Canada that were not already 

allowed importation prior to May 2003, 

when a BSE-infected cow was 

diagnosed in Canada. One difference 

between the current situation and preMay 2003, however, is that certain of 

the commodities that are now eligible 

for importation, or that will become 

eligible when this rule becomes 

effective, are subject to risk mitigating 

importation conditions appropriate to 

the fact that BSE has been detected in 

Canada and that we consider that 

country a minimal-risk region for BSE. 

As noted above, both Canada and the 

United States have been classified as 

controlled risk countries for BSE under 

the OIE guidelines. Additionally, even 

under these rules, there are some 

commodities (e.g., cattle born before 

March 1, 1999) that continue to be 

ineligible for importation into the 

United States. Nevertheless, this 

rulemaking and our January 2005 final 

rule represent to a great extent a return 

to trade patterns that existed between 

the United States and Canada for many 

years previously. As discussed in the 

January 2007 proposal for this rule, in 

this final rule, and in the risk 

assessment for this rule, we have 

determined that the commodities 

eligible for importation from Canada 

under this rulemaking can be imported 

into the United States under the 

conditions specified with a negligible 

BSE risk to the United States. 

With regard to exports markets that 

were closed to U.S. beef following the 

December 2003 detection of BSE in a 

cow of Canadian origin in Washington 

State, U.S. Government agencies are 

actively negotiating with trading 

partners to reestablish our export 

markets. After the 2003 detection of an 

imported BSE-infected cow in 

Washington State, many of the 114 

nations that imported U.S. beef banned 

our beef and live animals, despite the 

apparent lack of scientific basis for such 

measures. The efforts of multiple U.S. 

Government agencies have succeeded in 

removing bans in over half of those 

markets, including our largest export 

market, Japan. U.S. Government 

agencies continue to work to reopen or 

further open markets where restrictions 

remain; the results of these negotiations 

are posted on the USDA APHIS Web site 

(http://www.aphis.usda.gov). 

Issue: Some commenters took issue 

with the economic analysis that we 

conducted for our January 2007 

proposed rule. One commenter stated 

that the economic analysis ignored any 

multiplier effects (i.e., the impact of a 

change in the level of economic activity 

in one sector on other sectors of the 

economy and on households in terms of 

employment and income) that would 

come from the broader economic 

impacts on the beef wholesale sector. 

Response: We used the multi-sector 

model in our economic analysis to 

examine impacts for the major vertically 

linked marketing channels for beef and 

other livestock products. We estimate 

consumer surplus for the beef sector 

will increase by 1 to 1.3 percent at the 

retail level in scenario 3 of the economic 

analysis. Indirect downstream effects on 

income and employment are not 

modeled; however, we do not believe 

APHIS is required to analyze the 

impacts of regulation on every sector of 

the economy that may be indirectly 

affected by these changes. As in many 

regulations, opportunity costs imposed 

on one sector of the economy are often 

passed on to other sectors of the 

economy. We anticipate that there may 

be indirect economic benefits to 

communities where, for example, cull 

cattle imported from Canada result in 

increased slaughter plant employment. 

In other communities, there may be 

income and employment losses due to 

reduced spending by producers who 

face a fall in prices for cull cattle. These 

impacts are expected to be small on a 

national basis, although they may show 

some geographic concentration. Overall, 

the effects of this rule are expected to 

reflect a return to trade circumstances 

similar to those that existed prior to 

May 2003. 

Issue: One commenter indicated that 

APHIS acknowledged the sensitive 

nature of the results of the economic 

analysis based on the parameters 

(elasticities) used to drive the economic 

model and requested public comment 

on those parameter assumptions. The 

commenter stated that APHIS should 

have done a literature search for studies 

that report on these parameters and 

should have made those reported 

parameters available, in order to provide 

policy analysts with fuller knowledge to 

assess the accuracy of the results 

reached by APHIS. 

Response: APHIS agrees that this 

would be useful information to provide 

for those interested in the impact 

analysis. The two tables that follow 

summarize our overview of demand and 

supply elasticities estimated or used in 

published research. The referenced 

sources are identified in a footnote 

following the tables.12 The elasticities 

we use in the economic analysis fall 

within a reasonable range of the 

elasticities found in these various 

sources. 


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13Office of Management and Budget, Circular No. 

A–4, Regulatory Analysis, September 17, 2003. 

http://www.whitehouse.gov/omb/circulars/a004/a4.pdf 

Issue: One commenter stated that the 

type of ‘‘welfare’’ analysis APHIS used 

in its economic analysis is invalid 

because it relies upon the unscientific 

concept of interpersonal utility 

comparison. 

Response: We disagree. Our economic 

analysis does not attempt to make 

interpersonal utility comparisons. We 

recognize that an additional dollar of 

income provides a different level of 

utility to every individual. APHIS uses 

techniques that are quite standard in 

welfare and trade economics; we 

estimate changes in consumer and 

producer surplus that may result from 

projected changes in cattle and beef 

imports from Canada under different 

scenarios. For a given transaction, 

consumer surplus refers to the value 

that the purchase of the good provides 

the buyer over and above its price. 

Producer surplus refers to the value that 

the sale of the same good provides the 

seller over and above the lowest price at 

which he would have been willing to 

sell it. 

The estimated changes in welfare and 

prices are generalized across all entities 

that would take part in transactions 

concerning the particular commodity at 

hand, such as the purchase and sale of 

cull cattle. We make no attempt to 

evaluate impacts on income distribution 

or the utility gained or lost by 

individual market participants. In a 

transaction, the buyer and the seller 

both gain utility, as individually 

determined, compared to their next best 

alternatives. Otherwise the transaction 

wouldn’t occur. But for some entities, 

the ‘‘gain’’ in utility may be, in fact, a 

smaller welfare loss than the participant 

anticipates would be incurred without 

the transaction (e.g., selling a cull 

animal rather than keeping it past the 

optimal point of sale, even though the 

price has declined). Commodity-wide 

changes in welfare (changes in 

consumer and producer surplus) reflect 

the changes in utility across all buyers 

and sellers of the commodity. 

The common measure of value and, 

therefore, of changes in welfare is, of 

course, the dollar. Our analysis 

appropriately uses changes in consumer 

and producer surplus, expressed in 

dollars, to evaluate net benefits of this 

rule and other scenarios considered. As 

pointed out in the Office of Management 

and Budget’s Circular A–4, a distinctive 

feature of benefit-cost analysis is that 

both benefits and costs are expressed in 

monetary measures, which allows a 

common measure for evaluation of 

different regulatory options.13

Issue: One commenter stated that the 

economic analysis for the proposed rule 

is invalidated by its assumption that 

import numbers will be exogenous, 

rather than determined within the 

context of a dynamic North American 

livestock market. 

Response: APHIS disagrees. We agree 

that the North American livestock 

market is a dynamic system, with the 

interplay of changing prices and 

changing supply and demand quantities 

continually redefining market 

equilibria. The projected imports from 

Canada may be exogenous to the 

particular model we used to estimate 

domestic impacts; however, they are 

derived from USDA baseline projections 

and anticipated market changes that 

reflect the fluidity of interacting 

markets. In other words, the impacts 

were not modeled as external exogenous 

shocks, but rather as rational responses 

to changing market conditions. We also 

note that every model is an abstraction 

from reality that relies upon selected 

exogenously determined values and 

parameters. Our import projections are 


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well based in theory and market 

considerations. Imports of Canadian cull 

cattle will be newly reestablished by the 

rule, and effects for the other modeled 

commodities will derive from the 

resumption of the cull cattle imports. 

The principal model we use to evaluate 

expected effects of the rule is a net trade 

model, and its operation is driven by 

projected changes in net trade. 

Issue: One commenter stated that our 

economic analysis overstates consumer 

benefits associated with the availability 

of cull cattle for slaughter in the United 

States, because it does not adequately 

account for substitution among the 

modeled products in both the United 

States and Canada. 

Response: Consumer welfare benefits 

are expected to be gained under the rule 

by buyers of processing beef at the 

wholesale level. Lean processing beef 

from cull cattle and trimmings from fed 

beef are complementary goods that are 

combined to produce ground beef. At 

the level of the retail shopper, there is 

a degree of substitution between ground 

beef and fed beef cuts, but this 

relationship is not expected to 

significantly influence the estimated 

consumer benefits attributable to the 

rule. 

As part of the economic analysis for 

the final rule, we simulate substitution 

among livestock products in response to 

relative price changes. The simulations 

yield measures of consumer welfare 

changes at the retail level. Results of 

this analysis indicate that, with the rule 

under scenario 3 as discussed in our 

economic analysis and in the summary 

of that analysis in this document (entry 

of Canadian cattle born on or after 

March 1, 1999, and resumption of 

imports of beef from Canadian cattle 

slaughtered at 30 months of age or 

older), consumer surplus for the beef 

sector at the retail level will increase by 

1 to 1.3 percent compared to a 2006 

baseline. 

Issue: One commenter stated that, 

based on normal culling rates, the 

January 2007 herd size, the 

modernization and expansion of 

Canada’s slaughter plants, and the 

increased use of Canadian beef in the 

Canadian domestic market, the number 

of animals that might be available for 

export is considerably lower than the 

number estimated by USDA. The 

commenter calculated that the number 

of older, age verified, beef and dairy 

animals that might be eligible for export 

would total about 471,000 head 

annually, consisting of approximately 

250,000 dairy cows, 154,000 beef cows, 

and 67,000 bulls. The commenter noted 

that the estimate of 471,000 head should 

be viewed as an upper bound and that, 

if confirmation of an animal’s age 

proves to be a complex procedure, that 

number would be reduced. 

One commenter stated that, in 

assessing the potential economic effects 

of this rulemaking, the use of any 

historical references regarding trade 

flows and regional basis levels to assess 

potential impacts are not likely to be of 

much use, due to changes in cattle 

usage. The commenter stated that the 

vast majority of Canadian cull cows and 

bulls will be converted into beef in 

Canada, and, after subtracting the 

elimination of the supplemental tariff 

rate quota (TRQ) supplies, the balance 

could be exported to the United States 

depending on the influence of the 

exchange rate. (‘‘TRQ’’ is the total 

annual quantity of a commodity that can 

be imported at a lower tariff rate, 

excluding imports from NAFTA 

countries. Canada’s supplemental TRQ 

beef supplies were quantities of beef 

above the tariff rate quota that were 

allowed by Canada to enter at the lower 

tariff rate. In eliminating supplemental 

TRQ certificates—that is, by not 

allowing additional beef imports at a 

lower tariff rate, Canada is relying to a 

greater extent on domestic production 

and less on imports.) 

Response: We have considered these 

observations carefully and reassessed 

the proposed rule import projections 

and, as a result, have revised our 

economic analysis based on a smaller 

quantity of cull cattle projected to be 

imported from Canada. Although the 

modernization and expansion of 

Canada’s slaughter plants and increased 

reliance on Canadian beef in the 

Canadian domestic market will tend to 

dampen cull cattle imports from that 

country, we expect the major reason for 

a smaller number of imports will be the 

requirement that the cattle be verified as 

having been born on or after March 1, 

1999. In the preliminary regulatory 

impact analysis (RIA) we conducted for 

our January 2007 proposed rule, we 

projected that cull cattle imports from 

Canada in 2008, for example, would 

total 657,000 head (586,000 cows and 

71,000 bulls and stags). In scenario 3 of 

the final RIA, however, we are 

projecting cull cattle imports in 2008 

totaling 75,000 head (63,000 cows and 

12,000 bulls and stags). We believe that 

the commenter who estimated that there 

would be approximately 471,000 older 

cattle eligible for import from Canada, 

and who acknowledged that number 

was an upper bound estimate, did not 

fully consider the extent to which the 

age verification requirement would 

reduce the number of eligible cattle. Of 

the cull cattle that might be imported by 

the United States if there were no age 

restriction and no age verification 

requirement, only about one-fourth are 

expected to be eligible for importation 

in 2008 under this rule, and only about 

one-half may be eligible by 2012. 

Issue: One comment stated that 

APHIS did not provide an explanation 

in its economic analysis for the different 

percentages of cattle over 30 months of 

age and of such cattle plus beef from 

cattle over 30 months of age assumed to 

displace other processing beef imports. 

Response: We agree that it is 

reasonable to expect, for all of the 

scenarios set forth in the economic 

analysis, that a consistent percentage of 

Canadian imports across the scenarios 

would displace other imports. We have 

revised the final RIA accordingly. In this 

final rule, we estimate that 25 percent 

of cull cattle imports from Canada 

(scenarios 1 and 2 in our economic 

analysis) and 25 percent of cull cattle 

and beef derived from cattle 30 months 

of age or older (OTM beef) from Canada 

(scenario 3 in our economic analysis) 

will displace U.S. processing beef 

imports from elsewhere. The estimate of 

25 percent comes from simulations of 

the multi-sector model and takes into 

account interactions of the processing 

beef sector with the beef cattle and dairy 

cattle sectors. The model allows cattle 

prices to adjust to an increase in beef 

imports from one source (in this case, 

cull cattle and OTM beef imports from 

Canada), spreading the market response 

across both beef and cattle. This 

interaction dampens the beef price 

decline and reduces the amount of 

displacement below that would be 

expected to occur by considering only 

the market for processing beef. We also 

examine the sensitivity of the impacts to 

changes in the quantities of cull cattle 

and processing beef imported from 

Canada that displace processing beef 

from elsewhere: The RIA presents 

results assuming 50 percent of the 

imports from Canada displace imports 

from elsewhere as well as results 

assuming none of the imports from 

Canada displace other imports. 

Issue: Several commenters, in 

addressing the potential economic 

effects of this rulemaking, stated that the 

time of year a final rule would go into 

effect is an extremely important variable 

in assessing its initial economic impact. 

One commenter stated that U.S. cull 

cow marketings are highly seasonal 

because the majority of calves are born 

in the spring and the decisions to retain 

cows are generally made during the fall. 

As a result, the months of October, 

November, December, and January are 

typically lowest for cull cow prices. 

Another commenter stated that 

implementation of the rule in the fall of 


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14An additional revenue loss of $659,000 per 

month, October through January, multiplied by the 

four months, yields an additional annual revenue 

loss of $2,636,000. This amount divided by the total 

baseline revenue from cow slaughter projected in 

the regulatory impact analysis of $2,892,770,580 

(5,084,000 cows slaughtered, at a price of $54.19 

per cwt and an average weight of 1,050 pounds) 

yields an additional revenue loss on an annual basis 

of 0.09 percent. 

15Compiled by APHIS using data from the 

Department of Commerce, U.S. Census Bureau, 

Foreign Trade Statistics. 

2007 (post-weaning) would likely result 

in a larger impact on U.S. cull cow 

prices in the very short term. 

Response: We agree with the 

commenters that, in the short term, the 

timing of the resumption of imports of 

cull cattle and processing beef from 

Canada could have an impact on 

producers’ monthly revenues. 

Historically, cull cow slaughter in the 

United States is highest in the months 

of October, November, December, and 

January. As the commenters noted, 

because of this, cull cow prices are 

typically lower in these months. 

Limited data prevent analysis on a 

monthly basis of price changes in 

response to projected cull cattle imports 

from Canada. However, we do 

acknowledge that, because of the larger 

number of cull cattle marketed per 

month, during October through January, 

a slight price decline during this period 

would result in larger total monthly 

revenue losses for U.S. producers than 

during the other months of the year. 

This seasonal difference in monthly 

revenue losses would not be large on an 

annual basis. 

This outcome is demonstrated in 

research conducted at Montana State 

University (Brester et al., 2007). This 

study examined effects of additional 

cull cattle slaughter using two scenarios: 

One in which Canadian cull cattle 

imports return to pre-2003 levels and do 

not displace beef imports from other 

countries, and a second in which 50 

percent of cull cattle and processing 

beef imports from Canada displace beef 

imports from Uruguay. The changes in 

U.S. cull cattle prices estimated for 

these two scenarios are declines of $1.55 

per cwt and $0.78 per cwt, respectively. 

The average of the price changes 

reported in the Montana State study, 

$1.17 per cwt (2.5 percent of the 2006 

average U.S. cull cow price of $47.56 

per cwt), would correspond to 25 

percent of imports from Canada 

displacing processing beef imports from 

other countries, which is the percentage 

share used in the economic analysis for 

this final rule. 

As reported by Brester et al. for the 

period, 2000–2006, monthly cull cattle 

sales averaged 488,000 head, October 

through January, compared to an 

average of 434,000 head per month, 

February through September. Based on 

the Montana State study results, a 25 

percent level of displacement would 

correspond to a decrease in total 

monthly revenue for cow-calf producers 

of $5,956,500, October through January, 

and $5,297,000, February through 

September. In other words, there would 

be an additional revenue loss of 

$659,000 (12 percent) per month, 

October through January. 

We project in our economic analysis 

a baseline for beef and dairy cow 

slaughter in 2008 totaling 5,084,000 

head, and a nominal 2008 price of 

$54.19 per cwt. Based on an average live 

slaughter weight of 1,050 pounds, total 

baseline gross revenue from the sale of 

cull cows in 2008 would be $2.89 

billion. The increase in producer losses 

because of increased cull cattle sales 

occurring during the months of October 

through January, rather than during the 

months of, February through September, 

based on the Montana State study 

results, would total less than 0.1 percent 

of the projected baseline annual revenue 

from cow slaughter.14

While we recognize that the timing of 

the resumption of cull cattle imports 

from Canada may influence the size of 

the short-term impacts for producers, 

differences in revenue losses due to the 

timing of the implementation of the rule 

are considerably smaller when 

considered on an annual basis. Our 

analysis is in terms of annual cattle 

import projections and, therefore, yields 

annual price and welfare effects. The 

within-year distribution of effects is 

smoothed in the annual estimate. 

Issue: Many commenters addressed 

the issue of the potential economic 

impact on U.S. cattle producers should 

a bovine of Canadian origin be 

diagnosed in the United States as BSEinfected. A number of the commenters 

expressed general concern regarding 

such a potential impact, and suggested 

that APHIS’ analysis of the potential 

economic effects of the proposed rule 

was incomplete because it did not 

consider such impacts. Commenters 

stated that such impacts have been large 

in other countries and could overwhelm 

the effects estimated by APHIS if a BSEinfected animal imported into the 

United States under the provisions of 

this rule caused the spread of BSE in the 

United States, and that a comprehensive 

economic analysis should include 

consideration of the demand reactions 

that would be triggered by identification 

of additional Canadian-born BSE cases 

in the United States, even at the low 

levels projected in APHIS’ risk 

assessment. 

Other comments stated that the cost 

associated with the projected 

importation of up to 160 BSE-infected 

cattle into the U.S. (based on APHIS’

estimate for the 95th percentile of 

confidence) over 20 years, or the 

projected 2 to 20 U.S.-born infected 

cattle, should have been considered. 

Several commenters expressed concern 

that the existence of 21 to 180 cases of 

BSE-infected animals could 

substantially undercut demand for beef, 

as it has done in Europe, or dairy, if the 

public begins to identify BSE with the 

older dairy breeding stock that are most 

at risk of manifesting the disease. 

A number of commenters expressed 

concern regarding the potential 

economic impact of the detection in the 

United States of a Canadian-born BSEinfected cow on U.S. export markets. 

Commenters stated that the reaction of 

the beef markets to the first U.S. case of 

BSE—despite that cow’s being of 

Canadian origin—demonstrates the very 

substantial potential costs to U.S. cattle 

industries of introducing even a limited 

number of infected animals into the U.S. 

herd. Commenters stated that APHIS 

should examine such potential 

economic impacts. 

Response: Expected economic 

impacts if new cases of BSE were to 

occur in the U.S. cattle population 

because of the rule are addressed in the 

consequence assessment portion of the 

risk assessment we conducted for this 

rulemaking. The consequence 

assessment notes that effects of BSE 

include a variety of costs. Some costs 

are long-term; others are one-time costs 

uniquely associated with new cases. 

The major long-term cost for the 

United States due to the diagnosis of 

BSE in a cow of Canadian origin in 

Washington State in December 2003 has 

been reduced access since then to beef 

export markets. Principal Asian 

markets, in particular, remain largely 

restricted. In 2003, the value of U.S. 

exports of beef and beef by-products (as 

measured by the 33 ‘‘beef only’’ Census 

Bureau categories) totaled over $3.9 

billion, of which the value of sales to 

Asian markets totaled $2.4 billion. In 

2004, these totals had fallen to $863 

million and $16 million, respectively. In 

2006, the value of U.S. beef and beef byproduct exports worldwide was $2.1 

billion, and exports to Asia were valued 

at $197 million.15

Trade impacts tend to decline over 

time as exporting and importing 

countries find ways to resume mutually 

beneficial trade while maintaining the 

safety of the beef supply. The OIE has 

developed international science-based 


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16The temporary closure of the U.S. export 

market to Japan in January 2006 was in response 

to a specific commodity concern and not to the 

likelihood of BSE infection in the U.S. herd. 

animal health standards to permit safe 

international trade in beef from 

countries that have BSE, based on the 

risk level of such countries. The OIE has 

classified both the United State and 

Canada as controlled risk countries for 

BSE. 

We anticipate that the economic 

impact of any additional cases of BSEinfected cows imported from Canada 

will likely be minimal. As noted above, 

after the 2003 detection of BSE in 

Washington State, many of the 114 

nations which imported U.S. beef 

banned our beef and live animals, but 

over half—including our largest export 

market, Japan—have resumed importing 

U.S. beef (USDA 2006).16 The joint U.S.- 

Japan press statement for resuming trade 

in beef and beef products after market 

closures in response to finding BSE in 

the United States noted that the United 

States has a ‘‘robust’’ food safety system, 

and stated that ‘‘identification of a few 

additional BSE cases will not result in 

market closures and disruption of beef 

trade patterns without scientific 

foundations’’ (USDA 2004). Adherence 

to science is imperative to expanding 

trade opportunities and maintaining 

existing market access. Continued 

import bans by other countries without 

sufficient scientific basis to warrant 

such measures, and maintained without 

adequate assessment of specific risks, 

may not be consistent with international 

trade obligations, and U.S. Government 

agencies continue to work to reopen 

such markets. 

One of the potential incremental costs 

of the detection of BSE in an imported 

cow is the regulatory expense of 

investigating such cases and paying 

indemnity for animals that are 

destroyed. Based on the U.S. experience 

with native BSE cases that have been 

detected, the regulatory costs per case 

total approximately $250,000 for 

epidemiological investigations and 

indemnification of depopulated 

animals. 

The potential domestic market effects 

of any new cases of BSE are difficult to 

predict. However, as described in the 

consequence assessment in our risk 

assessment, there is little reason to 

expect that additional U.S. cases of BSE 

would have a significant impact on U.S. 

beef consumption, based on past 

experience. 

Although the first U.S. discovery of 

BSE, a cow of Canadian origin, resulted 

in major restrictions on U.S. beef 

exports, that case and subsequent cases 

have not, to use the commenter’s term, 

‘‘substantially undercut’’ U.S. demand 

for beef or dairy products. Studies show 

that any negative consumer response to 

the discoveries of BSE in Canada and 

the United States in May and December 

2003, respectively, was neither 

significant nor long-lasting. 

Consumer opinion surveys as 

summarized by Coffey et al. (2005) 

indicated that between 14 and 29 

percent of respondents reported 

reducing their beef consumption. 

However, as Kuchler and Tegene (2006) 

point out, survey responses may 

systematically differ from actual market 

behavior. Coffey et al. found that, in the 

months following the December 2003 

BSE discovery, consumer demand for 

beef increased. 

Vickner, Bailey, and Dustin (2006) 

analyzed weekly grocery store 

purchases, from May 9, 2004, to May 1, 

2005. The authors studied the impact of 

BSE announcements on consumer 

demand for beef in Utah over this time 

period and found that Utah consumers 

were not responsive to BSE 

announcements during that period. 

Kuchler and Tegene found similar 

results on a national scale. The authors 

studied three separate markets, 

including fresh beef from grocery store 

meat counters, frozen beef, and 

frankfurters. The study concluded that 

the announcement of the finding of BSE 

in a Washington State cow may have 

reduced purchases of fresh and frozen 

beef over a 2-week period, but had no 

impact on purchases of frankfurters. A 

similar announcement for the finding of 

BSE in Canada had no noticeable impact 

on beef purchases in the United States. 

Although various consumer studies 

have concluded that discovery of 

additional cases of BSE in the United 

States may lead to decreased 

consumption of beef, the market has not 

substantiated this conclusion. In the 

first year after the December 2003 BSE 

discovery, beef consumption increased. 

While consumption in 2005 was above 

1998 levels, consumer demand started 

to decline. This decline was likely due 

to a combination of factors, including 

increased supplies of poultry and a 

slowing of growth in consumers’

disposable incomes (Mintert, 2006). 

There is no evidence to suggest a 

decline in consumption related to the 

confirmation of additional cases of BSE 

in the United States. 

Issue: Several commenters stated that 

APHIS’ economic analysis does not 

consider potential demand changes 

regarding exports of U.S. beef that could 

result from implementation of the 

proposed rule. A number of commenters 

expressed concern that the rulemaking 

would exacerbate the limited access of 

U.S. beef to world markets and harm the 

ability of the United States to restore 

lost export markets. Commenters stated 

that imports of Canadian cattle and beef 

are currently banned by 35 countries, 

including the important U.S. export 

markets of the Republic of Korea, 

Singapore, and Taiwan, and that APHIS 

should not consider relaxing its BSE 

import restrictions in light of ongoing 

international concerns regarding the 

safety of Canadian beef and cattle. Other 

commenters stated that the United 

States should allow imports only of 

classes of cattle and beef that U.S. 

export markets are willing to accept 

from the United States. 

Several commenters expressed 

concern that, should Mexico cease 

accepting imports of cattle and beef 

from Canada, the commingling of 

Canadian and U.S. cattle and beef 

products would negatively affect the 

reopening of Mexico to U.S. live 

breeding cattle and the present export of 

processed beef to Mexico. 

Response: The commenters raise the 

concern that, by allowing Canadian 

cattle born on or after March 1, 1999, to 

be imported into the United States, U.S. 

beef export markets will become more 

restrictive. Various countries have 

enacted different levels of restriction on 

beef imports from the United States and 

Canada. However, we expect any 

restrictions placed on beef from the 

United States and Canada by an 

importing country to become more 

uniform, as discussed below, and, 

therefore, for the rule to have little effect 

on U.S. beef export markets. 

The reason for the expected 

uniformity is the May 2007 OIE decision 

to classify both Canada and the United 

States as BSE controlled risk countries. 

By this decision, the OIE recognized the 

effectiveness of the science-based 

mitigations and interlocking safeguards 

in both countries. This classification is 

expected to help the beef industries in 

both the United States and Canada to 

expand their access to export markets. 

Issue: One commenter stated that 

APHIS’ economic analysis does not 

truly analyze the potential ‘‘consumer 

welfare’’ of the rulemaking. The 

commenter stated that the closest the 

analysis gets to considering the 

consumer is its consideration of 

wholesale buyers of processing beef and 

fed beef—whom the commenter stated 

APHIS should identify as the primary 

beneficiary of the rule. 

Response: The principal model that 

we use to estimate welfare effects 

resulting from the rule does not extend 

beyond the wholesale level to retailers 

and end buyers of beef. We 


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53358 Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 

17Ontario and Quebec account for approximately 

two-thirds of the dairy cattle inventory in Canada. 

Source: Statistics Canada, as cited in Al Mussell, 

Graeme Hedley, Don Ault, and David Bullock, 

‘‘Role and Impact of Renewed Canada—U.S. Trade 

in Dairy Heifers and Dairy Breeding Stock,’’ George 

Morris Centre, Informa Economics, February 2006. 

http://www.informaecon.com/ 

18Heifers 500 pounds and over kept for milk cow 

replacements. Source: Agricultural Statistics, 

National Agricultural Statistics Service, USDA. 

19 In table 17 of the preliminary Regulatory 

Impact Analysis that accompanied our January 2007 

proposed rule (Docket No. APHIS 2006–0041), 

under column ‘‘Average Annual U.S. Heifer 

Replacements’’ the numbers for Beef and Dairy 

were transposed. 

20Mussell, et al. (February 2006). 

21http://www.cwt.coop 

acknowledge this modeling choice in 

our discussion of sector impacts in the 

analysis for the final rule, and note that 

benefits received at the wholesale level 

can be expected to be at least partly 

distributed downstream to retailers and 

final buyers, depending on the levels of 

competition. Nevertheless APHIS 

believes this modeling choice is 

consistent with standard RIA practices, 

as recommended by OMB Circular A–4, 

and that it adequately identifies the 

impact of this regulatory action. 

APHIS agrees, however, that some 

indication of the distribution of benefits 

in different product markets would be 

an interesting addition to the model. As 

part of the economic analysis for the 

final rule, we simulate substitution 

among livestock products in response to 

relative price changes using a multisector model. Although meant simply to 

be illustrative and subject to 

considerable uncertainty, included in 

the simulations is a derivation of 

consumer welfare changes at the retail 

level. Results of this analysis suggest 

that consumer surplus for buyers of beef 

at the retail level may increase by 1.0 to 

1.3 percent compared to a 2006 

baseline. 

Issue: One commenter stated that 

APHIS should also broaden the model 

used in the economic analysis to 

account for cull animal producers, so 

that welfare implications to producers 

of U.S. cull animals and processing beef 

could be separated from those of the 

packers. The commenter stated that 

APHIS’ analysis includes no single 

estimate of the economic impact of the 

rule on cow-calf producers resulting 

from the change in value and demand 

for U.S. cattle. 

A number of cow-calf producers 

provided estimates of the potential 

economic impact of the proposed rule 

on their individual operations. 

Response: In our regulatory flexibility 

analysis for this final rule, we present a 

sector-based analysis that includes a 

separate consideration of impacts of the 

rule for the cow-calf and dairy sector. 

The sector analysis uses the measures of 

welfare change estimated for cull cattle/ 

processing beef, feeder cattle, fed cattle, 

and fed beef, distributing these changes 

among the commodities’ principal 

buyers and sellers. 

Concerning the numerous comments 

we received regarding economic 

impacts of the rule on individual 

livestock producers, we acknowledge 

that analysis does not fully identify the 

distribution of all of the possible effects 

on the vast array of different types of 

entities that comprise the cattle and beef 

industries. Because of the different 

choices made by market participants, it 

would be difficult, if not impossible, to 

design such an analysis. For example, 

some large firms likely also act as 

wholesalers and distributors, and may 

be participants in fed cattle, feeder 

cattle, and other markets. The analysis 

APHIS has produced does identify the 

direct impacts of the regulation on the 

industry; the results of our analysis are 

based on baseline quantities and prices 

and import projections that are well 

supported by historical trends and 

economic research. The models that we 

use to estimate price and welfare effects 

are also well-grounded in theory and 

utilize methodologies widely accepted 

by economists. We are confident that 

the results of the analysis appropriately 

depict expected net effects of the rule 

for the modeled commodities. 

Issue: Commenters noted that APHIS 

estimated that 46,800 Canadian dairy 

breeding animals could be imported 

annually into the United States as a 

result of this rulemaking. The 

commenters expressed concern that 

these animals would have a negative 

impact on the effectiveness of the 

Cooperatives Working Together (CWT) 

herd retirement program, which the 

commenters noted is funded by 

voluntary dairy producer assessments. 

(CWT is a national program, organized 

by dairy farmers, with the goal of 

reducing milk supply and demand 

imbalances and, in doing so, of 

delivering a significant return on 

farmers’ investments through higher, 

more stable, milk prices.) 

The commenters stated that the 

proposed rule would have the effect of 

having U.S. dairy farmers assessed to 

reduce the U.S. dairy cattle herd, while, 

at the same time, cattle are being 

imported from Canada to replace those 

animals. 

One commenter stated that APHIS 

should have made the effort to 

incorporate ‘‘expected future net 

returns,’’ as well as impacts on milk 

prices, into an analysis of breeding 

cattle imports, and that the economic 

analysis should have modeled impacts 

on the milk market, and resulting 

impacts on producer incomes and the 

price of milk cows. Commenters 

expressed the opinion that APHIS failed 

to meet its obligations under Executive 

Order 12866 and the Regulatory 

Flexibility Act in its economic analysis 

by not performing the required analyses 

regarding imported dairy replacement 

animals. 

Response: We do not expect imports 

of dairy animals from Canada to add 

significantly to the U.S. national herd, 

but, rather, to serve as an additional 

source of replacement animals. Dairy 

breeding cattle replacements imported 

from Canada during 1992 to 2002 

represented about 1.1 percent of U.S. 

dairy heifer replacements over this 

period. We have no reason to expect the 

supply of Canadian heifer replacements 

to be greater than historical levels. In 

fact, the numbers of dairy heifer 

replacements present on all cattle 

operations in Canada have been in 

decline in recent years, from 512,000 on 

January 1, 2003, to 476,300 on January 

1, 2007. The number of operations that 

specialize in raising heifers has also 

decreased. In Ontario and Quebec, there 

were 487 of these operations on January 

1, 2003, and only 296 on January 1, 

2005.17 The currency exchange rate is 

also less favorable to Canadian exports 

than it was prior to 2003. 

There is no evidence that imports of 

dairy cattle from Canada have 

historically had any significant effect on 

the U.S. cow herd, U.S. dairy heifer 

prices, or U.S. milk prices. The U.S. 

milk herd declined from about 9.7 

million head in 1992 to about 9.1 

million in 2002. The number of U.S. 

milk cow replacements 18 remained 

essentially steady, fluctuating between 4 

million and 4.1 million head over that 

same time period.19 An empirical 

investigation by Mussell, et al. (2006) 20

concluded that imports from Canada 

prior to 2003 had no statistically 

significant impact on the U.S. dairy 

herd. Imports of dairy heifers from 

Canada were also found to have no 

statistically significant impact on U.S. 

heifer prices in the United States, nor on 

U.S. milk prices. 

As noted by commenters, a producer 

dairy herd retirement initiative called 

CWT is currently underway.21 The 

number of imported dairy breeding 

cattle projected in our economic 

analysis for the proposed rule was based 

on historical import levels prior to 

formation of CWT. Imports of dairy 

heifers are driven by the demand for 

replacement animals, relative prices, 

and the exchange rate. If dairy farmers 

are dedicated to reducing the national 


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Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 53359 

22Projected annual imports 2008–2012. 

23Assuming the additional heifers produce milk 

at the same average rate reported for the U.S. herd 

in 2006. 

24Milk supply elasticities of 0.12 in year 1 and 

2.46 in year 10 are cited in Chavas, J.P., and R.M 

Klemme, ‘‘Aggregate Milk Supply Response and 

Investment Behavior on U.S. Dairy Farms,’’

American Journal of Agricultural Economics 78 

(February 1986). A total dairy product demand 

elasticity of ¥0.31 is cited in Haidacher, R.C., J.R. 

Blaylock, and L.H. Meyers. ‘‘Consumer Demand for 

Dairy Products, A Summary Analysis.’’ USDA 

Economic Research Service, Agriculture 

Information Bulletin 537 (March 1988). 

dairy herd, they may purchase fewer 

replacement animals and the import 

projections may be overstated. However, 

if a replacement dairy heifer from 

Canada can be purchased at a lower 

price than a domestic one, then it is to 

the producer’s (and industry’s) 

advantage for the Canadian replacement 

to be purchased and a domestically 

raised animal to be retired. Therefore, 

APHIS disagrees with the commenters’

claims that dairy producers will 

somehow be worse off with this 

rulemaking. As a lower priced 

replacement heifer would represent a 

lower priced input into the production 

of dairy products, standard economic 

theory indicates that producers and 

consumers will be better off. 

Issue: One commenter stated that 

APHIS’ economic analysis indicates that 

imports of dairy cattle from Canada 

would be expected to represent ‘‘only’’

1.1 percent of the annual U.S. dairy 

heifer crop. The commenter stated that, 

although APHIS labels this percentage 

as small, a short-term change in the 

milking herd of 1 percent can change 

milk prices by 10 percent or more. 

Response: We agree that a 1 percent 

increase in the national dairy herd (and 

a corresponding increase in milk 

production) may result in a decline in 

milk prices. However, as we discuss 

above, imports of dairy animals from 

Canada that occur should serve as an 

additional source of replacement 

animals, rather than adding entirely to 

the national milking herd. First, we 

would reiterate that imports are 

voluntary; we believe any projected 

imports of dairy heifers would be 

undertaken because the cost saving 

associated with the import would be 

greater than any decrease in revenue 

due to relative price declines resulting 

from higher production and lower 

prices. We further note that we believe 

the comment overestimated the 

expected price declines due to this 

regulatory change. The projected 

number of imported dairy cattle is 

equivalent to 1 percent of the dairy 

heifer crop and not 1 percent of the 

entire milking herd, which is more than 

twice the size of the annual dairy heifer 

crop. Projected imports of dairy heifer 

replacements and other breeding cattle 

represent approximately 0.45 percent of 

the milking herd. 

In 2006, the farm-milk supply 

produced from 9.1 million dairy cows 

was 181.8 billion pounds of milk 

(19,951 pounds per cow) at an all-milk 

price of $12.90 per cwt, which is a 

weighted average of the fluid grade milk 

price of $12.92 per cwt and the 

manufacturing grade milk price of 

$12.21 per cwt. An increase in the size 

of the milking herd would increase milk 

production. 

If all 47,800 22 dairy heifers projected 

to be imported from Canada were to 

constitute an addition to the U.S. 

milking herd, they would represent a 

0.5 percent increase over the 2006 U.S. 

herd size. This increase would 

correspond to a change in milk 

production of approximately 0.5 

percent.23 We would expect the shortrun effects (more inelastic supply) of 

such an increase in the U.S. milking 

herd to be larger than the longer term 

effects (more elastic supply). Assuming 

a short-run supply elasticity of milk of 

0.15 and a demand elasticity of ¥0.30,24

a 0.5 percent increase in milk 

production is estimated to decrease the 

milk price by 15 cents per cwt. This 

translates into a 1.2 percent price 

decline. As supply becomes more 

elastic, the price decline resulting from 

a 0.5 percent increase in production 

becomes smaller. Assuming a longer run 

supply elasticity of 0.50 would lead to 

an estimated decline in price of 9 cents 

per cwt, or 0.7 percent. 

This example of potential effects on 

milk prices due to changes in the size 

of the U.S. milking herd assumes that 

the projected imports of Canadian 

breeding cattle would be absorbed into 

the U.S. milking herd in their entirety, 

thereby slightly expanding the overall 

size of the U.S. milking herd. An 

analysis of scenario 3 as discussed in 

our economic analysis and in the 

summary of that analysis in this 

document (entry of Canadian cattle born 

on or after March 1, 1999, and 

resumption of imports of beef from 

Canadian cattle slaughtered at 30 

months of age or older) using the multisector model indicates that dairy 

producers may experience price 

declines of 1.3 to 1.7 percent for dairy 

cattle, due to the small number 

projected to be imported from Canada. 

These imports translate into an increase 

in U.S. milk production of 0.1 percent 

or less, and a decline in the price of 

milk and increase in consumer surplus 

of less than 0.1 percent. 

Issue: One commenter noted that the 

importation of live animals from Canada 

has enabled many U.S. plants to better 

utilize their slaughter capacity, allowing 

them to maximize plant efficiencies. 

The commenter stated that allowing the 

resumption of imports of older animals 

to the United States, as envisaged in the 

proposed rule, might enable some 

previously closed plants to reopen. 

Response: The resumption of cull 

cattle imports from Canada will provide 

increased throughput for U.S. slaughter 

plants, especially those that principally 

slaughter and process cull animals. 

While the cattle from Canada will 

enable these businesses to more fully 

utilize their available capacities, we do 

not anticipate the effects to be highly 

significant. Nor are we aware of plants 

that have closed and will be reopened 

due to reestablished cull cattle imports. 

Our analysis for scenario 3 as discussed 

in our economic analysis and in the 

summary of that analysis in this 

document (entry of Canadian cattle born 

on or after March 1, 1999, and 

resumption of imports of beef from 

Canadian cattle slaughtered at 30 

months of age or older) indicates that 

the additional numbers of cull cattle 

marketed over the 5 years, 2008–2012, 

will not increase substantially. 

Compared to projected U.S. baseline 

slaughter numbers averaging 5.4 million 

head of cows and 570,000 head of bulls 

and stags over the 5-year period, 

imports of Canadian cows and bulls/ 

stags are projected to average 89,400 

head and 16,600 head over the same 

period, representing 1.7 percent and 2.9 

percent of the baseline quantities. These 

percentages in fact overstate the 

expected impact of the rule in terms of 

cull cattle slaughter because they do not 

take into account the effect of expected 

price declines on domestic sales. 

Notwithstanding this cautious 

assessment of the extent to which the 

rule will benefit U.S. facilities, the 

slaughter industry is expected to benefit 

from improved operating efficiencies. 

Issue: One commenter stated that 

APHIS’ economic analysis for the 

proposed rule did not consider the 

economic implications of the 

combination of the rule and Canada’s 

implementation of its expanded feed 

ban on July 12, 2007, which bans the 

inclusion of SRMs in any animal feeds, 

pet foods, and fertilizers. The 

commenter stated that, under the 

expanded Canadian feed ban, SRMs in 

Canada will have little or no economic 

value. Instead, said the commenter, the 

materials will generate a disposal cost, 

thereby providing increased incentive 

for Canadian producers to ‘‘send all 

their cattle over 30 months of age to the 


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53360 Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 

25 ‘‘Economic Impacts of Alternative Changes to 

the FDA Regulation of Animal Feeds to Address the 

Risk of Bovine Spongiform Encephalopathy: Final 

Report.’’ Submitted by Eastern Research Group, Inc. 

to the Office of Policy and Planning, Food and Drug 

Administration, July 25, 2005. 

26Boning utility cow, Sioux Falls, price of $54.19 

per cwt, multiplied by an average weight of 1,050 

pounds yields an average value of $569 per animal. 

Assuming a total value per cow for rendered SRMs 

of five dollars: $5/$569 = 0.0088. 

U.S. for slaughter where the SRMs can 

continue to be used as ingredients in 

other U.S. animal feed, pet food, and 

fertilizer * * *. The result would be an 

even greater supply of imported 

Canadian cattle than what APHIS 

presently predicts and a 

correspondingly greater decline in U.S. 

cattle prices.’’

Response: We acknowledge that 

Canada’s July 2007 expansion of its feed 

ban eliminates the value of SRMs for 

producers of cattle slaughtered in 

Canada, and we agree that the continued 

use of SRMs in the United States for 

rendered purposes other than as a 

component of ruminant feed will 

contribute to a difference in prices paid 

for cattle at slaughter in Canada and the 

United States. Because SRMs are 

defined more broadly for cattle 30 

months of age or older than for animals 

under 30 months of age, this effect on 

relative prices in the two countries will 

be more notable for cull cattle. For all 

cattle, the tonsils and distal ileum are 

considered SRMs, whereas for cattle 30 

months of age or older, SRMs also 

include the brain, skull, eyes, trigeminal 

ganglia, spinal cord, vertebral column 

(excluding the vertebrae of the tail, the 

transverse processes of the thoracic and 

lumbar vertebrae, and the wings of the 

sacrum), and dorsal root ganglia. 

However, even for cull cattle, the 

value of rendered SRMs is relatively 

minor in comparison to the total value 

of the slaughtered animal. In a 2005 

analysis of economic impacts of 

alternative FDA animal feed regulations, 

the value of SRMs was estimated using 

a 4-year average of byproduct market 

prices.25 For cattle slaughtered at greater 

than 30 months of age, the value of 

SRMs used in MBM products was 

valued at $2.35 per animal, and the 

value of SRMs used for tallow was 

valued at $2.19 per animal. Thus, the 

total value of SRMs from cull cattle used 

as rendered byproducts is estimated to 

be less than $5 per animal. Given a 

projected 2008 nominal value of about 

$569 per cow, the income from SRMs 

gained by selling the animal in the 

United States rather than in Canada will 

represent less than 1 percent of the 

projected price of the animal at 

slaughter.26 Canada’s July 2007 feed ban 

may make the U.S. market more 

attractive, but not appreciably. 

Issue: One commenter stated that 

APHIS’ analysis of the projected 

economic effects of the rule should be 

revised to take into account the 

handling of increased amounts of SRMs. 

Response: In the regulatory impact 

analysis we conducted for this rule, 

projected prices for processing beef and 

fed beef incorporate animal slaughter 

and meat packing costs, including costs 

of handling SRMs. Costs and returns per 

animal of handling SRMs are not 

expected to change for slaughtering 

facilities because of the rule and 

therefore do not require specific 

analysis. Copies of the full amended 

analysis may be viewed on the APHIS 

Web site (http://www.aphis.usda.gov/ 

newsroom/hot_issues/bse/index.shtml), 

or be obtained by contacting the person 

listed under FOR FURTHER INFORMATION

CONTACT. 

Environmental Assessment for the 

Rulemaking 

Consistent with the National 

Environmental Policy Act of 1969 

(NEPA), as amended (42 U.S.C. 4321 et 

seq.), regulations of the Council on 

Environmental Quality (CEQ) for 

implementing the procedural provisions 

of NEPA (40 CFR parts 1500–1508), and 

APHIS’ NEPA implementing procedures 

(7 CFR part 372), we prepared an 

environmental assessment (EA) 

regarding the potential impact on the 

quality of the human environment due 

to the importation of live bovines and 

products derived from bovines under 

the conditions specified in our proposed 

rule. We made the EA available to the 

public and accepted public comment on 

its provisions. We discuss below the 

issues raised by commenters who 

addressed the EA. 

Issue: One commenter stated that the 

EA that APHIS conducted for the 

proposed rule did not adequately 

discuss the impact of air emissions from 

additional truck round-trips entering the 

United States that would result from 

importation of cattle 30 months of age 

and older from Canada. The commenter 

stated that USDA apparently did not 

consider the fact that these emissions 

would be concentrated in relatively 

small parts of the country. Further, said 

the commenter, the EA’s discussion of 

air pollutants and mitigation measures 

is limited to those pollutants regulated 

under the Clean Air Act and does not 

recognize what the commenter 

described as substantial emissions of 

greenhouse gases that could result from 

the additional truck trips. 

Response: Our EA estimated that the 

number of additional cattle that would 

be available for importation into the 

United States as a result of this rule 

would result in a 0.05–0.16 percent 

increase in truck transports, compared 

to the annual truck transport baseline, 

discussed below. However, more recent 

data from ERS indicate that the number 

of additional cattle that would be 

available and eligible for import from 

Canada as a result of this rulemaking 

initially will be less than the number we 

used in the calculations for our October 

2006 EA. Consequently, the estimated 

number of truck transports initially will 

also be less, as will the emissions 

generated by such transports. 

In the finding of no significant impact 

(FONSI) (APHIS 2005a) that APHIS 

made in conjunction with our January 

2005 final rule, we discussed truck 

transports for cattle under 30 months of 

age. Prior to implementation of that 

final rule, the projected number of 

imports of cattle under 30 months of age 

would have caused the resumption of 

about 35,000 truck transports. The 

FONSI for our January 2005 final rule 

determined that the result of 

environmental impacts from resuming 

35,000 trucks transports would be de 

minimus. Afterward, based on a 

decrease in the projected number of 

available imported animals under 30 

months of age, the estimated number of 

truck transports projected to be resumed 

was adjusted downward to range 

between 19,460 to 22,140 annually. 

As discussed in the EA for this final 

rule, for cattle born on or after March 1, 

1999, cattle import numbers are 

projected to range between 130,000 to 

446,000 over a 20-year period after 

implementation of this rule. The 

number of associated truck transports 

that would resume for this rule would 

range from 2,600 to 8,920. When added 

to the truck transports resumed as a 

result of our January 2005 final rule, the 

total number of projected resumed truck 

transports is still within the amount 

described in the FONSI for our January 

2005 final rule as de minimus. 

Additionally, that projected number is 

within the number of truck transports 

for cattle trade that occurred between 

Canada and the United States before 

such trade was temporarily halted in 

May 2003. 

As we stated in our EA, the transport 

of cattle could occur through any of 20 

U.S.-Canadian border ports specifically 

equipped to handle cattle. These ports 

are not confined to one region of the 

United States, but stretch across nine 

northern border States from Washington 

to Vermont. Market patterns and 

geographic issues can cause fluctuations 

in the availability and importation of 

cattle. Availability of cattle for 


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Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 53361 

27Memorandum to All Federal NEPA Liaisons, 

dated October 8, 1997, from Dinah Bear, General 

Counsel, Executive Office of the President, Council 

on Environmental Quality, with attached draft 

memorandum from Kathleen A. McGinty, 

Chairman, on Guidance Regarding Consideration of 

Global Climatic Change in Environmental 

Documents Prepared Pursuant to the National 

Environmental Policy Act. 

28A sink is, simply speaking, the converse of a 

source. Instead of releasing carbon into the 

atmosphere as is done when fossil fuels or wood are 

burned, sinks absorb carbon and lock it in. The 

most obvious examples are trees and other plants. 

importation also can vary depending 

upon the time of year and geographic 

location. For example, most feeder cattle 

are imported through certain western 

ports from areas with the highest cattle 

population in Canada, and more feeder 

cattle may become available in the fall 

when ranchers wean calves and sell 

them. Cull cattle for immediate 

slaughter historically have come 

through different ports than feeder 

cattle, including some eastern ports. 

Emissions from trucks importing cattle 

from Canada could affect any of the 20 

locations at the U.S.-Canadian border 

and any location between transport 

origination and destination. 

In determining if the impacts from 

truck transport emissions from carrying 

additional cattle as a result of this rule 

could result in a significant impact on 

the environment, a baseline of the 

annual overall truck transports was 

used. In this case, the baseline used for 

comparison was for all incoming trucks 

from Canada to the United States 

through 20 approved ports of entry 

where cattle can transit to determine 

whether the increase in the numbers of 

imported cattle would cause a 

significant increase in air emissions. 

The comparison of the baseline (the 

average number of heavy-duty truck 

crossings annually between the U.S.- 

Canadian border) to the number of truck 

transports estimated for cattle 30 

months of age and older that would be 

available to be imported from Canada 

annually shows that the increase in the 

number of truck transports would not be 

significant. 

To a great extent, projecting the 

specific air emissions that would result 

from implementation of this rule would 

be speculative. Emissions vary 

according to many different factors, 

including type of truck engine, the year 

the engine was manufactured, fuel 

properties, the type of hauler and 

weight of the load, the grade of the 

highways on the transport routes, the 

distance traveled, speed and 

acceleration, and the amount of wait 

time at the border ports. Due to the 

comparatively small amount of truck 

transports (ranging from 2,600 to 8,920) 

that are projected to result from this rule 

in relation to the baseline, speculating 

on the specific air emissions that would 

result from this rule would not result in 

information indicating that the indirect 

impacts, unassociated with the scope of 

this rule, would contribute to significant 

adverse impacts on the environment 

from resuming imports from Canada of 

cattle over 30 months of age born on or 

after March 1, 1999. 

The method of transporting cattle and 

the type of vehicle to be used are not 

mandated by APHIS regulations. 

Emissions from the transport of cattle, 

or of any commodity moved by modern 

transport methods, are unavoidable. 

However, measures to reduce the 

impacts from vehicle emissions are 

enforced by environmental statutes, 

such as the Clean Air Act, at both the 

State and Federal levels and have been 

reported to be effective in regulating and 

decreasing vehicle emissions. 

Mitigations for vehicle emissions are 

under the jurisdiction of the U.S. 

Environmental Protection Agency and 

State government agencies and are 

outside of the mission of APHIS. 

The commenter is correct that the EA 

did not discuss the contribution of 

greenhouse gases from the transport 

trucks that would be used to import 

cattle and did not discuss mitigation 

measures for greenhouse gases. We note 

that draft guidance provided to Federal 

agencies from the Council on 

Environmental Quality with regard to 

consideration of global climatic change 

in environmental documents calls for 

consideration, in the context of NEPA, 

of how major Federal actions could 

influence the emissions and sinks of 

greenhouse gases and how climate 

change could potentially influence such 

actions.27 We interpret that this 

guidance does not apply to this 

rulemaking because it is not a major 

Federal action that could influence the 

emissions and sinks of greenhouse 

gases .28

Issue: One commenter stated that 

APHIS’ EA did not assess the 

environmental impact of holding and 

feeding in the United States each year 

hundreds of thousands of Canadian 

cattle 30 months of age or older. 

Response: Approximately 34 million 

head of cattle are slaughtered in the 

United States each year. Approximately 

0.13 to 0.45 million additional head of 

cattle would be available annually and 

eligible for importation from Canada 

under this rulemaking. The majority of 

cattle that we anticipate being imported 

from Canada and held in feedlots will 

be cattle under 30 months of age that are 

already allowed importation from 

Canada under our January 2005 final 

rule. The majority of additional cattle 

that we expect to be imported as a result 

of this rulemaking would consist of 

cows, bulls, and stags imported directly 

for slaughter that would remain in a 

holding facility of the slaughter facilities 

for approximately 1 to 2 days before 

slaughter. A small percentage of the 

remainder of the cattle that we expect to 

be imported as a result of this 

rulemaking would consist of breeding 

cattle (for example, dairy or beef cows 

and heifers and bulls) that would be 

integrated into a cattle herd for an 

indefinite period of time. Thus, for 

purposes of the EA, the cattle that 

would be imported would not be held 

in feedlots for a long duration and 

would not contribute to an increase to 

the baseline of the number of cattle 

produced in the United States and held 

and fed in feedlots each year. 

Pollutant discharges and emissions 

from holding cattle in feedlots are 

unavoidable; however, measures to 

reduce the impacts from feedlot 

discharges and emissions are enforced 

by environmental statutes, such as the 

Clean Water Act and the Clean Air Act, 

at both the State and Federal levels. 

Requirements for mitigating pollutant 

discharges and emissions, under the 

jurisdiction of Federal and State 

government agencies, are intended to 

protect the human environment of the 

United States. 

Issue: One commenter expressed the 

opinion that our EA was inadequate 

because, according to the commenter, it 

failed to explain why the potential for 

widespread distribution of infectious 

BSE prion proteins is not a significant 

environmental impact. The commenter 

expressed concern that blood and SRMs 

that will be collected when cattle of 

Canadian origin that are over 30 months 

of age are slaughtered can be used as 

fertilizer and be spread on the ground 

(and ingested as well as running off into 

streams) on farms throughout the United 

States. The commenter stated further 

that the EA did not assess the 

environmental impact of distributing 

infectious BSE prion proteins in animal 

feed that will be used (and spilled, 

disposed of, and excreted) on farms 

across the United States. The 

commenter stated that OIE guidelines 

prohibit trade in SRMs for use in 

fertilizer, as well as trade in fertilizer 

contaminated with SRMs. 

Response: The commenter did not 

specify, and it is not clear to us, in what 

manner the commenter anticipates 

prions being widely distributed through 

animal feed and fertilizer and having a 

significant impact on the quality of the 

human environment. Scientists believe 

that the primary route of BSE 


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transmission in cattle requires that an 

animal ingest feed that has been 

contaminated with a sufficient amount 

of tissue from an infected animal. In 

humans, vCJD, a chronic and fatal 

neurodegenerative disease of humans, 

has been linked via scientific and 

epidemiological studies to exposure to 

the BSE agent, most likely through 

consumption of cattle products 

contaminated with the BSE agent. 

Therefore, our assumption is that the 

commenter’s primary concern regarding 

the potential impact of feed and 

fertilizer on the environment is the 

potential consumption of BSEcontaminated feed or fertilizer by 

ruminants or humans. We also consider 

it possible that the commenter is 

concerned about the potential for the 

BSE agent to be consumed by animals 

other than ruminants, excreted by those 

animals, and subsequently consumed by 

ruminants or humans. 

The commenter stated that APHIS 

inadequately assessed the potential 

environmental impact of contaminated 

feed and fertilizer. We disagree with the 

commenter. Our EA evaluated the 

potential impact of the proposed rule on 

the physical environment, public 

health, and endangered species, as well 

as cumulative impacts of any of the 

above. The EA referenced and discussed 

the conclusions of the risk assessment 

we conducted for this rulemaking, in 

which we assessed the likelihood that 

U.S. cattle would be exposed to the BSE 

agent as a result of this rule. Our risk 

assessment examined the likelihood of 

exposure of ruminants to BSE via feed. 

Our evaluation of risk included an 

understanding that SRMs from live 

cattle imported under the conditions of 

the proposed rule would enter the U.S. 

rendering system, in the same fashion 

that SRMs from cattle of U.S. origin are 

generally disposed of. The protein 

products from the rendering system 

could then be incorporated into either 

animal feed or fertilizer. We assumed in 

the risk assessment that the vast 

majority of rendered protein products 

are sold for use in animal feed. The 

commenter makes this assumption as 

well, stating that ‘‘* * * SRMs can be 

used as a protein source for animal feed 

other than ruminant feed, and it is 

reasonable to assume that they will be, 

given the favorable economics of this 

use as compared to SRM disposal.’’

The quantitative exposure model used 

in the risk assessment specifically 

simulated potential exposures through 

feed—either through ruminant feed that 

was mislabeled or cross-contaminated, 

through other animal feed that was 

misfed to ruminants, or directly through 

poultry litter that could contain spilled 

feed and be fed back to cattle. These 

pathways are the most direct exposure 

of cattle that could occur. 

We disagree with the commenter’s 

assertion that APHIS did not consider 

‘‘spilled, disposed of, or excreted’’

animal feed as a potential pathway of 

BSE transmission. The poultry litter 

pathway modeled in the quantitative 

exposure model specifically addresses 

spilled and even undigested excreted 

feed, with very conservative 

assumptions about potential infectivity 

retained in such feed. The issue of feed 

being ‘‘disposed of’’ is addressed 

through the misfeeding component of 

the model, which incorporates 

situations where non-ruminant feed is 

fed directly to cattle. These situations 

would include those where a producer 

either mistakenly or intentionally feeds 

non-ruminant feed to ruminants. 

Mislabeling and misfeeding components 

would include situations where nonruminant feed is sold for salvage value. 

We are not aware of similar situations 

where litter or waste from other 

species—for example, swine litter—that 

contains quantities of either spilled or 

undigested feed is routinely used for 

cattle feed. Further, there is no evidence 

to date of environmental contamination 

(e.g., via fecal or other bodily 

excretions) being a route of transmission 

of BSE. Therefore, we do not consider 

there to be potentially significant 

pathways for exposure of susceptible 

animals to BSE-contaminated feed that 

were not considered in the risk 

assessment. 

With regard to potential exposure of 

humans to the BSE agent, there is no 

evidence, anecdotal or otherwise, to 

suggest any likelihood of BSEcontaminated animal feed, spilled or 

excreted, being consumed by humans, 

and we consider the risk of such 

exposure to be negligible. 

The commenter also stated that the 

EA should have examined the potential 

impact on the environment of BSEcontaminated fertilizer. As noted above, 

although rendered protein can be a 

component of fertilizer, such usage is 

not common because most rendered 

proteins are sold for use in feed. Any 

consideration of animal health exposure 

from fertilizer would be an evaluation of 

the risk of cattle exposure to BSE 

through oral consumption of fertilizer 

that contains rendered protein. Our 

quantitative exposure model evaluates 

the potential oral exposure of cattle to 

feed containing such rendered protein. 

It does not specifically model potential 

exposure through fertilizer. However, it 

assumes that all rendered ruminant 

protein products are sold for feed use. 

Therefore, any of the infectivity 

contained in rendered ruminant protein 

is already simulated through the 

potential for direct feed exposure. This 

is a more direct pathway than any 

potential consumption of a component 

of a fertilizer product, some undefined 

time after it was spread on a pasture. 

Therefore, any potential exposure 

through fertilizer would be assumed to 

be far less than the exposure the model 

already takes into account through the 

consumption of feed. 

It appears that the commenter is 

suggesting that raw, untreated SRMs 

might be spread directly on land as 

fertilizer. Raw or untreated tissues are 

not generally used as fertilizer, and, in 

fact, are often prohibited from being 

spread on land through environmental 

regulations on carcass/offal disposal and 

solid waste disposal. Therefore, this risk 

pathway was not considered in our risk 

assessment. 

With regard to the likelihood of 

exposure of humans to the BSE agent 

through fertilizer, we are assuming the 

commenter is not referring to potential 

consumption by humans of fertilizer, 

and is referring instead to some other 

method of BSE transmission to humans 

through fertilizer. As noted above, there 

is no evidence to date of environmental 

contamination being a route of 

transmission of BSE. 

Regarding the commenter’s statement 

that OIE guidelines recommend that 

trade not be carried out in SRMs for use 

in fertilizer, as well as trade in fertilizer 

contaminated with SRMs, the primary 

purpose of such guidelines is to reduce 

the possibility of the consumption by 

cattle of such product due to 

mislabeling or misdirection of 

shipments—e.g., through having SRMderived protein for fertilizer mistakenly 

sent to a feed mill. 

Other Issues 

A number of commenters raised other 

issues that did not address the 

provisions of the proposed rule. 

Requests Regarding the Importation of 

Additional Commodities 

We received comments that requested 

that bovine commodities not 

specifically addressed in our proposed 

rule be made eligible for importation 

into the United States. 

Issue: Several commenters requested 

that U.S. regulations with regard to BSE 

allow the importation of the same 

commodities that Canada considers 

eligible for importation from the United 

States. 

Response: Although in most cases, 

Canadian and U.S. import restrictions 

regarding BSE are comparable, we do 

not consider it practical or advisable to 


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attempt to mirror the regulations of 

another country, given differences in 

regulatory approach, structure, and 

authority. 

Issue: Commenters requested that the 

current regulations be amended to allow 

the importation from BSE minimal-risk 

regions of rendered feed products—

including bovine-derived meat-andbone meal and blood meal—that are 

manufactured in compliance with U.S. 

regulations if the products can be 

determined to meet the health 

protection objectives of the 

recommended standards of the OIE. 

Response: The recommended 

standards of the OIE clearly state that 

ruminant-derived rendered protein 

should not be traded from either 

controlled risk or undetermined risk 

countries. 

For the reasons discussed above, we 

are making no changes based on these 

comments. 

APHIS’s Use of the Term ‘‘Minimal-Risk 

Region’’

Issue: Several commenters requested 

that APHIS discontinue classifying and 

referring to countries as ‘‘BSE minimalrisk regions.’’ The commenters stated 

that APHIS’s definition of ‘‘minimal-risk 

regions’’ does not follow the scientific 

terminology of the OIE, which classifies 

countries with regard to BSE risk as 

‘‘negligible,’’ ‘‘controlled,’’ or 

‘‘undetermined.’’ One commenter stated 

that APHIS’s classification of BSE 

minimal-risk regions may create 

confusion and be seen as not accepting 

the OIE categorization criteria. 

Response: At the time APHIS 

published its January 2005 final rule to 

recognize a category of BSE minimalrisk regions, the OIE guidelines 

regarding BSE provided for five possible 

BSE classifications for regions. For each 

classification, the guidelines 

recommended different export 

conditions for live animals and 

products, based on the risk presented by 

the region. Although APHIS did not 

incorporate the text of OIE’s BSE 

guidelines into its January 2005 rule, the 

agency based its standards regarding 

BSE minimal-risk regions on these 

guidelines. Although we are making no 

changes based on the comments, it is 

APHIS’s intent to develop rulemaking 

that would more closely employ 

terminology used in the current OIE 

standards. 

BSE Surveillance in the United States 

Issue: Several commenters expressed 

general concern with the effectiveness 

of the current BSE testing program in 

the United States. One commenter 

stated that a report issued by the U.S. 

Office of the Inspector General (OIG) 

called into question USDA’s ability to 

adequately detect BSE, even before the 

most recent reduction in the U.S. 

surveillance program. The commenter 

stated that an OIG report pointed to the 

voluntary nature of the surveillance 

program and the program’s sampling 

protocols as indicators that the 

surveillance program may not have been 

providing an accurate picture of BSE 

prevalence in the United States. The 

report also noted that the surveillance 

program, which focused on high-risk 

cows, did not account for emerging 

evidence that BSE has been detected in 

seemingly healthy animals. 

Response: We assume the commenters 

are referring to an OIG audit report 

issued in August 2004. This audit was 

conducted prior to the implementation 

of the enhanced surveillance program 

and, therefore, was limited in the 

conclusions that could be made about 

the performance of that effort. The 

report stated the following: ‘‘Our review 

was limited because implementation 

plans have not been finalized and 

APHIS has not yet been able to address 

some of the questions we have raised.’’

Nevertheless, APHIS responded to the 

recommendations provided by OIG and 

addressed the issues raised. A second 

audit report was issued in January 2006, 

covering both the surveillance program 

and FSIS’ controls on SRM 

requirements and advanced meat 

recovery products. This report included 

a recommendation, among others, for 

transparency in the analysis and 

conclusions derived from the data 

obtained during the surveillance efforts. 

APHIS has subsequently completed and 

released a detailed summary of the data 

obtained during the enhanced 

surveillance effort, and an estimate of 

the prevalence of BSE in the United 

States adult cattle population. This 

analysis concluded that the prevalence 

of the disease in this country is 

extremely low, less than 1 case per 

million adult cattle. Two models were 

used to estimate the prevalence, and the 

most likely values calculated by these 

models for the estimated number of 

cases were 4 or 7 infected animals out 

of 42 million adult cattle. APHIS’

analysis was submitted to the scrutiny 

of a peer review process, and the expert 

panel agreed with the appropriateness 

of APHIS’ assumptions and the factors 

it considered, as well as with the 

estimate of BSE prevalence. 

Country-of-Origin Labeling 

A number of commenters 

recommended that APHIS postpone 

implementation of this rule until 

mandatory country-of-origin labeling, as 

prescribed by the 2002 Farm Bill, is in 

place in this country. 

Response: On May 13, 2002, President 

Bush signed into law the Farm Security 

and Rural Investment Act of 2002, more 

commonly known as the 2002 Farm Bill. 

One of its many initiatives requires 

country of origin labeling (COOL) for 

beef, lamb, pork, fish, perishable 

agricultural commodities and peanuts. 

On January 27, 2004, President Bush 

signed Public Law 108–199 which 

delays the implementation of mandatory 

COOL for all covered commodities 

except wild and farm-raised fish and 

shellfish until September 30, 2006. On 

November 10, 2005, President Bush 

signed Public Law 109–97, which 

delays the implementation for all 

covered commodities except wild and 

farm-raised and shellfish until 

September 30, 2008. As described in the 

legislation, program implementation is 

the responsibility of USDA’s 

Agricultural Marketing Service. 

The COOL program, when fully 

implemented, will address the concerns 

raised by commenters with regard to 

APHIS’ proposed rule. APHIS does not 

consider it necessary to delay 

implementation of this rule until those 

labeling provisions are implemented. In 

its October 30, 2004 proposal, AMS 

noted, in discussing Section 10816 of 

Public Law 107–171 (7 U.S.C. 1638–

1638d) regarding COOL that the ‘‘intent 

of the law is to provide consumers with 

additional information on which to base 

their purchasing decisions. It is not a 

food safety or animal health measure. 

COOL is a retail labeling program and 

as such does not address food safety or 

animal health concerns.’’

Comments on Other Issues Outside the 

Scope of This Rulemaking 

A number of other comments also 

addressed topics outside the scope of 

the proposed rule. These comments 

included the following issues: Concern 

that the examination and euthanization 

of cattle be carried out in a humane 

fashion; a request to extend the U.S. ban 

on the slaughter of nonambulatory cattle 

to include all livestock species; 

recommendations regarding the type of 

penalties USDA should impose for 

noncompliance with the regulations; 

comparison of U.S. and Canadian 

regulations regarding the rendering of 

cattle slaughtered on-farm; the 

importation of composted bovine 

manure from BSE minimal-risk regions; 

a request to allow the importation of 

breeding stock and embryos of small 

ruminants, such as sheep; a request that 

the USDA allow the importation from 

BSE minimal-risk regions of up to 5 

kilograms of bovine meat and meat 


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products for personal use without 

certification; and concerns regarding 

diseases other than BSE. 

For the reasons discussed above, we 

are making no changes to the proposed 

rule based on these comments. 

Final Report From Peer Review of 

APHIS’ Risk Assessment and Responses 

to Peer Reviewer Questions and 

Recommendations 

As discussed above under the heading 

‘‘Peer Review of APHIS’ Risk 

Assessment,’’ we requested an external, 

formal, and independent peer review of 

our risk assessment by recognized 

experts in the field. The objective of the 

peer review was to determine whether 

the risk assessment was scientifically 

sound, transparent, and consistent with 

international standards (e.g., those 

developed by OIE); the application of 

external assessments or models was 

appropriate; and the assumptions were 

justified, supported and reasonable. In 

summary, the reviewers found that the 

methods used in the risk assessment 

were scientifically rigorous in terms of 

using existing literature and models 

appropriately and making sound 

assumptions and that the risk 

assessment itself adhered to 

international risk assessment standards. 

The reviewers also agreed with the 

conclusion that the likelihood of 

establishment of BSE in the U.S. cattle 

population is negligible. They also 

asked a variety of questions and 

suggested minor refinements. APHIS’

full response to the comments and 

recommendation of the peer reviewers 

may be viewed on the APHIS Web site 

(http://www.aphis.usda.gov/newsroom/ 

hot_issues/bse/index.shtml ). 

Some of the questions raised by peer 

reviewers were also posed in public 

comments on our proposed rule and are 

addressed above in our responses to 

public comments. In addition, we set 

forth here certain other questions and 

recommendations from peer reviewers 

that we consider representative of the 

content-related questions and 

recommendations of the report, and our 

response to those questions and 

recommendations. 

Issue: A reviewer suggested that we 

more explicitly list the specific risks to 

be addressed in the assessment. 

Response: The risk of BSE evaluated 

in the assessment is the expected impact 

of importing from Canada live animals, 

blood and blood products, and small 

intestines excluding distal ileum. These 

impacts include the potential for 

establishment of BSE in the United 

States and the projected consequences 

of any additional cases that might occur 

even without establishment. The risk 

was evaluated qualitatively for all 

commodities and also quantitatively for 

additional live animal import scenarios. 

For the latter, the likelihood of 

establishment is measured by the 

disease reproductive rate (R0). We also 

simulated the total number of animals 

in the United States that might become 

infected with BSE as a result of the 

importation of live bovines from Canada 

over the 20 years. Of the infected 

animals, those that we assumed might 

have economic impacts were only the 

animals expected to live long enough to 

display clinical signs, as these are the 

most likely to be detectable with current 

testing methods. We have added this 

clarification to the Introduction of the 

revised risk assessment. 

Issue: A reviewer suggested that the 

analysis needs to acknowledge the 

exogenous sources of BSE into Canada. 

As phrased by the reviewer: 

For the assumption that BSE prevalence in 

Canada would decrease over the next 20 

years until the disease is eradicated, the 

authors relied on compelling evidence from 

the U.K. experience with the ruminant feed 

ban and the resulting dramatic decrease in 

BSE prevalence in cattle. However, this did 

not address any issues associated with 

exogenous sources of BSE into Canada 

(imports from other BSE-affected countries). 

The Canadian prevalence model used for this 

analysis appears to assume no new 

exogenous sources of BSE. The dilution of 

risk due to current practices that reduce the 

likelihood of spread of prions through the 

Canadian cattle herd make this risk minimal 

at best, but it should be addressed for the 

sake of completeness. 

Response: The prevalence estimation 

models use BSE surveillance data (test 

results from dead or slaughtered cattle) 

as inputs and therefore cannot 

differentiate whether the source of 

infectivity is endogenous (recycled) or 

exogenous (introduced). Also, because 

they are based on actual surveillance 

data, they cannot attempt to predict any 

changes in Canadian BSE prevalence 

over the next 20 years. The qualitative 

prediction of a drop in prevalence is 

based on the experience in the United 

Kingdom and does not assume that no 

additional infectivity can be introduced. 

In addition, the results of the U.S. 

Harvard model presented in our risk 

assessment illustrate that, despite the 

recurrent release of ‘‘exogenous 

infectivity’’ (in this case, from Canada), 

the reproductive constant, R0, remains 

well below one, indicating that the 

mitigations in place (particularly the 

ruminant feed ban) are effective in 

driving disease prevalence downward. 

Since the feed ban in Canada is very 

similar to that in the United States, we 

expect that any additional infectivity 

that may potentially enter Canada 

would fail to alter our predictions of a 

decrease in prevalence over time. For 

these reasons, we do not explicitly 

address the source of BSE infectivity in 

Canada as either endogenous or 

exogenous. 

Issue: A reviewer suggested that we 

address the amount of uncertainty that 

is associated with the conclusion that 

the likelihood of releasing BSE into the 

United States from Canada via 

importation of live bovines is extremely 

low. He suggested that we report and 

use the 95th confidence levels 

throughout the assessment. 

Response: Uncertainty between 

prevalence estimation models (BBC or 

BSurvE) is greater than the statistical 

uncertainty within prevalence 

estimation models (represented by 

confidence levels for a given model). 

Therefore, uncertainty about prevalence 

is addressed by considering the two 

expected (average) prevalence estimates 

obtained with different models. The 

reviewer also commented that the 

expectation that prevalence remains 

stable at the lower level estimated by 

the BBC model over the next 20 years 

is ‘‘a very pessimistic assumption.’’

Similarly, another reviewer stated that it 

is ‘‘very reasonable’’ to assume that BSE 

prevalence in Canada will decrease over 

the next 20 years until the disease is 

eradicated . If these assertions are 

correct, then assuming that prevalence 

remains stable at the 95 percent (or 99 

percent) confidence level estimated by 

the BSurvE model over the next 20 years 

would simply result in a more 

extremely pessimistic assumption. A 

reviewer commented: ‘‘It should’be 

pointed out that the other pessimistic 

assumptions in the Exposure 

Assessment model (for example no 

decrease in BSE prevalence over the 

next 20 years) would likely override any 

underestimate of the present BSE 

prevalence due to using the mean BBC 

prevalence estimate.’’ For the reasons 

noted above, we have elected not to 

rerun the exposure model using the 95 

(or 99) percent confidence level. 

Issue: A reviewer commented that 

‘‘[o]ne argument that might be made is 

that introduction will not lead to an 

establishment of a cycle of infection but 

may extend the temporal occurrence of 

the number of cases of BSE in the U.S. 

Are there any adverse economic effect[s] 

associated with this outcome? One 

possibility is that testing levels might 

need to be maintained for a longer time 

than if there were no more introduced 

and detected BSE cases. Market access 

and prices for beef and beef products 

might also be adversely affected.’’

Response: The APHIS risk assessment 

did not consider endogenous levels of 


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BSE in the U.S. cattle herd; however, 

continuous exogenous inputs of BSE 

infectivity from Canada (as is assumed 

in the less likely quantitative scenarios 

of the risk assessment) or any other 

source would extend the time to 

eradication of the disease in the United 

States. Although the incremental 

duration of the extended time to 

eradication is unknown, we expect that 

it would have little or no practical effect 

on the potential economic impacts of 

BSE in the United States. We note that 

the exposure model, which incorporates 

several risk-inflating assumptions, 

estimates that, over the 20 years of the 

analysis, there will be less than one 

clinical case of BSE in the United States 

as a result of the cattle imported from 

Canada. Given that the United States 

has already detected three BSE cases 

(two in native cattle), we do not expect 

any incremental impact (from a 

lengthened period of testing or from 

additional market impacts) of this very 

small number of potential additional 

cases. This point is described in detail 

in the consequence section of our risk 

assessment. 

Issue: One reviewer requested greater 

attention to uncertainty throughout the 

document. The reviewer stated, in 

reference to our risk assessment, that 

‘‘uncertainty is consistently 

underplayed if not ignored’’ and ‘‘it 

would perhaps be useful to actually list 

the sources of uncertainty in each of the 

sections. Another commenter suggested 

that we list all the model inputs 

considered to be variable. 

Response: We disagree with the 

reviewers. Though not always addressed 

as distinct lists, uncertainty and 

varibiality are incorporated throughout 

the risk assessment. The models used in 

the risk assessment are complex with a 

large number of inputs, which, as for 

most models, may be somewhat 

uncertain and/or variable. However, 

preparing a comprehensive list of 

uncertain and/or variable risk 

assessment model inputs is not 

necessary. In our judgment, the inputs 

are better discussed in the context of 

how they are used in the model. 

All of the BSE prevalence estimation 

model inputs represent best available 

estimates of either a variability 

distribution (e.g., BSE incubation 

period, cattle age structure) or a 

parameter value (e.g., number of adult 

animals in the herd, age of a BSE tested 

animal). Consequently, the calculated 

confidence intervals represent statistical 

uncertainty about current BSE 

prevalence related to random sampling 

error. The major source of uncertainty 

regarding BSE prevalence in the current 

standing cattle population was 

considered to be the effect of the 

Canadian feed ban. This uncertainty 

was addressed by considering two BSE 

prevalence estimation models: The BBC 

model, which incorporates an estimate 

of the effect of the feed ban based on 

evidence from the United Kingdom, and 

the BSurvE Prevalence B model, which 

makes no assumptions about the effect 

of the feed ban. Variability also entered 

into the prevalence calculation in that 

the BBC prevalence model assumes that 

birth year cohort prevalence declined 

during the first five years after Canada 

introduced a feed ban in 1997. 

Thereafter, both the BBC and BSurvE 

models were used to obtain the 

expected proportion of BSE infected 

animals, which is assumed to remain 

constant over time in the quantitative 

risk analysis. 

Another component of the release 

assessment, for which uncertainty has 

not been addressed, is the projection of 

imports. These projections were 

prepared by USDA ERS and were based 

on USDA baseline projections and a 

broad array of expert opinion. Because 

they are projections, they are uncertain. 

This uncertainty has been reduced 

somewhat by incorporating more recent 

data into the 2007 import projections, 

prepared for the final rule. Based on 

these updates, we expect lower numbers 

of older animals to be imported in the 

early years of the rule’s implementation. 

The total imports over the entire 20 

years of the analysis are only slightly 

(125,000 animals) higher than the 

original and so do not confer significant 

additional magnitude of release 

(125,000*0.68*10¥6=0.085 cases; 

125,000*3.9*10¥6=0.49 cases). 

Therefore, although the import 

projections are somewhat uncertain, 

reduction of this uncertainty has not 

significantly changed our release 

estimates or conclusions. 

The projections used in the original 

analysis incorporated temporal 

variability across years due to the cattle 

cycle. The variability considered did not 

include possible but less likely extremes 

(shocks), such as a temporary spike in 

slaughter rates due to severe weather. 

The parameters for the exposure 

model have been described in earlier 

documents (Cohen, et al., 2003). These 

documents explicitly examined the 

effects of uncertainty in key parameters 

in their respective sensitivity analyses. 

The version of the Harvard model 

performed for this rule included a 

sensitivity analysis to examine the 

uncertainty of several parameters—some 

of which were included in earlier 

models, and some of which were new 

parameters (e.g., the amount of chicken 

litter incorporated into ruminant feed) 

and the Canadian BSE prevalence 

estimate) (APHIS 2007a). Of the 

uncertain parameters examined, 

Canadian BSE prevalence over the next 

20 years was the most significant source 

of uncertainty for the model. This 

uncertainty contains two components: 

The estimate of prevalence in Canada’s 

current standing cattle population, and 

how prevalence of BSE in Canada will 

change over time. This latter component 

was not treated quantitatively, and its 

uncertainty was therefore not explicitly 

analyzed in the sensitivity analysis. 

Variability in this parameter was 

addressed, however. Assuming constant 

prevalence over the next 20 years, the 

simulated number of BSE infected cattle 

imported each year still varies, because 

it is a combination of the predicted 

import volume (which varies as 

described above), and the sampling 

variation (using a Poisson distribution) 

about the expected prevalence value. 

This source of variation has already 

been described in the risk assessment. 

In conclusion, rather than perform a 

comprehensive uncertainty analysis in 

which all model inputs are treated as 

statistical distributions, we identified 

and evaluated the potential 

contributions to variability and 

uncertainty that we deemed most 

relevant to our analysis. Given that the 

uncertainty about the key inputs to the 

risk assessment models has been 

considered, we agree with the reviewers 

that further uncertainty analysis will not 

affect the conclusions of the risk 

assessment. 

Adoption of this Final Rule 

Therefore, for the reasons given in the 

proposed rule and in this final rule, we 

are adopting the proposed rule as a final 

rule, without change. 

Applicability of the March 1, 1999, Date 

to Imports of Beef 

Issue: Several commenters stated that 

it was not clear from the proposed rule 

whether the March 1, 1999, date of birth 

requirement for live bovines imported 

into the United States from Canada 

would apply as well to frozen beef 

products derived from cattle slaughtered 

in Canada and shipped to the United 

States. If the same effective date does 

not apply, stated the commenter, USDA 

should specify what date would be used 

for imported frozen beef products. One 

commenter stated that, in addition to 

prohibiting the importation of beef from 

cows born before March 1, 1999, the 

regulations should limit the importation 

of beef from BSE minimal-risk regions to 

that derived from cows slaughtered no 

earlier than March 1, 1999. 


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Response: We do not consider it 

necessary to address the importation of 

beef from BSE minimal-risk regions in 

this rulemaking, because the 

importation conditions for meat, meat 

byproducts, and meat food products 

derived from bovines were addressed in 

the rulemaking for our January 2005 

final rule (in which we added the 

category of BSE minimal-risk regions to 

the regulations and specified which 

commodities may be imported from 

such regions). The risk analysis we 

conducted for that rulemaking indicated 

a low BSE risk from such commodities 

derived from bovines of any age if 

certain conditions are met. In that 

rulemaking, we discussed regulatory 

requirements implemented by FSIS in 

2004 that banned SRMs from the human 

food supply in the United States, and 

we stated that the Canadian Government 

had established similar safeguards in 

Canada. 

Consequently, we provided in § 94.19 

of the regulations that meat, meat 

byproducts, and meat food products 

derived from bovines are eligible for 

importation from BSE minimal-risk 

regions if the following conditions, as 

well as all other applicable 

requirements of the regulations, are met: 

• The commodity is derived from 

bovines that have been subject to a 

ruminant feed ban equivalent to the 

requirements established by the U.S. 

Food and Drug Administration at 21 

CFR 589.2000; 

• The commodity is derived from 

bovines for which an air-injected 

stunning process was not used at 

slaughter; and 

• The SRMs and small intestine of the 

bovines from which the commodity was 

derived were removed at slaughter. 

Because there is negligible risk from 

bovine meat, meat byproducts, and meat 

food products that meet the above 

requirements, there is no science-based 

reason to require that such commodities 

be derived from bovines born on or after 

March 1, 1999. As long as the 

commodities meet the conditions listed 

above (with the exception of the 

condition regarding small intestine as 

discussed in this rule), the regulations 

will allow for their importation into the 

United States. We note that the OIE 

guidelines for trade in fresh meat and 

meat products from cattle from 

controlled risk regions (both Canada and 

the United States are classified as BSE 

controlled risk regions under the OIE 

guidelines) recognize the negligible risk 

presented by such products as long as 

SRMs are removed, and, therefore, the 

guidelines do not recommend that the 

date of birth of the animal from which 

the commodity was derived be a 

condition for such trade. 

Comments Regarding the Partial Delay 

in Applicability of the January 2005 

Final Rule 

Issue: As discussed above in this 

document, in March 2005, APHIS 

published a final rule in the Federal 

Register that, pursuant to an 

announcement by the Secretary of 

Agriculture in February 2005, delayed 

the applicability of the provisions in our 

January 2005 final rule as they apply to 

the importation from Canada of meat, 

meat food products, and meat 

byproducts (other than liver) when 

derived from bovines 30 months of age 

or older when slaughtered, as well as 

certain other bovine products when 

derived from bovines 30 months of age 

or older. 

A number of commenters either 

questioned whether the delay in 

applicability would be lifted if our 

January 2007 proposed rule were made 

final, or requested that the delay be 

lifted. 

Response: As discussed above, it is 

the Secretary’s intent to remove the 

delay in applicability when this rule 

becomes effective. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This rule has been reviewed under 

Executive Order 12866. The rule has 

been determined to be economically 

significant for the purposes of Executive 

Order 12866 and, therefore, has been 

reviewed by the Office of Management 

and Budget. 

We have prepared an economic 

analysis for this rule. The economic 

analysis provides a cost-benefit analysis 

as required by Executive Order 12866 

and a final regulatory flexibility analysis 

that examines the potential economic 

effects on small entities as required by 

section 604 of the Regulatory Flexibility 

Act. The economic analysis is 

summarized below. Copies of the full 

analysis may be viewed on the APHIS 

Web site (http://www.aphis.usda.gov/ 

newsroom/hot_issues/bse/index.shtml), 

or be obtained by contacting the persons 

listed under FOR FURTHER INFORMATION

CONTACT. 

This rule will allow the importation, 

under certain conditions, of the 

following commodities from BSE 

minimal-risk regions (currently only 

Canada): 

• Live bovines that were born on or 

after March 1, 1999; 

• Bovine small intestines, minus the 

distal ileum; 

• Bovine casings; and 

• Bovine blood and blood products. 

APHIS has determined that the 

previous restrictions are not warranted 

by scientific research and evidence, and 

that they are unnecessary for 

maintaining a negligible risk (i.e., the 

likelihood of establishment and the 

potential impacts of cases that may 

occur even without establishment) to 

the United States via imports of live 

bovines and bovine products from such 

regions. 

Additionally, this rule removes the 

delay of applicability of provisions of 

our January 2005 final rule regarding the 

importation of meat, meat products, and 

meat byproducts derived from bovines 

in Canada that were 30 months of age 

or older when slaughtered. 

This regulatory impact analysis (RIA) 

addresses expected economic effects of 

allowing resumption of imports from 

Canada of the above commodities. 

Expected benefits and costs are 

examined in accordance with Executive 

Order 12866. Expected economic 

impacts for small entities are also 

evaluated, as required by the Regulatory 

Flexibility Act. Our analysis indicates 

that benefits of the rule will exceed 

costs overall. Effects for Canadian and 

other foreign entities are not addressed 

in this analysis. However, the Agency 

expects reestablished access to U.S. 

markets to benefit Canadian producers 

and suppliers of commodities included 

in the rule. 

Analytical Approach 

The approach and models used in this 

analysis are the same as were applied in 

the preliminary RIA that we prepared 

for our January 2007 proposed rule. 

Impacts for cattle for feeding or for 

immediate slaughter and impacts for 

beef are quantitatively modeled. Impacts 

for other affected commodities—

breeding cattle including dairy, vealers 

and slaughter calves, bison, bovine 

casings and small intestine products, 

and bovine blood and blood products—

are examined largely qualitatively. For 

the modeled cattle and beef, we project 

a 5-year baseline, 2008–2012, against 

which we measure expected price and 

welfare effects of projected levels of 

cattle and beef imports from Canada. We 

evaluate price and welfare effects for the 

three scenarios that were considered in 

the preliminary RIA, as follows: 

• Scenario 1: Allow imports of 

Canadian cattle born on or after March 

1, 1999; 

• Scenario 2: Allow imports of 

Canadian cattle unrestricted by date of 

birth; and 

• Scenario 3: The same as scenario 1, 

with the addition of the resumption of 

imports of beef from Canadian cattle 


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Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 53367 

29A complete description of the model is 

provided in: Forsythe, K.W. ‘‘An Economic Model 

for Routine Analysis of the Welfare Effects of 

Regulatory Changes.’’ V3.00. U.S. Department of 

Agriculture, Animal and Plant Health Inspection 

Service, Veterinary Services, Centers for 

Epidemiology and Animal Health. April 20, 2005 

(draft). http://www.aphis.usda.gov/peer_review/ 

content/printable_version/ 

bas_model_econOnly_apr20.pdf 

30Four examples of studies based on this type of 

model are: Paarlberg, P.L., A.H. Seitzinger, and J.G. 

Lee, ‘‘Economic Impacts of Regionalization of a 

Highly Pathogenic Avian Influenza Outbreak in the 

United States,’’ Journal of Agricultural and Applied 

Economics, forthcoming. Paarlberg, P.L. 

‘‘Agricultural Export Subsidies and Intermediate 

Goods Trade,’’ American Journal of Agricultural 

Economics. 77, 1(1995): 119–128. Paarlberg, P.L., 

J.G. Lee, and A.H. Seitzinger. ‘‘Potential Revenue 

Impact of an Outbreak of Foot-and-Mouth Disease 

in the United States,’’ Journal of the American 

Veterinary Medical Association. 220, 7(April 1, 

2002): 988–992. Sanyal, K.K. and R.W. Jones. ‘‘The 

Theory of Trade in Middle Products,’’ American 

Economic Review. 72(1982): 16–31. 

31http://www.usda.gov/oce/commodity/ 

ag_baseline.htm 

slaughtered at 30 months or older 

(called over-30-month, or OTM beef). 

As a fourth scenario, we consider 

imports of Canadian cattle unrestricted 

by date of birth, with the resumption of 

OTM beef imports. Projected imports 

under this scenario 4 are described, but 

the expected impacts are not evaluated, 

for reasons explained below. 

Beginning with baseline quantities 

and prices, we compute effects of the 

projected changes in imports from 

Canada for four commodity categories: 

Cull cattle/processing beef, feeder cattle, 

fed cattle, and fed beef. The resumption 

of cull cattle imports is expected to 

affect the slaughter mix in Canada, and 

that change in the slaughter mix will be 

reflected in changes in the mix of 

exports to the United States. 

As part of this adjustment, for 

example, we expect that more fed steers 

and heifers will be slaughtered in 

Canada and fewer will be exported to 

the United States than if cull cattle 

imports were not reestablished. 

Canada’s cattle inventory increased 

rapidly following the diagnosis of BSE 

in a Canadian cow in May 2003 and 

Canada’s subsequent loss of export 

markets for cattle and beef. In response, 

Canada’s slaughter capacity expanded. 

Beginning in July 2005, with the 

resumption of imports by the United 

States of Canadian feeder cattle and fed 

cattle, some Canadian plants continued 

to utilize their expanded slaughter 

capacity by shifting to increased cull 

cattle slaughter. Canadian cull cattle 

slaughter would likely continue to 

expand if the United States were to 

remain closed to imports of Canadian 

cull cattle. However, with this rule, we 

can expect some substitution in Canada 

of cull cattle slaughter by fed cattle 

slaughter. 

Importation of fewer fed cattle from 

Canada, all things equal, will cause the 

price of fed cattle in the United States 

to rise. We estimate the expected 

increase in price and, because of the 

price rise, the decrease in the quantity 

of fed cattle demanded by U.S. slaughter 

and packing establishments and the 

increase in the quantity of fed cattle 

supplied by U.S. feedlots. The analysis 

yields measures of welfare change, 

which in this example are in terms of 

surplus losses for U.S. buyers and 

surplus gains for U.S. sellers of fed 

cattle. 

For each of the first three scenarios, 

we compute impacts for the modeled 

commodities using the Baseline 

Analysis System (BAS) model.29

Impacts are also summed for each 

scenario. The BAS model is a net trade, 

non-spatial partial equilibrium model. 

Partial equilibrium means that the 

model results are based on maintaining 

a commodity-price equilibrium in a 

limited portion of an overall economy. 

Commodities not explicitly included in 

the model are assumed to have a 

negligible influence on the results. The 

simple summation of the separate 

partial equilibrium results using the 

BAS model does not take into account 

market dynamics, but does provide a 

reasonable approximation of the 

combined welfare effects for each 

scenario. 

We also examine impacts more 

broadly using a multi-sector model that 

takes into account substitution among 

livestock products in response to 

relative price changes.30 This model 

maps interactions among the grain, 

animal, and animal products industries. 

It takes into account substitution among 

livestock products in response to 

relative price changes, incorporates 

foreign trade, and yields expected price 

and revenue effects. The simulated 

multi-sector impacts tend to be smaller 

than the BAS model results because the 

model linkages specified between the 

livestock production and processing 

sectors capture at least some of the 

flexibility that industry enterprises 

exhibit when adjusting to supply 

shocks. These results support our 

expectation that broader impacts of the 

rule will be limited. 

Baseline quantities and prices and 

imports from Canada have been 

projected by staff of USDA ERS, Market 

and Trade Economics Division, Animal 

Products, Grains, and Oil Seeds Branch, 

based on their expert knowledge and 

reference to ‘‘USDA Agricultural 

Baseline Projections to 2016,’’ United 

States Department of Agriculture, 

Interagency Agricultural Projections 

Committee, Baseline Report OCE–2007–

1, February 2007.31

Projected Imports From Canada 

Scenario 1. Table A shows the 

projected changes in cattle and fed beef 

imports from Canada under scenario 1 

(in which imports of Canadian cattle 

born on or after March 1, 1999, are 

allowed). Under this scenario, cull cattle 

imports from Canada are projected to 

total 104,000 head in 2008 and average 

147,800 head over the 5-year period of 

analysis. These import numbers are 

considerably smaller than were 

projected in the preliminary RIA 

because we now have a better 

understanding of the extent to which 

the birth-date restriction and ageverification requirement may limit the 

number of cull cattle eligible for import. 

Annual declines in feeder cattle and fed 

cattle imports are projected to average 

6,800 head and 56,800 head, 

respectively. These declines correspond 

to projected changes in the overall 

Canadian cattle inventory, with the 

import volumes for fed cattle further 

adjusted downward to reflect greater 

competition from Canadian packers due 

to the resumption of U.S. imports of cull 

cattle. Yearly fed beef imports are 

projected to increase by an average of 

45.8 million pounds, carcass weight 

equivalent. 

All of the changes under scenario 1 

are small when compared to the 

commodities’ projected U.S. baseline 

supplies. The changes in imports for 

feeder cattle, fed cattle, and fed beef 

imports, in particular, are projected to 

be only fractions of 1 percent of baseline 

supplies. Under scenario 1, the number 

of cull cattle projected to be imported in 

2008 is less than 2 percent of projected 

U.S. baseline cull cattle slaughter 

quantities. Over the period of analysis, 

cull cattle imports are projected to 

average 2.5 percent of baseline 

quantities. Cull cattle imports are 

projected to increase in the latter years 

of the analysis, and even more so in 

subsequent years, as higher percentages 

of Canada’s cull cattle inventory are able 

to be verified as having been born on or 

after March 1, 1999. A relative increase 

in the number of cull cattle imported 

over time is projected to be associated 

with, in turn, a relative decrease in the 

quantity of fed cattle imports and a 

relative increase in the quantity of fed 

beef imports. 

Baseline projections over the 5-year 

period, 2008–2012, show the United 

States importing a little over 40 percent 

of its supply of processing beef. A share 


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of the cull cattle imported from Canada 

will yield processing beef that will 

substitute for processing beef that 

otherwise would be imported from other 

countries, while a share of the imported 

cull cattle will yield processing beef that 

will replace a quantity of processing 

beef that would otherwise be 

domestically supplied, as U.S. 

producers respond to lower prices. The 

remaining share of cull cattle imports 

will yield processing beef that will 

represent a net increase in U.S. 

processing beef supplies. 

We use 25 percent as the percentage 

of cull cattle imports from Canada 

projected to displace U.S. processing 

beef imports from elsewhere. The 25 

percent share is estimated using the 

multi-sector model and takes into 

account the interactions of the beef 

processing sector with the beef cattle 

and dairy cattle sectors. For comparison, 

we also compute price and welfare 

effects assuming that 50 percent of cull 

cattle imported from Canada displace 

processing beef imports, and assuming, 

alternatively, that none of the imported 

cull cattle displace processing beef 

imports. 

Scenario 2. In Table B, we show the 

projected changes in cattle and fed beef 

imports from Canada under scenario 2 

(in which imports of Canadian cattle 

unrestricted by birth date are allowed). 

Under this scenario, imports of cull 

cattle and changes in imports of fed 

cattle and fed beef are all projected to 

be much larger than in scenario 1. 

Feeder cattle imports are projected to be 

the same under all of the scenarios. 

Projected cull cattle imports in scenario 

2 average 459,800 head per year over the 

period of analysis, or 7.8 percent of U.S. 

baseline slaughter quantities. This 

amount is more than three times cull 

cattle imports projected in scenario 1. 

The fed cattle and fed beef changes 

remain a fraction of 1 percent of the U.S. 

baseline supplies, but are also larger. 

The increased number of cull cattle 

imported in this scenario is projected to 

be associated with larger declines in fed 

cattle imports and larger increases in the 

fed beef imports. We again estimate that 

25 percent of cull cattle imports from 

Canada under this scenario displace 

processing beef imports from other 

sources. Price and welfare analyses 

assuming that 50 percent of the 

imported cull cattle displace processing 

beef imports and that none of the cull 

cattle displace processing beef imports 

are also presented. 

Scenario 3. Table C shows the 

projected changes in cattle and beef 

imports from Canada under scenario 3 

(in which imports of Canadian cattle 

born on or after March 1, 1999, are 

allowed and imports of OTM beef 

resume). In scenario 3, impacts derive 

from the resumption of OTM beef 

imports as well as the cull cattle imports 

from Canada. Projected cull cattle 

imports are lower than in scenario 1 

(averaging 106,000 head per year over 

the 5-year period, compared to 147,800 

head) because of the entry of OTM beef. 

Similarly, changes in projected fed 

cattle and fed beef imports are 

somewhat smaller than the changes 

projected in scenario 1. Processing beef 

imports from Canada under scenario 3 

are projected to average 254.6 million 

pounds per year, carcass weight 

equivalent, or about 4.1 percent of the 

U.S. baseline supply. The quantity of 

processing beef imported is projected to 

decline and the quantity of cull cattle 

imported is projected to increase in the 

latter years of the 5-year period, as an 

increasing number of cull cattle become 

eligible for importation—i.e., can be 

verified as having been born on or after 

March 1, 1999. Under scenario 3, and 

considering imports of cull cattle (based 

on the cattle’s processing beef 

equivalence) and processing beef as a 

single market, 77 percent of cull cattle 

and processing beef imports from 

Canada are projected to enter the United 

States as OTM beef over the 5-year 

period of the analysis, while 23 percent 

of these imports are projected to enter 

as cull cattle. Consistent with scenarios 

1 and 2, we use 25 percent as the share 

of the cull cattle and OTM beef imports 

from Canada that displaces processing 

beef imports from other countries. We 

also present the price and welfare 

effects assuming that either 50 percent 

or none of the cull cattle and OTM beef 

imports from Canada displace 

processing beef imports from elsewhere. 

Scenario 4. In table D, we show the 

projected changes in cattle and fed beef 

imports from Canada under scenario 4 

(in which imports of Canadian cattle 

unrestricted by birth date are allowed 

and imports of OTM beef resume). As in 

scenario 2, imports of cull cattle and 

changes in imports of fed cattle and fed 

beef are all projected to be larger than 

in scenarios 1 and 3. 

Projected cull cattle imports in 

scenario 4 average 328,200 head per 

year over the period of analysis, or 5.5 

percent of U.S. baseline slaughter 

quantities. The fed cattle and fed beef 

changes remain a fraction of 1 percent 

of the U.S. baseline supplies. 

TABLE A.—PROJECTED CHANGES IN IMPORTS OF CULL CATTLE, FEEDER CATTLE, FED CATTLE, FED BEEF, AND PROCESSING BEEF FROM CANADA UNDER SCENARIO 1, AND PROJECTED CHANGES IN IMPORTS FROM CANADA AS A PERCENTAGE OF THE PROJECTED U.S. BASELINE SUPPLIES, 2008–2012 

2008 2009 2010 2011 2012 

Projected changes in imports from Canada: 

Cull cattle (thousand head) ...................................................................................................... 104 110 113 187 225 

Feeder cattle (thousand head) ................................................................................................. ¥1 9 ¥5 ¥16 ¥21 

Fed cattle (thousand head) ...................................................................................................... ¥30 ¥4 ¥43 ¥93 ¥114 

Fed beef (million pounds, carcass weight equivalent) ............................................................. 24 3 35 75 92 

Processing beef (million pounds, carcass weight equivalent) ................................................. 0 0 0 0 0 

Projected changes in imports from Canada as a percentage of the projected U.S. baseline supply: 

Cull cattle .................................................................................................................................. 1.8% 1.9% 1.9% 3.1% 3.7% 

Feeder cattle ............................................................................................................................. nil nil nil nil ¥0.1% 

Fed cattle .................................................................................................................................. ¥0.1% nil ¥0.1% ¥0.3% ¥0.4% 

Fed beef .................................................................................................................................... 0.1% nil 0.2% 0.3% 0.4% 

Processing beef ........................................................................................................................ 0 0 0 0 0 


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TABLE B.—PROJECTED CHANGES IN IMPORTS OF CULL CATTLE, FEEDER CATTLE, FED CATTLE, FED BEEF, AND PROCESSING BEEF FROM CANADA UNDER SCENARIO 2, AND PROJECTED CHANGES IN IMPORTS FROM CANADA AS A PERCENTAGE OF THE PROJECTED U.S. BASELINE SUPPLIES, 2008–2012 

2008 2009 2010 2011 2012 

Projected changes in imports from Canada: 

Cull cattle (thousand head) ...................................................................................................... 459 459 459 460 462 

Feeder cattle (thousand head) ................................................................................................. ¥1 9 ¥5 ¥16 ¥21 

Fed cattle (thousand head) ...................................................................................................... ¥119 ¥91 ¥129 ¥161 ¥173 

Fed beef (million pounds, carcass weight equivalent) ............................................................. 96 74 105 131 140 

Processing beef (million pounds, carcass weight equivalent) ................................................. 0 0 0 0 0 

Projected changes in imports from Canada as a percentage of the projected U.S. baseline supply: 

Cull cattle .................................................................................................................................. 8.2% 7.8% 7.6% 7.6% 7.6% 

Feeder cattle ............................................................................................................................. nil nil nil nil ¥0.1 

Fed cattle .................................................................................................................................. ¥0.4% ¥0.3% ¥0.4% ¥0.5% ¥0.6% 

Fed beef .................................................................................................................................... 0.4% 0.3% 0.5% 0.6% 0.6% 

Processing beef ........................................................................................................................ 0 0 0 0 0 

TABLE C.—PROJECTED CHANGES IN IMPORTS OF CULL CATTLE, FEEDER CATTLE, FED CATTLE, FED BEEF, AND PROCESSING BEEF FROM CANADA UNDER SCENARIO 3 AND PROJECTED CHANGES IN IMPORTS FROM CANADA AS A PERCENTAGE OF THE PROJECTED U.S. BASELINE SUPPLIES, 2008–2012 

2008 2009 2010 2011 2012 

Projected changes in imports from Canada: 

Cull cattle (thousand head) ...................................................................................................... 75 79 81 134 161 

Feeder cattle (thousand head) ................................................................................................. ¥1 9 ¥5 ¥16 ¥21 

Fed cattle (thousand head) ...................................................................................................... ¥23 4 ¥34 ¥80 ¥98 

Fed beef (million pounds, carcass weight equivalent) ............................................................. 18 ¥3 28 65 79 

Processing beef (million pounds, carcass weight equivalent) ................................................. 277 273 272 234 217

Projected changes in imports from Canada as a percentage of the projected U.S. baseline supply: 

Cull cattle .................................................................................................................................. 1.3% 1.3% 1.3% 2.2% 2.7% 

Feeder cattle ............................................................................................................................. nil nil nil nil ¥0.1 

Fed cattle .................................................................................................................................. ¥0.1% nil ¥0.1% ¥0.3% ¥0.3% 

Fed beef .................................................................................................................................... 0.1% nil 0.1% 0.3% 0.3% 

Processing beef ........................................................................................................................ 4.7% 4.5% 4.4% 3.7% 3.4% 

TABLE D.—PROJECTED CHANGES IN IMPORTS OF CULL CATTLE, FEEDER CATTLE, FED CATTLE, FED BEEF, AND PROCESSING BEEF FROM CANADA UNDER SCENARIO 4, AND PROJECTED CHANGES IN IMPORTS FROM CANADA AS A PERCENTAGE OF THE PROJECTED U.S. BASELINE SUPPLIES, 2008–2012 

2008 2009 2010 2011 2012 

Projected changes in imports from Canada: 

Cull cattle (thousand head) ...................................................................................................... 328 328 327 328 330 

Feeder cattle (thousand head) ................................................................................................. ¥1 9 ¥5 ¥16 ¥21 

Fed cattle (thousand head) ...................................................................................................... ¥86 ¥58 ¥96 ¥129 ¥140 

Fed beef (million pounds, carcass weight equivalent) ............................................................. 70 47 78 104 114 

Processing beef (million pounds, carcass weight equivalent) ................................................. 94 94 94 94 95 

Projected changes in imports from Canada as a percentage of the projected U.S. baseline supply: 

Cull cattle .................................................................................................................................. 5.8% 5.6% 5.4% 5.4% 5.4% 

Feeder cattle ............................................................................................................................. nil nil nil nil ¥0.1% 

Fed cattle .................................................................................................................................. ¥0.3% ¥0.2% ¥0.3% ¥0.4% ¥0.5% 

Fed beef .................................................................................................................................... 0.3% 0.2% 0.3% 0.5% 0.5% 

Processing beef ........................................................................................................................ 1.6% 1.5% 1.5% 1.5% 1.5% 

Effects for Commodities Not Analyzed 

Using the BAS Model 

Five categories of commodities that 

will be affected by this rule have not 

been included in the modeled 

quantitative analysis described above. 

They are: Breeding cattle, including 

dairy; vealers and slaughter calves; 

bison; bovine casings and small 

intestine products; and bovine blood 

and blood products. Projected imports 

of breeding cattle including dairy, and 

projected changes in imports of vealers, 

slaughter calves, and bison, are 

relatively small, suggesting that impacts 

on affected U.S. entities will not be 

significant. For bovine casings, small 

intestine products, and blood and blood 

products, the analysis is constrained by 

a scarcity of information about the 

quantities that would be imported and 

levels of U.S. production and 

consumption. 

With regard to dairy producers, we do 

not expect imports of dairy cattle from 

Canada to add significantly to the U.S. 

herd, but rather to serve as an additional 


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source of replacement animals. From 

1992 to 2002, U.S. producers annually 

raised about 4.1 million dairy 

replacement heifers and about 5.9 

million beef replacement heifers. The 

average number of Canadian breeding 

cattle imported during that period 

(including bulls) totaled only 0.5 

percent of these combined quantities. 

The breeding cattle imports from 

Canada during this period represented 

about 1.1 percent of dairy heifer 

replacements and less than 0.1 percent 

of beef heifer replacements. Imports of 

dairy cows and heifers from Canada are 

projected to be similar to their historic 

levels, 1992–2002, averaging 47,800 

head per year over the period of analysis 

in all of the scenarios. 

Analysis using the multi-sector model 

indicates that, in scenario 3, dairy 

producers may experience price 

declines of 1.3 to 1.7 percent for dairy 

cattle due to the small number projected 

to be imported from Canada. These 

imports translate into an increase in 

U.S. milk production of 0.1 percent or 

less, and a decline in the price of milk 

and increase in consumer surplus of less 

than 0.1 percent. As sellers of cull 

cattle, dairy producers as well as beef 

producers are expected to be negatively 

affected by the price decline for cull 

cattle due to this rule. 

We expect market effects for vealers 

and slaughter calves to be insignificant, 

given the small change in the number 

projected to be imported from Canada. 

The decline in imports is projected in 

scenario 3 to average only 6 percent, or 

3,000 head per year. 

A larger number of bison are projected 

to be imported than was projected in the 

preliminary RIA. Reestablished imports 

of Canadian breeding bison will be the 

principal impact of this rule for that 

industry. Yearly imports of breeding 

bison are projected to average 1,200 

head, and are expected to represent 

about 1 percent of U.S. breeding bison, 

assuming the composition of the 

national bison herd is similar to that of 

the national cattle herd. 

This rule may directly affect the U.S. 

supply of bovine casings and small 

intestine products through resumption 

of imports from Canada, and may affect 

it indirectly through changes in U.S. 

cattle slaughter numbers and the 

reestablished importation of Canadian 

bovine small intestines, minus the distal 

ileum. For scenario 3, the annual supply 

of bovine casings produced from 

additional U.S. cattle slaughter is 

projected to increase on average over the 

period of analysis by less than 0.2 

percent. 

Fetal bovine serum (FBS) is the most 

important blood product that will be 

affected by this rule. Resumption of 

commercial imports of FBS from 

Canada, directly as serum and indirectly 

through increased U.S. pregnant cow 

slaughter, is expected to benefit FBS 

users, given current strong demand for 

this blood product in the United States. 

Expected Impacts for Modeled 

Commodities 

In this summary, prices and welfare 

impacts are expressed in 2007 dollars; 

price and quantity averages and 

percentage averages are over the 5-year 

period of analysis, 2008–2012; 

annualized values are discounted at 3 

percent; and beef prices and quantities 

are in carcass weight equivalent. 

Percentage changes in prices and 

estimated welfare effects are shown in 

table E. 

Scenario 1. In this scenario, buyers of 

cull cattle and processing beef can be 

expected to benefit from welfare gains 

and sellers of cull cattle and processing 

beef can be expected to bear welfare 

losses due to the cull cattle imports. For 

this commodity, the estimated 

annualized consumer gains are $90.3 

million, producer losses are $53.2 

million, and net benefits are $37.1 

million. 

Welfare changes for the cull cattle/ 

processing beef category dominate the 

modeled effects in all of the scenarios. 

The relatively large impacts are not 

unexpected, given that this is the one 

modeled commodity category for which 

imports from Canada would be newly 

reestablished and projected changes 

from the baseline are much larger than 

for the other commodities. The numbers 

of cull cattle projected to be imported in 

scenario 1, averaging 124,800 cows and 

23,000 bulls and stags per year, are 

much larger than the projected average 

annual declines in imports of Canadian 

fed cattle (56,800 head) and feeder cattle 

(6,800 head). 

Another reason the welfare effects 

computed for the cull cattle/processing 

beef category are large is the inelastic 

demand (¥0.40) compared to the price 

elasticities of demand—i.e., buyers’

responsiveness to changes in price—for 

the other modeled commodities (feeder 

cattle, –0.88; fed cattle, ¥0.76; fed beef, 

¥0.60). In the preliminary RIA, we 

examined the significance of processing 

beef’s more inelastic demand by 

considering welfare changes for the cull 

cattle/processing beef category when a 

price elasticity of demand of ¥0.60 is 

used, that is, the same elasticity as for 

fed beef. This exercise found that all 

impacts—consumer gains, producer 

losses, net benefits, and price declines—

are reduced by nearly one-fifth when a 

price elasticity of demand of ¥0.60 is 

used in place of ¥0.40. The price 

elasticity of demand is an important 

determinant of the magnitude of welfare 

and price changes for the cull cattle/ 

processing beef category. 

Lastly, the large difference between 

consumer welfare gains and producer 

welfare losses for the cull cattle/ 

processing beef category can be 

attributed to the fact that the United 

States is projected to import about 40 

percent of its supply of processing beef 

over the period of analysis. In modeling 

the welfare effects, demand (defined as 

U.S. consumption) is much larger than 

supply (defined as U.S. production 

minus exports). Consequently the 

change in consumer surplus is large 

compared to the change in producer 

surplus because the effects are estimated 

only for U.S. entities. 

Slightly fewer feeder cattle are 

projected to be imported from Canada in 

scenario 1 than would otherwise enter, 

and the analysis indicates small gains in 

producer welfare (higher prices and less 

competition from Canadian suppliers) 

and small losses in consumer welfare 

for this commodity (higher prices and 

fewer feeder cattle available for 

purchase). Estimated annualized values 

are producer gains of $3.6 million, 

consumer losses of $3.8 million, and net 

losses of $0.2 million. 

As with feeder cattle, fewer fed cattle 

are projected to be imported under 

scenario 1 than would otherwise be 

imported. Once again, producers (sellers 

of fed cattle for slaughter) would benefit 

from welfare gains and consumers 

(buyers of fed cattle for slaughter) would 

bear welfare losses. Estimated 

annualized values are producer gains of 

$43.6 million, consumer losses of $44.7 

million, and net losses of about $1.1 

million. 

Scenario 1 is projected to result in 

increased imports of Canadian fed beef 

ranging from an additional 3 million 

pounds in 2009 to 92 million pounds in 

2012. Estimated annualized values are 

consumer gains of $48.8 million, 

producer losses of $46.8 million, and 

net gains of $2 million. 

The analysis shows annualized 

combined welfare changes under 

scenario 1 as consumer gains of $90.6 

million and producer losses of $52.7 

million, yielding net benefits of $37.9 

million. As can be seen in table E, the 

combined annualized values of 

consumer welfare losses for feeder cattle 

and fed cattle are similar to the 

consumer welfare gains for fed beef. 

Combined consumer welfare gains are 

very similar to the consumer welfare 

gains estimated for the cull cattle/ 

processing beef category. A similar but 

opposite outcome is evident with 


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respect to producer welfare changes, 

with combined gains for feeder cattle 

and fed cattle somewhat larger than the 

producer welfare losses for fed beef. The 

result is combined producer welfare 

losses that are close to the producer 

welfare losses estimated for cull cattle/ 

processing beef. Under scenario 1, the 

combined annualized net welfare 

benefits, $37.9 million, are only slightly 

more than the $37.1 million in net 

benefits estimated for cull cattle/ 

processing beef. 

TABLE E.—COMPARISON OF PERCENTAGE PRICE CHANGES AND ANNUALIZED WELFARE EFFECTS FOR SCENARIOS 1, 2, 

AND 3 BY COMMODITY CATEGORY, 2008–2012, DISCOUNTED AT 3 PERCENT, 2007 DOLLARS

Commodity category Scenario 

Percentage 

change in 

price 

Change in 

consumer 

welfare 

Change in 

producer welfare 

Net welfare 

change 

Thousand dollars 

Cull cattle/Processing beef .................................................. 1 ¥1.4% 90,307 ¥53,207 37,100 

2 ¥4.5% 286,936 ¥165,615 121,320 

3 ¥4.5% 286,912 ¥165,603 121,308 

Feeder cattle ........................................................................ 1 nil ¥3,795 3,605 ¥190 

2 nil ¥3,795 3,605 ¥190 

3 nil ¥3,795 3,605 ¥190 

Fed cattle ............................................................................. 1 0.1% ¥44,703 43,636 ¥1,066 

2 0.3% ¥107,513 105,101 ¥2,412 

3 0.1% ¥36,263 35,388 ¥874 

Fed beef ............................................................................... 1 ¥0.1% 48,800 ¥46,757 2,044 

2 ¥0.3% 117,459 ¥112,426 5,033 

3 ¥0.1% 39,791 ¥38,131 1,660 

Categories combined ........................................................... 1 ........................ 90,609 ¥52,723 37,888 

2 ........................ 293,087 ¥169,335 123,751 

3 ........................ 286,645 ¥164,741 121,904 

The three import scenarios considered in this table are (1) Canadian cattle born on or after March 1, 1999; (2) Canadian cattle unrestricted by 

date of birth; and (3) Canadian cattle born on or after March 1, 1999, plus resumption of imports of meat from Canadian cattle slaughtered at 30 

months or older. The percentage change in price is the average annual change over the 5-year period. Welfare changes may not sum due to 

rounding. 

Scenario 2. Because of the 

significantly larger number of cull cattle 

projected to be imported in scenario 2, 

the estimated price and welfare effects 

are also much larger than for scenario 1. 

Table E shows these differences, with 

the percentage changes in price about 

three times greater in all cases (other 

than for feeder cattle, for which imports 

are projected to be the same in all 

scenarios). Whereas the combined net 

benefit in scenario 1 is estimated to be 

an annualized $37.9 million, in scenario 

2 it is $123.8 million. 

As described in the risk assessment, 

transmission of BSE requires that 

bovines ingest feed that contains the 

infectious agent. The OIE establishes 

standards for the international trade in 

animals and animal products. It 

recommends that cattle be imported 

from a controlled risk region for BSE 

only if the cattle selected for export 

were born after that date from which a 

ban on the feeding of ruminants with 

meat-and-bone meal and greaves (the 

residue left after animal fat or tallow has 

been rendered) derived from ruminants 

had been effectively enforced. In May 

2007, the OIE classified both the United 

States and Canada as BSE controlled 

risk regions. 

On August 4, 1997, Canada issued 

regulations prohibiting the use of 

mammalian protein in ruminant feeds. 

Implementation of the feed ban was a 

gradual process, with producers, feed 

mills, retailers, and feed manufacturers 

given grace periods before they were 

required to be in full compliance with 

the regulations. It is believed that this 

implementation period may have lasted 

6 months, making February 1998 a more 

realistic date on which the ban can be 

considered to have gone into effect. 

APHIS considers that a period of 1 

year following the full implementation 

of the feed ban allowed sufficient time 

for the measures taken by Canada to 

have their desired effect. Therefore, 

APHIS concludes that there is an 

extremely low likelihood that cattle 

born in Canada on or after March 1, 

1999, will have been exposed to the BSE 

agent via feed. Therefore, these animals 

have an extremely low likelihood of 

being infected and can be imported into 

the United States for any purpose. 

We do not have a quantitative 

estimate of the additional risk posed by 

importation of Canadian cattle born 

before March 1, 1999. The importance of 

a feed ban as a risk mitigation measure 

is demonstrated in science and 

experience, and is incorporated into the 

OIE guidelines. We conclude that there 

could be some degree of increased 

likelihood of BSE infectivity entering 

the United States via imports of live 

bovines from Canada under scenario 2, 

compared to the very low likelihood 

posed in scenario 1, because of the 

greater likelihood of cattle born prior to 

the effective enforcement of a feed ban 

having been exposed to infectivity. 

Scenario 3. The price and welfare 

effects under scenario 3 are similar to 

the effects under scenario 2 for cull 

cattle/processing beef, but more like the 

scenario 1 effects for fed cattle and fed 

beef (table E). This outcome is expected 

because scenario 3 includes 

reestablishment of OTM beef imports 

from Canada. Combined net welfare 

benefits for scenarios 2 and 3 are very 

similar, with the projected cull cattle 

imports in scenario 2 and the projected 

imports of cull cattle and OTM beef in 

scenario 3 both based on cattle and beef 

import quantities prior to May 2003. 

The additional quantities of cull cattle/ 

processing beef in scenarios 2 and 3 are 

essentially the same, entering as live 

cattle in scenario 2 and as beef in 

scenario 3. 

The BSE risk mitigations under 

scenario 3 are comparable to those 

under scenario 1. The restriction on live 

bovine imports by date of birth, age 

verification, and other safeguard 

measures are the same in both cases. 

Consequently, as in scenario 1, the 

likelihood of BSE infectivity entering 

the United States via imports of live 

bovines from Canada in this scenario is 


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53372 Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 

32USDA, NASS. 2002 Census of Agriculture, 

Volume 1, Chapter 1, Table 16. The $26,000 average 

is for operations with fewer than 1,000 head. 

http://www.nass.usda.gov/Census_of_Agriculture/ 

index.asp 

33Boning utility cow (Sioux Falls) nominal price. 

34 ($26,600/2) (0.047) = $625.10. 

35USDA, NASS, 2002 Census of Agriculture, 

Volume 1, Chapter 1, Table 17. For small-entity 

producers, revenue from cattle and calf sales totaled 

$1.7 billion and revenue from dairy product sales 

totaled $11.2 billion. http://www.nass.usda.gov/ 

Census_of_Agriculture/index.asp 

36 In 2002, the average revenue from cattle sales 

for small-entity dairy operations was $22,197 ($453 

per head multiplied by 49 head). ($22,197)(0.047) 

= $1,043.26. 

37 $1,043 divided by $175,912 (average income 

for small dairy farms from combined dairy product 

and cattle sales) equals 0.59 percent. 

extremely low. Resumption of OTM beef 

imports from Canada will not affect the 

likelihood of BSE infectivity entering 

the United States because SRMs will be 

removed and disposed of in Canada. 

Scenario 4. A fourth scenario, as 

indicated above, would be to allow 

entry of Canadian cattle unrestricted by 

birth date, along with resumption of 

OTM beef imports from Canada. A 

quantitative analysis of expected price 

and welfare effects for this particular 

scenario was not performed. When we 

compare projected imports under this 

scenario with those projected for 

scenario 3, we find the differences in 

combined cattle and beef imports to be 

very small and conclude that the 

welfare effects for this scenario would 

be very similar to the effects of scenario 

3. 

Cull cattle imports from Canada are 

projected to average about 328,000 head 

per year under scenario 4, compared to 

106,000 head per year under scenario 3. 

Conversely, annual processing beef 

imports under scenario 4 are projected 

to average 94 million pounds, carcass 

weight equivalent, compared to 255 

million pounds for scenario 3. 

Similar differences between the two 

scenarios are projected for fed cattle and 

fed beef imports. The larger number of 

cull cattle that would be imported from 

Canada under scenario 4 could be 

expected to be associated with increased 

fed cattle slaughter in Canada, with 

fewer fed cattle and more fed beef 

exported to the United States. Under 

scenario 4, fed cattle imports from 

Canada are projected to average about 

624,000 head per year, compared to 

679,000 head per year under scenario 3. 

Annual fed beef imports under scenario 

4 are projected to average 992 million 

pounds, compared to 947 million 

pounds for scenario 3. 

The average annual net difference 

between scenarios 3 and 4 in projected 

cull cattle and processing beef imports 

from Canada, after converting the cull 

cattle to processing beef, is about 

700,000 pounds (330.8 million pounds 

in scenario 3, and 330.1 million pounds 

in scenario 4). This amount represents 

about 0.2 percent of projected cull 

cattle/processing beef imports under 

scenario 3. For fed cattle and fed beef 

imports from Canada, the average 

annual net difference between scenarios 

3 and 4 after converting the fed cattle to 

fed beef, is about 1.3 million pounds 

(1,483.7 million pounds in scenario 3, 

and 1,485.0 million pounds in scenario 

4). This amount represents about 0.1 

percent of the projected fed cattle and 

fed beef imports under scenario 3. 

Hence, we conclude that the overall 

welfare effects of scenario 4 would be 

very similar to those for scenario 3. 

Effects on Small Entities 

There were no significant issues 

raised in public comment on the initial 

regulatory flexibility analysis (RFA) for 

this rulemaking. However, as described 

below, the majority of businesses that 

may be affected by this rule are small 

entities. Therefore, while none of the 

comments received on the proposed 

rule raised specific issues regarding the 

initial RFA, comments on the 

preliminary RIA can be inferred to 

express small-entity concerns. 

Topics that received public comment 

and that concerned the estimated 

economic impacts of the proposed rule 

included modeling issues; the timing of 

the rule’s implementation; 

consequences of a BSE occurrence; and 

impacts of the rule for consumers, cowcalf producers, the dairy industry, and 

the packing industry, and on beef 

exports. These comments are addressed 

in the Agency’s responses that are 

included as part of the final rule. 

Small entities comprise the majority 

of the establishments engaged in the 

production, processing, and sale of the 

commodities affected by this rule. These 

small entities number at least in the 

hundreds of thousands, with cow-calf 

and dairy producers comprising the 

largest single industry sector share. The 

entities are classified within the 

following industries according to the 

North American Industry Classification 

System: Beef Cattle Ranching and 

Farming (NAICS 112111), Dairy Cattle 

and Milk Production (NAICS 112120), 

All Other Animal Production (NAICS 

112990), Cattle Feedlots (NAICS 

112112), Animal (except Poultry) 

Slaughtering (NAICS 311611), Meat 

Processed from Carcasses (NAICS 

311612), Meat and Meat Product 

Merchant Wholesalers (NAICS 424470), 

Supermarkets and Other Grocery 

(except Convenience) Stores (NAICS 

445110), Meat Markets (NAICS 445210), 

In-Vitro Diagnostic Substance 

Manufacturing (NAICS 325413), and 

Biological Product (except Diagnostic) 

Manufacturing (NAICS 325414). 

We are unable to determine the extent 

to which cull cattle prices may fall 

because of the rule. Assuming that the 

price decline for cull cattle is 

proportional to the estimated price 

decline for processing beef, cow-calf 

and dairy producers in scenario 3 may 

experience a fall in price for cull cattle 

of 4.7 percent in 2008, and an average 

price decline of 4.5 percent ($4.61 per 

cwt). To place this average price decline 

in perspective, we consider the effect it 

may have on gross earnings of smallentity cow-calf operations. Based on 

data from the 2002 Census of 

Agriculture, the average value of cattle 

and calves sold by small-entity beef cow 

operations was about $26,600.32 The 

projected 2008 price for a culled cow is 

$54.19 per cwt.33 Assuming the cow 

weighs 1,100 pounds, its price in 2008 

would be $596.09 per head. A 4.7 

percent decline would result in a price 

of $568.07. Presumably, most of a cowcalf operation’s revenue is earned from 

the sale of calves. If one-half of an 

operation’s revenue were to derive from 

the sale of cull cattle, the reduction in 

revenue attributable to the decline in 

the price of cull cattle in scenario 3 

would total about $625 for the year.34

For dairy enterprises, the expected 

price decline for cull cattle because of 

imports from Canada is expected to 

have a small effect on their incomes 

because most revenue (over 86 percent 

in 2002) is earned from the sale of milk 

and other dairy products.35 The average 

per animal value of cattle and calves 

sold by small-entity dairy cow 

operations in 2002 was about $453. A 

price decline of 4.7 percent, 

notwithstanding the fact that not all of 

the animals sold would be cull cattle, 

would mean a decrease in annual 

revenue for the average small-entity 

dairy operation of about $1,040, 

assuming no change in the number of 

cattle sold.36 This forgone income 

would represent a decline in average 

revenue of about 0.6 percent.37

The scenario 3 analysis indicates that 

decreases in the price of fed beef due to 

increased fed beef imports from Canada 

are expected to be very small, resulting 

in a loss for the average meat packing 

and processing establishment of less 

than 0.2 percent of average revenue (18 

cents per cwt, with projected baseline 

fed beef prices averaging $151.80 per 

cwt). Effects for those packers and 

processors that utilize processing beef 

will be larger, due to the resumption of 

cull cattle and OTM beef imports from 


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Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 53373 

38This approximation is based on 1,000 entities 

filling out Form VS 17–130 on 20 occasions per 

year, with each form requiring two hours. The 

estimated total time saved by not having to 

complete Form VS 1–27 is calculated on this same 

basis. 

Canada. Annual prices of processing 

beef are expected to fall by an average 

of $4.61 per cwt in scenario 3. This 

decline in price will benefit 

establishments that use processing beef 

to produce ground beef for the 

wholesale market. Conversely, 

establishments that sell processing beef 

will be negatively affected by the 

expected price decline. 

In response to public comments on 

the preliminary RIA, we include an 

evaluation of welfare effects by industry 

sector for scenario 3. While this 

evaluation is admittedly broad, it 

provides an indication of the extent to 

which major sectors of the cattle and 

beef industries may be affected. We 

group the entities that we expect to be 

directly affected into four generalized 

categories: cow-calf and dairy 

producers, feedlot establishments, 

slaughter and packing establishments, 

and wholesaler and successive 

establishments. Admittedly, this simple 

categorization does not capture the 

many complexities of the cattle and beef 

industries, but it does provide a level of 

specification sufficient for examining 

expected effects for the industries’

principal stages of economic activity. In 

reality, businesses combine the 

slaughter, packing, processing, and 

wholesaling functions in various ways. 

This consideration of sector-level effects 

indicates that cow-calf and dairy 

producers and slaughter and packing 

establishments are expected to incur net 

welfare losses, while feedlots and 

wholesalers are expected to accrue net 

welfare gains. 

Currently, bovines imported from 

Canada are restricted to animals that are 

slaughtered at less than 30 months of 

age. Bovines not imported for 

immediate slaughter must be moved 

from the port of entry to a feedlot in a 

sealed means of conveyance and from 

the feedlot to a recognized slaughtering 

establishment again in a sealed means of 

conveyance. The animals may not be 

moved to more than one feedlot. With 

this rule, these movement restrictions 

will no longer be imposed. Canadian 

bovines imported other than for 

immediate slaughter will be able to be 

moved any number of times to any 

destinations in unsealed means of 

conveyance. 

Under this rule, feeder bovines 

imported from BSE minimal-risk regions 

will not need to be accompanied by 

APHIS Form VS 17–130, which 

currently is used to identify the feedlot 

of destination. (The name of the 

individual responsible for the 

movement of an imported animal and 

individual identification of the animal 

will still be required information on the 

accompanying health certificate.) APHIS 

estimates that the time saved by entities 

no longer needing to acquire APHIS 

Form VS 17–130 will total 

approximately 40,000 hours per year.38

Also under this rule, bovines of 

Canadian origin moved from a U.S. 

feedlot to a slaughtering establishment 

will not need to be accompanied by 

APHIS Form VS 1–27. APHIS estimates 

the same total time savings by entities 

no longer needing to acquire APHIS 

Form VS 1–27: 40,000 hours per year. 

Removal of these movement and 

paperwork requirements will benefit 

buyers and sellers of Canadian-origin 

bovines. Many of the beneficiaries are 

likely to be small entities, given their 

predominance among beef and dairy 

operations and feedlot establishments. 

Affected businesses will be able to take 

advantage of a broader range of 

transactional opportunities than 

previously. For example, the sale of a 

young steer first for backgrounding, then 

for confined feeding at one or more 

facilities, and finally for slaughter may 

enable the original and subsequent 

owners of the animal to better maximize 

returns compared to current marketing 

possibilities. While we are not able to 

quantify impacts of removing current 

movement restrictions on Canadian 

cattle imports, we expect their removal 

will benefit the cattle industry acrossthe-board. 

The Agency has identified 

alternatives to the rule and analyzed 

them in this RIA. We have found that 

the chosen alternative (scenario 3) best 

strikes the balance of continuing to 

provide an acceptable level of 

protection against BSE infectivity 

entering the United States via imports of 

live bovine and bovine product imports, 

while removing unnecessary 

prohibitions on the importation of 

certain commodities from Canada. 

Without this rule, restrictions on U.S. 

importation of certain Canadian bovine 

commodities that are without scientific 

merit would continue. With this rule, 

importation of these Canadian 

commodities will be allowed to resume 

under certain conditions and the BSE 

risk to the United States via imports of 

live bovines and bovine products from 

Canada will be negligible. 

Small Business Regulatory Enforcement 

Fairness Act of 1996 

This rule has been designated by the 

Administrator, Office of Information 

and Regulatory Affairs, Office of 

Management and Budget, as a major rule 

under the Small Business Regulatory 

Enforcement Fairness Act of 1996 (5 

U.S.C. 801–808). Accordingly, the 

effective date of this rule has been 

delayed the required 60 days pending 

congressional review. 

Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. This rule: (1) Preempts 

all State and local laws and regulations 

that are inconsistent with this rule; (2) 

has no retroactive effect; and (3) does 

not require administrative proceedings 

before parties may file suit in court 

challenging this rule. 

National Environmental Policy Act 

An environmental assessment and 

finding of no significant impact have 

been prepared for this final rule. The 

environmental assessment provides a 

basis for the conclusion that the 

importation of live bovines and of 

bovine products as specified in this rule 

will not have a significant impact on the 

quality of the human environment. 

Based on the finding of no significant 

impact, the Decisionmaker of the 

Animal and Plant Health Inspection 

Service has determined that an 

environmental impact statement need 

not be prepared. 

The environmental assessment and 

finding of no significant impact were 

prepared in accordance with: (1) The 

National Environmental Policy Act of 

1969 (NEPA), as amended (42 U.S.C. 

4321 et seq.), (2) regulations of the 

Council on Environmental Quality for 

implementing the procedural provisions 

of NEPA (40 CFR parts 1500–1508), (3) 

USDA regulations implementing NEPA 

(7 CFR part 1b), and (4) APHIS’ NEPA 

Implementing Procedures (7 CFR part 

372). 

The environmental assessment and 

finding of no significant impact may be 

viewed on the APHIS Web site (http:// 

www.aphis.usda.gov/newsroom/ 

hot_issues/bse/index.shtml), or be 

obtained by contacting the person listed 

under FOR FURTHER INFORMATION

CONTACT. Copies of the environmental 

assessment and finding of no significant 

impact are also available for public 

inspection at USDA, room 1141, South 

Building, 14th Street and Independence 

Avenue, SW., Washington, DC, between 

8 a.m. and 4:30 p.m., Monday through 

Friday, except holidays. Persons 

wishing to inspect copies are requested 

to call ahead on (202) 690–2817 to 

facilitate entry into the reading room. In 

addition, copies may be obtained by 


pwalker on PROD1PC71 with RULES2
53374 Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 

writing to the individuals listed under 

FOR FURTHER INFORMATION CONTACT. 

Paperwork Reduction Act 

This final rule contains no new 

information collection or recordkeeping 

requirements under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.). 

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Laude. (2006). Isolation from cattle of a 

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Morignat, C. Ducrot. (2004). Estimating the 

trend of the French BSE epidemic over six 

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abattoir screening in 2001 and 2002. 

Veterinary Research. 35(3): 299–308. 

Bradley, R., and P. Liberski. (2004). Bovine 

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List of Subjects 

9 CFR Part 93 

Animal diseases, Imports, Livestock, 

Poultry and poultry products, 

Quarantine, Reporting and 

recordkeeping requirements. 

9 CFR Part 94 

Animal diseases, Imports, Livestock, 

Meat and meat products, Milk, Poultry 

and poultry products, Reporting and 

recordkeeping requirements. 

9 CFR Part 95 

Animal feeds, Hay, Imports, 

Livestock, Reporting and recordkeeping 

requirements, Straw, Transportation. 

9 CFR Part 96 

Imports, Livestock, Reporting and 

recordkeeping requirements. 

■ Accordingly, we are amending 9 CFR 

parts 93, 94, 95, and 96 as follows: 

PART 93—IMPORTATION OF CERTAIN 

ANIMALS, BIRDS, AND POULTRY, 

AND CERTAIN ANIMAL, BIRD, AND 

POULTRY PRODUCTS; 

REQUIREMENTS FOR MEANS OF 

CONVEYANCE AND SHIPPING 

CONTAINERS 

■ 1. The authority citation for part 93 

continues to read as follows: 

Authority: 7 U.S.C. 1622 and 8301–8317; 

21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 

CFR 2.22, 2.80, and 371.4. 

§ 93.405 [Amended] 

■ 2. In § 93.405, paragraph (a)(4) is 

amended by removing the words 

‘‘feedlot or recognized slaughtering 

establishment’’ and adding in their 

place the words ‘‘destination’’. 

■ 3. Section 93.419 is amended as 

follows: 

■ a. Paragraphs (b) and (c) are revised to 

read as set forth below. 

■ b. Paragraph (d) is redesignated as 

paragraph (e). 

■ c. A new paragraph (d) is added to 

read as set forth below. 

■ d. In newly redesignated paragraph 

(e)(2), the reference to ‘‘paragraph 

(d)(7)’’ is removed and a reference to 

‘‘paragraph (e)(7)’’ is added in its place. 

§ 93.419 Sheep and goats from Canada. 

* * * * * 

(b) If the sheep or goats are 

unaccompanied by the certificate 


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Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 53377 

required by paragraph (a) of this section, 

or if they are found upon inspection at 

the port of entry to be affected with or 

exposed to a communicable disease, 

they shall be refused entry and shall be 

handled or quarantined, or otherwise 

disposed of, as the Administrator may 

direct. 

(c) Any sheep or goats imported from 

Canada must not be pregnant, must be 

less than 12 months of age when 

imported into the United States and 

when slaughtered, must be from a flock 

or herd subject to a ruminant feed ban 

equivalent to the requirements 

established by the U.S. Food and Drug 

Administration at 21 CFR 589.2000, and 

must be individually identified by an 

official Canadian Food Inspection 

Agency eartag, applied before the 

animal’s arrival at the port of entry into 

the United States, that is determined by 

the Administrator to meet standards 

equivalent to those for official eartags in 

the United States as defined in § 71.1 of 

this chapter and to be traceable to the 

premises of origin of the animal. No 

person may alter, deface, remove, or 

otherwise tamper with the individual 

identification while the animal is in the 

United States or moving into or through 

the United States, except that the 

identification may be removed at the 

time of slaughter. The animals must be 

accompanied by the certification issued 

in accordance with § 93.405 that states, 

in addition to the statements required 

by § 93.405, that the conditions of this 

paragraph have been met. Additionally, 

for sheep and goats imported for 

immediate slaughter, the certificate 

must state that the conditions of 

paragraphs (d)(1) through (d)(3) of this 

section have been met, and, for sheep 

and goats imported for other than 

immediate slaughter, the certificate 

must state that the conditions of 

paragraphs (e)(1) and (e)(2) of this 

section have been met. 

(d) Sheep and goats imported for 

immediate slaughter. Sheep and goats 

imported from Canada for immediate 

slaughter must be imported only 

through a port of entry listed in 

§ 93.403(b) or as provided for in 

§ 93.403(f) in a means of conveyance 

sealed in Canada with seals of the 

Canadian Government, and must be 

moved directly as a group from the port 

of entry to a recognized slaughtering 

establishment for slaughter as a group. 

The sheep and goats shall be inspected 

at the port of entry and otherwise 

handled in accordance with § 93.408. 

The seals on the means of conveyance 

must be broken only at the port of entry 

by the APHIS port veterinarian or at the 

recognized slaughtering establishment 

by an authorized USDA representative. 

If the seals are broken by the APHIS port 

veterinarian at the port of entry, the 

means of conveyance must be resealed 

with seals of the U.S. Government 

before being moved to the recognized 

slaughtering establishment. The 

shipment must be accompanied from 

the port of entry to the recognized 

slaughtering establishment by APHIS 

Form VS 17–33, which must include the 

location of the recognized slaughtering 

establishment. Additionally, the sheep 

and goats must meet the following 

conditions: 

(1) The animals have not tested 

positive for and are not suspect for a 

transmissible spongiform 

encephalopathy; 

(2) The animals have not resided in a 

flock or herd that has been diagnosed 

with BSE; and 

(3) The animals’ movement is not 

restricted within Canada as a result of 

exposure to a transmissible spongiform 

encephalopathy. 

* * * * * 

■ 4. Section 93.420 is revised to read as 

follows: 

§ 93.420 Ruminants from Canada for 

immediate slaughter other than bovines, 

sheep, and goats. 

The requirements for the importation 

of sheep and goats from Canada for 

immediate slaughter are contained in 

§ 93.419. The requirements for the 

importation of bovines from Canada for 

immediate slaughter are contained in 

§ 93.436. All other ruminants imported 

from Canada for immediate slaughter, in 

addition to meeting all other applicable 

requirements of this part, must be 

imported only through a port of entry 

listed in § 93.403(b) or as provided for 

in § 93.403(f) to a recognized 

slaughtering establishment for slaughter, 

in conveyances that must be sealed with 

seals of the U.S. Government at the port 

of entry. The seals may be broken only 

at a recognized slaughtering 

establishment in the United States by an 

authorized USDA representative. The 

shipment must be accompanied from 

the port of entry to the recognized 

slaughtering establishment by APHIS 

Form VS 17–33, which must include the 

location of the recognized slaughtering 

establishment. Such ruminants shall be 

inspected at the port of entry and 

otherwise handled in accordance with 

§ 93.408. 

(Approved by the Office of Management and 

Budget under control number 0579–0277) 

■ 5. Section 93.436 is amended as 

follows: 

■ a. Paragraphs (a) and (b) are revised to 

read as set forth below. 

■ b. In paragraph (c), the reference to 

‘‘§§ 93.419(c) and 93.420’’ is removed 

and a reference to ‘‘§§ 93.405 and 

93.419’’ is added in its place. 

§ 93.436 Ruminants from regions of 

minimal risk for BSE. 

* * * * * 

(a) Bovines for immediate slaughter. 

Bovines from a region listed in 

§ 94.18(a)(3) of this subchapter may be 

imported for immediate slaughter under 

the following conditions: 

(1) The bovines must have been born 

on or after a date determined by APHIS 

to be the date of effective enforcement 

of a ruminant-to-ruminant feed ban in 

the region of export. For bovines 

imported from Canada, that date is 

March 1, 1999. 

(2) Each bovine must be individually 

identified by an official eartag of the 

country of origin, applied before the 

animal’s arrival at the port of entry into 

the United States, that is determined by 

the Administrator to meet standards 

equivalent to those for official eartags in 

this chapter and to be traceable to the 

premises of origin of the animal. No 

person may alter, deface, remove, or 

otherwise tamper with the official 

identification while the animal is in the 

United States or moving into or through 

the United States, except that the 

identification may be removed at the 

time of slaughter; 

(3) The bovines must be accompanied 

by a certificate issued in accordance 

with § 93.405 that states, in addition to 

the statements required by § 93.405, that 

the conditions of paragraphs (a)(1) and 

(a)(2) of this section have been met; 

(4) The bovines must be imported 

only through a port of entry listed in 

§ 93.403(b) or as provided for in 

§ 93.403(f). The bovines shall be 

inspected at the port of entry and 

otherwise handled in accordance with 

§ 93.408; 

(5) The bovines must be moved 

directly from the port of entry to a 

recognized slaughtering establishment. 

Bovines imported from Canada must be 

moved to the slaughtering establishment 

in conveyances that are sealed with 

seals of the U.S. Government at the port 

of entry. The seals may be broken only 

at the recognized slaughtering 

establishment by an authorized USDA 

representative; and 

(6) The bovines must be accompanied 

from the port of entry to the recognized 

slaughtering establishment by APHIS 

Form VS 17–33. 

(b) Bovines for other than immediate 

slaughter. Bovines from a region listed 

in § 94.18(a)(3) of this subchapter may 

be imported for other than immediate 


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53378 Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 

slaughter under the following 

conditions: 

(1) The bovines must have been born 

on or after a date determined by APHIS 

to be the date of effective enforcement 

of a ruminant-to-ruminant feed ban in 

the region of export. For bovines 

imported from Canada, that date is 

March 1, 1999. 

(2) The bovines must be permanently 

and humanely identified before arrival 

at the port of entry with a distinct and 

legible mark identifying the exporting 

country. Acceptable means of 

permanent identification include the 

following: 

(i) A mark properly applied with a 

freeze brand, hot iron, or other method, 

and easily visible on the live animal and 

on the carcass before skinning. Such a 

mark must be not less than 2 inches nor 

more than 3 inches high, and must be 

applied to each animal’s right hip, high 

on the tail-head (over the junction of the 

sacral and first cocygeal vertebrae). 

Bovines exported from Canada so 

marked must be marked with ‘‘C∧N’’; 

(ii) A tattoo with letters identifying 

the exporting country must be applied 

to the inside of one ear of the animal. 

For bovines exported from Canada, the 

tattoo must read ‘‘CAN’’; 

(iii) Other means of permanent 

identification upon request if deemed 

adequate by the Administrator to 

humanely identify the animal in a 

distinct and legible way as having been 

imported from the BSE minimal-risk 

exporting region. 

(3) Each bovine must be individually 

identified by an official eartag of the 

country of origin, applied before the 

animal’s arrival at the port of entry into 

the United States, that is determined by 

the Administrator to meet standards 

equivalent to those for official eartags in 

§ 71.1 of this chapter and to be traceable 

to the premises of origin of the animal. 

No person may alter, deface, remove, or 

otherwise tamper with the official 

identification while the animal is in the 

United States or moving into or through 

the United States, except that the 

identification may be removed at the 

time of slaughter; 

(4) The bovines must be accompanied 

by a certificate issued in accordance 

with § 93.405 that states, in addition to 

the statements required by § 93.405, that 

the conditions of paragraphs (a)(1) and 

(a)(2) of this section have been met; and 

(5) The bovines must be imported 

only through a port of entry listed in 

§ 93.403(b) or as provided for in 

§ 93.403(f). 

* * * * * 

PART 94—RINDERPEST, FOOT-ANDMOUTH DISEASE, FOWL PEST (FOWL 

PLAGUE), EXOTIC NEWCASTLE 

DISEASE, AFRICAN SWINE FEVER, 

CLASSICAL SWINE FEVER, AND 

BOVINE SPONGIFORM 

ENCEPHALOPATHY: PROHIBITED 

AND RESTRICTED IMPORTATIONS 

■ 6. The authority citation for part 94 

continues to read as follows: 

Authority: 7 U.S.C. 450, 7701–7772, 7781–

7786, and 8301–8317; 21 U.S.C. 136 and 

136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 

371.4. 

§ 94.19 [Amended] 

■ 7. Section 94.19 is amended as 

follows: 

■ a. By removing the words ‘‘and small 

intestine’’ each time they appear in 

paragraphs (a)(2), (b)(2), and (f). 

■ b. By removing the Note to paragraph 

(a). 

■ c. By removing the Note to paragraph 

(b). 

■ d. By removing the Note to paragraph 

(f). 

PART 95—SANITARY CONTROL OF 

ANIMAL BYPRODUCTS (EXCEPT 

CASINGS), AND HAY AND STRAW, 

OFFERED FOR ENTRY INTO THE 

UNITED STATES 

■ 8. The authority citation for part 95 

continues to read as follows: 

Authority: 7 U.S.C. 8301–8317; 21 U.S.C. 

136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 

2.80, and 371.4. 

■ 9. Section 95.4 is amended as follows: 

■ a. The section heading and paragraph 

(a) introductory text are revised to read 

as set forth below. 

■ b. Paragraphs (a)(1)(ii) and (a)(1)(iv) 

are revised to read as set forth below. 

■ c. In paragraph (b), the words 

‘‘paragraphs (d) and (h)’’ are removed 

and the words ‘‘paragraphs (d), (e), and 

(i)’’ are added in their place. 

■ d. Paragraph (d) introductory text is 

revised to read as set forth below. 

■ e. The ‘‘Note to paragraph (f)’’ and the 

‘‘Note to paragraph (g)’’ are removed. 

■ f. Paragraphs (e) through (h) are 

redesignated as paragraphs (f) through 

(i), respectively. 

■ g. The ‘‘Note’’ currently following 

newly redesignated paragraph (f) is 

redesignated as ‘‘Note to paragraph (f)’’. 

■ h. New paragraph (e) is added to read 

as set forth below. 

■ i. In newly redesignated paragraph 

(h)(1)(i), the words ‘‘and small 

intestine’’ are removed. 

■ j. In newly redesignated paragraph (i) 

introductory text, the words 

‘‘paragraphs (h)(1) through (h)(3)’’ are 

removed and the words ‘‘paragraphs 

(i)(1) through (i)(3)’’ are added in their 

place, and the words ‘‘paragraphs (h)(1) 

through (h)(4)’’ are removed and the 

words ‘‘paragraphs (i)(1) through (i)(4)’’

are added in their place. 

■ k. In newly redesignated paragraph 

(i)(4)(iii), the reference to ‘‘paragraph 

(h)(2)’’ is removed and a reference to 

‘‘paragraph (i)(1)’’ is added in its place. 

§ 95.4 Restrictions on the importation of 

processed animal protein, offal, tankage, 

fat, glands, certain tallow other than tallow 

derivatives, and blood and blood products 

due to bovine spongiform encephalopathy. 

(a) Except as provided in paragraphs 

(c) through (i) of this section, the 

importation of the following is 

prohibited: 

(1) * * * 

(ii) Glands, unprocessed fat tissue, 

and blood and blood products derived 

from ruminants; 

* * * * * 

(iv) Derivatives of glands and blood 

and blood products derived from 

ruminants. 

* * * * * 

(d) Except as provided in paragraph 

(e) of this section, the importation of 

serum albumin, serocolostrum, amniotic 

liquids or extracts, and placental liquids 

derived from ruminants that have been 

in any region listed in § 94.18(a) of this 

chapter, and collagen and collagen 

products that meet any of the conditions 

listed in paragraphs (a)(1) through (a)(3) 

of this section, is prohibited unless the 

following conditions have been met: 

* * * * * 

(e) Bovine blood and blood products 

that are otherwise prohibited 

importation under paragraph (a)(1) or 

(d) of this section may be imported into 

the United States if they meet the 

following conditions: 

(1) For blood collected at slaughter 

and for products derived from blood 

collected at slaughter: 

(i) The blood was collected in a closed 

system in which the blood was 

conveyed directly from the animal in a 

closed conduit to a closed receptacle, or 

was collected otherwise in a hygienic 

manner that prevents contamination of 

the blood with SRMs. 

(ii) The slaughtered animal passed 

ante-mortem inspection and was not 

subjected to a pithing process or to a 

stunning process with a device injecting 

compressed air or gas into the cranial 

cavity; 

(2) For fetal bovine serum: 

(i) The blood from which the fetal 

bovine serum was derived was collected 

in a closed system in which the blood 

was conveyed directly from the animal 

in a closed conduit to a closed 


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Federal Register / Vol. 72, No. 180 / Tuesday, September 18, 2007 / Rules and Regulations 53379 

receptacle, or was collected otherwise in 

a hygienic manner that prevents 

contamination of the blood with SRMs; 

(ii) The dam of the fetal calf passed 

ante-mortem inspection and was not 

subjected to a pithing process or to a 

stunning process with a device injecting 

compressed air or gas into the cranial 

cavity; 

(iii) The uterus was removed from the 

dam’s abdominal cavity intact and taken 

to a separate area sufficiently removed 

from the slaughtering area of the facility 

to ensure that the fetal blood was not 

contaminated with SRMs when 

collected. 

(3) For blood collected from live 

donor bovines and for products derived 

from blood collected from live donor 

bovines: 

(i) The blood was collected in a closed 

system in which the blood was 

conveyed directly from the animal in a 

closed conduit to a closed receptacle, or 

was collected otherwise in a hygienic 

manner that prevents contamination of 

the blood with SRMs; 

(ii) The donor animal was free of 

clinical signs of disease. 

(4) Each shipment to the United States 

is accompanied by an original certificate 

signed by a full-time salaried veterinary 

officer of the national government of the 

region of origin, or issued by a 

veterinarian designated by or accredited 

by the national government of the region 

of origin, representing that the 

veterinarian issuing the certificate was 

authorized to do so. The certificate must 

state that the requirements of paragraph 

(e)(1), (e)(2), or (e)(3) of this section, as 

applicable, have been met. 

* * * * * 

PART 96—RESTRICTION OF 

IMPORTATIONS OF FOREIGN ANIMAL 

CASINGS OFFERED FOR ENTRY INTO 

THE UNITED STATES 

■ 10. The authority citation for part 96 

continues to read as follows: 

Authority: 7 U.S.C. 8301–8317; 21 U.S.C. 

136 and 136a; 7 CFR 2.22, 2.80, and 371.4. 

■ 11. In § 96.1, definitions of Food and 

Drug Administration and Food Safety 

and Inspection Service are added, in 

alphabetical order, to read as follows: 

§ 96.1 Definitions. 

* * * * * 

Food and Drug Administration. The 

Food and Drug Administration of the 

United States Department of Health and 

Human Services. 

Food Safety and Inspection Service. 

The Food Safety and Inspection Service 

of the United States Department of 

Agriculture. 

* * * * * 

■ 12. In § 96.2, paragraph (b) is revised 

to read as follows: 

§ 96.2 Prohibition of casings due to 

African swine fever and bovine spongiform 

encephalopathy. 

* * * * * 

(b) Ruminant casings. The 

importation of casings, except stomachs, 

from ruminants that originated in or 

were processed in any region listed in 

§ 94.18(a) of this subchapter is 

prohibited, except as provided in 

paragraphs (b)(1) and (b)(2) of this 

section: 

(1) Casings that are derived from 

sheep that were slaughtered in a region 

listed in § 94.18(a)(3) of this subchapter 

at less than 12 months of age and that 

were from a flock subject to a ruminant 

feed ban equivalent to the requirements 

established by the U.S. Food and Drug 

Administration at 21 CFR 589.2000 may 

be imported. 

(2) Casings that are derived from 

bovines that were slaughtered in a 

region listed in § 94.18(a)(3) of this 

subchapter may be imported, provided, 

if the casings are derived from the small 

intestine, the casings are derived from 

that part of the small intestine that is 

eligible for use as human food in 

accordance with the requirements 

established by the Food Safety and 

Inspection Service at 9 CFR 310.22 and 

the Food and Drug Administration at 21 

CFR 189.5. 

(3) Casings imported in accordance 

with either paragraph (b)(1) or (b)(2) of 

this section must be accompanied by a 

certificate that: 

(i) States that the casings meet the 

conditions of this section; 

(ii) Is written in English; 

(iii) Is signed by an individual eligible 

to issue the certificate required under 

§ 96.3; and 

(iv) Is presented to an authorized 

inspector at the port of entry. 

* * * * * 

■ 13. In § 96.3, paragraph (d) is revised 

to read as follows: 

§ 96.3 Certificate for animal casings. 

* * * * * 

(d) In addition to meeting the 

requirements of this section, the 

certificate accompanying sheep casings 

from a region listed in § 94.18(a)(3) of 

this subchapter must state that the 

casings meet the requirements of 

§ 96.2(b)(1), and the certificate 

accompanying bovine casings from a 

region listed in § 94.18(a)(3) of this 

subchapter must state that the casings 

meet the requirements of § 96.2(b)(2). 

* * * * * 

Done in Washington, DC, this 12th day of 

September 2007. 

Charles D. Lambert, 

Acting Under Secretary for Marketing and 

Regulatory Programs. 

[FR Doc. 07–4595 Filed 9–14–07; 8:45 am] 

BILLING CODE 3410–34–P 


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