1102 Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Proposed Rules 

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: Proposed rule. 

SUMMARY: We are proposing to amend 

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 (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. 

We are proposing these amendments 

after conducting a risk assessment and 

comprehensive evaluation of the issues 

that concluded that such bovines and 

bovine products can be safely imported 

under the conditions described in this 

proposed rule. 

DATES: We will consider all comments 

that we receive on or before March 12, 

2007. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov, select 

‘‘Animal and Plant Health Inspection 

Service’’ from the agency drop-down 

menu, then click ‘‘Submit.’’ In the 

Docket ID column, select APHIS–2006– 

0041 to submit or view public 

comments and to view supporting and 

related materials available 

electronically. Information on using 

Regulations.gov, including instructions 

for accessing documents, submitting 

comments, and viewing the docket after 

the close of the comment period, is 

available through the site’s ‘‘User Tips’’ 

link. 

• Postal Mail/Commercial Delivery: 

Please send four copies of your 

comment (an original and three copies) 

to Docket No. APHIS 2006–0041, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3A–03.8, 4700 

River Road Unit 118, Riverdale, MD 

20737–1238. Please state that your 

comment refers to Docket No. APHIS 

2006–0041. 

Reading Room: You may read any 

comments that we receive on this 

docket in our reading room. The reading 

room is located in room 1141 of the 

USDA South Building, 14th Street and 

Independence Avenue, SW., 

Washington, DC. Normal reading room 

hours are 8 a.m. to 4:30 p.m., Monday 

through Friday, except holidays. To be 

sure someone is there to help you, 

please call (202) 690–2817 before 

coming. 

Other Information: Additional 

information about APHIS and its 

programs is available on the Internet at 

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

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) 734–4356. 

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: 

I. Background 

The Animal and Plant Health 

Inspection Service (APHIS) of the U.S. 

Department of Agriculture (USDA or 

Department) 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 

bovine spongiform encephalopathy 

(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 APHIS 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 notice in the Federal 

Register (69 FR 10633–10636, Docket 

No. 03–080–2) reopening and extending 

the comment period. 

On January 5, 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 


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1The current regulations regarding BSE minimalrisk regions apply to bison as well as cattle. In 

current §§ 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 proposed rule 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 proposed rule are also applicable 

to bison. Given that no cases of BSE have been 

detected in bison, this is likely a cautious 

assumption. The provisions of this proposed rule 

would apply to bovines as defined in the current 

regulations, which include bison. 

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 

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 

notice 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 allow 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. The risk analysis we 

conducted for that rule found that, 

because of the nature, incubation 

period, and progression of BSE 

infectivity, young cattle exposed to low 

levels of BSE will accumulate very little 

BSE infectivity within the first few years 

of life, and that cattle under 30 months 

of age from a BSE minimal-risk region 

are highly unlikely to have accumulated 

significant amounts of BSE infectivity 

even if infected. We concluded, 

therefore, that the risk to U.S. livestock 

presented by the importation of such 

bovines was low. 

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, notice that reopened and 

extended 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 

this proposed rule regarding live 

bovines are the result of that evaluation. 

The regulations established by the 

January 2005 final rule also allow 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 are 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 § 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. We have 

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, which are the subject of this 

proposed rule. 

Under the Animal Health Protection 

Act (7 U.S.C. 8301 et seq.), the Secretary 

of Agriculture may prohibit the 

importation of any animal or article if 

the Secretary determines that the 

prohibition is necessary to prevent the 

introduction into or dissemination 

within the United States of any pest or 

disease of livestock. The Secretary has 

determined that it is not necessary to 

continue to prohibit the importation 

from BSE minimal-risk regions 

(currently only Canada) of live bovines 

born after the date a feed ban was 

effectively enforced in the region of 

export, bovine blood or blood products, 

bovine small intestine other than the 

distal ileum, or bovine casings, 

provided that the conditions described 

in this proposal are met.1 This 

determination is based on a number of 

factors, which are discussed in this 

document and, in greater detail, in the 

risk assessment prepared for this 

rulemaking. The risk assessment, and 

the peer review plan and charge for this 

assessment may be viewed on the 

Regulations.gov Web site or in our 

reading room. Instructions for accessing 

Regulations.gov and information on the 

location and hours of the reading room 

are provided under the heading 

ADDRESSES at the beginning of this 

proposed rule.) In addition, copies may 

be obtained by calling or writing to the 


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individuals listed under FOR FURTHER

INFORMATION CONTACT. 

II. BSE and the Government’s Role in 

Protecting Human and Animal Health 

A. Nature of BSE 

BSE is a progressive and fatal 

neurological disorder of cattle that 

results from an unconventional 

transmissible agent. BSE belongs to the 

family of diseases known as 

transmissible spongiform 

encephalopathies (TSEs). All TSEs 

affect the central nervous system of 

infected animals. However, the 

distribution of infectivity in the body of 

the animal and mode of transmission 

differ according to the species and TSE 

agent. In addition to BSE, TSEs include, 

among other diseases, scrapie in sheep 

and goats, chronic wasting disease in 

deer and elk, and Creutzfeldt-Jakob 

disease in humans. 

The agent that causes BSE has yet to 

be fully characterized. The theory that is 

most accepted in the international 

scientific community is that the agent is 

an abnormal form of a normal protein 

known as cellular prion protein. The 

BSE agent does not evoke a traditional 

immune response or inflammatory 

reaction in host animals. BSE is 

confirmed by post-mortem microscopic 

examination of an animal’s brain tissue 

or by detection of the abnormal form of 

the prion protein in an animal’s brain 

tissues. The pathogenic form of the 

protein is both less soluble and more 

resistant to degradation than the normal 

form. The BSE agent is resistant to heat 

and to normal sterilization processes. 

BSE is not a contagious disease, and 

therefore is not spread through casual 

contact between animals. (The 

possibility of maternal transmission 

(i.e., from a bovine dam directly to her 

offspring) was suggested by a 1997 

study (Ref 1) conducted in the United 

Kingdom. However, subsequent studies 

have shown that it is unlikely that 

maternal transmission of BSE occurs at 

any epidemiologically significant level, 

if it occurs at all (Ref 2)). 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. This route of 

transmission can be prevented by 

excluding potentially contaminated 

materials from ruminant feed. 

B. U.S. Government’s Role in Protecting 

Human and Animal Health 

Because variant Creutzfeldt-Jakob 

Disease (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, 

APHIS collaborates with other Federal 

agencies to implement a coordinated 

U.S. response to BSE. 

Protecting human and animal health 

from the risks of BSE is carried out on 

the Federal level primarily by APHIS 

regarding animal health and the 

Department’s Food Safety and 

Inspection Service (FSIS) regarding the 

food safety of meat and poultry, in 

coordination with the following Centers 

of the Food and Drug Administration 

(FDA), U.S. Department of Health and 

Human Services: The Center for 

Veterinary Medicine regarding animal 

feed and animal drugs; the Center for 

Food Safety and Applied Nutrition 

regarding foods other than meat, 

poultry, and egg products; the Center for 

Biologics Evaluation and Research 

regarding blood and blood products and 

other products; the Center for Drug 

Evaluation and Research regarding 

drugs containing bovine material; and 

the Center for Devices and Radiological 

Health regarding devices containing 

bovine material. 

APHIS recognizes that, although 

Federal agencies may differ somewhat 

in their specific mandates, it is 

necessary to conduct a coordinated 

Federal effort to safeguard human and 

animal health. We consider it important 

to base APHIS’ regulatory actions on the 

best scientific evidence. Additionally, as 

the agencies make BSE-related 

documents available for public 

comment, or otherwise solicit public 

response, the agencies share and discuss 

information received. 

Of recent note is information solicited 

and received by FSIS between July and 

October 2006 regarding the 2005 

updated Harvard Risk Assessment of 

BSE associated with public health 

exposure. FSIS discussed with APHIS 

and FDA public comments it received in 

response to a notice of availability (71 

FR 39282–39283, Docket No. FSIS–

2006–0011, published in the Federal 

Register July 12, 2006) and a public 

technical meeting regarding the risk 

assessment and the potential of BSE 

exposure and animal health. APHIS has 

taken relevant comments received into 

consideration with regard to its risk 

assessment for this proposed rule. 

III. Commodities Covered by This 

Proposed Rule 

This rule would amend the APHIS 

regulations as they apply to the 

importation of the following 

commodities from BSE minimal-risk 

regions: 

• Live bovines; 

• Blood and blood products derived 

from bovines; 

• Small intestine, other than the 

distal ileum, derived from bovines; and 

• Casings derived from bovines. 

This part of the Supplementary 

Information section of this proposed 

rule discusses the risks associated with 

each commodity, mitigations that 

address the risk, and how we propose to 

amend the regulations to allow the 

importation of these commodities. 

A. Live Bovines 

BSE Transmission 

As noted above under ‘‘Nature of 

BSE,’’ oral ingestion of feed 

contaminated with the BSE agent is the 

only documented route of field 

transmission of BSE (Ref 2 and 3). 

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 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 BSE-contaminated 

feed to become infected (Ref 4).) 

Proposed Regulatory Change; OIE 

Guideline 

The first step that must occur for BSE 

to be transmitted to cattle in the United 

States from a BSE-infected bovine 

imported live into this country from a 

BSE minimal-risk region is that such a 

bovine must enter the United States. 

Under our current regulations, the risk 

of such a bovine entering the United 

States is already very low because of the 

APHIS regulatory standards for 

importation from BSE minimal-risk 

regions. 

In this document, we are proposing 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. Experience around 

the world in countries with BSE has 

demonstrated that feed bans are 


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effective control measures, and that the 

incidence of BSE worldwide continues 

to decline because of these measures 

(Ref 5 and 6). 

Because of the demonstrated efficacy 

of an effectively enforced feed ban in 

reducing the possibility of exposure of 

cattle to the BSE agent, the World 

Organization for Animal Health (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). The condition in this proposed 

rule for the importation of live bovines 

from BSE minimal-risk regions is 

consistent with the OIE guideline. 

Importance of a Feed Ban in Reducing 

the Likelihood of BSE Transmission 

By eliminating transmission, an 

effective feed ban reduces the 

possibility of the existence of infected 

animals in a given cattle population, 

which in turn reduces even further the 

chances of healthy animals being 

exposed to the BSE agent via subsequent 

recycling of infectivity. 

Experience in the United Kingdom 

demonstrates that implementation of a 

ruminant-to-ruminant feed ban causes 

BSE prevalence to decrease. Animal 

feed restrictions were implemented in 

the United Kingdom in 1988, when the 

use of ruminant meat-and-bone meal 

(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 (Ref 7). 

Although the data presented in the 

following figure and table represent the 

specific situation in Great Britain during 

the years identified in the graph, there 

is every reason to expect downward 

pressure on the prevalence of BSE in 

any country that implements a feed ban. 

Figure 1. Confirmed cases in cattle in 

Great Britain born after feed ban 

implementation. Note: The first feed ban 

was implemented in the summer of 

1988 (before fall calving) (Ref 8). 

The raw data that provided the basis 

for Figure 1 are reproduced in Table 1: 

TABLE 1.—CONFIRMED CASES IN

GREAT BRITAIN BY YEAR OF BIRTH, 

WHERE KNOWN

Year Cases 

1974 .......................................... 1 

1975 .......................................... 0 

1976 .......................................... 2 

1977 .......................................... 10 

1978 .......................................... 6 

1979 .......................................... 41 

1980 .......................................... 102 

1981 .......................................... 262 

1982 .......................................... 1,394 

TABLE 1.—CONFIRMED CASES IN

GREAT BRITAIN BY YEAR OF BIRTH, 

WHERE KNOWN—Continued 

Year Cases 

1983 .......................................... 4,463 

1984 .......................................... 8,069 

1985 .......................................... 11,071 

1986 .......................................... 19,752 

1987 .......................................... 36,935 

1988 .......................................... 22,266 

1989 .......................................... 12,748 

1990 .......................................... 5,748 

1991 .......................................... 4,779 

1992 .......................................... 3,531 

1993 .......................................... 2,997 

1994 .......................................... 2,182 

1995 .......................................... 1,100 

1996 .......................................... 67 

1997 .......................................... 45 

1998 .......................................... 37 

1999 .......................................... 24 

2000 .......................................... 6 

TABLE 1.—CONFIRMED CASES IN

GREAT BRITAIN BY YEAR OF BIRTH, 

WHERE KNOWN—Continued 

Year Cases 

2001 .......................................... 5 

2002 .......................................... 1 

Unknown birth year .................. 43,342 

Total ................................... 180,986 

(Ref 8) 

Determining a Date of Effective 

Enforcement of a Feed Ban 

Under the current regulations, one of 

the conditions that must be met for a 

region to be recognized by APHIS as a 

BSE minimal-risk region is that the 

region must have in place a ruminantto-ruminant feed ban that is effectively 

enforced. APHIS bases its determination 


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of whether a region has in place an 

effectively enforced ruminant-toruminant feed ban on an evaluation of 

the laws and regulations in place in the 

region, the adequacy of the 

infrastructure to implement the 

regulations, and the evidence of 

effective implementation and 

monitoring (i.e., compliance 

inspections, training and records). 

We are proposing in this rule to 

require that bovines from a BSE 

minimal-risk region intended for 

importation into the United States have 

been born on or after the date 

determined by APHIS to be the date of 

effective enforcement of a ruminant-toruminant feed ban in the region of 

export. In determining the date of 

effective enforcement of a feed ban, we 

believe it is first necessary to consider 

the amount of time, if any, between the 

regulatory establishment of the feed ban 

in the region of export and the practical 

implementation of the ban. The period 

of practical implementation can be 

determined by evaluating 

implementation guidance and policies, 

such as allowing grace periods for 

certain aspects of the industry. In 

addition, the time necessary for initial 

education of industry and training of 

inspectors must be considered. 

After the practical implementation 

period is determined, we believe it is 

then necessary to consider whether, in 

the region being evaluated, an 

additional period of time was needed to 

allow most feed products to cycle 

through the system, given the 

management practices in the country. 

Feed Ban in Canada 

In conjunction with the rulemaking 

that resulted in the January 2005 final 

rule, APHIS conducted a risk analysis in 

2003 and 2004 to evaluate the BSE risk 

from ruminants and ruminant products 

imported from regions presenting a 

minimal BSE risk, and to evaluate 

whether Canada could be classified as a 

minimal risk region (Ref 9 and 10). As 

part of the risk analysis, USDA 

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 the 

Canadian Food Inspection Agency 

(CFIA) as well as epidemiological 

information in concluding that 

compliance with the feed ban was good, 

and that the feed ban was effectively 

enforced. In response to the detection of 

two additional BSE cases in Canada, in 

January 2005, USDA reassessed the 

oversight of Canada’s feed ban. Based on 

review of inspection records and on-site 

observations, USDA confirmed that 

Canada has a robust inspection program, 

that overall compliance with the feed 

ban is good, and that the feed ban is 

reducing the risk of transmission of BSE 

in the Canadian cattle population (Ref 

11). In addition to the USDA audit of 

the Canadian feed ban, CFIA conducted 

its own review in 2005, and concluded 

that the ban is providing an effective 

mitigation that is contributing to 

reducing the BSE risk in the country to 

an extremely low level (Ref 12). 

Components of the Canadian Feed Ban 

Canada’s feed ban came into force on 

August 4, 1997, when CFIA issued 

regulations prohibiting the use of 

mammalian protein in ruminant feeds 

as follows: ‘‘Any feed that is, or that 

contains any prohibited material 

originating from a mammal (with 

exceptions) shall not be fed to a 

ruminant’’ (Ref 12). The ban provided 

exceptions for milk, blood, gelatin, and 

protein derived solely from porcine or 

equine sources. Canadian feed 

regulations also prohibit the use of plate 

waste and poultry litter in ruminant 

feed. 

The feed ban includes requirements 

for labeling and recordkeeping. Feed 

manufacturers, renderers, retailers, and 

livestock producers must document 

their production procedures and feeding 

practices to verify their compliance with 

the feed ban. Feed manufacturers must 

keep records regarding the composition, 

identity, and distribution of all feeds for 

the species named in the regulations. 

Renderers, feed manufacturers and 

farmers must take steps to prevent the 

material prohibited under the feed ban 

from being incorporated into or 

contaminating ruminant feed. To 

prevent the misfeeding of prohibited 

material to ruminants, users of livestock 

feed must keep labels or invoices from 

all purchased feeds containing 

prohibited material; these records must 

be kept for 2 years. 

Measures Required at Rendering 

Facilities 

The rendering industry is important 

in reducing the risk of transmitting BSE 

infectivity, not only because of its role 

in inactivation of the BSE agent, but also 

because it serves as a control point for 

the redirection of ruminant protein 

away from cattle feeds. Since 1998, all 

Canadian rendering facilities have been 

subject to annual inspections and 

permitting (Ref 11). Three types of 

permits are issued, allowing companies 

to produce either non-prohibited 

material only, prohibited material only, 

or both non-prohibited and prohibited 

material (Ref 11). Permitting requires 

implementation of manufacturing 

controls (such as Good Manufacturing 

Practices and a risk-based Hazard 

Analysis and Critical Control Point 

(HACCP) plan, recordkeeping (for both 

production and distribution) and 

labeling requirements (i.e., ‘‘Do not feed 

to cattle, sheep, deer or other 

ruminants’’ on labels and invoices for 

all prohibited material) directed at 

preventing cross-contamination or 

misfeeding. 

Measures to Prevent Contamination of 

Feed 

As mentioned earlier, renderers, feed 

manufacturers, and farmers must take 

steps to prevent material prohibited 

under the feed ban from being 

incorporated into or contaminating 

ruminant feed. Such incorporation or 

contamination can be prevented by 

having dedicated processing lines or 

facilities that use only prohibited or 

non-prohibited material. If a facility 

handles both prohibited and nonprohibited material, procedures must be 

established and maintained to conduct 

flushing and/or clean-out between 

batches of product to prevent crosscontamination. 

The feed industry in Canada has also 

taken a number of aggressive steps to 

comply with measures in the feed ban 

designed to reduce the risk of 

contamination of feed for cattle with 

prohibited material. Recently both the 

United States and Canada reviewed the 

changes made to industry procedures 

and governmental inspectional 

oversight. (Ref 11 and 12). These 

reviews demonstrated, for example, that 

the Canadian rendering industry has 

moved toward establishment of 

dedicated facilities or dedicated 

processing lines within rendering 

facilities (Ref 11 and 12). Of the 29 

rendering facilities in Canada, 6 handle 

both prohibited and non-prohibited 

material, compared to 13 that initially 

handled both types of material. Of the 

six, four use dedicated processing lines 

(Ref 12). According to CFIA’s reports, 

the feed manufacturing industry has 

also moved toward dedicated facilities. 

According to the most recent review 

(March 2005), 94 (17%) of the 550 

commercial feed mills in Canada 

handled prohibited material and also 

manufactured feeds for ruminants, 

compared to 120 (22%) in 2002–2003 

(Ref 12). These actions, in addition to 

the labeling and recordkeeping 

requirements for all products containing 

prohibited material, decrease the 

likelihood of contamination of ruminant 

feeds with prohibited material. 


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Inspections and Compliance 

Following establishment of the feed 

ban in 1997, CFIA broadened its 

communications with the affected 

industries and implemented an 

inspection program. This program was 

introduced in phases. From 1997–2000, 

inspection activities focused on 

integrating the feed ban’s requirements 

into standard industry practices. For 

example, starting in 1998, rendering 

facilities were required to pass an 

annual inspection in order to renew 

their permits to operate. In 2000 and 

2001, CFIA modified its compliance 

programs by increasing the frequency of 

inspections of commercial feed mills 

from once every 3 years to every year 

and by continuing the annual inspection 

and permitting of all rendering facilities. 

Since 2002, CFIA has been conducting 

annual inspections of all rendering and 

commercial feed mill facilities and some 

ruminant feeders and retail feed 

distributors. 

Recent Regulatory Amendments in 

Canada 

In June 2006, CFIA issued 

amendments to the feed ban regulations 

in Canada to enhance the feed ban in 

that country. Those amendments 

require, among other things, the removal 

of potentially BSE-infective tissues 

(specified risk materials, or SRMs) from 

all animal feeds, pet food, and fertilizer. 

The amendments will not be effective 

until July 12, 2007, and, therefore, they 

are not included in this discussion. 

Date of Effective Enforcement of 

Ruminant-to-Ruminant Feed Ban in 

Canada 

For the purposes of this proposed 

rule, we have determined a date we 

consider to be the date of effective 

enforcement of ruminant-to-ruminant 

feed ban in Canada, the only country 

currently recognized by APHIS as a BSE 

minimal-risk region. Although the 

regulations establishing the feed ban in 

Canada came into force upon their 

publication in August 1997, full 

implementation and effective 

enforcement was a gradual process. In 

determining a date when the feed ban 

could be considered to be effectively 

enforced, we carefully considered 

information drawn from the 

epidemiological investigations to date 

and the reports noted above under the 

heading ‘‘Feed Ban in Canada.’’

From the outset, CFIA recognized that 

a phase-in period would be required 

before prohibited materials that were 

already in feed channels would be 

exhausted and labeling and 

recordkeeping requirements would be 

met. CFIA estimated that it would take 

approximately 30 days for feed mills 

and retailers to use up and distribute 

existing supplies of ‘‘old’’ product; 60 

days to add a caution statement to the 

necessary documents; and 60 days for 

farms to use up their stores of ‘‘old’’

product (Ref 13). All retailers were 

given until September 3, 1997, to use or 

distribute feed already produced. Feed 

manufacturers received a grace period 

until October 3, 1997, to comply with 

labeling requirements. Livestock 

producers were given a grace period 

until October 3, 1997, to use the feed 

manufactured and purchased prior to 

the feed ban. However, feed tracing 

associated with one of the Canadian 

BSE cases suggested that feed produced 

prior to implementation of the feed ban 

may have been available at feed stores 

beyond the grace period. Therefore, a 

period of 6 months has been estimated 

for practical implementation of the feed 

ban, making February 1998 a more 

reasonable baseline from which to 

assess effective implementation (Ref 13). 

However, based on our evaluation of 

the situation in Canada, we believe that 

the feed ban there achieved full efficacy 

only at some time after the practical 

implementation period. We believe that 

additional time was necessary to allow 

for most old feed to cycle through and 

out of the system. To evaluate the 

duration of this time frame in Canada, 

we considered on-farm feeding practices 

in that country. Most cattle producers in 

Canada do not hold extensive long-term 

inventories of purchased feeds on their 

farms due to limited storage space and 

expense. These practices make it 

unlikely that feeds containing 

prohibited material were available for 

more than a few months after practical 

implementation of the feed ban. The 

possible exception is mineral mixes 

produced before the feed ban that may 

have contained ruminant MBM. Mineral 

mixes are typically fed daily but in very 

small quantities (grams rather than 

pounds per day) (Ref 14 and 15) and 

may be stored on the farms for longer 

periods of time. We believe, however, 

that they are not likely to have been 

purchased for use for periods longer 

than a year. 

Both beef and dairy cattle production 

can be considered to have an annual, or 

12-month, calving cycle, in that a cow 

on a beef or dairy farm will generally 

give birth once a year. Calving occurs 

among cows year-round on Canada’s 

dairy farms to ensure a constant supply 

of fluid milk. Most dairy farms in 

Canada produce their own forage and 

grains (Ref 16). Forages produced 

seasonally are stored on the farm to 

provide the basis for the diet fed to 

dairy cattle of all ages and production 

stages. Protein supplements and 

specialty feeds, such as mixed calf 

feeds, are typically purchased 

commercially in quantities to be fed out 

over a few months, because these 

supplemental feeds are expensive to 

purchase, costly to store, and may 

deteriorate with time. Typically, 

purchased feeds are available 

throughout the year with only moderate 

price variations, so there is little 

incentive for producers to maintain 

large on-farm inventories (Ref 17). The 

Canadian beef production cycle is very 

seasonal in that cows are bred so that 

calving occurs at the same time of year, 

generally in the spring (Ref 16). 

Producers are not likely to carry 

extensive feed inventories from season 

to season (Ref 16 and 18). Therefore, in 

both Canadian dairy and beef 

production, a 12-month period would 

generally be sufficient to allow 

purchased feed products that may 

contain MBM to be completely used. 

We arrived at our determination that 

the Canadian feed ban was fully 

implemented and effectively enforced as 

of March 1, 1999, by adding this 

additional 12-month period to the 6- 

month ‘‘practical implementation 

period’’ following the August 1997 

establishment of the feed ban in Canada. 

We believe that prohibiting the 

importation of bovines from Canada that 

were born before March 1, 1999, would 

provide an appropriate additional 

mitigation to what is an already 

extremely low risk of the introduction of 

BSE from Canada. 

Assessment of Risk From Cattle of 

Canadian Origin 

As noted above, Canada is currently 

the only country recognized by APHIS 

as a BSE minimal-risk region. In 

conjunction with this rulemaking, we 

have conducted an assessment that both 

quantitatively and qualitatively 

addresses the potential BSE risk of 

importing live bovines from Canada. 

Arriving at an estimation of risk 

begins with laying out the risk pathway 

(a series of occurrences or steps 

necessary for disease to enter and 

become established). Next, the 

likelihood of each of the multiple steps 

must be estimated. In our risk 

assessment, although we analyze the 

likelihood of each individual step in the 

process occurring, we interpret its 

significance in the context of the entire 

process. 

BSE Prevalence in Canada 

One of the conditions for being 

recognized by APHIS as a BSE minimalrisk region is that the region have in 


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2The current adult cattle population in the 

United States is approximately 42 million animals. 

place and maintain risk mitigation 

measures adequate to prevent 

widespread exposure and/or 

establishment of the disease. In 

classifying Canada as a BSE minimalrisk region in our January 2005 final 

rule, we determined that such 

mitigation measures are in place and are 

maintained in Canada. For the risk 

assessment for this proposed rule, we 

have made a quantitative estimate of the 

prevalence of BSE among Canadian 

cattle, using data available to us through 

August 15, 2006, and have used this 

estimate as part of our quantification of 

the risk of transmission of BSE to U.S. 

livestock as a result of this rule. Our 

estimate indicates a very low level of 

BSE prevalence in Canada. 

From the time of detection of the first 

native case of BSE in Canada in 2003, 

nine cases of Canadian-born BSEinfected cattle have been identified, as 

follows: 

• In May 2003, BSE was confirmed in 

a cow in the Province of Alberta. The 

cow was determined to have been born 

in March 1997. 

• In December 2003, BSE was 

confirmed in a cow of Canadian origin 

in Washington State. The cow was 

determined to have been born in April 

1997. 

• In January 2005, BSE was 

confirmed in two cows in the Province 

of Alberta. One of the cows was 

determined to have been born in 

October 1996. The other cow was 

determined to have been born in March 

1998. 

• In January 2006, BSE was 

confirmed in a cow in the Province of 

Alberta. The cow was determined to 

have been born in April 2000. 

• In April 2006, BSE was confirmed 

in a cow in the Province of British 

Columbia. The cow was determined to 

have been born in April 2000. 

• In June 2006, BSE (of a different 

phenotype than that in the other 

diagnoses) was confirmed in a cow in 

the Province of Manitoba. The cow was 

determined to have been born in 

approximately 1991. 

• In July 2006, BSE was confirmed in 

a cow in the Province of Alberta. The 

cow was determined to have been born 

in April 2002. 

• In August 2006, BSE was confirmed 

in a cow in the Province of Alberta, 

which, according to preliminary 

information available to APHIS, was 

born in 1996. 

Of the nine Canadian-born cows 

diagnosed with BSE, three were born 

after March 1, 1999, the date we are 

proposing as the date of effective 

enforcement of a ruminant-to-ruminant 

feed ban in Canada. This is not 

unexpected, nor do we consider such 

diagnoses in any way to undercut our 

conclusion that March 1, 1999, can be 

considered the date of effective 

enforcement of the feed ban in Canada. 

Experience worldwide has 

demonstrated that, even in countries 

with an effective feed ban in place, BSE 

has occurred in cattle born after a feed 

ban was implemented. No regulatory 

effort can ensure 100 percent 

compliance. Isolated incidents, such as 

feed made from non-prohibited material 

being contaminated with prohibited 

material during processing, can occur 

due to human error. However, 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. 

Based on our determination that 

Canada has had in place since March 1, 

1999, an effectively enforced feed ban 

that continues at a robust level, and the 

demonstrated effectiveness of a feed ban 

in reducing the likelihood of BSE 

transmission, our expectation is that the 

prevalence of BSE in Canada will 

continue to decline from its present 

minimal level. As we discuss in our risk 

assessment for this rulemaking, such a 

decline would decrease any possibility 

of BSE being introduced into the United 

States by Canadian cattle, and therefore 

decrease the negligible risk of the spread 

of BSE to U.S. cattle. 

However, in our risk assessment, we 

also evaluated scenarios that are less 

likely than the one we expect, including 

no decrease in BSE prevalence in 

Canada over the next 20 years. Even 

using this extremely unlikely scenario, 

which would mean the continued 

detection of additional BSE—infected 

Canadian cattle born after March 1, 

1999, our conclusion is that the BSE risk 

to U.S. livestock due to implementation 

of this proposed rule would be 

negligible. 

We used a mathematical model to 

approximate the proportion of BSE—

infected, but not necessarily clinically 

diseased, cattle in Canada. Our 

mathematical model is discussed in 

detail in the risk assessment we 

conducted in conjunction with this 

proposed rule. Using this mathematical 

model, we estimated that the prevalence 

of BSE in Canada, based on data 

available as of August 15, 2006, is 6.8 

animals per every 10 million adult 

cattle. (The current adult cattle 

population in Canada is approximately 

5.9 million animals.) In comparison, the 

same model was recently used to 

estimate the prevalence of BSE in the 

United States. The findings of that 

analysis supported a conclusion that 

BSE prevalence in the United States is 

below 1 case per million adult cattle, 

with a most likely estimate for the 

United States of 1 infected animal per 

10 million adult cattle (Ref 19).2

Our estimate of BSE prevalence in 

Canada incorporates the United 

Kingdom data on the effectiveness of a 

feed ban. However, it should be noted 

that the actual prevalence of BSE in 

Canada is most probably lower than our 

estimate. This is because, where we 

needed to incorporate simplifying 

assumptions in our calculations, due to 

data uncertainty or the constraints of the 

mathematical model itself, we chose 

assumptions that, if anything, erred on 

the side of assuming greater prevalence. 

An example of this is the data we 

used related to the diagnosis of BSE in 

a cow of Canadian origin in Washington 

State in December 2003. Although we 

incorporated that case into the number 

of Canadian-born cattle that have been 

diagnosed with BSE—which increased 

the estimate of overall BSE prevalence 

in Canada—we did not numerically 

increase the total Canadian cattle 

population by including in that 

country’s number of cattle those animals 

of Canadian origin that had been 

imported into the United States and that 

tested negative for BSE. If those animals 

had been included in the figure used for 

the total Canadian cattle population, the 

estimated BSE prevalence would have 

been reduced. Additionally, we did not 

include in our calculations cows that 

were tested in Canada with negative 

results as part of investigations 

conducted after the diagnosis of BSE in 

cows of Canadian origin. 

Projected Future Prevalence Rates in 

Canada 

Our qualitative conclusion is that, due 

to the feed ban in Canada, BSE 

prevalence rates will progressively 

decline in that country over the next 20 

years. However, because we could not 

provide an accurate prediction for the 

rate at which we would expect 

prevalence to decrease, we did not 

attempt to numerically represent the 

actual expected annual release over the 

20 years of our analysis. For example, it 

would be guesswork to attempt to 

estimate exactly what the prevalence of 

BSE in Canada will be in the year 2012 

and to use that figure in our 

mathematical model, even though, 

qualitatively, we consider it very likely 

that the prevalence will be less than it 

was in August 2006. Therefore, when 

creating a scenario for our quantitative 


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calculations, we assume that the 

prevalence of BSE in Canada will 

remain the same for each of the next 20 

years as it was in August 2006. 

BSE Risk From Live Bovines From 

Minimal-Risk Regions 

BSE prevalence, however, is just one 

factor that must be considered when 

determining the risk of BSE 

transmission. Requiring, as this rule 

would do, that live bovines imported 

into the United States from a BSE 

minimal-risk region be born after the 

date of effective enforcement of a feed 

ban, would mitigate the risk of exposure 

of U.S. livestock to the BSE agent. As 

discussed above, such a requirement 

would be consistent with the OIE 

recommendation to allow trade in live 

cattle from regions that have reported 

BSE if such regions have an effective 

feed ban in place. 

Moreover and importantly, however, 

if an infected bovine from a BSE 

minimal-risk region were to be imported 

into the United States, for that bovine to 

transmit infection to a U.S. cow, each in 

a series of additional mitigations against 

such transmission would have to fail or 

be breached. The effect of such 

mitigations, discussed in greater detail 

in our risk assessment, was also 

discussed in the APHIS risk assessment 

that was conducted for our January 2005 

final rule establishing the category of 

BSE minimal-risk regions (Ref 9). In the 

risk assessment for this rulemaking, we 

assess with regard to imports of live 

bovines from Canada (currently the only 

region recognized by APHIS as a BSE 

minimal-risk region), using updated 

data and assumptions, the likelihood of 

that series of mitigations failing if this 

proposed rule were implemented. 

The mitigations that would have to be 

breached include: 

• Slaughter controls and dead animal 

disposal; 

• Rendering inactivation; 

• Feed manufacturing and use 

controls; 

• Biologic limitations to 

susceptibility. 

As discussed in our risk assessments, 

these mitigations work in a series and 

are multiplicative in their risk-reduction 

effects; i.e., however small the chances 

that BSE infected material would make 

it past the first mitigation, the likelihood 

of the material eventually infecting a 

U.S. animal would shrink to a 

significantly smaller level with each 

subsequent mitigation. The risk 

assessment for this proposed rule 

simulated the impact of these 

mitigations on the likelihood of 

exposure, establishment, and spread of 

BSE infectivity in the United States if 

this proposed rule were to be 

implemented, and quantified those 

impacts where possible. 

Both qualitative and quantitative 

methods were used in the exposure 

assessment to evaluate the likelihood of 

exposing susceptible animals, given the 

release of infectivity via imported 

bovines. The most likely scenario of the 

release assessment included the 

assumption that the prevalence of BSE 

in the standing adult cattle population 

in Canada will continuously decrease. 

As explained earlier, this expected 

decrease could not be incorporated into 

the quantitative methods and, therefore, 

the possible exposures were assessed 

qualitatively. This qualitative exposure 

assessment of the most likely scenario of 

the release assessment—decreasing 

Canadian prevalence—indicates that the 

likelihood of BSE exposure and 

establishment in the U.S. cattle 

population as a consequence of 

infectivity in the United States 

introduced via imports from Canada is 

negligible. 

Even though we concluded that it is 

most likely that Canadian prevalence 

will decrease, we also considered the 

less likely scenarios and quantitatively 

analyzed the impact of an assumed 

constant prevalence in Canada to 

simulate potential BSE exposure in U.S. 

cattle. The quantitative model used in 

the exposure assessment and its results 

include the much less likely scenario 

that Canadian BSE prevalence remains 

constant through 2026. Because we 

believe this situation is much less likely 

to occur, we have concluded that 

prevalence and release and, therefore, 

the number of infected animals 

occurring in the United States would be 

lower than the values derived from the 

quantitative exposure model. 

Using a base-case assumption that the 

August 2006 BSE prevalence rate in 

Canada remains the same over the next 

20 years, our quantitative model 

predicts the importation of a total of 

approximately 19 infected bovines over 

that period under the provisions of this 

proposed rule. (As discussed above, 

however, as a result of implementation 

of an effective feed ban, we expect the 

already low prevalence in Canada to 

decline over time.) The model further 

predicts that, if 19 infected bovines 

were imported over a 20-year period, 

approximately 2 U.S. animals would 

consequently be infected during that 

period due to such importations. (For 

purposes of comparison, the standing 

U.S. cattle population in 2006 is 

approximately 97 million animals, 

which would be multiplied over a 20- 

year period.) 

Of the total number of infected 

animals predicted over the next 20 years 

(i.e., the total of infected imported 

animals and infected U.S. cattle), only a 

small fraction (numerically, fewer than 

1 (0.67)) would live long enough to 

develop clinical signs and be likely to 

contain significant levels of infectivity, 

due to the lengthy incubation period for 

BSE and the fact that most U.S. cattle 

are slaughtered before reaching the age 

when infectivity is manifested in 

clinical signs. Even assuming the 

unlikely event of no decline in the 

Canadian BSE prevalence rate over the 

next 20 years, the predicted results from 

our risk assessment indicate that, given 

the nature of BSE and the mitigations in 

place that prevent its transmission in 

the United States, it is highly unlikely 

that BSE would become established in 

the United States due to implementation 

of this proposed rule. And, as noted, we 

believe the quantitative component of 

our risk assessment overestimates the 

likely number of infected animals that 

would be present in the United States 

over the next 20 years as a result of 

importing cattle from Canada under the 

provisions of this proposed rule. 

Sensitivity Analysis to Account for 

Uncertain Parameters 

In reaching the conclusions discussed 

above, we used what we consider basecase conditions. In order to account for 

uncertainty, however, and to allow for 

possible divergence from those expected 

base case conditions, we have also done 

‘‘sensitivity analyses.’’ Sensitivity 

analysis evaluates the degree to which 

changes in the data used in a model 

affect the model’s results. Even 

assuming a combination of pessimistic 

values (i.e., those generating greater risk 

than base-case conditions) for every 

model parameter used, we concluded 

that factors mitigating BSE risk in the 

United States (e.g., at slaughter, during 

rendering, regarding feed manufacturing 

and use, and biological factors (the 

effect of an animal’s age on its BSE 

susceptibility)) would prevent BSE 

amplification in the United States, and 

that any imported infectivity would 

disappear from the U.S. cattle 

population. A detailed discussion of the 

sensitivity analyses is contained in our 

risk assessment. 

Proposed Regulatory Changes Regarding 

Live Bovines 

Based on the information available to 

us, we believe that allowing the 

importation from a BSE minimal-risk 

region of live bovines born on or after 

the date of effective enforcement of a 

ruminant-to-ruminant feed ban in the 

region of export would continue to 


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protect against the introduction and 

spread of BSE in the United States, 

while removing unnecessary restrictions 

on the importation of such animals, and 

are proposing to amend § 93.436(a) of 

the regulations to allow such 

importations. The regulations would 

specify March 1, 1999, as the date of the 

effective enforcement a ruminant-toruminant feed ban in Canada, currently 

the only country recognized by APHIS 

as a BSE minimal-risk region. 

We would remove the requirement in 

§ 93.436(a)(1) of the current regulations 

that live bovines imported from BSE 

minimal-risk regions be less than 30 

months of age when imported into the 

United States and when slaughtered. We 

would additionally remove the 

requirement in § 93.436(a)(1) and (b)(1) 

that such bovines not be pregnant when 

imported into the United States and the 

provisions in § 93.436 that limit 

importation to those bovines imported 

either for immediate slaughter or for 

movement to a feedlot and then to 

slaughter. 

Identification and Movement of Live 

Bovines From BSE Minimal-Risk 

Regions 

Section 93.436 also includes 

movement restrictions to help ensure 

that all bovines imported from BSE 

minimal-risk regions are slaughtered in 

the United States before they are 30 

months of age. If we remove the 

requirement that the bovines be less 

than 30 months of age when 

slaughtered, certain of the movement 

restrictions in § 93.436 would no longer 

be necessary. We are proposing to 

remove those restrictions that would be 

unnecessary, as discussed below. 

Permanent Identification of Bovines 

Moving to Other Than Immediate 

Slaughter 

Current § 93.436(b)(3) requires that 

bovines imported from a BSE minimalrisk region for other than immediate 

slaughter (i.e., for movement to a feedlot 

in the United States and then to 

slaughter) be permanently and 

humanely identified before arrival at the 

port of entry with a distinct and legible 

mark identifying the exporting country. 

The permanent identification required 

by the current regulations can be either 

a freeze brand, a hot iron brand, or some 

other method of identification applied 

to each animal’s right hip. In this 

proposal, we retain the requirement that 

bovines imported from a BSE minimalrisk region for other than immediate 

slaughter be permanently marked to 

identify the exporting country. In the 

event a bovine from a BSE minimal-risk 

region were to be diagnosed in the 

United States with BSE, such marking 

would expedite initial identification of 

the animal’s country of export. 

Traceback to the animal’s premises of 

origin would then be facilitated by the 

animal’s unique individual 

identification, which is currently 

required under § 93.436(b)(4) and which 

would continue to be required under the 

provisions of this proposed rule. 

However, we are proposing to specify an 

alternative to the requirement that the 

animal be marked on the right hip by 

freeze brand, hot iron, or some other 

method. (The current regulations allow 

in a general way for alternative means 

of identification with the 

Administrator’s approval, but don’t 

include any specifications for such 

alternative means of identification.) 

We are proposing to specify in 

§ 93.436(b)(2) that, in addition to the 

options for permanent identification 

already included there, the permanent 

identification of bovines imported from 

BSE minimal-risk regions can be in the 

form of a tattoo on the inside of one ear 

of each animal that identifies the 

exporting country. Bovines imported 

from Canada that are identified by tattoo 

would have to be identified with the 

letters ‘‘CAN’’. 

We proposed in our November 2003 

proposed rule to limit the country-ofexport permanent identification to a 

tattoo. However, comments from the 

public on that proposed rule expressed 

concern that tattoos might become 

illegible over time, could not be 

effectively monitored without 

restraining the animal, might become 

obscured by dirt and hair, and are not 

readily visible—particularly on animals 

with dark-skinned ears. In our January 

2005 final rule, we agreed that tattoos 

might not provide readily visible 

identification of the country of origin of 

bovines, and set forth instead the 

requirement described above. 

We continue to believe that tattoos 

might not be the most readily visible 

means of identification of live animals 

in groups of animals. However, as noted 

above, the purpose of requiring 

permanent identification of the animal’s 

country of export in this proposed rule 

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 would be an effective means of 

identification. 

Sealing of Means of Conveyance and 

Movement as a Group; Bovines 

Imported for Movement to a Feedlot 

We are proposing to remove the 

requirement in § 93.436(b)(6) that live 

bovines imported from a BSE minimalrisk region for feeding and then 

slaughter be imported in a means of 

conveyance sealed in the region of 

origin with seals of the national 

government of the region origin, and be 

moved directly from the port of entry as 

a group to a feedlot identified on the 

APHIS movement documentation 

currently required for such animals. 

Under this proposed rule, the 

importation of bovines from a BSE 

minimal-risk region would not be 

dependent on whether the animals are 

less than 30 months of age when 

imported and when slaughtered, but, 

rather, would be governed by whether 

the animals were born on or after the 

date of effective enforcement of a 

ruminant-to-ruminant feed ban in the 

exporting region. Once imported, the 

bovines would be handled in the same 

way as U.S. bovines. Therefore, we do 

not believe it would be necessary to 

retain the provisions in the regulations 

that were designed to help ensure that 

bovines from a BSE minimal-risk region 

are moved directly to a feedlot and are 

handled as an easily identifiable group. 

Sealing of Means of Conveyance and 

Movement as a Group; Bovines 

Imported for Immediate Slaughter 

We are also proposing to remove the 

requirement in § 93.436(a)(6) that the 

bovines imported from BSE minimalrisk regions for immediate slaughter be 

slaughtered as a group. However, we 

would continue to require that bovines 

from Canada imported for immediate 

slaughter be moved directly as a group 

from the port of entry in a sealed means 

of conveyance. We would require that 

the means of conveyance be sealed at 

the port of entry with seals of the U.S. 

Government, rather than requiring the 

sealing to occur in the region of export 

with seals of the national government of 

the region of export, as required in the 

current regulations. We explain our 

rationale for these proposed provisions 

in the following paragraphs. 

With regard to BSE, the purpose of 

requiring in the current regulations that 

bovines from BSE minimal-risk regions 

that are imported for immediate 

slaughter be moved to the slaughtering 

establishment in a sealed means of 

conveyance is to guard against diversion 

of any of the animals between the port 

of entry and the slaughtering 

establishment, in order to ensure that 

the animals are slaughtered as a group 


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before 30 months of age. Because this 

proposed rule would not require that 

the animals be slaughtered before 30 

months of age, there would be no BSErelated reason to require sealing of the 

means of conveyance. 

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.) 

Where Sealing Must Take Place 

We are proposing to 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. 

APHIS Form VS 17–130 

Currently, § 93.436(b)(8) requires that 

bovines imported from BSE minimalrisk regions for movement to feeding 

and then slaughter be accompanied 

from the port of entry to the feedlot by 

APHIS Form VS 17–130 or other 

movement documentation deemed 

acceptable by the Administrator, which 

must identify the physical location of 

the feedlot, the individual responsible 

for the movement of the animals, and 

the individual identification of the 

animal. Because, under this proposed 

rule, bovines imported from a BSE 

minimal-risk region that are not moved 

for immediate slaughter would not be 

limited to moving to a feedlot and then 

slaughter, it would no longer be 

necessary to require that the bovines be 

accompanied by a VS Form 17–130 that 

identifies the feedlot of destination. The 

other necessary information on the VS 

Form 17–130–e.g., the individual 

responsible for the movement of the 

animals and the individual 

identification of the animal-is already 

required on the health certificate that 

must accompany the animals under 

§ 93.405. Therefore, we are proposing to 

remove the requirement that live 

bovines imported from BSE minimalrisk regions for other than immediate 

slaughter be accompanied by VS Form 

17–130. 

Transport From Feedlots to Slaughter 

We are proposing to remove the 

requirement in § 93.436(b)(9) that the 

bovines imported from BSE minimalrisk regions for other than immediate 

slaughter remain at a feedlot until 

transported from the feedlot to a 

recognized slaughtering establishment 

for slaughter, and we are proposing to 

remove the requirement in 

§ 93.436(b)(10) that the bovines be 

moved directly from the feedlot to a 

recognized slaughtering establishment 

in conveyances sealed at the feedlot 

with seals of the U.S. Government. We 

are also proposing to remove the 

requirement in § 93.436(b)(11) that the 

bovines be accompanied from the 

feedlot to a recognized slaughtering 

establishment by APHIS Form VS 1–27 

or other movement documentation 

deemed acceptable by the 

Administrator, identifying the physical 

location of the recognized slaughtering 

establishment, the individual 

responsible for the movement of the 

animals, and the individual 

identification of the animal. This 

requirement would not be necessary 

because, under this proposed rule, cattle 

imported for other than immediate 

slaughter would not be limited to those 

less than 30 months of age that are 

moved directly to a feedlot and then to 

slaughter. 

Immediate Slaughter 

Section 93.420 contains provisions 

regarding the importation of ruminants 

from Canada for immediate slaughter, 

and applies to all ruminants from 

Canada imported for immediate 

slaughter, including sheep, goats, 

bovines, and other types of ruminants. 

However, as applied to sheep, goats, and 

bovines, many of the requirements in 

§ 93.420 are duplicative of provisions 

set forth in § 93.419 for sheep and goats 

and in § 93.436 for bovines. Because the 

majority of provisions in the current 

regulations regarding the importation of 

bovines and sheep and goats from 

Canada for immediate slaughter are 

contained in § 93.436 and § 93.419, 

respectively, we are proposing to 

rewrite § 93.420 so that it applies only 

to ruminants imported from Canada for 

immediate slaughter other than bovines, 

sheep, and goats. Any provisions of 

current § 93.420 that are still applicable 

to bovines, sheep, and goats under this 

proposed rule and that do not already 

appear in § 93.436 or § 93.419 would be 

moved to those sections. 9 CFR 93.405. 

In accordance with § 93.405 of the 

regulations, bovines, sheep, and goats 

imported from BSE minimal-risk regions 

must be accompanied by a health 

certificate. Among the information that 

must be recorded on the health 

certificate is the specific physical 

location of the feedlot or recognized 

slaughtering establishment where the 

ruminants are to be moved after 

importation. Because, under this 

proposed rule, bovines imported from 

BSE minimal-risk regions would not be 

limited to moving to a feedlot or 

slaughtering establishment, we are 

proposing to change that provision in 

§ 93.405(a)(4) to refer to ‘‘destination,’’

rather than to ‘‘feedlot or recognized 

slaughtering establishment.’’

B. Bovine Blood and Blood Products 

Blood and blood products can be 

divided into two main groups: 

1. In addition to whole blood, those 

products derived from blood that are 

composed of cells, such as red cell 

concentrate and platelets; and 

2. Plasma (that portion of blood that 

is cell-free) and products derived from 

plasma, such as serum (plasma with 

fibrinogen and clotting factors 

removed), clotting factors, 

immunoglobins and albumin (Ref 20). 

Fetal bovine serum (FBS) is the most 

commonly imported blood-derived 

commodity. FBS is serum derived from 

blood of bovine fetuses. As serum, it is 

the cell-free portion of blood with 

fibrinogen and clotting factors removed. 

It is used in tissue culture media, 


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including those used to produce 

pharmaceuticals and biological 

products, such as vaccines, and cannot 

be derived synthetically. 

BSE Risk Associated With Bovine Blood 

and Blood Products From BSE MinimalRisk Regions 

Our January 2005 final rule did not 

include provisions for the importation 

of bovine blood and blood products 

from BSE minimal-risk regions. We 

considered it advisable at the time to 

continue to prohibit the importation of 

blood and blood products from such 

regions (with the exception of those 

commodities that were already allowed 

to be imported for restricted use from 

BSE-affected regions under § 95.4(b) and 

(d)). 

In consultation with FDA, we have 

continued to assess the risk of BSE from 

blood and blood products from BSE 

minimal-risk regions. Based on the 

conclusions of our assessment, we are 

proposing to amend the regulations in 

§ 95.4 to allow the importation of blood 

and blood products from such regions 

under specified conditions, which we 

discuss below. 

Consistent with the approach of the 

risk assessment conducted for this 

proposed rule with regard to live 

animals and bovine small intestine, the 

risk estimation for blood and blood 

products relies on a comprehensive 

understanding of the multiple steps in 

the risk pathway. Thus, to understand 

the likelihood of BSE spreading and 

becoming established in the United 

States as a result of importing blood and 

blood products from a BSE minimal-risk 

region (currently only Canada), we 

examine the entire risk pathway. We 

evaluate the evidence from research to 

date—including research that has not 

detected infectivity in bovine blood and 

research in other species where 

infectivity has been detected—in the 

context of this larger risk pathway. 

Analysis of this risk pathway, discussed 

below, is the basis for our proposal to 

allow, under specified conditions, the 

importation of blood and blood 

products derived from bovines from 

BSE minimal-risk regions. 

One of the conditions for being 

recognized by APHIS as a BSE minimalrisk region is that the region have in 

place and enforce risk mitigation 

measures adequate to prevent 

widespread exposure and/or 

establishment of the disease, so that, 

even if one of the very few infected 

bovines in a BSE minimal-risk region 

were a source of imported blood or 

blood products, additional factors 

would act to further diminish the 

likelihood of the BSE agent’s entering 

the United States in bovine blood or 

blood products. 

Perhaps the most important factor is 

that, in research using infected bovines, 

infectivity has not been detected in 

cattle blood or any tested derivatives 

(Ref 21). This finding is applicable to 

clotted blood and fetal calf blood, and 

to products derived from whole blood, 

such as serum or buffy coat (the white 

cell fraction of centrifuged whole 

blood). As noted below, research in 

other species with BSE or other TSE 

agents has demonstrated infectivity in 

blood, and we use these studies to 

further inform our risk assessment. In 

addition, because blood components—

such as FBS and bovine serum albumin 

(BSA)—are used in the manufacture of 

vaccines, it is worthwhile to address 

injection vs. oral consumption as a route 

of exposure. 

Injection presents a different risk 

pathway than does oral consumption of 

BSE-contaminated bovine materials. 

The route of exposure can affect the risk 

of disease transmission. The relative 

efficiencies of different transmission 

routes of BSE have been reported to be, 

in decreasing order, intracerebral 

(injecting directly into the brain), 

intravenous (injecting directly into a 

vein), intraperitoneal (injected directly 

into the abdominal cavity), 

subcutaneous/intramuscular (injecting 

below the skin and/or into a muscle), 

and oral. It is estimated that the 

subcutaneous/intramuscular route of 

transmission requires 10 times the dose 

of a TSE agent to cause infection as does 

the intracerebral route and that oral/ 

intragastric transmission requires 10 

times the dose needed for 

subcutaneous/intramuscular 

transmission. In other words, injection 

of a BSE agent into an animal is a more 

efficient way of transmitting the disease 

agent to that animal than getting it into 

the animal through its food. 

The difficulty in examining the 

possibility of BSE transmission through 

injection is that BSE infectivity has not 

been detected in unprocessed bovine 

blood. We generally avoid extrapolating 

from studies of TSEs other than BSE in 

species other than bovines; however, in 

order to consider the only available 

evidence, we elected to use such studies 

as potential indicators of the behavior of 

BSE in cattle blood if, contrary to 

current evidence, it were to be present 

at previously undetectable levels. These 

studies are discussed in detail in our 

risk assessment. 

It is important to restate that no 

studies have demonstrated BSE 

infectivity in bovine blood and that we 

considered studies that involved TSEs 

other than BSE and species other than 

bovines. If, contrary to current research, 

BSE infectivity were to be distributed in 

bovine blood, research indicates that the 

BSE infectivity would likely be highest 

in the cellular components of the blood. 

These cellular fractions of the whole 

blood, both red and white cells, are 

excluded from the blood when 

harvesting FBS and BSA for use in the 

preparation of vaccines and drugs. 

Another component of the pathway of 

interest consists of the ways in which 

bovine blood that is collected might in 

some way become contaminated with 

SRMs at the time of collection, 

particularly in a slaughter environment. 

To guard against such possible 

contamination, it would be necessary to 

collect the blood in a closed system (a 

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. 

Additionally, to prevent blood collected 

from a fetal calf from becoming 

contaminated with SRMs, the uterus 

from a slaughtered dam should be 

removed intact and taken to a separate 

area away from the slaughtering area of 

the facility. Further, pithing or use of air 

injection stunning devices at slaughter 

could cause macro-emboli from higher 

risk tissues from the animal’s central 

nervous system to be introduced into 

the animal’s circulatory system. 

Prohibiting the use of these processes is 

necessary to prevent contamination of 

the blood. 

Proposed Regulatory Changes Regarding 

Blood and Blood Products 

Currently, the regulations in § 95.4 

specify that only the following blood 

products for the following uses are 

eligible for importation from any region 

listed in § 94.18(a) (including (a)(1) 

through (a)(3)), based on the fact that the 

manner in which they are used makes 

it highly unlikely they will come in 

contact with ruminants in the United 

States: 

• Under § 95.4(b), serum derived from 

ruminants that have been in any region 

listed in § 94.18(a) may be imported into 

the United States for scientific, 

educational, or research purposes if the 

APHIS Administrator determines that 

the importation can be made under 

conditions that will prevent the 

introduction of BSE into United States. 

Such serum is allowed importation into 

the United States only if it is 

accompanied by an import permit 

issued by APHIS in accordance with 9 

CFR 104.4 (a U.S. Veterinary Biological 

Product Permit), and must be moved 

and handled as specified on the permit. 

• Under § 95.4(d), serum albumin (a 

blood plasma protein) derived from 


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ruminants that have been in any region 

listed in § 94.18(a) may be imported into 

the United States for use as an 

ingredient in cosmetics (provided FDA 

import requirements are also met), if the 

person importing the article obtains a 

United States Veterinary Permit for 

Importation and Transportation of 

Controlled Materials and Organisms and 

Vectors, which states the intended use 

of the article and the name and address 

of the consignee in the United States. 

All other serum and serum albumin 

from regions listed in § 94.18(a) is 

prohibited importation into the United 

States. 

The regulations in § 95.4 regarding 

BSE do not specifically reference blood 

and blood products other than those 

described above—either to prohibit or to 

allow their importation—largely 

because commercial interest in 

importing blood products from regions 

listed in § 94.18(a) has focused on serum 

and serum albumin. By policy, however, 

APHIS has prohibited the importation of 

any blood and blood products from 

§ 94.18(a) regions, other than those 

described above. 

Based on our evaluation of the BSE 

risk associated with bovine blood and 

blood products from BSE minimal-risk 

regions, we believe that bovine blood 

and blood products may be imported 

from BSE minimal-risk regions if 

properly protected against 

contamination. We are, therefore, 

proposing the following changes to the 

regulations at § 95.4(e). 

In general, blood collected from 

bovines can be obtained in one of three 

ways: It can be collected from an animal 

that has been slaughtered, it can be 

collected from a live donor animal 

(similar to human blood collection), and 

it can be collected from the fetal calf of 

a bovine dam that has been slaughtered. 

For all of the above three manners of 

collection, we would require that the 

blood be collected in a closed system or 

in an otherwise hygienic manner that 

prevents contamination of the blood 

with SRMs. This requirement is 

necessary to ensure that the blood is not 

contaminated after collection. 

Prohibited Methods of Stunning 

When a bovine is slaughtered as part 

of the process of blood collection, we 

would require in § 95.4(e)(1)(ii) and 

(e)(2)(ii) that the slaughtered animal was 

not subjected to a stunning process with 

a device injecting compressed air or gas 

into the cranial cavity, or subjected to a 

pithing process. Either of those 

processes create the possibility that 

macro-emboli from higher risk tissues 

from the animal’s central nervous 

system might be introduced into the 

animal’s circulatory system. 

Fetal Calves 

For blood collected from a fetal calf, 

we would require in § 95.4(e)(2)(iii) that 

the uterus be removed from the 

slaughtered 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 is not 

contaminated with SRMs when 

collected. 

Animal Health Requirements 

Also, although it is extremely unlikely 

that any given bovine in a BSE minimalrisk region would be infected with BSE, 

because of the often undifferentiated 

clinical signs of BSE (i.e., clinical signs 

that could be attributed to either BSE or 

some other disease(s)), we consider it 

prudent to disqualify from importation 

into the United States blood and blood 

products drawn from live bovines 

showing signs of any type of disease. 

Therefore, we would require in 

§ 95.4(e)(1)(ii) and (e)(2)(ii) that bovines 

slaughtered as part of the process of 

collection (e.g., when blood is collected 

directly from the slaughtered animal or 

from the fetal calf of a slaughtered dam) 

have passed ante-mortem inspection to 

ensure that the animals are clinically 

normal and have no obvious signs of 

disease. If the blood is collected from a 

live bovine donor, the donor animal 

must be free of clinical signs of disease. 

We are proposing to add language to 

§ 95.4 to prohibit the importation of the 

blood and blood products and 

derivatives of blood and blood products, 

except as specifically provided in § 95.4. 

This would codify current policy. 

Required Certification 

We would require in § 95.4 that the 

shipment of blood or blood products to 

the United States be 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, attesting that the veterinarian 

issuing the certificate was authorized to 

do so. The certificate must state that the 

applicable requirements of § 95.4 have 

been met. 

C. Small Intestine of Bovines 

The requirement established in the 

January 2005 final rule for removal of 

the entire small intestine of bovines 

from BSE minimal-risk regions was 

consistent with the FSIS regulations at 

that time, which govern the slaughter of 

animals in the United States for meat 

and meat products for human 

consumption. The FSIS regulations also 

apply to slaughtering establishments in 

other countries that wish to export meat 

to the United States. FSIS regulations (9 

CFR 327.2) provide that a country can 

be considered eligible to export meat 

and meat products to the United States 

only if it maintains a meat inspection 

program equivalent to that of the United 

States. A country must demonstrate 

‘‘equivalence’’ by implementing 

measures that provide the same level of 

protection against food hazards as is 

achieved domestically. FSIS conducts 

audits of eligible foreign countries’ meat 

inspection systems at least annually. At 

the time of our January 2005 final rule, 

FSIS required that the entire small 

intestine be removed and be disposed of 

as inedible, in order to ensure removal 

of the entire distal ileum. 

Research Regarding BSE and the 

Gastrointestinal System of Cattle 

As discussed in our risk assessment 

for this proposed rule, in studies 

regarding the pathogenesis of BSE in the 

gastrointestinal system of cattle 

experimentally and naturally exposed to 

the BSE agent, no BSE infectivity was 

detected at any time in the esophagus, 

reticulum, rumen, abomasum, proximal 

small intestine, proximal colon, distal 

colon, and rectum (Ref 21). The studies 

demonstrated that, if infectivity in 

intestinal tissues of bovines (other than 

distal ileum) exists, it is below the level 

of detection by mouse bioassay (i.e., the 

insertion of tissue with infectivity from 

a bovine into a mouse). Based on these 

studies, we have concluded that 

intestine other than the distal ileum is 

highly unlikely to contain 

epidemiologically significant levels of 

infectivity, if any infectivity is present 

at all. 

These studies have been compelling 

to the international scientific 

community, and the OIE has based 

international trade guidelines on the 

likelihood that the distal ileum, but not 

the remainder of the bovine intestine, is 

a potential source of BSE infectivity. 

The distal ileum is the only portion of 

the bovine intestine for which OIE 

recommends any trade restrictions 

because of BSE. 

FSIS and FDA Regulations Regarding 

the Small Intestine 

On September 7, 2005, FSIS 

published in the Federal Register an 

interim final rule that allowed for use as 

human food, under certain conditions, 

beef small intestine, excluding the distal 

ileum, derived from cattle slaughtered 

in official U.S. establishments or in 


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certified foreign establishments in 

countries listed by FSIS in 9 CFR 

327.2(b) as eligible to export meat 

products to the United States (Ref 22). 

FSIS also provided that it will permit 

casings derived from beef small 

intestine, excluding the distal ileum, to 

be used as containers of meat food 

products only if the casings are derived 

from cattle that have been inspected and 

passed in an official U.S. establishment 

or a certified foreign establishment. 

Also on September 7, 2005, FDA 

published an interim final rule (Ref 23) 

and request for comments in which it 

provided that small intestine is not 

considered a prohibited cattle material 

if the distal ileum is removed by a 

qualifying procedure. FSIS imposed a 

similar requirement in its interim rule. 

The small intestine of cattle attaches 

at its most proximal end (closest to the 

mouth) to the most distal (closest to the 

anus) chamber of the ruminant stomach. 

The most proximal segment of small 

intestine is the duodenum. Distal to the 

duodenum is the very long jejunum. 

The duodenum and jejunum are used 

for natural beef casings. Distal to the 

jejunum is the ileum, which is 

estimated to be 2- to 3-feet long (Ref 24). 

The distal-most portion of the ileum, or 

‘‘distal ileum,’’ is estimated to be 12- to 

18-inches long. It attaches at the most 

proximal portion of the large intestine, 

the cecum, at what is termed the 

‘‘ileocecal junction’’ or ‘‘ileocecal 

orifice.’’ Just distal to the ileocecal 

junction is the cecocolic junction. 

FSIS and FDA have determined that 

the distal ileum can be effectively 

removed from the rest of the small 

intestine (Ref 22 and 23). They have also 

determined that the remaining small 

intestine can be used as human food if 

the distal ileum is removed (Ref 22 and 

23). To ensure complete removal of the 

distal ileum, both FSIS and FDA require 

the removal of at least 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. Based on 

bovine anatomy as described above, we 

concur that removal of at least 80 inches 

of the uncoiled and trimmed small 

intestine as measured from the cecocolic 

junction will remove the distal ileum. 

Proposed Regulatory Changes Regarding 

Bovine Small Intestine 

In our January 2005 final rule, we 

provided in § 94.19 that one of the 

conditions for the importation of meat, 

meat byproducts, and meat food 

products derived from bovines from 

BSE minimal-risk regions is that the 

commodity have been derived from 

bovines from which the SRMs were 

removed at slaughter. This same 

condition is set forth in § 95.4(g) with 

regard to offal derived from bovines 

from BSE minimal-risk regions. 

The regulations at § 94.19 also 

require, in addition to the removal of 

SRMs, the removal of the entire small 

intestine, even though only part of the 

small intestine (the distal ileum) has 

been determined to be an SRM. 

Because it is possible to effectively 

separate and remove the distal ileum 

from the remainder of a bovine’s small 

intestine, we are proposing to remove 

the requirements in § 94.19(a)(2), (b)(2), 

and (f) that bovine meat, meat 

byproducts, meat food products, and 

whole or half carcasses intended for 

importation from BSE minimal-risk 

regions be derived from animals from 

which the entire small intestine was 

removed at slaughter. We would require 

instead only that SRMs have been 

removed. (Under FSIS regulations, in 

effect, the distal ileum SRM includes 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.) Similarly, 

we are proposing to remove the 

importation condition in § 95.4(g)(1)(i) 

(which we are proposing in this 

document to redesignate as 

§ 95.4(h)(1)(i)) that offal derived from 

bovines from BSE minimal-risk regions 

be derived from animals from which the 

small intestine was removed, and would 

provide instead that the offal must have 

been derived from bovines from which 

SRMs were removed. 

D. Bovine Casings 

Currently, § 96.2(b) prohibits the 

importation of casings, except stomachs, 

from bovines and other ruminants that 

originated in or were processed in any 

region listed in § 94.18(a), which 

includes BSE minimal-risk regions. In 

§ 96.1, animal casings are defined as 

intestines, stomachs, esophagi, and 

urinary bladders from cattle, sheep, 

swine, or goats that are used to encase 

processed meats in foods such as 

sausage. 

As explained above, only the distal 

ileum of the small intestine of bovines 

presents a BSE risk, and FSIS and FDA 

have established procedures for 

effective removal of the distal ileum 

from the remainder of the small 

intestine. There is no scientific evidence 

of BSE infectivity in ruminant esophagi 

or urinary bladders. 

Proposed Regulatory Changes Regarding 

Bovine Casings 

Therefore, we are proposing to amend 

§ 96.2 of the regulations to allow the 

importation of casings derived from 

bovines from BSE minimal-risk regions 

if 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 FSIS at 

9 CFR 310.22 and FDA at 21 CFR 189.5 

and 21 CFR 700.27. We are also 

proposing to allow the importation from 

BSE minimal-risk regions of casings 

derived from bovine esophagi and 

urinary bladders. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This proposed 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. 

Under the Animal Health Protection 

Act of 2002 (7 U.S.C. 8301 et seq.), the 

Secretary of Agriculture is authorized to 

promulgate regulations if he or she 

determines that the regulations are 

necessary to prevent the introduction 

into or dissemination within the United 

States of any pest or disease of livestock. 

This proposed rule would amend the 

regulations by establishing conditions 

for the importation of the following 

commodities from regions that present a 

minimal risk of introducing 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 (for live 

bovines from Canada, that date is March 

1, 1999); blood and blood products 

derived from bovines; and casings and 

part of the small intestine derived from 

bovines. 

In accordance with Executive Order 

12866 and the Regulatory Flexibility 

Act, we assessed the potential economic 

costs and benefits of this rule and 

potential effects on small entities. Below 

is a summary of our economic analysis. 

The full economic analysis may be 

viewed on the Regulations.gov Web site 

or in our reading room. (Instructions for 

accessing Regulations.gov and 

information on the location and hours of 

the reading room are provided under the 

heading ADDRESSES at the beginning of 

this proposed rule.) In addition, copies 

may be obtained by calling or writing to 

the individuals listed under FOR

FURTHER INFORMATION CONTACT. 

We do not have enough data for a 

comprehensive analysis of the potential 


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3A 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). It can be found at http:// 

www.aphis.usda.gov/peer_review/content/

printable_version/bas_model_econOnly_apr20.pdf. 

economic effects of this proposed rule 

on small entities. Therefore, in 

accordance with 5 U.S.C. 603, we have 

performed an initial regulatory 

flexibility analysis for this proposed 

rule. We are inviting comments about 

this proposed rule as it relates to small 

entities. In particular, we are interested 

in determining the number and type of 

small entities that would incur benefits 

or costs from the implementation of this 

proposed rule and the economic effect 

of those benefits or costs. 

The Proposed Rule and This Analysis 

The purpose of this proposed rule is 

to remove certain restrictions on the 

importation of certain bovine 

commodities from BSE minimal-risk 

regions. APHIS has determined that the 

restrictions are unwarranted to prevent 

the introduction and dissemination of 

BSE into the United States from such 

regions. 

The risk assessment for this proposed 

rule analyzes the likelihood that 

importing those commodities from 

Canada would introduce and 

disseminate BSE into the U.S. cattle 

population. The likelihood of release 

(introduction of the disease agent), the 

likelihood of exposure for susceptible 

animals given release, and the 

magnitude of consequences given 

release and exposure are evaluated 

either quantitatively or qualitatively. 

The risk estimation that combines these 

components concludes that the BSE risk 

posed by the proposed rule would be 

negligible. 

This preliminary regulatory impact 

analysis addresses expected economic 

effects of allowing resumption of 

imports from Canada of the 

commodities listed above. Expected 

benefits and costs are examined in 

accordance with Executive Order 12866. 

Expected economic impacts for small 

entities are also considered, as required 

by the Regulatory Flexibility Act. 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 proposed rule and, for at least one 

commodity, cull cattle/processing beef, 

to result in partial displacement of 

processing beef imports from other 

sources. 

Analytical Approach 

We expect the proposed rule to have 

effects for several different categories of 

commodities, and benefits to exceed 

costs overall. Using projected baseline 

data for the United States and projected 

imports from Canada with and without 

the rule, we compute impacts for four 

commodity categories: Cull cattle/ 

processing beef would be the 

commodity primarily affected, due to 

the resumption of cull cattle imports 

from Canada; and feeder cattle, fed 

cattle, and fed beef would be affected 

secondarily, as Canada’s slaughter mix 

adjusts to reestablished exports of 

culled cows, bulls, and stags to the 

United States. 

The demand for cull cattle is derived 

from the demand for processing beef, 

and only a small portion of the U.S. 

supply of processing beef would come 

from imported Canadian cull cattle. 

Therefore, cull cattle and processing 

beef are combined into a single 

commodity category. Processing beef 

refers to lean, boneless beef that is 

mixed with trimmings from grain-fed 

cattle to produce ground beef, thereby 

complementing the domestic 

production of fed beef. Demand for 

processing beef is high, as reflected in 

robust ground beef sales. Despite higher 

domestic cull cattle slaughter in past 

months in response to drought 

conditions, U.S. production of 

processing beef is currently trending 

low because the industry is in the early 

stages of the expansion phase of the 

cattle cycle. 

Historically, Canada has been a major 

trading partner of the United States in 

livestock and meat. In 2002, prior to the 

discovery of BSE in Canada, the United 

States imported 1.7 million live bovines 

from Canada, valued at more than $1.1 

billion and accounting for more than 67 

percent of U.S. total bovine imports. 

That same year, the United States 

imported from Canada 382,110 MT of 

bovine meat, also valued at $1.1 billion, 

which comprised about 44 percent of 

bovine meat imports from all sources. 

U.S.-Canadian cattle and beef trade 

changed dramatically following 

Canada’s May 2003 BSE discovery. 

Canada’s cattle population increased 

rapidly following the loss of export 

markets for its cattle and beef. Its excess 

cow population and the strong U.S. 

demand for cull cattle/processing beef 

underlie imports of Canadian cull cattle 

expected to occur with this rule. 

We evaluate welfare impacts of the 

proposed rule for cull cattle/processing 

beef, feeder cattle, fed cattle, and fed 

beef using a net trade, non-spatial 

partial equilibrium model.3 Present and 

annualized values of welfare gains and 

losses for the 5-year period, 2007–2011, 

are computed using 3 percent and 7 

percent discount rates. The present and 

annualized values are expressed in 2006 

and 2001 dollars. 

For five other commodity categories—

breeding cattle, vealers and slaughter 

calves, bison, bovine casings and small 

intestine products, and bovine blood 

and blood products—we do not 

quantitatively model expected effects of 

the proposed rule. For the first three of 

these categories, changes in import 

quantities projected under the proposed 

rule are very small, suggesting that 

impacts for U.S. entities would not be 

significant. For bovine casings, small 

intestine products, and blood and blood 

products, insufficient information about 

the commodities and quantities that 

would be imported and levels of U.S. 

production and consumption prevents 

us from modeling expected effects of the 

rule. 

Price and Quantity Impacts for the 

Modeled Commodities 

The proposed rule is expected to 

result in the resumption of cull cattle 

imports from Canada. In addition, 

declines in imports of feeder cattle, fed 

cattle, and fed beef are expected to 

occur as a result of the resumption of 

cull cattle imports affecting the 

slaughter mix in Canada. The baseline, 

along with the projected changes, are 

presented in Table VIII, below. Relative 

prices highlight the different situations 

for the Canadian and U.S. cull cattle 

markets. For example, in September, 

2006, the price of slaughter cows in 

Canada was only 70 percent of the 

comparable U.S. price. 

Cull cattle/processing beef. With the 

rule, imports of cull cattle from Canada 

would result in price declines for 

processing beef. Over the period of 

analysis, the annual decrease in the 

price of processing beef, all things 

equal, is expected to average about 4.3 

percent, ranging from declines of $5 per 

cwt (hundredweight, 100 pounds) in 

2007, to $3 per cwt in 2009. In response 

to this price effect, wholesale demand 

for processing beef would increase by an 

average of about 114 million pounds per 

year over the period of analysis, and 

domestic supply would decrease by an 

annual average of about 131 million 

pounds. 

Feeder cattle, fed cattle, and fed beef. 

Imports of feeder cattle, fed cattle, and 

fed beef are projected to decrease 

because of the rule. Of these 

commodities affected secondarily, the 


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largest impacts would be for feeder 

cattle. We estimate that the price of 

feeder cattle would increase in 2007 by 

about 0.3 percent, from $733 to about 

$735 per head in 2006 dollars. Over the 

5-year period of analysis, the annual 

increase in feeder cattle prices 

attributable to the proposed rule, all 

things equal, is expected to average 

about 0.6 percent, ranging from about 

$2.20 per head in 2007, to about $4.60 

per head in 2010. In response to these 

price increases, there would be an 

average annual decrease in the demand 

for feeder cattle of about 152,000 head 

over the period of analysis, and an 

average annual increase in domestic 

supply of about 66,000 head. 

For fed cattle, our analysis indicates 

that the price would increase by less 

than 0.1 percent in 2007. Over the 5- 

year period, the annual increase in fed 

cattle prices attributable to the proposed 

rule, all things equal, is expected to 

average less than 0.2 percent, ranging in 

2006 dollars from 35 cents per head in 

2007, to about $1.90 per head in 2009. 

We estimate that these small changes in 

price would cause the demand for fed 

cattle to decrease by an average of about 

33,000 head per year and the domestic 

supply of fed cattle to increase by an 

average of 26,000 head per year. 

Impacts of the proposed rule for fed 

beef are expected to be very small, with 

the price increasing in 2007 by less than 

0.3 percent, or about 36 cents per cwt 

carcass weight equivalent from a base 

price of $142. Over the 5-year period of 

analysis, the increase in fed beef prices, 

all things equal, is expected to average 

less than 0.1 percent, with no effect 

projected for the last 3 years. 

Clearly, the largest price effects would 

result from the resumption of cull cattle 

imports from Canada, an expected 

outcome matched by estimated welfare 

impacts. 

Welfare Effects for the Modeled 

Commodities 

In this analysis, consumption and 

production have commodity-specific 

definitions that differ from their 

commonly understood meanings. These 

definitions are central to interpreting 

the changes in welfare, and are shown 

in Table I. They imply that the proposed 

rule may have mixed effects for at least 

some entities in the affected industries. 

TABLE I.—DEFINITIONS OF CONSUMERS AND PRODUCERS FOR THE MODELED COMMODITY CATEGORIES

Commodity category Consumers Producers 

Feeder cattle ...................................................... Buyers of cattle for feedlot feeding in the 

United States.

Sellers of U.S.-raised cattle for feedlot feeding 

in the United States. 

Fed cattle ........................................................... Buyers of fed cattle for slaughter in the United 

States.

Sellers of U.S.-sourced fed cattle for slaughter 

in the United States. 

Cull cattle/processing beef ................................. U.S. buyers of processing beef at the wholesale level.Sellers of U.S.-produced processing beef at 

the wholesale level. 

Fed beef ............................................................. U.S. buyers of fed beef at the wholesale level Sellers of U.S.-produced fed beef at the 

wholesale level. 

Cull cattle/processing beef. Projected 

cull cattle imports from Canada are 

converted to their processing beef 

equivalent using projected carcass 

weights for cows, bulls, and stags, as 

shown in the note to Table II. 

Consumers (buyers of processing beef at 

the wholesale level) can be expected to 

benefit from welfare gains and 

producers (sellers of processing beef at 

the wholesale level) can be expected to 

bear welfare losses due to the cull cattle 

imports. The present value of the 

welfare changes in 2006 dollars when 

using a 3 percent discount rate would be 

$1.24 billion in consumer gains, $657 

million in producer losses, for a net 

benefit of about $587 million. 

Annualized values over the 5 years, in 

2006 dollars when using a 3 percent 

discount rate, would be consumer gains 

of $271 million, producer losses of $143 

million, and net benefits of $128 

million. 

TABLE II.—CULL CATTLE/PROCESSING BEEF: PRESENT AND ANNUALIZED VALUES OF WELFARE CHANGES WITH THE

PROPOSED RULE, 2007–2011 

Discount 

rate 

(percent) 

Changes in welfare 

Consumer Producer Net 

(Thousand dollars) 

Present value: 

2006 Dollars ............................................................................................................. 3 1,243,147 ¥656,540 586,607 

7 1,120,778 ¥590,070 530,708 

2001 Dollars ............................................................................................................. 3 1,080,856 ¥570,814 510,043 

7 974,488 ¥513,038 461,450 

Annualized value: 

2006 Dollars ............................................................................................................. 3 271,447 ¥143,358 128,089 

7 273,347 ¥143,912 129,435 

2001 Dollars ............................................................................................................. 3 236,010 ¥124,640 111,370 

7 237,669 ¥125,125 112,544 

Note: Consumers are U.S. buyers of processing beef at the wholesale level; producers are sellers of U.S.-produced processing beef at the 

wholesale level. Cull cattle imports from Canada in thousand head are converted to processing beef in million pounds carcass weight equivalent 

by multiplying by the following carcass weights (pounds) for cows and bulls/stags, respectively: 2007, 576 and 888; 2008, 579 and 893; 2009, 

583 and 899; 2010, 586 and 904; and 2011, 590 and 909 (Source: Expert opinion, USDA Economic Research Service, Market and Trade Economics Division, Animal Products, Grains, and Oil Seeds Branch). 


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Welfare changes for the cull cattle/ 

processing beef category dominate the 

modeled effects. 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. The 

numbers of cull cattle that would be 

imported with the rule, projected to 

average 545,000 cows and 66,000 bulls 

and stags per year, 2007–2011, are much 

larger than the projected average annual 

declines in feeder cattle (218,000 head) 

and fed cattle (59,000 head). 

Feeder cattle, fed cattle, and fed beef. 

Fewer feeder cattle and fed cattle and 

less fed beef are projected to be 

imported from Canada with the rule 

than would enter without the rule, and 

the model indicates for these 

commodities gains in producer welfare 

(higher prices and less competition from 

Canadian suppliers) and losses in 

consumer welfare (higher prices and 

fewer feeder, fed cattle, and less fed beef 

available for purchase). Of these three 

commodities, the largest impact would 

be for feeder cattle, with estimated 

producer welfare gains of $494 million 

and consumer welfare losses of $518 

million, for a net loss of $24 million 

(2006 dollars, discounted at 3 percent). 

Combined welfare effects. Effects of 

the proposed rule for cull cattle/ 

processing beef, feeder cattle, fed cattle, 

and fed beef are summed in Table III. 

TABLE III.—PRESENT AND ANNUALIZED VALUES OF COMBINED WELFARE CHANGES FOR THE MODELED COMMODITIES

WITH THE PROPOSED RULE, 2007–2011 

Discount 

rate 

(percent) 

Changes in welfare 1

Consumer Producer Net 

(Thousand dollars) 

Present value: 

2006 Dollars ............................................................................................................. 3 444,740 111,662 556,401 

7 407,740 96,136 503,876 

2001 Dollars ............................................................................................................. 3 386,246 97,526 483,775 

7 302,447 133,266 435,714 

Annualized value: 

2006 Dollars ............................................................................................................. 3 97,110 24,384 121,494 

7 99,452 23,457 122,908 

2001 Dollars ............................................................................................................. 3 84,339 21,296 105,634 

7 86,339 20,514 106,851 

1 Combined welfare changes for cull cattle/processing beef, feeder cattle, fed cattle, and fed beef. 

The analysis tells us that the present 

value of the combined welfare changes 

in 2006 dollars when using a 3 percent 

discount rate, for example, would be 

$445 million in consumer gains, $112 

million in producer gains, for a total 

welfare benefit of $556 million. 

Annualized values over the 5 years, in 

2006 dollars when using a 3 percent 

discount rate, would be consumer gains 

of $97 million and producer gains of 

$24 million, yielding benefits of over 

$121 million. 

Our analysis shows producer welfare 

changes to be negative in 2007 and 

positive in each of the following 4 years, 

2008–2011. In 2007, producer welfare 

losses for the cull cattle/processing beef 

category would be larger than the 

combined producer welfare gains for the 

other three commodities. For the years 

2008–2011, the opposite would occur. 

This is largely due to the fact that, given 

Canada’s excess cull cattle supply, the 

largest annual number of cull cattle 

would be imported in 2007, with 

imports diminishing thereafter. Table III 

shows positive changes in producer 

welfare because the discounted 

producer welfare gains in 2008–2011 

would exceed producer welfare losses 

in 2007. 

By far, the largest effects of the 

proposed rule would be due to 

resumption of Canadian cull cattle 

imports. As shown in Table IV, the 

present value of consumer welfare gains 

for the cull cattle/processing beef 

category outweighs the combined 

consumer welfare losses for the other 

three categories ($1.24 billion in 

consumer benefits, compared to $798 

million in combined consumer losses, 

in 2006 dollars and discounted at 3 

percent). Producer welfare losses 

attributable to resumption of cull cattle/ 

processing beef imports are smaller in 

magnitude than the combined producer 

welfare gains for the other three 

categories ($657 million in producer 

losses, compared to over $768 million in 

combined producer gains). 

We invite public comment on these 

estimates of welfare changes. In 

particular, we welcome informed 

opinion regarding the price elasticities 

we use in the analysis for cull cattle/ 

processing beef (price elasticity of 

supply, 0.84; price elasticity of demand, 

¥0.40) that result in the welfare gains 

for buyers of processing beef being so 

much larger than the welfare losses for 

sellers of processing beef. 

TABLE IV.—PRESENT VALUES OF SEPARATE AND COMBINED WELFARE CHANGES WITH THE PROPOSED RULE FOR CULL

CATTLE/PROCESSING BEEF, FEEDER CATTLE, FED CATTLE, AND FED BEEF, IN 2006 DOLLARS AND DISCOUNTED AT 3 

PERCENT, 2007–2011 

Cull cattle/ 

processing 

beef 

Feeder 

cattle Fed cattle Fed beef Combined 

(Thousand dollars) 

Change in consumer welfare ................................................................... 1,243,147 518,352 176,136 ¥103,919 444,740 

Change in producer welfare .................................................................... ¥656,540 494,483 171,791 101,928 111,662 

Net change .............................................................................................. 586,607 ¥23,870 4,345 ¥1,991 556,401 


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4These projections are based on the expert 

opinion of staff of the USDA Economic Research 

Service, Market and Trade Economics Division, 

Animal Products, Grains, and Oil Seeds Branch. 

Displacement of Processing Beef 

Imports From Other Countries 

The net impact of cull cattle imports 

from Canada would depend upon the 

extent to which they would displace 

(substitute for) processing beef imports 

from other countries. About 35 percent 

of cull cattle imports from Canada over 

the period of analysis are projected to 

displace processing imports from other 

countries and the remainder are 

projected to contribute to an increase in 

the U.S. supply of processing beef 

(respectively, 5-year averages of 132 

million pounds and 245 million 

pounds, carcass weight equivalent).4 We 

consider here the effects of extreme 

displacement possibilities, that is, if 

either none or all of the Canadian cull 

cattle imports were to displace 

processing beef imports from other 

countries. 

Projected imports of cull cattle from 

Canada are shown in Table V, together 

with changes in the U.S. supply of 

processing beef under the three 

displacement scenarios: None of the 

Canadian imports displacing imports 

from other countries; projected 

displacement; or all of the Canadian 

imports displacing imports from other 

countries. In the third scenario, we 

assume that the cull cattle imports from 

Canada would have no impact on the 

U.S. supply of processing beef. 

Table VI compares the present and 

annualized values of welfare changes 

and average annual price changes for 

the cull cattle/processing beef category 

under the three displacement scenarios, 

in 2006 dollars. Discounting at 3 

percent, the present value of net welfare 

benefits for the cull cattle/processing 

beef category would be about $927 

million when no displacement is 

assumed to occur, compared to net 

benefits of about $587 million when 

projected levels of displacement occur, 

and zero benefits or costs when we 

assume all imported Canadian 

processing beef would displace imports 

from other countries. Annualized net 

values for the three scenarios, 

discounted at 3 percent, range from 

$203 million, to $128 million, to no 

impact. Over the 5-year period, annual 

declines in prices would average about 

$6 per cwt if no displacement were to 

occur, and about $4 per cwt with 

projected levels of displacement. There 

would be no price effect if all processing 

beef imports from Canada were to 

displace imports from other countries. 

TABLE V.—PROJECTED IMPORTS OF CULL CATTLE FROM CANADA WITH THE PROPOSED RULE AND CHANGES IN THE U.S. 

SUPPLY OF PROCESSING BEEF IF (I) NONE OF THE CULL CATTLE IMPORTED FROM CANADA DISPLACE PROCESSING

BEEF IMPORTED FROM OTHER COUNTRIES, (II) PROJECTED DISPLACEMENT OCCURS, OR (III) ALL OF THE CULL CATTLE IMPORTED FROM CANADA DISPLACE PROCESSING BEEF IMPORTS FROM OTHER COUNTRIES, 2007–2011, IN MILLION POUNDS CARCASS WEIGHT EQUIVALENT

2007 2008 2009 2010 2011 

Projected cull cattle imports from Canada .................................................................. 458 403 333 343 346 

Projected processing beef imports from Canada ........................................................ 0 0 0 0 0 

Projected displacement of processing beef imports from other countries by processing beef imports from Canada ............................................................................ 170 149 128 106 106 

Change in U.S. supply if none of the processing beef imports from Canada displace imports from other countries .......................................................................... 458 403 333 343 346

Change in U.S. supply of processing beef if projected displacement occurs ............. 288 254 205 237 240 

Change in U.S. supply if all the processing beef imports from Canada displace imports from other countries ........................................................................................ 0 0 0 0 0 

Note: Cull cattle (slaughter cows, bulls, and stags) are converted from thousand head to million pounds carcass weight equivalent by multiplying by the following carcass weights (pounds) for cows and bulls/stags, respectively: 2007, 576 and 888; 2008, 579 and 893; 2009, 583 and 

899; 2010, 586 and 904; and 2011, 590 and 909 (Source: Expert opinion, USDA Economic Research Service, Market and Trade Economics Division, Animal Products, Grains, and Oil Seeds Branch). 

TABLE VI.—PRESENT AND ANNUALIZED VALUES OF WELFARE CHANGES AND AVERAGE ANNUAL PRICE CHANGES FOR

CULL CATTLE/PROCESSING BEEF IF (I) NONE OF THE CULL CATTLE IMPORTED FROM CANADA DISPLACES PROCESSING BEEF IMPORTED FROM OTHER COUNTRIES, (II) PROJECTED DISPLACEMENT OCCURS, OR (III) ALL OF THE

CULL CATTLE IMPORTED FROM CANADA DISPLACE PROCESSING BEEF IMPORTS FROM OTHER COUNTRIES, IN 2006 

DOLLARS, 2007–2011 

Discount rate 

(percent) 

Amount of imports 

from Canada assumed to displace 

imports from other 

countries 1

Changes in welfare 

Consumer Producer Net 

(Thousand dollars) 

Present value: 

3 ........................................................................................................ None ...................... 1,928,548 ¥1,001,140 927,408 

3 ........................................................................................................ Projected ............... 1,243,147 ¥656,540 586,607 

3 ........................................................................................................ All .......................... 0 0 0 

7 ........................................................................................................ None ...................... 1,742,482 ¥901,619 840,864 

7 ........................................................................................................ Projected ............... 1,120,778 ¥590,070 530,708 

7 ........................................................................................................ All .......................... 0 0 0 

Annualized value: 

3 ........................................................................................................ None ...................... 421,107 ¥218,603 202.504 

3 ........................................................................................................ Projected ............... 271,447 ¥143,358 128,089 


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TABLE VI.—PRESENT AND ANNUALIZED VALUES OF WELFARE CHANGES AND AVERAGE ANNUAL PRICE CHANGES FOR

CULL CATTLE/PROCESSING BEEF IF (I) NONE OF THE CULL CATTLE IMPORTED FROM CANADA DISPLACES PROCESSING BEEF IMPORTED FROM OTHER COUNTRIES, (II) PROJECTED DISPLACEMENT OCCURS, OR (III) ALL OF THE

CULL CATTLE IMPORTED FROM CANADA DISPLACE PROCESSING BEEF IMPORTS FROM OTHER COUNTRIES, IN 2006 

DOLLARS, 2007–2011—Continued 

Discount rate 

(percent) 

Amount of imports 

from Canada assumed to displace 

imports from other 

countries 1

Changes in welfare 

Consumer Producer Net 

3 ........................................................................................................ All .......................... 0 0 0 

7 ........................................................................................................ None ...................... 424,975 ¥219,896 205,079 

7 ........................................................................................................ Projected ............... 273,347 ¥143,912 129,435 

7 ........................................................................................................ All .......................... 0 0 0 

Average annual price change and percentage price change: 

(Dollars 

per cwt) 

(Percentage) 

None ...................... ¥6.00 ¥6.57 

Projected ............... ¥4.00 ¥4.26 

All .......................... ¥0 0 

Note: Prices are in carcass weight equivalent. 1Projected displacement quantities for the 5 years, 2007–2011, in million pounds carcass weight equivalent, are 170, 149, 128, 106, and 106. 

Displaced quantities for the 5 years, if all cull cattle imported from Canada were to displace processing beef imports from other countries, would 

be 458, 403, 333, 343, and 346 (Source: Expert opinion, USDA Economic Research Service, Market and Trade Economics Division, Animal 

Products, Grains, and Oil Seeds Branch). 

It is evident that the extent of import 

displacement would influence impacts 

of the proposed rule for the cull cattle/ 

processing beef category. Table VII 

shows the significance of the 

displacement assumption for the 

combined welfare effects. The larger the 

quantity of processing beef imports from 

other countries that would be displaced, 

the smaller the net benefits. The 

difference between consumer gains and 

producer losses would exceed $897 

million (discounted at 3 percent) if no 

displacement of processing beef imports 

from other countries were to occur. The 

present value of net benefits would be 

about $556 million with projected 

displacement, and there would be a net 

welfare loss of $30 million if all of the 

imported Canadian cull cattle were to 

displace imports from other countries. 

In the third scenario, the modeled 

effects of the rule would be due to 

changes in the supply of Canadian 

feeder cattle, fed cattle, and fed beef as 

a result of the cull cattle imports 

affecting the slaughter mix in Canada. In 

this case, consumer welfare losses for 

these commodities would exceed 

producer welfare gains, resulting in a 

net decline in welfare. 

TABLE VII.—PRESENT AND ANNUALIZED VALUES OF COMBINED WELFARE CHANGES FOR THE MODELED COMMODITIES IF

(I) NONE OF THE PROCESSING BEEF IMPORTS FROM CANADA DISPLACE IMPORTS FROM OTHER COUNTRIES, (II) PROJECTED DISPLACEMENT OCCURS, OR (III) ALL OF THE PROCESSING BEEF IMPORTS FROM CANADA DISPLACE IMPORTS

FROM OTHER COUNTRIES, IN 2006 DOLLARS, 2007–2011 

Discount rate 

(percent) 

Amount of imports 

from Canada assumed to displace 

discount imports 

from other countries 

Changes in welfare 

Consumer Producer Net 

(Thousand dollars) 

Present value: 

3 ................................................................................................................. None ........................ 1,130,141 ¥232.938 897,202 

3 ................................................................................................................. Projected .................. 444,740 111,662 556,401 

3 ................................................................................................................. All ............................. ¥798,407 768,202 ¥30,206 

7 ................................................................................................................. None ........................ 1,029,444 ¥215,413 814,032 

7 ................................................................................................................. Projected .................. 407,740 96,136 503,876 

7 ................................................................................................................. All ............................. ¥713,038 686,206 ¥26,832 

Annualized value: 

3 ................................................................................................................. None ........................ 246,770 ¥50,861 195,909 

3 ................................................................................................................. Projected .................. 97,110 ¥24,384 121,494 

3 ................................................................................................................. All ............................. ¥174,337 167,742 ¥6,595 

7 ................................................................................................................. None ........................ 251,080 ¥52,527 198,552 

7 ................................................................................................................. Projected .................. 99,452 23,457 122,908 

7 ................................................................................................................. All ............................. ¥173,895 167,369 ¥6,527 


ycherry on PROD1PC64 with PROPOSALS3
1120 Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Proposed Rules 

5Three examples of studies based on this type of 

model are: 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. 

Multi-sector impacts. For a broader 

examination of impacts, we map 

interactions among the grain, animal, 

and animal products industries using a 

second model.5 This model takes into 

account substitution among livestock 

products in response to relative price 

changes. It incorporates foreign trade 

and yields expected price and revenue 

effects, but does not allow for 

computation of welfare changes. 

Our results show for the combined 

livestock, feed, and grain sectors, an 

estimated decline in gross revenues 

with the proposed rule of less than one 

percent in 2007. For the beef and cattle 

sectors, the gross revenue declines are 

also less than one percent. The analysis 

indicates declines of less than one 

percent, as well, in cattle and beef 

prices in 2007. 

As expected, these simulated impacts 

are small because they describe effects 

for aggregated commodity groupings (all 

cattle production and all beef 

production are grouped within single 

categories) and because of the linkages 

specified between the livestock 

production and processing sectors that 

allow for greater flexibility in adjusting 

to supply shocks. The larger effects 

reported above for cull cattle/processing 

beef are subsumed within a combined 

beef sector in this multi-sector model. 

These results support our expectation 

that broader impacts of the proposed 

rule would be limited. 

Effects for Commodities Not Modeled 

Commodity categories not modeled 

that would be affected by the proposed 

rule are breeding cattle, vealers and 

slaughter calves, bison, bovine casings 

and small intestine products, and 

bovine blood and blood products. 

Breeding cattle. We do not expect the 

resumption of dairy and beef breeding 

cattle imports from Canada to 

significantly affect the U.S. market for 

these animals. The number that would 

be imported under the proposed rule is 

small in comparison to projected cattle 

imports from Canada overall (4 percent) 

and even smaller in comparison to the 

number of replacement breeding heifers 

supplied on average by U.S. producers 

(0.5 percent). Breeding cattle imported 

from Canada would augment the U.S. 

breeding herd very slightly. Demand for 

these animals, like the demand for 

breeding cattle generally, would derive 

from management decisions based on 

herd composition and expected future 

net returns, with price variations 

influencing secondarily the quantity of 

breeding cattle purchased. 

Vealers and slaughter calves. The 

proposed rule is expected to have a 

small effect on the number of vealers 

and slaughter calves imported from 

Canada. A decline in imports is 

projected in each year of the period of 

analysis, compared to quantities that 

would be imported without the rule, as 

Canadian slaughter patterns adjust to 

reestablished export opportunities for 

cull cattle. Over the 5-year period, an 

average of 11,800 fewer vealers and 

slaughter calves are projected to be 

imported annually with the proposed 

rule than would be imported without 

the rule. 

For the 10-year period, 1994–2003, 

slaughter of vealers and calves in the 

United States averaged 1.3 million head 

per year. We expect annual U.S. vealer 

and calf slaughter during the period of 

analysis to be similar to this earlier 

average. On this basis, the average 

annual decrease in vealer and slaughter 

calf imports from Canada under the 

proposed rule would be equal to less 

than 1 percent of U.S. vealer and calf 

slaughter. Any effect on vealer and 

slaughter calf prices because of the 

smaller number expected to be imported 

under the proposed rule would not be 

significant. 

Bison. Like the cattle industry, the 

commercial bison industry is comprised 

primarily of cow-calf operations that 

sell weaned calves to other operations 

for finishing and processing. Projected 

bison imports from Canada total 4,000 

head in 2007, 3,150 head in 2008, and 

2,500 head each year thereafter. Each 

year, 250 head of breeding bison are 

projected to be imported. The remainder 

would be mainly bison for immediate 

slaughter (2,500 head in 2007, 2,400 

head in 2008, and 2,000 head in each of 

the following years), with a lesser 

number of feeders (1,250 head in 2007, 

500 head in 2008, and 250 head in each 

year thereafter). 

The 2,500 bison projected to be 

imported for immediate slaughter in 

2007 would represent about 7 percent of 

the U.S. slaughter total in 2005. We 

assume that most if not all of these 

slaughter bison (as well as the 1,250 

head projected to be imported in 2007 

for feeding) would be slaughtered at less 

than 30 months of age, that is, they 

would be of the same age as Canadian 

bison that are currently allowed to be 

imported. Thus, the only change in 

bison imports in 2007, as well as in 

subsequent years, under the proposed 

rule would be imports of 250 head of 

breeding bison. 

Yearly imports from Canada of 250 

head of breeding bison would augment 

the U.S. bison breeding herd only 

slightly. They would annually represent 

only about two-tenths of one percent of 

the U.S. bison breeding herd, assuming 

the composition of the national bison 

herd is similar to that of the national 

cattle herd, with breeding stock (cows, 

replacement heifers, and bulls) 

constituting about 56 percent of the 

animals. 

As the market for bison meat becomes 

better established, the demand for 

breeding stock will continue to 

strengthen. The projected imports of 

breeding bison under the proposed rule 

would help meet this growing demand. 

However, they would constitute a very 

small addition to the U.S. breeding 

herd. Any effects on bison prices and 

the welfare of U.S. bison producers are 

expected to be insignificant. 

Bovine casings and small intestine 

products. The proposed rule may affect 

the supply of bovine casings and small 

intestine products in the United States 

in three ways: By allowing importation 

of bovine casings from Canada; by 

allowing importation of Canadian 

bovine small intestines, minus the distal 

ileum, that are used to make certain 

casings and variety meats; and by 

reducing restrictions on live bovine 

imports from Canada and thereby 

changing the U.S. supply of bovine 

products in general, including intestines 

and other material used to produce 

casings and variety meats. 

We calculate that with the rule the 

annual supply of bovine casings and 

variety meats produced from small 

intestines would increase on average 

over the period of analysis by about 1.6 

percent. The largest increase would 

occur in 2007, with production of 2.5 

million pounds of additional small 

intestine for use as casings and variety 

meats. These supply projections 

presume a ready market for these 

products. 

The proposed rule would allow 

importation from Canada of bovine 

small intestine minus the distal ileum 

that could then be processed into 

casings and variety meats in the United 

States. APHIS does not have 

information on the volume of bovine 

small intestine that may be imported 

from Canada because of the proposed 

rule. We welcome information that 

would enable us to evaluate effects on 

the U.S. supply of bovine small 

intestine of allowing their importation 

from Canada. 


ycherry on PROD1PC64 with PROPOSALS3
Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Proposed Rules 1121 

Current regulations prohibit the 

importation of bovine and other 

ruminant casings from BSE minimalrisk regions. The proposed rule would 

remove this prohibition, and therefore 

allow resumption of bovine casings 

imports from Canada. The Agency does 

not have information on levels of 

production or consumption of bovine 

casings in the United States, and trade 

data do not distinguish between bovine 

and ovine casings; import and export 

quantities and prices for bovine casings 

alone are unavailable from the U.S. 

Department of Commerce. We welcome 

information that the public may provide 

that would enable us to better 

understand the U.S. bovine casings 

industry and levels of historic trade in 

bovine casings between the United 

States, Canada, and the world. 

Bovine blood and blood products. The 

proposed rule would allow resumption 

of imports of bovine blood and blood 

products from BSE minimal-risk 

regions, that is, of Canadian origin. The 

primary commodities affected would be 

products used in the manufacture of 

vaccines and drugs, of which fetal 

bovine serum (FBS) is the most 

important. It is the most widely used 

serum in the culturing of cells, tissues 

and organs. 

Since the detection of BSE in Canada 

in 2003, imports of FBS from Canada 

have been restricted to either research 

samples of Canadian-origin FBS (limited 

to 1 liter per shipment), or FBS that is 

derived from animals that originate in 

the United States, Australia, Mexico, or 

Central America and is processed at a 

designated Canadian facility under 

USDA permit. 

The proposed rule may affect the 

supply of FBS in the United States in 

two ways: By allowing Canadian-origin 

FBS imports for commercial purposes, 

and by reducing restrictions on bovine 

imports from Canada and thereby 

changing the U.S. supply of pregnant 

cows presented for slaughter. We 

approximate that the proposed rule 

would allow for the importation of up 

to 24,000 liters of FBS derived from 

Canadian cows. Had this amount been 

imported in 2005, it would have 

represented about 13 percent of U.S. 

imports of FBS from all sources. In 

addition, the increase in pregnant cow 

slaughter projected with the proposed 

rule may provide an additional 23,000 

to 32,000 liters. Other than for these 

upper-bound approximations, we are 

unable to project the extent to which the 

U.S. supply of FBS may be affected by 

the proposed rule. The additional 

supplies would benefit U.S. 

establishments that use FBS in their 

manufacturing processes. 

Alternative to the Proposed Rule 

An alternative to the proposed rule 

considered by APHIS would be to allow 

resumption of live bovine imports from 

BSE minimal-risk regions without 

restriction by date of birth. In other 

words, Canadian bovines could be 

imported for any destination or purpose 

without regard to their age. 

Cattle imports from Canada. In Table 

VIII, projected imports under the 

alternative are compared to projected 

imports if no regulatory action were 

taken (baseline import quantities) and to 

projected imports under the proposed 

rule. The alternative would allow entry 

of bovines born before the date specified 

in the proposed rule as when a 

ruminant-to-ruminant feed ban in 

Canada was effectively enforced: March 

1, 1999. For convenience, we refer to 

these animals as older cull cattle. 

Under the proposed rule, cattle that 

are 8 years or older prior to March 1, 

2007 would be prohibited. Each year 

thereafter, the prohibited older cull 

cattle would comprise a smaller age 

group: 9 years or older prior to March 

1, 2008, 10 years or older prior to March 

1, 2009, and so on. Within a few years, 

the proposed rule’s requirement that 

bovines be born on or after March 1, 

1999, would not limit bovine imports 

from Canada; bovine imports allowed 

under the proposed rule and the 

alternative would be the same. 

TABLE VIII.—PROJECTED IMPORTS OF CANADIAN FEEDER CATTLE, FED CATTLE, CULL CATTLE/PROCESSING BEEF, AND

FED BEEF: BASELINE, PROPOSED RULE, AND ALTERNATIVE OF NO RESTRICTION BY DATE OF BIRTH ON LIVE BOVINE

IMPORTS, 2007–2011 

2007 2008 2009 2010 2011 

Feeder cattle from Canada 

(Thousand head) 

Baseline .............................................................................................................................................. 302 371 425 440 441 

Proposed Rule .................................................................................................................................... 189 175 167 178 179 

Alternative ........................................................................................................................................... 189 175 167 178 179 

Fed cattle from Canada 

(Thousand head) 

Baseline .............................................................................................................................................. 742 731 729 755 756 

Proposed Rule .................................................................................................................................... 728 673 644 685 688 

Alternative ........................................................................................................................................... 728 673 644 685 688 

Cull cattle from Canada, net of imports assumed to displace processing beef imports from other countries 

(Million pounds carcass weight equivalent) 

Baseline .............................................................................................................................................. 0 0 0 0 0 

Proposed Rule .................................................................................................................................... 288 254 205 237 240 

Alternative ........................................................................................................................................... 360 318 205 237 240 

Fed beef from Canada 

(Million pounds carcass weight equivalent) 

Baseline .............................................................................................................................................. 446 425 420 419 419 

Proposed Rule .................................................................................................................................... 371 390 420 419 419 


ycherry on PROD1PC64 with PROPOSALS3
1122 Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Proposed Rules 

TABLE VIII.—PROJECTED IMPORTS OF CANADIAN FEEDER CATTLE, FED CATTLE, CULL CATTLE/PROCESSING BEEF, AND

FED BEEF: BASELINE, PROPOSED RULE, AND ALTERNATIVE OF NO RESTRICTION BY DATE OF BIRTH ON LIVE BOVINE

IMPORTS, 2007–2011—Continued 

2007 2008 2009 2010 2011 

Alternative ........................................................................................................................................... 371 390 420 419 419 

Source: Expert opinion, USDA Economic Research Service, Market and Trade Economics Division, Animal Products, Grains, and Oil Seeds 

Branch. 

Note: For the cull cattle/processing beef category, cull cattle imports are converted from thousand head to million pounds carcass weight 

equivalent for 2007–2011 by multiplying by the following carcass weights (pounds) for cows and bulls/stags, respectively: 2007, 576 and 888; 

2008, 579 and 893; 2009, 583 and 899; 2010, 586 and 904; and 2011, 590 and 909. 

Projected imports of Canadian feeder 

cattle, fed cattle, and fed beef are the 

same under the proposed rule and 

under the alternative. In both cases, 

feeder and fed cattle imports would be 

fewer than would enter without the 

rule, and fed beef imports would be less 

in the first 2 years of the period of 

analysis. The only difference between 

imports under the proposed rule and 

under the alternative is with respect to 

cull cattle imports projected for 2007 

and 2008. Under the alternative, imports 

of cull cattle are projected in these 2 

years to be one-fourth greater, net of 

displaced processing beef imports, than 

they would be under the proposed rule. 

The older cull cattle that would be 

imported under the alternative would 

total 168,000 cows and 20,000 bulls and 

stags in 2007, and 147,000 cows and 

18,000 bulls and stags in 2008. These 

older cull cattle would yield 72 million 

pounds and 64 million pounds of 

processing beef, carcass weight 

equivalent, for the 2 years. 

Table IX shows the present and 

annualized values of welfare changes 

under the alternative for the cull cattle/ 

processing beef category. The present 

value of the welfare changes (2006 

dollars, 3 percent discount rate) would 

be $1.4 billion in consumer gains, $731 

million in producer losses, for a net 

benefit of about $667 million. 

Annualized values over the 5 years 

would be consumer gains of $305 

million, producer losses of $160 

million, and net benefits of $146 

million. 

TABLE IX.—ALTERNATIVE OF NO RESTRICTION BY DATE OF BIRTH ON LIVE BOVINE IMPORTS: PRESENT AND ANNUALIZED

VALUES OF WELFARE CHANGES FOR CULL CATTLE/PROCESSING BEEF, 2007–2011 

Discount 

rate 

(percent) 

Changes in welfare 

Consumer Producer Net 

(Thousand dollars) 

Present Value: 

2006 Dollars ............................................................................................................. 3 1,397,680 ¥730,800 666,880 

7 1,267,061 ¥660,333 606,728 

2001 Dollars ............................................................................................................. 3 1,215,348 ¥635,446 579,902 

7 1,101,796 ¥574,189 527,606 

Annualized Value: 

2006 Dollars ............................................................................................................. 3 305,190 ¥159,573 145,617 

7 309,025 ¥161,049 147,976 

2001 Dollars ............................................................................................................. 3 265,377 ¥138,752 126,624 

7 268,718 ¥140,039 128,678 

Note: Consumers are U.S. buyers of processing beef at the wholesale level; producers are sellers of U.S.-produced processing beef at the 

wholesale level. Cull cattle imports from Canada in thousand head are converted to processing beef in million pounds carcass weight equivalent 

by multiplying by the following carcass weights (pounds) for cows and bulls/stags, respectively: 2007, 576 and 888; 2008, 579 and 893; 2009, 

583 and 899; 2010, 586 and 904; and 2011, 590 and 909. 

To exemplify the differences in 

welfare effects between the alternative 

and the proposed rule for the cull cattle/ 

processing beef category, we compare in 

Table X their present and annualized 

values in 2006 dollars when discounted 

at 3 percent. Compared to effects under 

the proposed rule, consumer welfare 

gains under the alternative would be 

12.4 percent larger, producer welfare 

losses would be 11.3 percent larger, and 

net benefits would be 13.7 percent 

larger. The annual decrease in 

processing beef prices under the 

alternative over the 5-year period, all 

things equal, is computed to average 

$4.80 per cwt, compared to an average 

annual decrease of $4.00 under the 

proposed rule. 


ycherry on PROD1PC64 with PROPOSALS3
Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Proposed Rules 1123 

TABLE X.—PRESENT AND ANNUALIZED VALUES OF WELFARE CHANGES FOR CULL CATTLE/PROCESSING BEEF, WITH THE

ALTERNATIVE AND WITH THE PROPOSED RULE, 3 PERCENT DISCOUNT RATE, 2006 DOLLARS, 2007–2011 

Changes in welfare 

Consumer Producer Net 

(Thousand dollars) 

Present Value: 

Alternative ......................................................................................................................................... 1,397,680 ¥730,800 666,880 

Proposed Rule .................................................................................................................................. 1,243,147 ¥656,540 586,607 

Difference ......................................................................................................................................... 154,533 ¥74,260 80,273 

Annualized Value: 

Alternative ......................................................................................................................................... 305,190 ¥159,573 145,617 

Proposed Rule .................................................................................................................................. 271,447 ¥143,358 128,089 

Difference ......................................................................................................................................... 33,743 ¥16,215 17,528 

Difference as a percentage of welfare changes with the proposed rule ................................................ 12.4% 11.3% 13.7% 

When we compare present and 

annualized values of combined welfare 

changes under the alternative and under 

the proposed rule, we find that the net 

welfare benefits would be 15 to 16 

percent larger under the alternative than 

would be realized under the proposed 

rule. For example, the annualized net 

benefit (2006 dollars, 3 percent rate of 

discount) would be $140 million under 

the alternative, compared to $121 

million under the proposed rule. 

Impacts under the alternative and under 

the proposed rule would also differ for 

some of the commodities not modeled. 

For example, we would expect the 

supply of bovine casings to be larger 

with the alternative, due to larger 

projected slaughter numbers. 

BSE risk. As described in the risk 

assessment for this proposed rule, 

transmission of BSE requires that 

bovines ingest feed that contains the 

infectious agent. Feed contamination 

results from the incorporation of 

ingredients that contain certain 

ruminant protein derived from infected 

animals. Standard rendering processes 

do not completely inactivate the BSE 

agent. Therefore, rendered protein such 

as meat-and-bone meal derived from 

infected animals may remain 

contaminated. Prohibitions on the use of 

ruminant protein in ruminant feed are 

imposed by FDA to mitigate the risk of 

BSE transmission. 

The OIE establishes standards for the 

international trade in animals and 

animal products. It recommends that 

cattle be imported from a region that has 

reported an indigenous case of BSE only 

if the cattle selected for export were 

born after the date from which a ban on 

the feeding of ruminants with meat-andbone meal and greaves (the residue left 

after animal fat or tallow has been 

rendered) derived from ruminants had 

been effectively enforced. 

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 estimated that this 

implementation period may have lasted 

several months, making February 1998 a 

more realistic date on which the ban can 

be considered to have been practically 

implemented. 

The likelihood that Canadian cattle 

born after February 1998 would be 

exposed to the BSE agent continues to 

decrease over time. APHIS considers 

that a period of 1 year following the 

practical implementation of the feed ban 

allows sufficient time for the measures 

taken by Canada to have their desired 

effect. Therefore, APHIS concludes that 

cattle born on or after March 1, 1999, are 

unlikely to have been exposed to the 

BSE agent via feed and can be imported 

into the United States for any purpose 

with a low risk that they will be infected 

with the BSE agent. 

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 feed ban recommendation. We 

conclude that there may be some degree 

of increased risk of BSE introduction 

under the alternative, compared to the 

minimal risk posed by the proposed 

rule, because of the greater likelihood of 

the older cull cattle having been 

exposed to infectivity. While our 

analysis indicates larger net welfare 

benefits may be realized under the 

alternative 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 

introduction into the United States and 

would be consistent with demonstrated 

science, experience, and OIE guidance. 

Expected Impacts Assuming 

Resumption of Processing Beef Imports 

From Canada 

Current regulations require that 

imported Canadian cattle be slaughtered 

at less than 30 months of age and that 

imported Canadian beef come from 

cattle slaughtered at less than 30 months 

of age. Our analysis assumes no imports 

of processing beef from Canada. As a 

second scenario, we consider effects if 

imports of Canadian beef from cattle 

slaughtered at 30 months or older were 

to resume at the same time that the 

proposed rule is finalized. 

Importation of ruminant products and 

byproducts was included in the BSE 

minimal-risk regions final rule, and this 

proposed rule would not change 

regulations regarding the importation of 

beef from Canada. However, in March 

2005, APHIS gave notice in the Federal 

Register that the applicability of certain 

provisions of the rule pertaining to 

bovine meat, meat byproducts, whole 

and half carcasses, and certain other 

bovine products was being delayed until 

further notice. This partial delay of 

applicability of the BSE minimal-risk 

regions rule prohibits the importation of 

such products if derived from bovines 

30 months of age or older at slaughter. 

As discussed, the United States is a 

large importer of processing beef, with 

Australia, New Zealand, and Uruguay 

currently our primary suppliers. Over 

the period of analysis, total processing 

beef imports are projected to provide 

about 45 percent of U.S. consumption of 

processing beef (decreasing from 49 

percent in 2007 to 42 percent in 2011). 

We assume annual imports of Canadian 

processing beef, 2007–2011, would 

average 240 million pounds carcass 

weight equivalent, of which about twothirds would displace processing beef 

imports from other countries and about 


ycherry on PROD1PC64 with PROPOSALS3
1124 Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Proposed Rules 

6The import quantities and extent of 

displacement are projections made by staff of the 

USDA Economic Research Service (ERS), Market 

and Trade Economics Division, Animal Products, 

Grains, and Oil Seeds Branch, based on their expert 

opinion and reference to the ‘‘USDA Agricultural 

Baseline Projections to 2015,’’ United States 

Department of Agriculture, Interagency Agricultural 

Projections Committee, Baseline Report OCE–2006–

1, February 2006. 

one-third would represent a net increase 

in U.S. supply. It is further assumed 

under this scenario that the Canadian 

cull cattle imported would not displace 

processing beef imports from other 

countries.6 The net addition of 

processing beef from Canada would be 

equivalent to 2.8 percent of projected 

baseline imports (without the rule) over 

the period of analysis, or 1.3 percent of 

U.S. supply. When the processing beef 

produced from projected cull cattle 

imports from Canada is included, the 

increase in the U.S. supply of 

processing beef under this scenario 

would be equivalent to 4.3 percent of 

projected imports without the proposed 

rule. 

Projected imports of cull cattle and 

processing beef from Canada under this 

scenario are compared in Table XI to 

projected imports of cull cattle alone 

used to evaluate the proposed rule. 

Results of the analysis show the price of 

processing beef decreasing in 2007 by 

6.3 percent under this scenario, from 

$99 to about $93 per cwt carcass weight 

equivalent in 2006 dollars. Over the 

period of analysis, the annual decrease 

in processing beef prices because of the 

proposed rule, all things equal, is 

expected to average about 5 percent, 

ranging from about $6.20 per cwt in 

2007 to about $3.80 per cwt in 2009. 

TABLE XI.—SCENARIO COMPARISON OF QUANTITIES OF (1) CULL CATTLE ALONE AND (II) CULL CATTLE AND PROCESSING

BEEF PROJECTED TO BE IMPORTED FROM CANADA, NET OF DISPLACED PROCESSING BEEF IMPORTS FROM OTHER

COUNTRIES, 2007–2011, IN MILLION POUNDS OF PROCESSING BEEF, CARCASS WEIGHT EQUIVALENT

Year Cull cattle only Cull cattle and 

processing beef 

2007 ............................................................................................................................................................. 288 339 

2008 ............................................................................................................................................................. 254 299 

2009 ............................................................................................................................................................. 205 242 

2010 ............................................................................................................................................................. 237 279 

2011 ............................................................................................................................................................. 240 282 

Source: Expert opinion, USDA Economic Research Service, Market and Trade Economics Division, Animal Products, Grains, and Oil Seeds 

Branch. 

Notes: Cull cattle are converted to processing beef by multiplying by the following carcass weights (pounds) for cows and bulls/stags, respectively: 2007, 576 and 888; 2008, 579 and 893; 2009, 583 and 899; 2010, 586 and 904; and 2011, 590 and 909. All of the quantities that follow 

are expressed in million pounds of processing beef, carcass weight equivalent. For the cull cattle imports only scenario, the quantities are based 

on projected imports of slaughter cows, bulls, and stags, and are equivalent to: 2007, 458; 2008, 403; 2009, 333; 2010, 343; and 2011, 346. 

These quantities are reduced by the following projected displaced processing beef imports from other countries: 2007, 170; 2008, 149; 2009, 

128; 2010, 106; and 2011, 106. For the scenario that assumes importation from Canada of both cull cattle and processing beef, quantities of cull 

cattle imported are: 2007, 214; 2008, 199; 2009, 192; 2010, 204; and 2011, 207. Projected processing beef imports are: 2007, 325; 2008, 275; 

2009, 200; 2010, 200; and 2011, 200. Combined cull cattle and processing beef imports are 2007, 539; 2008, 474; 2009, 392; 2010, 404; and 

2011, 407. These quantities are reduced by the following projected displaced processing beef imports from other countries: 2007, 200; 2008, 

175; 2009, 150; 2010, 125; and 2011, 125. 

As shown in Table XII, the present 

value of the welfare changes in 2006 

dollars when using a 3 percent discount 

rate would be $1.47 billion in consumer 

gains, $770 million in producer losses, 

for a net benefit of about $695 million. 

Annualized values over the 5 years, in 

2006 dollars when using a 3 percent 

discount rate, would be consumer gains 

of $320 million, producer losses of $168 

million, and net benefits of $152 

million. 

TABLE XII.—CULL CATTLE/PROCESSING BEEF: PRESENT AND ANNUALIZED VALUES OF WELFARE CHANGES ASSUMING

CULL CATTLE IMPORTS AND PROCESSING BEEF IMPORTS FROM CANADA WOULD RESUME AT THE SAME TIME, 2007–2011 

Discount 

rate 

(percent) 

Changes in welfare 

Consumer Producer Net 

(Thousand dollars) 

Present Value: 

2006 Dollars ............................................................................................................. 3 1,465,829 ¥770,389 695,440 

7 1,321,580 ¥692,393 629,187 

2001 Dollars ............................................................................................................. 3 1,274,467 ¥669,797 604,670 

7 1,149,081 ¥602,002 547,078 

Annualized Value: 

2006 Dollars ............................................................................................................. 3 320,071 ¥168,218 151,853 

7 322,321 ¥168,868 153,453 

2001 Dollars ............................................................................................................. 3 278,286 ¥146,253 132,033 

7 280,250 ¥146,823 133,427 

Compared to impacts for the cull 

cattle/processing beef category when 

only cull cattle would enter, this 

scenario would result in consumer 

welfare gains larger by 17.9 percent, 

producer welfare losses larger by 17.3 

percent, and net benefits larger by 18.6 

percent. 


ycherry on PROD1PC64 with PROPOSALS3
Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Proposed Rules 1125 

Combined effects under this scenario 

for cull cattle/processing beef, feeder 

cattle, fed cattle, and fed beef are shown 

in Table XIII. 

TABLE XIII.—PRESENT AND ANNUALIZED VALUES OF COMBINED WELFARE CHANGES FOR THE MODELED COMMODITIES, 

ASSUMING CULL CATTLE IMPORTS AND PROCESSING BEEF IMPORTS FROM CANADA WOULD RESUME AT THE SAME

TIME, 2007–2011 

Discount 

rate 

(percent) 

Changes in welfare 

Consumer Producer Net 

(Thousand dollars) 

Present Value: 

2006 Dollars ............................................................................................................. 3 669,191 2,387 671,578 

7 610,108 ¥2,145 607,963 

2001 Dollars ............................................................................................................. 3 581,395 2,519 583,917 

7 529,956 ¥1,342 528,614 

Annualized Value: 

2006 Dollars ............................................................................................................. 3 146,122 523 146,643 

7 148,808 ¥513 148,294 

2001 Dollars ............................................................................................................. 3 126,951 551 127,501 

7 129,252 ¥327 128,923 

Removal of the delay of applicability, 

thereby allowing importation of 

Canadian beef from cattle slaughtered at 

30 months or older, is a decision that 

will be taken at the discretion of the 

Secretary of the U.S. Department of 

Agriculture. 

Expected Impacts for Small Entities 

We have prepared an initial 

regulatory flexibility analysis that 

indicates that industries expected to be 

affected by the proposed rule are 

composed largely of small entities. 

Industries that may be affected, as 

categorized by the North American 

Industry Classification System, are 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). 

Average effects for small entities 

would be small. As examples, we 

approximate that gross receipts for 

small-entity beef and dairy operations 

would increase, respectively, by $160 

(0.6 percent of annual revenue) and 

$133 (less than 0.1 percent of annual 

revenue), due to the rule’s projected 

impact on feeder cattle prices. We 

approximate that small-entity feedlots 

may incur a revenue loss of about 

$5,040 (less than 0.3 percent of annual 

revenue), due to the rule’s expected 

effects on feeder cattle and fed cattle 

prices. Small-entity meat packing and 

processing establishments may benefit 

marginally with the rule, with estimated 

price increases for fed beef in 2007 and 

2008 representing an increase in annual 

revenue of less than 0.2 percent. Effects 

of the proposed rule for packers and 

processors that utilize processing beef 

would be larger, due to the resumption 

of cull cattle imports from Canada. 

Annual prices of processing beef are 

expected to fall by an average of $4 per 

cwt over the period of analysis. The 

price declines would benefit 

establishments that use processing beef 

to produce ground beef for the 

wholesale market. Conversely, 

establishments that sell processing beef 

would be negatively affected by the 

expected price declines. 

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. Under 

the proposed rule, these movement 

restrictions would no longer be 

imposed. Canadian bovines imported 

other than for immediate slaughter 

could be moved any number of times to 

any destinations in unsealed means of 

conveyance. 

Under the proposed rule, feeder 

bovines imported from BSE minimalrisk regions would not need to be 

accompanied by APHIS Form VS 17–

130, which currently is used to identify 

the feedlot of destination. (The 

individual responsible for the 

movement of an imported animal and 

the individual identification of the 

animal would still be required 

information on the accompanying 

health certificate.) Also under the 

proposed rule, bovines of Canadian 

origin moved from a U.S. feedlot to a 

slaughtering establishment would not 

need to be accompanied by APHIS Form 

VS 1–27. 

Removal of these movement and 

paperwork requirements would benefit 

buyers and sellers of Canadian-origin 

bovines. Many of the beneficiaries are 

likely to be small entities, given their 

predominance among cattle and dairy 

operations and feedlot establishments. 

Affected businesses would be able to 

take advantage of a broader range of 

transactional opportunities than under 

current regulations. 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 

would benefit the cattle industry acrossthe-board. 

The Agency has found no significant 

alternatives to the proposed rule that 

would continue to protect against the 

introduction and dissemination of BSE 

into the United States while removing 

unnecessary prohibitions on the 

importation of certain commodities 

from Canada. Without the proposed 

rule, restrictions on U.S. importation of 


ycherry on PROD1PC64 with PROPOSALS3
1126 Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Proposed Rules 

certain Canadian bovine commodities 

that are without scientific merit would 

continue. With the proposed rule, 

importation of these Canadian 

commodities would be allowed to 

resume under certain conditions and the 

risk of introduction of BSE into the 

United States would remain minimal. 

Executive Order 12988 

This proposed rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. If this proposed rule is 

adopted: (1) All State and local laws and 

regulations that are inconsistent with 

this rule will be preempted; (2) no 

retroactive effect will be given to this 

rule; and (3) administrative proceedings 

will not be required before parties may 

file suit in court challenging this rule. 

National Environmental Policy Act 

To provide the public with 

documentation of APHIS’ review and 

analysis of any potential environmental 

impacts associated with the importation 

of bovine and bovine products from 

Canada under this proposed rule, we 

have prepared an environmental 

assessment. The environmental 

assessment was 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 may 

be viewed on the Regulations.gov Web 

site or in our reading room. Instructions 

for accessing Regulations.gov and 

information on the location and hours of 

the reading room are provided under the 

heading ADDRESSES at the beginning of 

this proposed rule. In addition, copies 

may be obtained by calling or writing to 

the individuals listed under FOR

FURTHER INFORMATION CONTACT. 

Paperwork Reduction Act 

This proposed rule contains no new 

information collection or recordkeeping 

requirements under the Paperwork 

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

et seq.). 

References 

1. Wilesmith, J.W., G.A.H. Wells, J.B.M. 

Ryan, D. Gavier-Widen, and M.M. Simmons. 

(1997). A cohort study to examine 

maternally-associated risk factors for BSE. 

Vet Rec 141: 239–43. 

2. Prince, M.J., J.A. Bailey, P.R. 

Barrowman, K.J. Bishop, G.R. Campbell, and 

J.M. Wood. (2003). Bovine Spongiform 

Encephalopathy. Rev. sce. tech. OIE; 22 (1): 

37–60. 

3. Wilesmith, J.W., G.A.H. Wells, M.P. 

Cranwell, and J.B.M. Ryan. (1988). Bovine 

spongiform encephalopathy epidemiological 

studies. Vet. Rec. 123: 638–644. 

4. De Koeijer, A., H. Heesterbeek, B. 

Schreuder, R. Oberthur, J. Wilesmith, H. van 

Roermund, and M. de Jong. (2004). 

Quantifying BSE control by calculating the 

basic reproduction ratio R0 for the infection 

among cattle. J. Math. Biol. 2004. Jan:48(1): 

1–22. Epub June 12, 2003. 

5. European Commission (EC). (2005). 

Report on the monitoring and Testing of 

Ruminants for the Presence of Transmissible 

Spongiform Encephalopathy (TSE) in the EU 

in 2004. June 13. (http://europa.eu.int/ 

comm/food/food/biosafety/bse/

annual_report_tse2004_en.pdf). 

6. European Commission (EC). (2005a). The 

TSE Roadmap. July 15. COM(2005) 322 

FINAL. (http://europa.eu.int/comm/food/ 

food/biosafety/bse/roadmap_en.pdf). 

7. Department of Environment Food and 

Rural Affairs (DEFRA), United Kingdom. 

(2006b). BSE: Statistics—BSE–GB weekly 

cumulative statistics; As of April 28, 2006. 

Page last modified May 5, available at http:// 

www.defra.gov.uk/animalh/bse/statistics/

weeklystats.html#pass. 

8. Department of Environment Food and 

Rural Affairs (DEFRA), United Kingdom. 

(2006a). BSE: Statistics—Confirmed cases of 

BSE in GB by year of birth where known; As 

of October 2, 2006. Page last modified 

October 26, 2006, available at http:// 

www.defra.gov.uk/animalh/bse/statistics/ 

bse/yrbirth.html. 

9. Animal and Plant Health Inspection 

Service (APHIS). (2004). Analysis of risk—

update for the Final Rule: bovine spongiform 

encephalopathy; minimal risk regions and 

importation of commodities, page 13. 

December 2004, available at http:// 

www.aphis.usda.gov/lpa/issues/bse/risk_ 

assessment/03-080-3_risk_doc.pdf. 

10. Animal and Plant Health Inspection 

Service (APHIS). (2003). Risk Analysis: BSE 

Risk from Importation of Designated 

Ruminants and Ruminant Products from 

Canada into the United States, page 18. 

October 2003, available at http:// 

aphis.usda.gov/lpa/issues/bse/bsecan_

risk_anal.pdf. 

11. United States Department of 

Agriculture (USDA). (2005). Assessment of 

the Canadian Feed Ban. February, available 

at http://www.aphis.usda.gov/lpa/issues/bse/ 

CAN-FeedBanReview.pdf. 

12. Canadian Food Inspection Agency 

(CFIA). (2005). Canadian Food Inspection 

Agency Feed Ban Review. March 2, available 

at http://www.inspection.gc.ca/english/ani

ma/feebet/rumin/revexa/revexae.shtml. 

13. United States Department of 

Agriculture (USDA). (2005a). U.S. 

Department of Agriculture’s Summary of the 

Epidemiological Findings of North American 

Bovine Spongiform Encephalopathy Positive 

Cattle. April 29, available at http:// 

www.aphis.usda.gov/lpa/issues/bse/bse_

epi_report_4-29-05.doc. 

14. National Research Council (NRC). 

(1996). Nutrient Requirements of Beef Cattle. 

7th edition. National Academy Press. 

Washington, DC. 

15. National Research Council (NRC). 

(2001). Nutrient Requirements of Dairy 

Cattle. 7th edition. National Academy Press. 

Washington, DC. 

16. Canadian Food Inspection Agency 

(CFIA). (2002). Risk Assessment on Bovine 

Spongiform Encephalopathy in Cattle in 

Canada. December, available at http:// 

www.inspection.gc.ca/english/sci/ahra/ 

bseris/bserise.shtml. 

17. Leger, David. (2005). Public Health 

Agency of Canada, personal communication, 

December. 

18. Gow, Sheryl. (2005). Public Health 

Agency of Canada, personal communication, 

December. 

19. Animal and Plant Health Inspection 

Service (APHIS). (2006). An Estimate of the 

Prevalence of BSE in the United States. July 

2006, available at http:// 

www.aphis.usda.gov/newsroom/hot_issues/ 

bse/bse_in_usa.shtml. 

20. Farshid, M., R.E. Taffs, D. Scott, D.M. 

Asher, and K. Brorson. (2005). The clearance 

of viruses and transmissible spongiform 

encephalopathy agents from biologicals. 

Current Opinion in Biotechnology. 16: 561–

567. 

21. European Commission Scientific 

Steering Committee (EC SSC). (2002b). 

Update of the opinion on TSE infectivity 

distribution in ruminant tissues. November, 

available at http://www.europa.eu.int/comm/ 

food/fs/sc/ssc/out296_en.pdf. 

22. Food Safety and Inspection Service 

(FSIS) (2005). Federal Register Volume 70, 

No. 173, 53043–53050. Interim final rule, 

‘‘Prohibition of the Use of Specified Risk 

Materials for Human Food and Requirements 

for the Disposition of Non-Ambulatory 

Disabled Cattle.’’ Docket No. 03–025IFA. 

September 7. Page 53043, available at http:// 

frwebgate.access.gpo.gov/cgi-bin/getpage. 

cgi?position=all&page=53043&

dbname=2005_register. 

23. Food and Drug Administration (FDA). 

(2005). Federal Register Volume 70. Interim 

final rule and request for comments, ‘‘Use of 

Materials Derived From Cattle in Human 

Food and Cosmetics.’’ Docket No. 2004N–

0081. September 7. Pages 53063–53069, 

available at http://a257.g.akamaitech.net/7/ 

257/2422/01jan20051800/ 

edocket.access.gpo.gov/2005/pdf/05-

17693.pdf. 

24. North American Natural Casings 

Association (NANCA). (2004). Public 

comment to FDA on interim final rule, ‘‘Use 

of Materials Derived From Cattle in Human 

Food and Cosmetics; and Recordkeeping 

Requirements for Human Food and 

Cosmetics Manufactured From, Processed 

With, or Otherwise Containing, Material 

From Cattle; Final Rule and Proposed Rule 

(69 FR, No. 134, Wednesday, July 14, 2004, 

pp. 42256–42285). October, available at 

http://www.fda.gov/ohrms/dockets/dailys/ 

04/oct04/100604/04n-0081-c00081-01- 

vol12.pdf. 

List of Subjects 

9 CFR Part 93 

Animal diseases, Imports, Livestock, 

Poultry and poultry products, 

Quarantine, Reporting and 

recordkeeping requirements. 


ycherry on PROD1PC64 with PROPOSALS3
Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Proposed Rules 1127 

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 proposing to 

amend 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 

would continue 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) would 

be amended by removing the words 

‘‘feedlot or recognized slaughtering 

establishment’’ and adding in their 

place the words ‘‘destination’’. 

3. Section 93.419 would be amended 

as follows: 

a. Paragraphs (b) and (c) would be 

revised to read as set forth below. 

b. Paragraph (d) would be 

redesignated as paragraph (e). 

c. A new paragraph (d) would be 

added to read as set forth below. 

d. In newly designated paragraph 

(e)(2), the reference to ‘‘paragraph 

(d)(7)’’ would be removed and a 

reference to ‘‘paragraph (e)(7)’’ would be 

added in its place. 

§ 93.419 Sheep and goats from Canada. 

* * * * * 

(b) If the sheep or goats are 

unaccompanied by the certificate 

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 shall 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 would be 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 would be amended 

as follows: 

a. Paragraphs (a) and (b) would be 

revised to read as set forth below. 

b. In paragraph (c), the reference to 

‘‘§§ 93.419(c) and 93.420’’ would be 

removed and a reference to ‘‘§§ 93.405 

and 93.419’’ would be 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 


ycherry on PROD1PC64 with PROPOSALS3
1128 Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Proposed Rules 

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 

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 ‘‘CAN’’; 

(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 

would continue 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. In § 94.19, paragraphs (a)(2), (b)(2), 

and (f) would be amended by removing 

the words ‘‘and small intestine’’ each 

time they appear. 

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 

would continue 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 would be amended as 

follows: 

a. The heading and the paragraph (a) 

introductory text would be revised to 

read as set forth below. 

b. Paragraphs (e) through (h) would be 

redesignated as paragraphs (f) through 

(i), respectively. 

c. Paragraphs (a)(1)(ii) and (a)(1)(iv) 

would be revised to read as set forth 

below. 

d. In paragraph (b), the words 

‘‘paragraphs (d) and (h)’’ would be 

removed and the words ‘‘paragraphs (d), 

(e), and (i)’’ would be added in their 

place. 

e. Paragraph (d) introductory text 

would be revised to read as set forth 

below. 

f. New paragraph (e) would be added 

to read as set forth below. 

g. In newly designated paragraph 

(h)(1)(i), the words ‘‘and small 

intestine’’ would be removed. 

h. In newly designated paragraph (i) 

introductory text, the words 

‘‘paragraphs (h)(1) through (h)(3)’’

would be removed and the words 

paragraphs ‘‘paragraphs (i)(1) through 

(i)(3)’’ would be added in their 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; 

* * * * * 


ycherry on PROD1PC64 with PROPOSALS3
Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Proposed Rules 1129 

(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 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 an 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 

receptacle, or was collected otherwise in 

an 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 

would continue 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, new definitions of Food 

and Drug Administration and Food 

Safety and Inspection Service would be 

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) would be 

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. 

(Approved by the Office of Management 

and Budget under control number 0579–

0015) 

13. In § 96.3, paragraph (d) would be 

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 3rd day of 

January 2007. 

Bruce Knight, 

Under Secretary for Marketing and Regulatory 

Programs. 

[FR Doc. 07–17 Filed 1–4–07; 3:00 pm] 

BILLING CODE 3410–34–P 


ycherry on PROD1PC64 with PROPOSALS3