Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines, 1102-1129 [07-17]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 72, Number 5 (Tuesday, January 9, 2007)]
[Proposed Rules]
[Pages 1102-1129]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-17]



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Part III





Department of Agriculture





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Animal and Plant Health Inspection Service



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9 CFR Parts 93, 94, 95, and 96



 Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of 
Live Bovines and Products Derived From Bovines; Proposed Rule

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

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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.

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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 https://
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 https://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: For information regarding ruminant 
products, contact Dr. Karen James-Preston, 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 
Sec.  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 Sec.  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 Sec.  94.18(a)(3) of the 
regulations).

Chronology of APHIS Federal Register Publications Regarding BSE 
Minimal-Risk Regions

    We added the Sec.  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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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 minimal-risk 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 Sec.  95.4(a)(1)(i) of the regulations; and (5) 
gelatin derived from bones of bovines that is not otherwise eligible 
for importation under Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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.
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    \1\ The current regulations regarding BSE minimal-risk regions 
apply to bison as well as cattle. In current Sec. Sec.  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.
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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.
[GRAPHIC] [TIFF OMITTED] TP09JA07.002

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
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                            Year                                Cases
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1974.......................................................            1
1975.......................................................            0
1976.......................................................            2
1977.......................................................           10
1978.......................................................            6
1979.......................................................           41
1980.......................................................          102
1981.......................................................          262
1982.......................................................        1,394
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
2001.......................................................            5
2002.......................................................            1
Unknown birth year.........................................       43,342
                                                            ------------
    Total..................................................      180,986
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(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 ruminant-to-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-to-
ruminant 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-to-ruminant 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 non-
prohibited material, procedures must be established and maintained to 
conduct flushing and/or clean-out between batches of product to prevent 
cross-contamination.
    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.

[[Page 1107]]

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 
minimal-risk region is that the region have in

[[Page 1108]]

place and maintain risk mitigation measures adequate to prevent 
widespread exposure and/or establishment of the disease. In classifying 
Canada as a BSE minimal-risk 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 BSE-infected 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\
---------------------------------------------------------------------------

    \2\ The current adult cattle population in the United States is 
approximately 42 million animals.
---------------------------------------------------------------------------

    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

[[Page 1109]]

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 base-case 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

[[Page 1110]]

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 Sec.  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-to-
ruminant feed ban in Canada, currently the only country recognized by 
APHIS as a BSE minimal-risk region.
    We would remove the requirement in Sec.  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 Sec.  93.436(a)(1) and (b)(1) that such bovines not be 
pregnant when imported into the United States and the provisions in 
Sec.  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 Sec.  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 Sec.  93.436(b)(3) requires that bovines imported from a 
BSE minimal-risk 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 minimal-risk 
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 Sec.  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 Sec.  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-of-export 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 Sec.  93.436(b)(6) 
that live bovines imported from a BSE minimal-risk 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 Sec.  
93.436(a)(6) that the bovines imported from BSE minimal-risk 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 
conveyanc