[Federal Register Volume 68, Number 213 (Tuesday, November 4, 2003)]
[Proposed Rules]
[Pages 62386-62405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27611]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 68, No. 213 / Tuesday, November 4, 2003 / 
Proposed Rules  

[[Page 62386]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 93, 94, and 95

[Docket No. 03-080-1]
RIN 0579-AB73


Bovine Spongiform Encephalopathy; Minimal Risk Regions and 
Importation of Commodities

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 recognize a category of 
regions that present a minimal risk of introducing bovine spongiform 
encephalopathy (BSE) into the United States via live ruminants and 
ruminant products, and are proposing to add Canada to this category. We 
are also proposing to allow the importation of certain live ruminants 
and ruminant products and byproducts from such regions under certain 
conditions. We believe this action is warranted because it would 
continue to protect against the introduction of BSE into the United 
States while removing unnecessary prohibitions on certain commodities 
from Canada and other regions that qualify as BSE minimal-risk regions.

DATES: We will consider all comments that we receive on or before 
January 5, 2004.

ADDRESSES: You may submit comments by postal mail/commercial delivery 
or by e-mail. If you use postal mail/commercial delivery, please send 
four copies of your comment (an original and three copies) to: Docket 
No. 03-080-1, Regulatory Analysis and Development, PPD, APHIS, Station 
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. 03-080-1. If you use e-mail, 
address your comment to [email protected]. Your comment must 
be contained in the body of your message; do not send attached files. 
Please include your name and address in your message and ``Docket No. 
03-080-1'' on the subject line.
    You may read the risk assessment, environmental assessment, 
economic analysis, and 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.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Karen James-Preston, Director, 
Technical Trade Services, National Center for Import and Export, VS, 
APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-
4356.

SUPPLEMENTARY INFORMATION: 

Background

    The Animal and Plant Health Inspection Service (APHIS) of the 
United States Department of Agriculture (USDA or the 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).
    BSE is a progressive neurological disorder of cattle that results 
from infection by an unconventional transmissible agent and is not 
known to exist in the United States. The disease has been difficult to 
define experimentally with precision, although risk factors that are 
independent of the causative agent have been identified and can be 
mitigated. Much of the available data originated from epidemiological 
observations and not from controlled studies. Controlled studies are 
often difficult to conduct because of limitations in experimental 
models and the length of time necessary to conduct the studies, which 
may require years. Currently, the most accepted theory is that the 
agent is a modified form of a normal cell surface component known as 
prion protein, although other types of agents have been implicated, 
including virinos. The pathogenic form of the protein is both less 
soluble and more resistant to degradation than the normal form. The BSE 
agent is extremely resistant to heat and to normal sterilization 
processes. It does not evoke any demonstrated immune response or 
inflammatory reaction in host animals.
    Despite the difficulty in defining BSE experimentally with 
precision, risk factors for BSE that can be mitigated have been 
identified. These factors are based on technical knowledge and disease 
epidemiology and do not require definition of the nature of the agent. 
We believe that risk mitigation measures that address the risk factors 
for BSE will be effective regardless of the precise nature of the BSE 
agent.
    It appears that BSE is spread primarily through the use of ruminant 
feed containing protein and other products from ruminants infected with 
BSE. Ruminants in the United States could be exposed to the disease if 
materials carrying the BSE agent--such as certain meat, animal 
products, or animal byproducts from ruminants--were imported into the 
United States and were fed to ruminants in this country. BSE could also 
be introduced into the United States if ruminants with BSE were 
imported into the United States.
    Because of these risks, the regulations prohibit the importation of 
live ruminants and certain ruminant products and byproducts from two 
categories of regions: (1) Those regions in which BSE is known to 
exist, which are listed in Sec.  94.18(a)(1) of the regulations; and 
(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. 
These regions of ``undue

[[Page 62387]]

risk'' are listed in Sec.  94.18(a)(2) of the regulations.
    The prohibitions on the importation of animals, meat, and other 
animal products into the United States from regions listed in Sec.  
94.18(a)(1) or (a)(2) are set forth in 9 CFR parts 93, 94, 95, and 96. 
Section 93.401 prohibits the importation of any ruminant that has been 
in these regions. Except for certain controlled transit movements, 
paragraph (b) of Sec.  94.18 prohibits the importation of fresh 
(chilled or frozen) meat, meat products, and most other edible products 
of ruminants that have been in any of the regions. Paragraph (c) of 
Sec.  94.18 restricts the importation of gelatin derived from ruminants 
that have been in any of the regions. Section 95.4 prohibits or 
restricts the importation of certain byproducts from ruminants that 
have been in any of the regions, and Sec.  96.2 prohibits the 
importation of casings, except stomach casings, from ruminants that 
have been in any of the regions.
    Essentially then, under the current regulations, there are three 
categories of regions with regard to BSE. Currently, a region is 
considered either: (1) A region free of BSE; (2) a region in which BSE 
is known to exist; or (3) a region that presents an undue risk of BSE. 
Imports from free regions are generally not subject to restrictions 
because of BSE. Imports from BSE-affected regions and those that 
present an undue risk are governed by the same set of restrictions.
    We believe it is appropriate to recognize an additional category of 
regions with regard to BSE--the BSE minimal-risk region. This category 
would include (1) those regions in which a BSE-infected animal has been 
diagnosed, but in which measures have been taken that make it unlikely 
that BSE would be introduced from the region into the United States, 
and (2) those regions that cannot be considered BSE free even though 
BSE has not been detected, but that have taken sufficient measures to 
be considered minimal risk. For instance, a region listed in Sec.  
94.18(a)(2) as an ``undue risk'' region might have increased its levels 
of surveillance or import restrictions to the point that the risk of 
BSE introduction from that region becomes unlikely, but not yet have 
had mitigation measures in place long enough to be considered BSE-free.
    In Sec.  94.0, we would define bovine spongiform encephalopathy 
(BSE) minimal-risk region by listing the factors we would consider in 
determining the region's risk status. In a new Sec.  94.18(a)(3), we 
would list the regions that the Administrator has approved for this 
designation. At this time, we are proposing to designate one country, 
Canada, as a BSE minimal-risk region according to the newly proposed 
factors. (These factors, and the reasons why we believe Canada meets 
them, are discussed in detail below.) In Sec.  94.18(a)(4), we would 
explain that a region may request to be designated a BSE minimal-risk 
region by following the procedures set forth in our regulations in 9 
CFR part 92, ``Importation of Animals and Animal Products: Procedures 
for Requesting Recognition of Regions.''

Canada as a BSE Minimal-Risk Region

    On May 20, 2003, the Canadian Food Inspection Agency reported a 
case of BSE in a beef cow in northern Alberta. Therefore, in order to 
prevent the introduction of BSE into the United States, we published an 
interim rule on May 29, 2003 (68 FR 31939-31940, Docket No. 03-058-1), 
effective retroactively to May 20, 2003, to add Canada to the list of 
regions where BSE exists. As a result of that action, the importation 
of ruminants that have been in Canada and the importation of meat, meat 
products, and certain other products and byproducts of ruminants that 
have been in Canada are prohibited or restricted.
    Following the detection of the BSE-infected cow, Canada conducted 
an epidemiological investigation of the BSE occurrence, and took action 
to guard against any spread of the disease, including the quarantining 
and depopulation of herds and animals determined to possibly be at risk 
for BSE. Subsequently, Canada asked APHIS to consider reestablishing 
the importation of ruminants and ruminant products into the United 
States from that country, based on information made available to APHIS 
regarding Canada's veterinary infrastructure, disease history, 
practices for preventing widespread introduction, exposure, and/or 
establishment of BSE, and measures taken following detection of the 
disease.
    In this document, we are proposing to list Canada as a BSE minimal-
risk region based on an analysis we conducted of the conditions 
considered for such a designation and the information available to us 
regarding how Canada meets those conditions. The risk document, ``Risk 
Analysis: BSE Risk from Importation of Designated Ruminants and 
Ruminant Products from Canada into the United States,'' also identifies 
the measures we believe are necessary to mitigate any BSE risk that 
specific commodities imported from Canada might present to the United 
States (discussed in this proposed rule, below, under the heading 
``Importation of Ruminant Commodities from a BSE Minimal-Risk 
Region'').
    You may view the analysis in our reading room (information on the 
location and hours of the reading room is provided under the heading 
ADDRESSES at the beginning of this proposed rule). You may also request 
a copy by calling or writing to the person listed under FOR FURTHER 
INFORMATION CONTACT. Please refer to the title of the analysis when 
requesting copies. You may also view the analysis on the Internet by 
accessing the APHIS Web site at http://www.aphis.usda.gov. At the APHIS 
Web site, click on the ``Hot Issues'' button. On the next screen, click 
on the listing for ``Bovine Spongiform Encephalopathy (BSE).'' On the 
next screen, click on the listing for ``Risk Analysis: BSE Risk from 
Importation of Designated Ruminants and Ruminant Products from Canada 
into the United States.''
    In this proposed rule, we first discuss the factors we would 
consider in classifying a region as a BSE minimal-risk region. We would 
consider these factors in considering requests from any region to be 
classified as a BSE minimal-risk region. We then discuss why we believe 
Canada qualifies as a BSE minimal-risk region. Following that, we 
discuss mitigations that we would apply to specific commodities from 
Canada.

Proposed Factors for BSE Minimal-Risk Regions

    APHIS has developed a list of factors we would use to evaluate the 
BSE risk from a region and classify a region as a BSE minimal-risk 
region. We would use these factors as a combined and integrated 
evaluation tool. We are proposing to base the classification on an 
evaluation of the sum total of these factors, focusing on overall 
effectiveness of control mechanisms in place (e.g., surveillance, 
import controls, and a ban on the feeding of ruminant protein to 
ruminants). For regions in which BSE has been diagnosed, we would base 
our evaluation on the overall effectiveness of such control mechanisms 
in place at the time BSE was diagnosed in the region, and on actions 
taken after the diagnosis (e.g., an epidemiological investigation of 
the occurrence). For regions in which BSE has not been diagnosed, we 
would base our evaluation on the adequacy of surveillance mechanisms to 
detect disease, efficacy of a feed ban, and effectiveness of programs 
in place to prohibit entry into and establishment of disease in the 
region. This approach differs from some of the numerical criteria 
specified by the Office

[[Page 62388]]

International des Epizooties (OIE) in its recommendations for a BSE 
minimal-risk country or zone. (The OIE recommendations are recognized 
by the World Trade Organization as international recommendations for 
animal disease control.)
    For example, according to OIE recommendations, a ban on the feeding 
of ruminant protein to ruminants should have been in place for a 
minimum of 7 years for a region to meet the criteria for BSE minimal 
risk, even though there is a significant level of variability in 
current estimates of the BSE incubation period, which should govern the 
recommended length of time of an effective feed ban. According to this 
criterion, a region could fail to be classified as a BSE minimal-risk 
region because it had not had a feed ban in effect for the precise 
period of time specified, even if it has excelled in surveillance and 
control mechanisms. We believe it is more appropriate to evaluate the 
overall combined effect of the factors described below when assessing 
the BSE risk level of a region.

Definition of Bovine Spongiform Encephalopathy Minimal-Risk Region

    We propose to define bovine spongiform encephalopathy (BSE) 
minimal-risk region in Sec.  94.0 to mean a region that:
    1. Maintains, and, in the case of regions where BSE was detected, 
had in place prior to the detection of BSE, risk mitigation measures 
adequate to prevent widespread exposure and/or establishment of the 
disease. Such measures include the following:
    a. Restrictions on the importation of animals sufficient to 
minimize the possibility of infected ruminants being imported into the 
region, and on the importation of animal products and animal feed 
containing ruminant protein sufficient to minimize the possibility of 
ruminants in the region being exposed to BSE;
    b. Surveillance for BSE at levels that meet or exceed OIE 
recommendations for surveillance for BSE; and
    c. A ban on the feeding of ruminant protein to ruminants that 
appears to be an effective barrier to the dissemination of the BSE 
infectious agent, with no evidence of significant noncompliance with 
the ban.
    2. In regions where BSE was detected, conducted an epidemiological 
investigation following detection of BSE sufficient to confirm the 
adequacy of measures to prevent the further introduction or spread of 
BSE, and continues to take such measures.
    3. In regions where BSE was detected, took additional risk 
mitigation measures, as necessary, following the BSE outbreak based on 
risk analysis of the outbreak, and continues to take such measures.
    Each element of this definition is explained below.
    1. The region maintains, and, in the case of regions where BSE was 
detected, had in place prior to the detection of BSE, risk mitigation 
measures adequate to prevent widespread exposure and/or establishment 
of the disease.
    This factor is important in determining those regions in which a 
BSE outbreak is unlikely to occur, or, if an outbreak does occur, in 
which it is likely to be limited. If a region maintains controls 
designed to minimize BSE introduction or exposure of animals, and, in 
those regions where BSE has been detected, if the region had such 
controls in place at the time of detection, it is more likely to 
present minimal risk than a region that does not have such controls in 
place. According to our definition of a BSE minimal-risk region, such 
measures would include importation restrictions, surveillance, and a 
feeding ban, as follows:
    1a. Restrictions on the importation of animals sufficient to 
minimize the possibility of infected ruminants being imported into the 
region, and on the importation of animal products and animal feed 
containing ruminant protein sufficient to minimize the possibility of 
ruminants in the region being exposed to BSE.
    This factor addresses whether the region faces a high risk of 
initial or recurrent BSE outbreaks from multiple importations of 
animals or products that may spread BSE. In those regions in which BSE 
has been detected, it addresses whether the region's BSE outbreak was 
more likely the result of a point failure in its import controls or 
possible exposure prior to the implementation of such import controls. 
Because the incubation period for BSE is generally measured in years, 
the finding of a case of BSE reflects an exposure that occurred several 
years in the past.
    A region that has prohibited the importation of high-risk animals 
and products from regions that are affected with or pose an undue risk 
of BSE will have minimized its possible exposure to the disease. 
Conversely, a region that continues to import high-risk commodities 
until a case of BSE is diagnosed has continued exposure and presents a 
more significant risk. Whether commodities are considered low-risk or 
high-risk can be based on the commodities' inherent lack of risk, the 
low risk level of the exporting region, and/or controls on the movement 
and use of the commodities after entry.
    1b. Surveillance for BSE at levels that meet or exceed OIE 
recommendations for surveillance for BSE.
    This factor addresses whether BSE outbreaks are or would be likely 
to be quickly and reliably identified in a region, helping support a 
minimal-risk designation, or whether lack of effective surveillance 
suggests the possibility that BSE-infected animals may be overlooked 
and the scale of a BSE problem may be greater than is officially 
recognized.
    As noted above, the OIE recommendations are recognized by the World 
Trade Organization as international recommendations for animal disease 
control. The OIE Code provides guidelines for surveillance and 
monitoring systems for BSE, identifying the minimum number of annual 
investigations recommended based on the adult cattle population of a 
country.
    1c. A ban on the feeding of ruminant protein to ruminants that 
appears to be an effective barrier to the dissemination of the BSE 
infectious agent, with no evidence of significant noncompliance with 
the ban.
    The primary source of BSE infection appears to be feed contaminated 
with the infectious agent. Scientific evidence \1\ shows that feed 
contamination results from the incorporation of ingredients that 
contain 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 contain the infectious agent. Bans prohibiting 
incorporation of mammalian or ruminant protein into ruminant feed are 
imposed to mitigate risk.
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    \1\ Wilesmith, J.W., Wells, G.A.H., Cranwell, M.P., and Ryan, 
J.B.M.; 1988; Bovine spongiform encephalopathy; epidemiological 
studies; Veterinary Record; 123, pg 638-644.
    Wilesmith, J.W., Ryan, J.B.M, and Atkinson, M.J.; 1991; Bovine 
spongiform encephalopathy; epidemiological studies of the origin; 
Veterinary Record; 128, pg 199-203.
    Wilesmith, J.W., Ryan, J.B.M, and Hueston W.D.; 1992; Bovine 
spongiform encephalopathy: Case control studies of calf feeding 
practices and meat-and-bone meal inclusion in proprietary 
concentrates; Res Vet Sci; 52, pg 325-331.
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    This factor distinguishes between regions with effective feed bans 
and those without them. In a region in which BSE has been detected, if 
an animal with BSE was born after a feed ban was implemented, it is a 
sign that the feed ban may not be effectively enforced.
    2. In a region in which BSE has been detected, the region conducted 
an

[[Page 62389]]

epidemiological investigation following detection of BSE sufficient to 
confirm the adequacy of measures to prevent the further introduction or 
spread of BSE, and continues to take such measures.
    This factor addresses whether a region adequately investigates a 
case of BSE to determine if any of the risk factors have changed. If 
there has been any significant change in risk factors, there might be 
the possibility of increased incidence of BSE. Such an investigation 
would include, at the minimum, a traceback from the BSE-infected animal 
to determine possible herds of origin of the animal, a traceforward of 
any animals that moved from the BSE-affected herd, a traceforward of 
feed or rendered material that was derived from the carcass of the 
infected animal, and an investigation to determine the most likely 
source of the animal's exposure to BSE.
    3. In a region in which BSE has been detected, the region took 
additional risk mitigation measures, as necessary, following the BSE 
outbreak based on risk analysis of the outbreak, and continues to take 
such measures.
    This factor addresses whether a region implements all necessary 
risk mitigation measures to prevent further exposure to BSE. It 
distinguishes between those regions that thoroughly analyze their 
situation and address any problems from those that do not take 
mitigation measures and thus prolong possible exposure to BSE. 
Depending on the conclusions of the risk analysis conducted following 
the diagnosis of BSE, additional risk mitigation measures could include 
a broad eradication program, increased surveillance, or additional 
import restrictions.

Evaluating Canada as a BSE Minimal-Risk Region

    We considered the above factors in combination in evaluating 
whether Canada qualifies as a BSE minimal-risk region, and discuss 
below the actions Canada took and continues to take regarding each of 
the factors.

Import Restrictions

    Canada has maintained stringent import restrictions since 1990,\2\ 
prohibiting the importation of live ruminants and most ruminant 
products from countries that had not been recognized as free of BSE by 
either the United States, Canada, or Mexico, which have an agreement to 
recognize country evaluations conducted by any of the three countries, 
using the same standards. Canada prohibited the importation of live 
cattle from the United Kingdom and the Republic of Ireland starting in 
1990, and subsequently applied the same prohibitions to other countries 
as those additional countries identified native cases of BSE. In 1996, 
Canada made this policy even more restrictive and prohibited the 
importation of live ruminants from any country that had not been 
recognized as free of BSE. Some animals were imported into Canada from 
high-risk countries prior to the imposition of these import 
restrictions. A total of 182 cattle were imported into Canada from the 
United Kingdom between 1982 and 1990. Similar to actions taken in the 
United States, efforts were made in Canada to trace these animals. In 
late 1993, after Canada identified a case of BSE in one of the imported 
bovines, all cattle imported from the United Kingdom or the Republic of 
Ireland that remained alive at that time were killed.
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    \2\ Canadian Food Inspection Agency (CFIA), December 2002; Risk 
Assessment on Bovine Spongiform Encephalopathy in Cattle in Canada.
    Morley, R.S., Chen, S., Rheault, N.; 2003; Assessment of the 
risk factors related to bovine spongiform encephalopathy; Rev. Sci. 
Tech. OIE; 22(1); pg 157-178.
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    Import restrictions have also been imposed on ruminant products, 
including import restrictions on meat-and-bone meal that have been in 
place since 1978. In general, Canada has prohibited the importation of 
most meat-and-bone meal from countries other than the United States, 
Australia, and New Zealand. Limited amounts of specialty products of 
porcine or poultry origin were allowed to be imported into Canada under 
permit for use in aquaculture feed products. No meat-and-bone meal for 
livestock feed-associated uses has been imported, except from the 
United States, Australia, and New Zealand.

Surveillance

    Canada has conducted surveillance for BSE since 1992. The OIE Code, 
Appendix 3.8.4, provides guidelines for surveillance and monitoring 
systems for BSE, identifying the minimum number of annual 
investigations recommended based on the adult cattle population of a 
country. To meet this recommendation, Canada would have to test a 
minimum of 336 samples annually, based on a population of 5.5 million 
adult cattle. Canada exceeds this recommendation, and has tested more 
than this minimum number of samples for the past 7 years. Additionally, 
Canada exceeds OIE recommendations by conducting active targeted 
surveillance. (Active targeted surveillance involves sampling animals 
with risk factors for BSE, even if the animals have not shown clinical 
signs of disease.)

Feed Ban

    Canada implemented a feed ban in 1997 that prohibits the feeding of 
most mammalian protein to ruminants. This ban exceeds what we consider 
the minimal necessary measure of banning the feeding of ruminant 
material to ruminants. Under the ban in Canada, mammalian protein may 
not be fed to ruminants, with certain exceptions. These exceptions 
include pure porcine or equine protein, blood, milk, and gelatin. The 
feed ban is essentially the same as the feed ban in place in the United 
States.
    APHIS believes the length of the feed ban in Canada is sufficient 
to classify that country as a minimal-risk region for BSE. In 
comparison, classification as a minimal-risk country or zone by OIE 
criteria requires that a feed ban be in place for 8 years. This value 
may be set at a conservative level to account for the wide range that 
has been reported for the incubation period of BSE. Because of the 
variability in the incubation period for BSE, APHIS chose not to 
specify an amount of time that a feed ban needed to be in place in a 
minimal-risk region. Rather, we considered the sum total of the control 
mechanisms (e.g., effectiveness of surveillance, import controls, and 
feed ban) in place at the time of the diagnosis of BSE and the actions 
taken subsequently (e.g., epidemiological investigations and 
depopulation), thereby allowing the actions Canada took with regard to 
the other factors to compensate for a shorter feed ban. As an example, 
as discussed above, the level of surveillance in Canada, and the fact 
that it has been active and targeted, has exceeded OIE recommendations.
    Canadian Government authorities inspect rendering facilities, feed 
manufacturers, and feed retailers to ensure compliance with the feed 
ban. Rendering facilities are regulated under an annual permit system, 
and compliance with the regulations is verified through at least one 
inspection each year. Feed manufacturers or mills, feed retailers, and 
farms have been inspected on a routine basis. These inspections have 
shown a high level of compliance. As noted above, Canada has maintained 
an effective ban on feeding mammalian protein to ruminants, with 
requirements similar to the feed ban in place in the United States, 
since 1997. The animal in which BSE was diagnosed in May 2003 was an 6-
year-old native-born beef cow in the Province of Alberta that was born 
before the implementation of the feed ban.

[[Page 62390]]

Epidemiological Investigation

    Canada conducted an extensive epidemiological investigation after 
the one case of BSE in May 2003. This investigation included detailed 
tracebacks to identify possible herds of origin of the infected animal, 
traceforwards from the infected herd, and traceforwards of any possible 
feed or rendered material derived from the carcass of the infected 
animal. Fifteen premises were quarantined as part of the traceback and 
traceforward investigations, and cattle on the quarantined premises 
were slaughtered. Additionally, cattle that were determined to have 
moved from a quarantined herd to another herd were slaughtered.
    The investigation included any possible exposure from the use of 
rendered material or feed that could have been derived from the carcass 
of the infected cow. Using a broad definition to include all possible 
exposures, the rendered material could have been distributed to 
approximately 1,800 sites, including sites with no ruminants. These 
included 600 facilities that receive bulk shipments of either rendered 
protein or feed, and 1,200 individual producers or consumers who 
purchased finished feed by the bag. A survey was conducted of those 
entities that were at some risk of having received such rendered 
material or feed. This survey suggested that 99 percent of the sites 
surveyed experienced either no exposure of cattle (96 percent of the 
sites) to the feed or only incidental exposure (3 percent of the 
sites). The remaining 1 percent represented limited exposures, such as 
cattle breaking into feed piles, sheep reaching through a fence to 
access feed, and a goat with possible access to a feed bag.
    The investigation included a consideration of several possibilities 
for the source of the infected cow's exposure to BSE. Although it has 
not been confirmed, it is assumed, based on the age of the cow, that 
the infected cow was exposed through contaminated feed. The infected 
animal was born prior to the implementation of a feed ban within Canada 
and could have had exposure to contaminated feed at an early age.
    The renderers and feed mills associated with the investigation had 
records of good compliance with the feed ban. The on-farm inquiries 
demonstrated a very small probability of exposure of ruminants to 
prohibited feed. Although the possibility exists that the original 
source of the BSE agent could have been imported, there was no evidence 
that this was due to an illegal import. The BSE agent could have been 
from animals imported from the United Kingdom prior to import 
restrictions established in 1990. The surveillance program was 
sufficient to confirm the continued existence of adequate measures to 
prevent further introduction or spread of BSE.

Additional Risk Mitigation Measures

    Following the detection of BSE in Canada, a broad eradication 
program was followed during the epidemiological investigation, in which 
more than 2,700 head of cattle were culled. As part of the culling 
activity, more than 2,000 animals 24 months of age or older were tested 
(those animals less than 24 months of age were not tested), with no 
further evidence of BSE found in any of these animals.

Importation of Ruminant Commodities From a BSE Minimal-Risk Region

    Because we believe regions, such as Canada, that qualify as BSE 
minimal-risk regions based on the factors described above, would pose a 
minimal risk of introducing BSE into the United States, we believe it 
is warranted to allow the importation from such regions of some animals 
and animal products and byproducts that are prohibited importation from 
regions in which BSE exists and regions that present an undue risk of 
BSE. However, because BSE is a difficult disease to define 
experimentally with precision, epidemiological evidence suggests that 
risk factors are specific to the commodity, and multiple risk sources 
may be associated with a given commodity, we believe it is necessary to 
also apply individual risk mitigation measures to specified commodities 
intended for importation from BSE minimal-risk regions.
    For example, as noted above and discussed further below, 
contaminated feed appears to be the most likely pathway of BSE 
transmission. However, it has not been established with certainty that 
contaminated feed is the only pathway. Furthermore, we cannot assume 
complete compliance with a ban on the feeding of ruminant protein to 
ruminants, which is the most effective mitigation for contaminated 
feed. Therefore, we believe it is necessary to apply certain other 
mitigation measures, in addition to implementation of a feed ban, to 
reduce the risk of the introduction of BSE into the United States. Each 
of these proposed mitigation measures is discussed below.
    We are proposing to add the conditions for importing specified 
ruminant commodities from a BSE minimal-risk region to the regulations 
in 9 CFR parts 93, 94, and 95. The measures appropriate for specific 
commodities intended for importation would be determined by the 
presence or absence of factors that make it more or less likely the 
commodity might be contaminated or infected with the BSE. These factors 
are discussed in the following paragraphs.

Feed Source and Exposure

    Oral ingestion of feed contaminated with the abnormal BSE prion 
protein is the only documented route of field transmission of BSE.\3\ 
Thus, animals that have not ingested contaminated feed are unlikely to 
harbor the agent, so feed exposure influences risk. Animals, and the 
products derived from those animals, are unlikely to have infectious 
levels of the agent and will present a lower risk if the animals were 
(a) born after the implementation of an effective feed ban or (b) not 
fed risk material (e.g., wild animals or farmed animals that are not 
fed feeds containing meat-and-bone meal).
---------------------------------------------------------------------------

    \3\ Prince, M.J., et al.; 2003; Bovine Spongiform 
Encephalopathy; Rev. sce. tech. OIE; 22 (1), pg 37-60.
    Wilesmith et al.; 1988; 1991; 1992.
---------------------------------------------------------------------------

    The risks associated with feed source and exposure can be mitigated 
by accepting for import only animals or products derived from animals 
that have not been fed commercial feed that is likely to be 
contaminated with infectious levels of the agent.

Animal Age

    Levels of infectious agent in certain tissues vary with the age of 
an animal, so the age of the animal influences risk. Pathogenesis 
studies, where tissues obtained from orally infected calves were 
assayed for infectivity, have illustrated this.\4\ Infectivity was not 
detected in most tissues until at least 32 months post-exposure. The 
exception to this is the distal ileum (a part of the intestines), where 
infectivity was

[[Page 62391]]

confirmed from the experimentally infected cattle as early as 6 months 
post-exposure. In this proposed rule, we take these findings into 
account when establishing measures to mitigate the risk of infectious 
levels of the BSE agent being present in animals and animal products 
imported from a BSE minimal-risk region. For example, with regard to 
bovines, because BSE infectivity has not been found in most bovine 
tissues until at least 32 months post-exposure, we believe that by 
requiring that bovines imported into the United States from BSE 
minimal-risk regions be less than 30 months of age, the risk of the BSE 
agent being present at infectious levels in most tissues in the animal 
is minimized. The 30-month age limit is accepted internationally in BSE 
standards set by various countries and is consistent with OIE 
recommendations. Similarly, the proposed regulations would require that 
imported meat from bovines be derived from animals less than 30 months 
of age when slaughtered. However, because of evidence that the BSE 
agent may be present at infectious levels in the distal ileum of 
infected bovines as early as 6 months post-exposure, we would require 
that the intestines of bovines imported into the United States be 
removed at slaughter, and that meat imported from bovines from BSE 
minimal-risk regions be derived from animals from which the intestines 
were removed at slaughter.
---------------------------------------------------------------------------

    \4\ Wells, G.A.H., et al.; 1994; Infectivity in the ileum of 
cattle challenged orally with bovine spongiform encephalopathy; 
Veterinary Record; 135 (2), pg 40-41.
    Wells, G.A.H., et al.; 1998; Preliminary observations on the 
pathogenesis of experimental bovine spongiform encephalopathy (BSE): 
An update; Veterinary Record; 142, pg 103-106.
    European Union Scientific Steering Committee (EU SSC), 2002; 
Update of the opinion on TSE infectivity distribution in ruminant 
tissues (initially adopted by the Scientific Steering Committee at 
its meeting of 10-11 January 2002 and amended at its meeting of 7-8 
November 2002) following the submission of (1) a risk assessment by 
the German Federal Ministry of Consumer Protection, Food, and 
Agriculture, and (2) new scientific evidence regarding BSE 
infectivity distribution in tonsils; European Commission, Scientific 
Steering Committee, Health and Consumer Protection Directorate 
General.
---------------------------------------------------------------------------

    Although the risks associated with age can be mitigated by 
accepting for import only animals or commodities derived from animals 
of an age where even high risk tissues (discussed below) are unlikely 
to have infectious levels of the BSE agent, restrictions applicable to 
age alone may not always be possible or sufficient. For instance, in 
the case of wild cervids, because it is not always possible to 
determine the age of the cervids, we believe that alternative risk 
measures, discussed below, are necessary.
    Research demonstrates that the incubation period for BSE is 
apparently linked to the infectious dose received--i.e., the larger the 
infectious dose received, the shorter the incubation period (EU SSC 
2002). While some cases of BSE have been found in animals less than 30 
months of age, these are relatively few and have occurred primarily in 
countries with significant levels of circulating infectivity (i.e., 
where infected ruminants are used for feed for other ruminants, which 
in turn become infected). The conditions, discussed above, for 
qualifying for a BSE minimal-risk region guard against such circulating 
infectivity.
    Similar observations regarding the importance of the size of the 
infectious dose were made in sheep and goats (EU SSC 2002). In these 
animals, infectivity could not be demonstrated in most tissues until at 
least 16 months post-exposure to the agent.
    In summary, infected cattle over 30 months of age or sheep and 
goats over 16 months of age may have levels of the abnormal prion in 
affected tissues that are sufficient to infect other animals fed 
protein derived from these tissues. Infected animals less than 30 
months of age or sheep and goats less than 16 months of age are 
unlikely to have infectious levels of the prion protein (EU SSC 2002; 
Wells, et al.; 1994; Wells, et al.; 1998).
    Animals that were born before the feed ban but were not fed risk 
material, such as wild ruminants or domestic livestock in the minimal-
risk region that were fed solely materials that are extremely unlikely 
to contain the infectious agent, are unlikely to contain infectious 
levels of BSE.

Tissue Localization

    Some bovine tissues have demonstrated infectivity, whereas others 
have not. Tissues that have demonstrated infectivity, and thus are 
likely to contain the infectious agent in infected cattle, are brain, 
tonsil, spinal cord, eyes, trigeminal ganglia, dorsal root ganglia, and 
distal ileum. (Please note that, as discussed above, the age of an 
animal is a key factor in whether the animal is likely or unlikely to 
be infected. Cattle less than 30 months of age unlikely to be infected 
with BSE, and, therefore, even the tissues listed above, except for the 
distal ileum, from such animals are unlikely to contain the infectious 
agent.) Affiliated tissues or structures such as skull or vertebral 
column are considered risk materials because of the difficulty in 
separating out small tissues such as dorsal root ganglia from the 
vertebral column. Possibilities for cross contamination from risk 
materials must be considered also. However, even cattle carrying the 
infectious agent are unlikely to carry that agent in tissues that have 
not demonstrated infectivity (e.g., muscle, liver, skin, hide, milk, 
embryos) or products derived from these tissues \5\ (also, Wells, et 
al.; 1994; Wells, et al.; 1998).
---------------------------------------------------------------------------

    \5\ Wrathall, A.E., et al.; 2002; Studies of embryo transfer 
from cattle clinically affected by bovine spongiform encephalopathy 
(BSE); Veterinary Record; 150; pg 365-378.
---------------------------------------------------------------------------

    The risks associated with tissue localization can be mitigated by 
accepting only tissues that are unlikely to have infectious levels of 
the agent, due to the nature of the tissue or the age of the animal (in 
cattle under 30 months of age, only the distal ileum is such a risk 
material), or commodities derived from those tissues.

Source Species

    Tissue distribution of the agent varies with species. Results from 
experimental infections of sheep have shown that the BSE prion is 
distributed more widely in sheep tissues than in cattle.\6\ This 
distribution is similar to the distribution of scrapie (a transmissible 
spongiform encephalopathy present in the United States) infections in 
sheep. In these infections, the agent may be found in the 
lymphoreticular system and in peripheral nerves (Foster et al.; 1996; 
Foster et al.; 2001).
---------------------------------------------------------------------------

    \6\ Foster, J.D., et al.; 1996; Detection of BSE infectivity in 
brain and spleen of experimentally infected sheep; Veterinary 
Record; 139; pg 912-915.
    Foster, J.D., et al.; 2001; Distribution of the prion protein in 
sheep terminally affected with BSE following experimental oral 
transmission; J. Gen Virol.; 82; pg 2319-2326.
---------------------------------------------------------------------------

    However, no natural infections with BSE have yet been confirmed in 
sheep, although testing is ongoing in Europe. Similarly, no natural 
infections have been confirmed in goats, although actual experiments 
have not been conducted in the species. In the absence of actual data, 
distribution of the agent in goat tissues has been assumed to be 
similar to distribution of the agent in sheep tissues, based on the 
fact that scrapie acts very similarly in sheep and goats.
    Similarly, natural infection of cervids (deer and elk species) with 
BSE has not been documented, and no challenge studies on cervid 
susceptibility to BSE have been conducted. In the absence of actual 
data, it is assumed that distribution of any BSE agent in cervid 
tissues would be similar to the distribution of the chronic wasting 
disease agent in cervid tissues, which is a naturally occurring 
transmissible spongiform encephalopathy.

Prevalence of BSE

    The possible prevalence of disease in the region of origin will 
influence the risk. Prevalence of the disease will be lower in a 
country with adequate prevention and control measures; thus, animals 
from such a region will be at lower risk of being exposed to infection. 
The risks associated with prevalence can be mitigated by accepting 
commodities only from a country with low prevalence that can be 
classified as minimal or low risk.

[[Page 62392]]

Importation of Live Ruminants

    We believe the categories of ruminants discussed below from BSE 
minimal-risk regions are unlikely to be a source of infectivity of the 
BSE agent if the conditions specified below are met, and we propose to 
allow for such importation under those conditions in a new Sec.  
93.436. In each case where we are proposing to allow importation, the 
animals would have to arrive through a designated port of entry as 
listed in current Sec.  93.403(b) (designated ports of entry for 
ruminants from Canada), or through some other port that has been 
designated as a port of entry by the Administrator under Sec.  
93.403(f). If, in the future, we add other countries to the list of BSE 
minimal-risk regions in Sec.  94.18(a)(3), we would adjust the list of 
designated ports accordingly.
    In those cases where a ruminant is imported into the United States, 
and subsequently does not meet one of the conditions set forth in Sec.  
93.436 (e.g., animals that die before reaching the slaughtering 
establishment; animals that are moved from a feedlot in this country to 
slaughter after they are 30 months of age), the regulations would 
provide that the animal must be disposed of in a manner approved by the 
Administrator.

Bovines Less Than 30 Months of Age for Immediate Slaughter

    Section 93.436, paragraph (a), would allow the importation of 
bovines for immediate slaughter under the following conditions:
    [sbull] The bovines are less than 30 months of age and are moved 
directly as a group from the port of entry to a recognized slaughtering 
establishment (the definition of recognized slaughtering establishment 
is set forth in Sec.  93.400) for immediate slaughter as a group. 
(Under the definition of immediate slaughter in Sec.  93.400, the 
bovines must be slaughtered within 2 weeks of the date of entry. In 
Sec.  93.400, we would add a definition of as a group to mean 
collectively, in such a manner that the identity of the animals as a 
unique group is maintained.)
    [sbull] The bovines are not known to have been fed ruminant 
protein, other than milk protein, during their lifetime.
    [sbull] The bovines are accompanied by a certificate issued by a 
full-time salaried veterinary officer of the national government of the 
region of origin, or issued by a veterinarian designated or accredited 
by the national government of the region of origin and endorsed by a 
full-time salaried veterinary officer of the national government of the 
region of origin, representing that the veterinarian issuing the 
certificate was authorized to do so, that certifies the above 
conditions have been met.
    [sbull] The bovines are moved as a group from the port of entry to 
the slaughtering establishment in conveyances sealed at the port of 
entry with seals of the United States Government, which are broken only 
at the slaughtering establishment by a USDA representative, and the 
shipment is accompanied by an APHIS Veterinary Services (VS) Form 17-
33, Animals Imported for Immediate Slaughter.
    [sbull] At the slaughtering establishment, the bovines are 
slaughtered as a group and each animal's intestines are removed.
    [sbull] The intestines removed from the bovines are disposed of in 
a manner approved by the Administrator.
    We believe the conditions described above, combined with the fact 
the exporting region is one of minimal risk for BSE, make it very 
unlikely that meat derived from bovines meeting those conditions would 
contain the BSE agent. The requirement that the bovines imported from a 
BSE minimal-risk region be less than 30 months of age would make it 
unlikely they would have infectious levels of the prion protein. The 
requirements that the bovines be moved to slaughter in a sealed 
conveyance and be slaughtered as a group are designed to ensure that 
the animals are not diverted while being moved to slaughter and that 
the intestines are removed at slaughter from all bovines imported from 
the minimal-risk region. If any bovines not from the minimal-risk 
region are commingled with the group of bovines from the minimal-risk 
region at the slaughtering establishment, then those added animals 
would be treated as if they were from the minimal-risk region and their 
intestines would have to be removed and disposed of in accordance with 
our proposed provisions. The requirement that the bovines be 
slaughtered at a recognized slaughtering establishment (as defined in 
Sec.  93.400) would ensure the animals are slaughtered at a facility 
approved by APHIS where slaughtering operations are regularly carried 
on under Federal or State inspection. The requirement that the 
intestines be removed from the animal at slaughter and be disposed of 
in a manner approved by the Administrator would minimize the 
possibility that such materials will be fed to ruminants. We believe it 
is necessary to provide the Administrator discretion in the specific 
means of disposal used, to allow for the use of different but equally 
effective methods of disposal.

Bovines Less Than 30 Months of Age Moved to a Designated Feedlot and 
Then to Slaughter

    We would apply the slaughtering conditions described above to 
bovines imported for slaughter in the United States after first being 
contained at a designated feedlot in this country. However, instead of 
being moved directly from the port of entry to a recognized 
slaughtering establishment, such animals would first be moved directly, 
as a group, to a designated feedlot for feeding, and then directly to a 
recognized slaughtering establishment. In Sec.  93.400, we would define 
designated feedlot to mean a feedlot indicated on the declaration 
required under Sec.  93.407 as the destination of the ruminants 
imported into the United States. Under current Sec.  93.407, the 
importer of ruminants (or the importer's agent) must present a 
declaration at the port of entry that provides information about the 
ruminants, their origin, and their destination. For identification 
purposes, prior to being imported into the United States, each bovine 
would have to have been tattooed inside one ear with letters 
identifying the exporting country. Bovines from Canada would have to be 
tattooed with the letters ``CAN.''
    Therefore, Sec.  93.436(b) would allow the importation of bovines 
for feeding under the following conditions:
    [sbull] The bovines are not known to have been fed ruminant 
protein, other than milk protein, during their lifetime and are less 
than 30 months of age when imported into the United States.
    [sbull] The inside of one ear on each animal is permanently and 
legibly tattooed with letters identifying the exporting country.
    [sbull] The bovines are accompanied by authorized official 
certification, as described above, that the above conditions have been 
met.
    [sbull] The bovines are moved directly from the port of entry as a 
group to the designated feedlot and the shipment is accompanied by an 
APHIS Form VS 1-27, Permit for Movement of Restricted Animals.
    [sbull] The bovines are moved directly from the designated feedlot 
to a recognized slaughtering establishment for slaughter, where each 
animal's intestines are removed. The shipment is accompanied by APHIS 
Form VS 1-27.
    [sbull] The intestines removed from the bovines are disposed of in 
a manner approved by the Administrator.
    [sbull] The bovines are less than 30 months of age when 
slaughtered.
    Unlike the requirement for bovines moved directly to immediate 
slaughter, we would not require that the animals

[[Page 62393]]

be moved from the port of entry to the designated feedlot in sealed 
conveyances. The only region we are proposing at this time to classify 
as BSE minimal-risk is the country of Canada. Under the current APHIS 
regulations and policy, bovines imported from Canada for movement 
directly to immediate slaughter do not have to be accompanied by the 
health certificate required under Sec.  93.405 that attests to the 
animal's health history with regard to various diseases and pests. 
However, the bovines must be moved to slaughter in a sealed conveyance. 
(Please note: The regulations in part 93 use the term ``cattle'' rather 
than ``bovines.'' However, in Sec.  93.400, cattle is defined as 
animals of the bovine species.) Because of the requirement for direct 
movement to slaughter in a sealed conveyance, there is little danger 
the bovines will be diverted on their way to the slaughtering 
establishment. Those requirements would remain unchanged by this 
proposed rule, although animals for immediate slaughter would have to 
be accompanied with the certification with regard to BSE specified in 
this proposal.
    Under the current regulations, however, bovines imported from 
Canada for other than immediate slaughter do have to be accompanied by 
a certificate attesting to their health history with regard to various 
diseases, in order to ensure they do not spread such diseases to other 
livestock in this country. Because of their acceptable health history, 
it has not been necessary to require that the animals be moved in a 
sealed conveyance. This requirement for a health certificate would 
remain in place for bovines imported from Canada for feeding before 
slaughter (and be joined with the certification with regard to BSE 
specified in this proposal). Because of this health certification, and 
because, with regard to BSE, the bovines would have to be tattooed with 
the letters CAN, possible diversion is not an issue and we do not 
consider it necessary to begin to require that feeder bovines be moved 
from the U.S. port of entry to the designated feedlot in a sealed 
conveyance.
    Additionally, we are not requiring that the bovines be moved from 
the designated feedlot to slaughter as a group. A shipment of bovines 
that arrives at a feedlot may contain animals of varying ages. Some 
will be ready for shipment to slaughter before others. However, we 
would require that all animals moved from the designated feedlot be 
moved directly to slaughter, where they would be identifiable as a 
shipment from a minimal-risk region by the required ear tattoo.

Sheep or Goats Less Than 12 Months of Age for Immediate Slaughter

    Section 93.436, paragraph (c), would allow the importation of sheep 
or goats under the following conditions:
    [sbull] The sheep or goats are less than 12 months of age at the 
time of importation.
    [sbull] The sheep or goats are not known to have been fed ruminant 
protein, other than milk protein, during their lifetime.
    [sbull] The sheep or goats are accompanied by authorized official 
certification, as described above, that the above conditions have been 
met.
    [sbull] The sheep or goats are moved directly from the port of 
entry as a group to a recognized slaughtering establishment in 
conveyances sealed at the port of entry with seals of the United States 
Government, which are broken only at the slaughtering establishment by 
a USDA representative, and must be slaughtered as a group. The shipment 
is accompanied by an APHIS Form VS 17-33.
    Although there is no naturally occurring BSE infection of sheep and 
goats, the species can be infected with the BSE agent experimentally. 
However, in view of the relatively young age of the sheep and goats 
that would be allowed importation (we would allow importation of sheep 
and goats only of 12 months of age or less, the industry standard for 
commercial shipments of such animals), the likelihood that these sheep 
or goats could provide a source of infection is extremely low.

Sheep or Goats Less Than 12 Months of Age Moved to a Designated Feedlot 
and Then To Slaughter

    We would apply the slaughtering conditions described above to sheep 
or goats imported for slaughter in the United States after first being 
contained at a designated feedlot in this country. However, instead of 
being moved directly from the port of entry to a recognized 
slaughtering establishment, such animals would be moved to a designated 
feedlot, and then directly to a recognized slaughtering establishment. 
For identification purposes, prior to being imported into the United 
States, each sheep and goat would have to have been tattooed inside one 
ear with letters identifying the exporting country. Sheep and goats 
from Canada would have to be tattooed with the letters ``CAN.''
    Therefore, Sec.  93.436(d) would allow the importation of sheep and 
goats under the following conditions:
    [sbull] The sheep and goats are not known to have been fed ruminant 
protein, other than milk protein, during their lifetime and are less 
than 12 months of age at the time of importation into the United 
States.
    [sbull] The inside of one ear on each animal is permanently and 
legibly tattooed with letters identifying the exporting country.
    [sbull] The sheep or goats are accompanied by authorized official 
certification, as described above, that the above conditions have been 
met.
    [sbull] The sheep or goats are moved directly from the port of 
entry as a group to a designated feedlot and the shipment is 
accompanied by an APHIS Form VS 1-27.
    [sbull] The sheep or goats are moved directly from the designated 
feedlot to a recognized slaughtering establishment for slaughter. The 
shipment is accompanied by APHIS Form VS 1-27.
    [sbull] The sheep and goats are less than 12 months of age when 
slaughtered.

Cervids for Immediate Slaughter

    Section 93.436, paragraph (e), would allow the importation of 
cervids under the following conditions:
    [sbull] The cervids were members of a herd in which surveillance 
for transmissible spongiform encephalopathies (TSE's) was conducted by 
appropriate authorities according to national standards or standards of 
the region itself if the region is a jurisdiction that has effective 
oversight of normal animal movements into, out of, or within the region 
and that, in association with national authorities if necessary, has 
the responsibility for controlling animal disease locally.
    [sbull] The herd is not known to have been infected with or exposed 
to a TSE.
    [sbull] The cervids were born after the implementation of a ban on 
feeding of ruminant protein to ruminants.
    [sbull] The cervids were not known to have been fed ruminant 
protein, other than milk protein, during their lifetime.
    [sbull] The cervids are accompanied by authorized official 
certification, as described above, that the above conditions have been 
met.
    [sbull] The cervids are moved from the port of entry as a group 
directly to a recognized slaughtering establishment in conveyances 
sealed at the port of entry with seals of the United States Government, 
which are broken only at the slaughtering establishment by a USDA 
representative. The cervids must be slaughtered as a group. The 
shipment is accompanied by an APHIS Form VS 17-33.
    As ruminants, cervids are subject to import restrictions because of 
BSE. We believe that the above conditions are necessary for the 
importation of cervids intended for immediate slaughter, because, 
although there have been no

[[Page 62394]]

confirmed cases of BSE in cervids, it is possible that they are 
susceptible to BSE. To date, there have been no challenge studies for 
BSE in cervids (i.e., studies in which cervids are intentionally 
exposed to the BSE agent) to indicate the level of susceptibility of 
cervids to BSE. Given the stringent controls described above, however, 
and the fact that there have been no confirmed cases of BSE in cervids, 
we believe the likelihood BSE would be introduced into the United 
States through cervid importations is extremely low, and we do not 
believe that mitigation measures other than those listed above are 
necessary.
    One of the requirements listed above is that the cervids have been 
members of a herd in which surveillance for TSE's was conducted by 
appropriate authorities according to national or regional standards. At 
present, the TSE program for cervids in Canada, the one region we are 
proposing to classify as BSE-minimal risk at this time, is one that 
monitors for chronic wasting disease (CWD). However, all sampling done 
to monitor for CWD would identify animals that might be affected with 
other TSE's such as BSE.

Ruminant Products From Minimal-Risk Regions

    We are proposing to add a new Sec.  94.19 to list those ruminant 
products that would be allowed importation from a BSE minimal-risk 
region and to set forth the conditions for such importation.
    In evaluating the risk that ruminant products imported into the 
United States might present, the same factors affecting the BSE risk of 
the live animals from which the products are derived are applicable. 
Additionally, other factors must be considered due to the processing 
the products undergo. Slaughter methods and the removal of risk 
material from source animals in the exporting region affect the level 
of risk associated with meat and meat products from those animals, as 
do intended use and the demonstrated likelihood of the animal product 
in question to contain the BSE agent.
    Similar to the slaughter requirements for ruminants imported live 
into the United States for immediate slaughter, it would be necessary 
to require that most ruminant products intended for importation into 
the United States from a BSE minimal-risk region come from animals from 
which intestines were removed during processing. In some cases, 
however, because of other mitigating factors, such as if no natural 
infection has been observed in the type of animal, we do not believe it 
would be necessary to require that the intestines have been removed 
from the animal from which the product is derived.
    We believe that the importation of the categories of meat and other 
edible products from ruminants from BSE minimal-risk regions discussed 
below would be unlikely to contain the BSE agent provided the following 
conditions are met, as certified to on an original certificate issued 
by a full-time salaried veterinary officer of the national government 
of the region of origin, or issued by a veterinarian designated or 
accredited by the national government of the region of origin and 
endorsed by a full-time salaried veterinary officer of the national 
government of the region of origin, representing that the veterinarian 
issuing the certificate was authorized to do so.
    As one of the conditions for bringing the commodity into the United 
States, we are proposing that the meat and edible products, if arriving 
at a land border port, arrive only at one of the ports we would list in 
new Sec.  94.19(k). At this time, the only region that would be listed 
in Sec.  94.18(a)(3) as a BSE minimal-risk region would be the country 
of Canada. Because the type of shipments that would require inspection 
under this proposed rule have not been subject to inspection in recent 
years when arriving at land border ports from Canada, we believe it is 
advisable to limit their arrival by land from Canada to those U.S. 
ports staffed with personnel fully trained in the inspection of such 
shipments.
    We would list the following as designated land border ports in 
Sec.  94.19(k): Eastport, ID; Houlton, ME; Detroit (Ambassador Bridge), 
Port Huron, and Sault St. Marie, MI; International Falls, MN; 
Sweetgrass, MT; Alexandria Bay, Buffalo (Lewiston Bridge and Peace 
Bridge), and Champlain, NY; Pembina and Portal, ND; Derby Line and 
Highgate Springs, VT; and Blaine (Pacific Highway and Cargo Ops), 
Lynden, Oroville, and Sumas (Cargo), WA. If, in the future, we add 
other countries to the list of BSE minimal-risk regions in Sec.  
94.18(a)(3), we would adjust the list of designated ports accordingly.

Fresh (Chilled or Frozen) Meat From Bovines Less Than 30 Months of Age

    Section 94.19, paragraph (a), would allow the importation of meat 
under the following conditions:
    [sbull] The meat is fresh (chilled or frozen) meat from bovines 
less than 30 months old at the time of slaughter that are not known to 
have been fed ruminant protein, other than milk protein, during their 
lifetime.
    [sbull] The bovines from which the meat is derived were slaughtered 
in a slaughtering establishment that slaughters only bovines less than 
30 months of age or complies with a segregation process approved by the 
national veterinary authority of the region of origin and the 
Administrator as adequate to prevent contamination or commingling of 
the meat with products not eligible for importation into the United 
States.
    [sbull] The intestines of the bovines were removed at slaughter.
    [sbull] The product qualifies as meat according to the definition 
of meat set forth in USDA's Food Safety and Inspection Service's (FSIS) 
regulations at 9 CFR 301.2.
    [sbull] The shipment is accompanied by authorized official 
certification, as described above, that the above conditions have been 
met.
    We would require that the commodity meet the definition of ``meat'' 
according to the FSIS regulations to ensure that, if imported as ground 
meat, it has not been combined with meat that might contain high-risk 
tissues from high-risk animals. Under the FSIS definition in 9 CFR 
301.2, to be considered ``meat,'' product that undergoes mechanical 
separation and meat recovery from the bones of livestock must be 
processed in such a way that the processing does not crush, grind, or 
pulverize bones, so that bones emerge comparable to those resulting 
from hand-deboning and the meat itself meets the criteria of no more 
than 0.15 percent or 150 mg/100 gm of product for calcium (as a measure 
of bone solids content) within a tolerance of 0.03 percent or 30 mg. We 
are proposing to use this standard for the eligibility of meat from 
bovines (and, as indicated later, for meat from sheep and goats) to 
ensure that the product contains no mechanically separated meat that 
might contain high risk-tissues. (Please note: Except where the FSIS 
definition of meat is specifically referenced in proposed Sec.  
94.19(a)(3) with regard to meat from bovines, and in proposed Sec.  
94.19(e)(2) with regard to meat from sheep or goats or other ovines or 
caprines, the standard dictionary definition of meat is intended 
throughout this proposed rule.)
    To avoid commingling or contamination of meat from bovines under 30 
months of age with materials from older bovines, we would require that 
the slaughtering facility in the region of origin either slaughter only 
bovines less than 30 months of age or comply with an approved 
segregation process. Such segregation during

[[Page 62395]]

slaughtering could be accomplished, for instance, by slaughtering 
bovines over 30 months of age only at the end of the day on lines and 
with equipment dedicated exclusively to slaughtering such older 
animals.

Fresh (Chilled or Frozen) Whole or Half Carcasses of Bovines Less Than 
30 Months of Age

    Section 94.19, paragraph (b), would allow the importation of bovine 
carcasses under the following conditions:
    [sbull] The products are fresh (chilled or frozen) whole or half 
carcasses derived from bovines that were less than 30 months of age 
when slaughtered and that are not known to have been fed ruminant 
protein, other than milk protein, during their lifetime.
    [sbull] The bovines from which the carcasses are derived were 
slaughtered in a slaughtering establishment that slaughters only 
bovines less than 30 months of age or complies with a segregation 
process approved by the national veterinary authority of the region of 
origin and the Administrator as adequate to prevent contamination or 
commingling with products not eligible for importation into the United 
States.
    [sbull] The intestines of the bovines were removed at slaughter.
    [sbull] The shipment is accompanied by authorized official 
certification that the above conditions have been met.

Fresh (Chilled or Frozen) Bovine Liver

    Section 94.19, paragraph (c), would allow the importation of fresh 
(chilled or frozen) bovine liver, provided the product is combined with 
no other product, is derived from bovines for which no air-injected 
stunning process was used at slaughter, and is accompanied by 
authorized official certification that the above conditions have been 
met. In and of itself, the liver is unlikely to contain infectious 
levels of the BSE agent, so we are not proposing to require that liver 
be derived from animals less than 30 months of age or not known to have 
been fed ruminant protein, other than milk protein, during their 
lifetime. However, we would prohibit the importation of liver derived 
from bovines for which an air-injected stunning process was used. The 
liver, because of its anatomical location and size of its blood 
vessels, is the organ that could potentially receive emboli or tissue 
fragments distributed in the animal due to the use of an air-injected 
stunning process. Because there would be no age limit on the bovines 
from which the liver is derived, we believe it is necessary to ensure 
that the liver be free of such potentially high-risk material.

Fresh (Chilled or Frozen) Bovine Tongues

    Section 94.19, paragraph (d), would allow the importation of fresh 
(chilled or frozen) bovine tongues that meet the following conditions:
    [sbull] The tongues are derived from bovines that were born after 
the implementation of an effective feed ban.
    [sbull] The bovines are not known to have been fed ruminant 
protein, other than milk protein, during their lifetime.
    [sbull] The tonsils of the bovines were removed at slaughter.
    [sbull] The tongues are accompanied by authorized official 
certification that the above conditions have been met.
    The tongue itself is unlikely to contain the BSE agent in animals 
of any age. However, because the tongue and the tonsils are connected, 
and the tonsils consist of tissue with demonstrated infectivity, we 
believe it is necessary to require that the tonsils have been removed 
from bovines greater than 30 months of age from which tongues for 
importation are derived. To eliminate the need to determine the exact 
age of the animals from which tongues are derived, we would require 
that the tonsils have been removed at slaughter from all bovines from 
which tongues intended for importation from a BSE minimal-risk region 
are derived.

Fresh (Chilled or Frozen) Meat of Sheep or Goats or Other Ovines or 
Caprines

    Section 94.19, paragraph (e), would allow the importation of meat 
under the following conditions:
    [sbull] The product is fresh (chilled or frozen) meat from sheep or 
goats or other ovines or caprines less than 12 months of age at the 
time of slaughter that are not known to have been fed ruminant protein, 
other than milk protein, during their lifetime.
    [sbull] The animals from which the meat is derived were slaughtered 
in a slaughtering establishment that slaughters only sheep and/or goats 
or other ovines or caprines less than 12 months of age or complies with 
a segregation process approved by the national veterinary authority of 
the region of origin and the Administrator as adequate to prevent 
contamination or commingling of the meat with products not eligible for 
importation into the United States.
    [sbull] The product qualifies as meat according to the definition 
of meat set forth in USDA's Food Safety and Inspection Service's (FSIS) 
regulations at 9 CFR 301.2.
    [sbull] The shipment is accompanied by authorized official 
certification that the above conditions have been met.

Fresh (Chilled or Frozen) Carcasses of Ovines or Caprines

    Section 94.19, paragraph (f), would allow the importation of fresh 
(chilled or frozen) carcasses of ovines and caprines under the 
following conditions:
    [sbull] The carcasses are derived from ovines or caprines that were 
less than 12 months old when slaughtered and that are not known to have 
been fed ruminant protein, other than milk protein, during their 
lifetime.
    [sbull] The ovines or caprines from which the carcasses were 
derived were slaughtered in a slaughtering establishment that 
slaughters only ovines and/or caprines less than 12 months of age or 
complies with a segregation process approved by the national veterinary 
authority of the region of origin and the Administrator as adequate to 
prevent contamination or commingling of the carcasses with products not 
eligible for importation into the United States.
    [sbull] The carcasses are accompanied by authorized official 
certification that the above conditions have been met.

Hunter-Harvested Wild Ruminant Products

    Section 94.19, paragraph (g), would allow the importation of 
hunter-harvested wild ruminant products under the following conditions:
    [sbull] The product is meat or a dressed (eviscerated and the head 
is removed) carcass of a wild sheep, goat, cervid, or other ruminant;
    [sbull] The meat or dressed carcass is intended for personal use, 
and the hunter provides proof to the U.S. Customs and Border Protection 
official that the animal was a legally harvested wild (not ranched) 
animal. Such proof will include the hunting license, tag, or 
equivalent;
    [sbull] The game and wildlife service of the jurisdiction where the 
ruminant was harvested has informed the Administrator that the 
jurisdiction either: (1) Conducts no type of game feeding program, or 
(2) has complied with, and continues to comply with, the ban on the 
feeding of ruminant protein to ruminants in the BSE minimal-risk 
region.
    Meat and meat products from wild animals not maintained on ranches 
or farms are unlikely to have ingested contaminated commercial feed and 
are unlikely to have infectious levels of the BSE agent. Also, the 
nature of hunter-harvested ruminant products to be used

[[Page 62396]]

for personal use makes it highly unlikely that the product will enter 
the commercial food chain for animals. (In Sec.  94.0, we would add a 
definition of personal use to mean only for personal consumption or 
display and not distributed further or sold.) If the game and wildlife 
service of the jurisdiction where the ruminant was harvested has not 
informed the Administrator either that the jurisdiction conducts no 
game feeding program or has complied with, and continues to comply 
with, the feed ban, we would direct U.S. inspectors at the designated 
ports of arrival not to allow such hunter-harvested ruminant products 
from the jurisdiction to be imported into the United States.

Fresh (Chilled or Frozen) Meat of Cervids Either Farm-Raised or 
Harvested on a Game Farm or Similar Facility

    Section 94.19, paragraph (h), would allow the importation of meat 
and meat products under the following conditions:
    [sbull] The product is fresh (chilled or frozen) meat derived from 
cervids that were born after an effective feed ban was implemented, 
that were not known to have been fed ruminant protein, other than milk 
protein, during their lifetime, and that were members of a herd not 
known to be infected with or exposed to a transmissible spongiform 
encephalopathy.
    [sbull] If the product is ground meat or sausage, it was derived 
either from all cervine meat or from cervine meat mixed with 
nonruminant meat.
    [sbull] The shipment is accompanied by authorized official 
certification that the above conditions have been met.
    No natural infection of BSE has been documented in cervids, and we 
believe there is a very low risk that any tissue in cervids is likely 
to contain the BSE agent. Therefore, we believe it is unnecessary to 
prohibit the importation of ground meat or sausage that is exclusively 
cervid meat or cervid meat and nonruminant meat. However, because it 
has not been proven that cervids are not susceptible to BSE, we believe 
it is necessary to require that the cervid meat and meat products be 
derived from cervids that were members of a herd not known to have been 
infected with or exposed to a transmissible spongiform encephalopathy.

Fresh (Chilled or Frozen) Meat From Wild-Harvested Caribou, Musk Ox, or 
Other Cervids

    Section 94.19, paragraph (i), would allow the importation of meat 
under the following conditions:
    [sbull] The meat is from wild caribou, musk ox, or other cervids 
harvested within a jurisdiction specified by the Administrator for 
which the game and wildlife service has informed the Administrator that 
the jurisdiction either: (1) Conducts no type of game feeding program, 
or (2) has complied with, and continues to comply with, the ban on the 
feeding of ruminant protein to ruminants in the BSE minimal-risk 
region.
    [sbull] The cervids from which the meat is derived were either 
slaughtered in a slaughtering establishment that slaughters only 
cervids eligible for entry into the United States or complies with a 
segregation process approved by the national veterinary authority of 
the region of origin and the Administrator as adequate to prevent 
contamination or commingling of the meat with products not eligible for 
importation into the United States.
    [sbull] The shipment is accompanied by authorized official 
certification that the above conditions have been met.
    This meat differs from the meat described above under the heading 
``Hunter-harvested wild ruminant products'' in that, although it is 
hunter-harvested, it is done so on a larger scale for commercial sale.

Gelatin

    Section 94.19, paragraph (j), would allow the importation of 
gelatin from bones of bovines that were less than 30 months of age when 
slaughtered and that are not known to have been fed ruminant protein, 
other than milk protein, during their lifetime, provided the shipment 
is accompanied by authorized official certification that these 
conditions have been met.

Importation of Certain Tallow and Offal

    Section 95.4 of the regulations currently restricts the importation 
of animal protein, tankage, fat, glands, tallow other than tallow 
derivatives, and serum from regions where BSE is known to exist or that 
present an undue risk of BSE. Of these products, we believe that 
certain tallow and offal could be imported from BSE minimal-risk 
regions under certain conditions with little likelihood of containing 
infectious levels of the BSE agent, and are proposing to amend Sec.  
95.4 to allow the importation of such materials. We do not have 
evidence at this time that the other products prohibited under Sec.  
95.4 could be imported with little likelihood of containing infectious 
levels of the BSE agent.
    As one of the conditions for importation, the tallow and offal, if 
arriving at a U.S. land border port, would have to arrive at one of the 
ports we would list in new Sec.  94.19(k).

Tallow

    In the case of tallow, we would require that it contain less than 
0.15 percent protein and be obtained from bovines less than 30 months 
of age when slaughtered. This product would be considered low risk 
because it is primarily lipid material with a minimal cellular 
component. When it is derived from low-risk bovines and the level of 
protein is low, the material would be unlikely to contain prion 
protein.
    Section 95.4, paragraph (f), would allow the importation of tallow 
under the following conditions:
    [sbull] The tallow is composed of less than 0.15 percent protein.
    [sbull] The tallow was derived from animals that were less than 30 
months of age when slaughtered, that were born after the region of 
origin implemented an effective ban on the feeding of ruminant protein 
to ruminants, and that were not known to have been ruminant protein, 
other than milk protein, during their lifetime.
    [sbull] The tallow is not derived from an animal that died 
otherwise than by slaughter.
    [sbull] The intestines were removed from each animal at slaughter.
    [sbull] The shipment of tallow to the United States is accompanied 
by authorized official certification that the above conditions have 
been met.

Cervine Offal

    In the case of offal, we would require that it be derived from 
cervids born after the implementation of an effective feed ban that 
were not known to have been fed ruminant protein, other than milk 
protein. Because the offal would be derived from low-risk animals, we 
would consider the product to be unlikely to contain the BSE agent. We 
would limit the importation of offal to cervine offal, because bovine 
offal could contain the distal ileum, which is a tissue with confirmed 
infectivity in BSE-infected bovines.
    Section 95.4, paragraph (g), would allow the importation of offal 
from cervids under the following conditions:
    [sbull] The offal was derived from cervids that were born after the 
feed ban, that were not known to have been fed ruminant protein, other 
than milk protein, during their lifetime, and that were members of a 
herd not known to be infected with or exposed to a transmissible 
spongiform encephalopathy.
    [sbull] The shipment of offal to the United States is accompanied 
by authorized

[[Page 62397]]

official certification that the above conditions have been met.
    Additionally, because offal can encompass a variety of materials, 
for clarification we would add a definition of offal to Sec.  95.1 to 
mean the parts of a butchered animal that are removed in dressing, 
consisting largely of the viscera and the trimmings, which may include, 
but are not limited to, brains, thymus, pancreas, liver, heart, and 
kidney.

APHIS Inspection of Processing and Handling Facilities; Certification 
of Compliance

    Although Sec.  95.4 restricts the importation of animal protein, 
tankage, fat, glands, tallow other than tallow derivatives, and serum 
from regions where BSE is known to exist or that present an undue risk 
of BSE (as listed in current Sec.  94.18(a)), paragraph (c) of Sec.  
95.4 exempts certain materials from the restrictions, under certain 
conditions, provided the material is derived from a nonruminant 
species, or from a ruminant species if the ruminants have never been in 
a region listed in Sec.  94.18(a). One of the conditions for such 
importation is that all steps of processing and storing the material be 
carried out in a facility that has not been used for the processing or 
storage of any materials derived from ruminants that have been in any 
region listed in Sec.  94.18(a). A further requirement is that, if the 
facility processes or handles any material derived from mammals, the 
facility must have entered into a cooperative service agreement with 
APHIS to pay for the costs of an APHIS veterinarian to make annual 
inspections of the facility.
    Because we believe the regions we are proposing to include in Sec.  
94.18(a)(3) of this proposal present a minimal risk for BSE, we believe 
that, in lieu of annual APHIS inspections of the facility, such 
inspections could be carried out by the government agency responsible 
for animal health in the region, although APHIS would reserve the right 
to inspect as deemed necessary. Therefore, we are proposing to amend 
Sec.  95.4(c)(4) to exclude facilities in BSE minimal-risk regions from 
the requirement for a cooperative service agreement and to require that 
annual inspections of the facility be carried out by a representative 
of the government agency responsible for animal health in the region. 
We would, however, still apply to BSE minimal-risk regions the 
provisions of Sec.  95.4(c)(5), which require the facility to allow 
periodic inspections by APHIS.
    Additionally, we are proposing to amend Sec.  95.4(c)(6), which 
currently specifies that each shipment imported into the United States 
in accordance with Sec.  95.4(c) be accompanied by an original 
certificate signed by a full-time, salaried veterinarian of the 
government agency responsible for animal health in the region of export 
certifying that the conditions of that section have been met. Because 
of the reduced risk of such exports from regions we would consider 
minimal risk, we are proposing to provide in Sec.  95.4(c)(6) that, for 
shipments of animal feed, the necessary certification may be signed by 
a person authorized to issue such certificates by the veterinary 
services of the national government of the region of origin.

Definitions

    In addition to adding definitions of as a group, designated 
feedlot, bovine spongiform encephalopathy (BSE) minimal-risk region, 
offal, and personal use to the regulations, as discussed above, we are 
proposing to define in Sec.  93.400 the term USDA representative to 
mean a veterinarian or other individual employed by the United States 
Department of Agriculture who is authorized to perform the services 
required by part 93.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been reviewed under Executive Order 12866. 
The rule has been determined to be 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 to prevent the introduction into the United States or 
dissemination of any pest or disease of livestock.
    On May 20, 2003, the Canadian Food Inspection Agency reported a 
case of BSE in a beef cow in northern Alberta. To prevent the 
introduction of this disease into the United States, APHIS issued an 
interim rule to classify Canada as a region where BSE exists, thereby 
prohibiting the importation of ruminants and most ruminant products 
from Canada, effective May 20, 2003.
    This proposed rule would amend the regulations by establishing a 
category of regions that present a minimal risk of introducing BSE into 
the United States. The rule would set forth factors considered for 
placing a region in this category, and risk mitigations that would be 
required for the importation of certain ruminants and ruminant products 
from such regions. Although the proposed rule would list Canada as the 
only BSE minimal-risk region at this time, APHIS would evaluate 
requests and supporting information submitted by other regions for 
inclusion in this category.
    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. Although not 
addressed in the analysis, Canadian producers/suppliers of ruminants 
and ruminant products would benefit from the resumption of exports to 
the United States.
    Below is a summary of our economic analysis. A copy of the full 
economic analysis is available for review in our reading room (see the 
ADDRESSES section at the beginning of this document). You may also view 
the economic analysis on the Internet by accessing the APHIS Web site 
at http://www.aphis.usda.gov. At the APHIS Web site, click on the ``Hot 
Issues'' button. On the next screen, click on the listing for ``Bovine 
Spongiform Encephalopathy (BSE).'' On the next screen, click on the 
listing for ``Economic Analysis, Proposed Rule, Bovine Spongiform 
Encephalopathy: Minimal Risk Regions and Importation of Commodities 
(APHIS Docket No. 03-080-1).'' We do not have enough data for a 
comprehensive analysis of the potential economic effect 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 kind 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.
    Because Canada is the only region we are proposing to include in 
the BSE minimal-risk category at this time, ruminant and ruminant 
product imports from Canada that would be reestablished under the 
proposed rule are the focus of our analysis. However, this minimal-risk 
category is not limited to Canada and could include other regions in 
the future. The analysis also considers effects of the rule for U.S. 
ruminant and ruminant product exports should other countries not 
consider our minimal-risk requirements sufficient to safeguard against 
BSE introduction into the United States and/or do not accept our 
listing of Canada as a region of minimal risk.

[[Page 62398]]

    The commodities that would be allowed to enter under the proposed 
rule are:
    [sbull] Cattle less than 30 months of age, sheep and goats less 
than 12 months of age, and cervids of any age, imported in all cases 
for immediate slaughter;
    [sbull] Cattle less than 30 months of age and sheep and goats less 
than 12 months of age imported for feeding at a designated feedlot (for 
slaughter at less than 30 months and 12 months of age, respectively);
    [sbull] Meat from cattle, sheep, and goats that have been 
slaughtered within these age restrictions;
    [sbull] Meat of cervids either farm-raised or harvested on a game 
farm or similar facility;
    [sbull] Meat from wild-harvested caribou, musk ox, or other cervids 
that has been commercially processed;
    [sbull] Certain hunter-harvested wild ruminant products for 
personal use; and
    [sbull] Certain other products and byproducts, including bovine 
livers and tongues, gelatin, tallow, and cervid offal.
    With respect to Canada, slaughter cattle, feeder cattle, and beef 
would be the main commodities affected by resumption of ruminant and 
ruminant product imports. The additional supplies would cause prices to 
fall. Welfare gains for consumers and losses for producers/suppliers 
are measured, and net benefits and losses estimated. Since May of this 
year, U.S. producers/suppliers of ruminants and ruminant products have 
benefited from high price levels at least partly attributable to the 
ban on imports from Canada. Estimated price declines for producers/
suppliers and consumers/buyers of slaughter cattle, feeder cattle, and 
beef largely reflect a return to the more normal market conditions that 
prevailed before Canada's BSE discovery.
    Expected effects due to reestablished slaughter cattle and feeder 
cattle imports from Canada are shown in table 1. (The model and 
parameters used are explained in the body of the economic analysis.) 
The estimated effects are near-term, and would occur during the first 
year or so following the resumption of imports. In the longer term, 
production and marketing adjustments in response to changed market 
conditions would create new price-quantity equilibriums.

 Table 1.--Economic Effects of Reestablished Slaughter Cattle and Feeder
                       Cattle Imports From Canada
------------------------------------------------------------------------
                                     Slaughter cattle    Feeder cattle
------------------------------------------------------------------------
Assumed reestablished slaughter              840,800            504,500
 and feeder cattle imports from
 Canada (head)....................
Change in numbers slaughtered and            366,350            221,318
 fed (head).......................
Change in numbers supplied by U.S.          (474,450)          (283,182)
 entities (head)..................
Change in the prices of slaughter             ($1.30)            ($0.72)
 and feeder cattle (dollars per
 100 pounds)......................
Change in consumer surplus........      $455,317,000       $188,220,000
Change in producer surplus........     ($448,744,000)     ($182,053,000)
Annual net benefit................        $6,573,000         $6,167,000
------------------------------------------------------------------------

    Reestablished slaughter cattle imports from Canada of 840,000 head 
would result in a price decline of $1.30 per 100 pounds. This price 
decline would be accompanied by an increase of about 366,350 head in 
the number of cattle slaughtered, and a decrease of 474,450 head in the 
number of slaughter cattle supplied by U.S. entities. These changes 
translate into an increase in consumer surplus of $455.3 million for 
buyers of slaughter cattle, and a decrease in producer surplus of 
$448.7 million for sellers of slaughter cattle, for an annual net 
benefit of $6.6 million.
    Whether a portion of this benefit would be realized by beef 
consumers would depend upon wholesale and retail margins and 
elasticities of demand. The price decline would reduce incomes of 
domestic suppliers who would be competing with slaughter cattle imports 
from Canada. The estimated price change is small, falling within 
expected variations of recent USDA price projections. A price decrease 
of $1.30 per 100 pounds would represent a decline of 1.7 percent and 
would not significantly affect buyers or sellers of slaughter cattle.
    Reestablished feeder cattle imports from Canada totaling 504,500 
head would result in a price decline of 72 cents per 100 pounds. This 
fall in price would be accompanied by an increase of 221,318 head in 
the number of cattle fed, and a decrease of 283,182 head in the number 
of cattle supplied to feedlots by U.S. entities. Consumer surplus would 
rise by $188.2 million for buyers of feeder cattle, and producer 
surplus would fall by $182 million for sellers of feeder cattle, for an 
annual net benefit of about $6.2 million.
    A price decline resulting from reestablished feeder cattle imports 
from Canada would benefit the receiving feedlots. The decline would 
also reduce incomes for domestic suppliers, such as stocker operations, 
in competition with importers of feeder cattle from Canada. The 
estimated effects are small. A price decrease of 72 cents per 100 
pounds would represent a decline of 0.9 percent and would not result in 
significant gains or losses for the affected entities.
    Beef is modeled as a single aggregate commodity, but two analyses 
are performed. Boneless beef and certain other ruminant products are 
allowed to enter the United States from Canada under permit. We do not 
know whether quantities of boneless beef that enter under permit will 
reach levels that prevailed prior to the ban. This uncertainty is 
acknowledged by using two different import levels. The first analysis 
assumes that boneless beef imports from Canada under permit will reach 
2002 levels; the effect of the proposed rule with respect to beef would 
be in reestablishing beef with bone and whole/half carcass imports. The 
second analysis assumes that no boneless beef is imported under permit, 
and all reestablished beef imports from Canada would be attributable to 
the proposed rule. The two analyses are hypothetical extremes that 
provide a lower bound and an upper bound of possible effects. Effects 
for two price levels of beef, $3.00 and $3.50 per pound, are estimated, 
as shown in table 2.

[[Page 62399]]



Table 2.--Economic Effects of Reestablished Beef Imports From Canada, for Hypothetical Lower and Upper Bounds of
                                      Possible Effects of the Proposed Rule
----------------------------------------------------------------------------------------------------------------
                                    Only reestablished beef with bone      All reestablished beef imports from
                                   and whole/half carcass imports from     Canada assumed attributable to the
                                   Canada assumed attributable to the                 proposed rule
                                              proposed rule            -----------------------------------------
                                 --------------------------------------
                                   $3.00 per pound    $3.50 per pound     $3.00 per pound      $3.50 per pound
                                         beef               beef                beef                 beef
----------------------------------------------------------------------------------------------------------------
Assumed beef imports from Canada            84,000             84,000              382,000              382,000
 (tons).........................
Change in U.S. consumption                  40,324             40,324              183,378              183,378
 (tons).........................
Change in U.S. production (tons)           (43,676)           (43,676)            (198,622)            (198,622)
Change in the price of beef (per        (1.1 cents)        (1.3 cents)          (5.2 cents)          (6.1 cents)
 pound).........................
Change in consumer surplus......      $313,260,000       $365,455,000       $1,416,390,000       $1,652,383,000
Change in producer surplus......     ($289,425,000)     ($337,648,000)     ($1,325,068,000)     ($1,545,845,000)
Annual net benefit..............       $23,835,000        $27,807,000          $91,322,000         $106,538,000
----------------------------------------------------------------------------------------------------------------

    For beef prices of $3.00 and $3.50 per pound, respectively, annual 
net benefits of established beef imports would be $23.8 million and 
$27.8 million (only beef with bone and whole/half carcass imports 
assumed to be reestablished due to the proposed rule), and $91.3 
million and $106.5 million (all beef imports assumed to be 
reestablished due to the proposed rule). As with reestablished imports 
of slaughter and feeder cattle, expected price declines due to 
reestablished beef imports from Canada would not be of a magnitude to 
significantly affect the economic welfare of producers or consumers. In 
the first case, price declines of 1.1 cents and 1.3 cents per pound are 
estimated for assumed beef prices of $3.00 and $3.50 per pound, 
respectively. In the second case, price declines of 5.2 cents and 6.1 
cents per pound are estimated. Even in the latter analysis (all 
reestablished beef imports from Canada attributable to the proposed 
rule), the price declines represent less than a 2 percent fall in 
price.
    Other, more minor commodities that would be allowed entry under the 
proposed rule and for which we have trade data are sheep, goats, and 
farmed cervids; meat from these ruminants; and bovine tongues and 
livers. In all cases, reestablished imports from Canada would not 
significantly affect the U.S. supply of these commodities or the 
welfare of U.S. entities.
    The United States prohibits ruminant imports from BSE-affected 
regions. Under the proposed rule, the United States would recognize 
Canada as a minimal-risk region for BSE, under which ruminant imports 
could resume. U.S. ruminant and ruminant product exports would be 
placed in jeopardy if importing countries do not agree that the factors 
the United States would consider justify the categorization of a region 
as one of minimal risk, and do not agree that the proposed age 
restrictions and other measures provide an adequate safeguard against 
the risk of BSE introduction from such a region.
    We therefore analyze the economic effects that would occur if the 
United States would lose major export markets due to this proposed rule 
and its inclusion of Canada as a minimal-risk region.
    Because U.S. ruminant and ruminant product exports to Canada and 
Mexico would not be jeopardized by this proposed rule, exports to these 
two countries are excluded from the analysis. Since nearly all U.S. 
cattle exports are to Canada and Mexico, we can also limit the analysis 
to possible effects for beef exports.
    Canada and Mexico together imported about 36 percent of U.S. beef 
exports in 2002. Removing these exports from consideration leaves about 
64 percent of U.S. beef exports that could be affected by the proposed 
rule. About 56 percent of U.S. beef exports (over 87 percent, excluding 
shipments to Canada and Mexico) were sold to Japan and Korea. Given the 
predominance of these two countries among importers of U.S. beef, the 
analysis is performed for two levels of export reduction: 32 percent of 
2002 exports, or 263,360 tons (loss of one-half of export markets other 
than Canada and Mexico), and 64 percent, or 546,720 tons (loss of all 
export markets other than Canada and Mexico). For each of these assumed 
levels of export reduction, impacts are estimated using the same beef 
prices, $3.00 and $3.50 per pound. The results of the analysis are 
shown in table 3.

               Table 3.--Economic Effects of the Loss of U.S. Beef Export Markets, Assuming Export Reductions of 32 Percent and 64 Percent
                      [Quantities equivalent to one-half and all U.S. beef exports when exports to Canada and Mexico are excluded]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Loss of export markets equivalent to      Loss of export markets equivalent to 64
                                                                       32 percent of 2002 beef exports              percent of 2002 beef exports
                                                                  --------------------------------------------------------------------------------------
                                                                    $3.00 per pound     $3.50 per pound      $3.00 per pound
                                                                          beef                beef                 beef           $3.50 per pound  beef
--------------------------------------------------------------------------------------------------------------------------------------------------------
Assumed reduction in beef exports (tons).........................           263,360              263,360              546,720                   546,720
Change in U.S. consumption (tons)................................           116,483              116,483              232,967                   232,967
Change in U.S. production (tons).................................          (146,877)            (146,877)            (293,753)                 (293,753)
Change in the price of beef (cents per pound)....................        (3.6 cents)          (4.2 cents)          (7.2 cents)               (8.4 cents)
Change in consumer surplus.......................................      $910,983,000       $1,062,767,000       $1,831,174,000            $2,136,278,000
Change in producer surplus.......................................     ($965,636,000)     ($1,126,526,000)     ($1,919,660,000)          ($2,239,507,000)
Annual net benefit...............................................      ($54,653,000)        ($63,759,000)        ($88,486,000)            ($103,229,000)
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 62400]]

    Loss of one-half of U.S. beef export markets other than Canada and 
Mexico and redirection of the beef to the U.S. market would result in 
annual net welfare losses of about $54.7 million and $63.8 million, for 
beef prices of $3.00 and $3.50 per pound, respectively. The associated 
declines in price would be 3.6 cents and 4.2 cents per pound. The 
effects if all U.S. beef export markets other than Canada and Mexico 
were to close would be annual net welfare losses of about $88.5 million 
and $103.2 million for the two beef price levels, with decreases in 
price of 7.2 cents and 8.4 cents per pound. As explained, these effects 
would occur only if the proposed rule is adopted as final and the 
countries to which the United States exports beef decided to refuse its 
entry as a result.
    The main industries that would be affected by the proposed rule, 
such as livestock producers, slaughtering establishments, and meat 
processors, are composed predominantly of small entities. As indicated 
above, since May of this year, U.S. producers/suppliers of ruminants 
and ruminant products have benefited from high price levels at least 
partly attributable to the ban on imports from Canada. By the same 
token, buyers of slaughter cattle, feeder cattle, and beef would 
benefit from price declines (slaughter cattle, 1.7 percent; feeder 
cattle, 0.9 percent; and beef, less than 2 percent) resulting from the 
reestablishment of these imports.
    Effects from the possible loss of U.S. export markets and 
subsequent industry contractions, if this proposed rule is adopted as 
final and other countries were to refuse entry of our beef as a result, 
would harm small as well as large entities. This outcome could occur, 
even though BSE has never been discovered in the United States, if, as 
described above, countries importing U.S. beef do not agree that the 
factors the United States would consider justify the categorization of 
a region as one of minimal risk, and do not agree that the proposed age 
restrictions and other measures provide an adequate safeguard against 
the risk of BSE introduction from such a region.
    Alternatives to the proposed rule would be to (1) leave the 
regulations unchanged--that is, continue to prohibit entry of ruminants 
and most ruminant products from regions of minimal BSE risk (other than 
products allowed entry under permit), or (2) allow the commodities to 
enter from such regions without the age restrictions or other measures 
set forth in the proposed rule. Because Canada is the only country we 
are proposing to list as a BSE minimal-risk region at this time, the 
alternatives are discussed in terms of Canada.
    By maintaining current import restrictions, estimated benefits of 
reestablishing slaughter cattle, feeder cattle, and beef imports from 
Canada would not be realized. Continuation of the status quo would also 
eliminate any possibility of adverse effects for U.S. exports.
    Concerning the second alternative, the proposed age requirements 
and other measures are based on the known epidemiology of BSE. Without 
these mitigations, we believe importation of ruminants and ruminant 
products (other than those allowed entry by permit) would expose the 
United States to greater risk of BSE introduction.
    A BSE discovery in the United States would have economic 
consequences similar to those that have occurred in Canada and 
elsewhere. Losses would take the form of lowered demand, closed export 
markets, animal depopulations, and increased government expenditures 
for disease management and compensation for depopulated livestock. Tens 
of thousands of jobs with total earnings in the hundreds of millions of 
dollars could be threatened by the loss of export markets due to a 
discovery of BSE.
    Because BSE has been linked to variant Creutzfield-Jakob disease, 
one of the most significant impacts of a BSE occurrence in the United 
States would be the potential loss of consumer confidence in the safety 
of the U.S. beef supply. An incidence of BSE could result in a downward 
shift in demand for beef, leading to lowered prices and production.
    APHIS acknowledges a theoretical increased risk of BSE introduction 
into the United States because of this rule. However, we conclude in 
the risk analysis used as a basis for this rule that, with the proposed 
mitigation measures, this risk is extremely small. If an introduction 
occurred, few, if any, additional animals would be infected. It is 
highly unlikely that such an introduction would pose a major animal 
health or public health threat in the United States; regulations and 
practices in the United States are robust and would militate against 
human exposure or disease spread.
    The proposed rule is considered preferable to either continuing to 
prohibit the entry of ruminants and certain ruminant products from a 
BSE minimal-risk region or allowing their entry unconditionally. We 
believe the factors considered in listing a region as one of minimal 
risk and the mitigations required for the entry of ruminants and 
ruminant products would make the likelihood of the introduction of even 
one animal or product containing infectious levels of the BSE agent 
extremely small. We also believe that listing Canada as a BSE minimal-
risk region, together with the risk-mitigation measures that would be 
required, is a balanced, science-based response to Canada's request 
that ruminants and certain ruminant product imports by the United 
States from Canada be allowed to resume.

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

    We have prepared an environmental assessment 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 this proposed rule. APHIS' 
review and analysis of the potential environmental impacts associated 
with these proposed importations are documented in an environmental 
assessment titled ``Proposed Rulemaking to Establish Criteria for the 
Importation of Designated Ruminants and Ruminant Products from Canada 
into the United States, Environmental Assessment (October 2003).'' We 
are making this environmental assessment available to the public for 
review and comment. We will consider all comments that we receive on or 
before the date listed under the heading DATES at the beginning of this 
notice.
    Copies of the environmental assessment are available for public 
inspection in our reading room (information on the location and hours 
of the reading room is provided under the heading ADDRESSES at the 
beginning of this proposed rule). In addition, copies may be obtained 
by writing to the individual listed under FOR FURTHER INFORMATION 
CONTACT. The environmental assessment may also be viewed on the 
Internet at http://www.aphis.usda.gov/ppd/es/vsdocs.html.
    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

[[Page 62401]]

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).

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. 03-080-1. 
Please send a copy of your comments to: (1) Docket No. 03-080-1, 
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 
River Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance 
Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue 
SW., Washington, DC 20250. A comment to OMB is best assured of having 
its full effect if OMB receives it within 30 days of publication of 
this proposed rule.
    This proposed rule would recognize a category of regions that 
present a minimal risk of introducing BSE into the United States via 
live ruminants and ruminant products, and would add Canada to this 
category. The proposed rule would also allow the importation of certain 
live ruminants and ruminant products from such BSE minimal-risk regions 
under certain conditions.
    Accomplishing this would require the use of several information 
collection activities, including the completion of certification 
statements for the importation of both ruminants and ruminant-derived 
products by the national veterinary authority of the region of origin, 
permits for the movement of restricted animals, forms associated with 
the importation of animals for immediate slaughter, the placing of 
seals on certain conveyances, and the tattooing of letters on certain 
livestock.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 2 hours per response.
    Respondents: Canadian veterinary authorities, herd owners, and 
exporters of ruminants and ruminant-derived products; slaughter plant 
and feedlot personnel in the United States, accredited veterinarians, 
and State veterinary authorities.
    Estimated annual number of respondents: 6,000.
    Estimated annual number of responses per respondent: 20.
    Estimated annual number of responses: 120,000.
    Estimated total annual burden on respondents: 240,000 hours. (Due 
to averaging, the total annual burden hours may not equal the product 
of the annual number of responses multiplied by the reporting burden 
per response.)
    Copies of this information collection can be obtained from Mrs. 
Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 
734-7477.

Government Paperwork Elimination Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the Government Paperwork Elimination Act (GPEA), which 
requires Government agencies in general to provide the public the 
option of submitting information or transacting business electronically 
to the maximum extent possible. For information pertinent to GPEA 
compliance related to this proposed rule, please contact Mrs. Celeste 
Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.

List of Subjects

9 CFR Part 93

    Animal diseases, Imports, Livestock, Poultry and poultry products, 
Quarantine, Reporting and recordkeeping requirements.

9 CFR Part 94

    Animal diseases, Imports, Livestock, Meat and meat products, Milk, 
Poultry and poultry products, Reporting and recordkeeping requirements.

9 CFR Part 95

    Animal feeds, Hay, Imports, Livestock, Reporting and recordkeeping 
requirements, Straw, Transportation.
    Accordingly, we propose to amend 9 CFR parts 93, 94, and 95 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.

    2. Section 93.400 would be amended by adding definitions of  as a 
group, designated feedlot, and USDA representative, in alphabetical 
order, to read as follows:


Sec.  93.400  Definitions.

* * * * *
    As a group. Collectively, in such a manner that the identity of the 
animals as a unique group is maintained.
* * * * *
    Designated feedlot. A feedlot indicated on the declaration required 
under Sec.  93.407 as the destination of the ruminants imported into 
the United States.
* * * * *
    USDA representative. A veterinarian or other individual employed by 
the United States Department of Agriculture who is authorized to 
perform the services required by this part.
* * * * *
    3. A new Sec.  93.436 would be added to subpart D to read as 
follows:


Sec.  93.436  Ruminants from regions of minimal risk for BSE.

    The importation of ruminants from regions listed in Sec.  
94.18(a)(3) of this subchapter is prohibited, unless the conditions of 
this section and any other applicable conditions of this part are met. 
Once the ruminants are imported, if they do not meet the conditions of 
this section, they must be disposed of as the Administrator may direct.
    (a) Bovines for immediate slaughter. Bovines from a region listed 
in Sec.  94.18(a)(3) of this subchapter may be imported for immediate 
slaughter under the following conditions:

[[Page 62402]]

    (1) The bovines must be less than 30 months of age when imported 
into the United States;
    (2) The bovines must not have been known to have been fed ruminant 
protein, other than milk protein, during their lifetime;
    (3) The bovines must be accompanied by a certificate issued by a 
full-time salaried veterinary officer of the national government of the 
region of origin, or issued by a veterinarian designated or accredited 
by the national government of the region of origin and endorsed by a 
full-time salaried veterinary officer of the national government of the 
region of origin, representing that the veterinarian issuing the 
certificate was authorized to do so, that states 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 Sec.  93.403(b) or as provided for in Sec.  93.403(f) and 
must be moved directly as a group from the port of entry to a 
recognized slaughtering establishment 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 the recognized slaughtering establishment 
by a USDA representative;
    (5) The shipment must be accompanied from the port of entry to the 
recognized slaughtering establishment by APHIS Form VS 17-33;
    (6) At the recognized slaughtering establishment, the animals must 
be slaughtered as a group and each animal's intestines must be removed; 
and
    (7) The intestines removed from the animals must be disposed of in 
a manner approved by the Administrator.
    (b) Bovines for feeding. Bovines from a region listed in Sec.  
94.18(a)(3) of this subchapter may be imported under the following 
conditions:
    (1) The bovines must be less than 30 months of age when imported 
into the United States;
    (2) The bovines must not have been known to have been fed ruminant 
protein, other than milk protein, during their lifetime;
    (3) The inside of one ear on each animal must be permanently and 
legibly tattooed with letters identifying the exporting country. 
Animals exported from Canada must be tattooed with the letters ``CAN'';
    (4) The bovines must be accompanied by a certificate issued in 
accordance with Sec.  93.405(a) that states, in addition to the 
statements required by Sec.  94.405(a), that the conditions of 
paragraphs (b)(1) through (b)(3) of this section have been met;
    (5) The bovines must be imported only through a port of entry 
listed in Sec.  93.403(b) or as provided for in Sec.  93.403(f) and 
must be moved directly from the port of entry as a group to the 
designated feedlot;
    (6) The shipment must be accompanied from the port of entry to the 
designated feedlot by APHIS Form VS 1-27;
    (7) The bovines must be moved directly from the designated feedlot 
to a recognized slaughtering establishment for slaughter;
    (8) The shipment must be accompanied from the designated feedlot to 
the recognized slaughtering establishment by APHIS Form VS 1-27;
    (9) The bovines must be less than 30 months of age when 
slaughtered;
    (10) At the recognized slaughtering establishment, each animal's 
intestines must be removed; and
    (11) The intestines removed from the animals must be disposed of in 
a manner approved by the Administrator.
    (c) Sheep or goats for immediate slaughter. Sheep and goats from a 
region listed in Sec.  94.18(a)(3) of this subchapter may be imported 
for immediate slaughter under the following conditions:
    (1) The sheep or goats must be less than 12 months of age when 
imported into the United States;
    (2) The sheep or goats must not have been known to have been fed 
ruminant protein, other than milk protein, during their lifetime;
    (3) The sheep or goats must be accompanied by a certificate issued 
by a full-time salaried veterinary officer of the national government 
of the region of origin, or issued by a veterinarian designated or 
accredited by the national government of the region of origin and 
endorsed by a full-time salaried veterinary officer of the national 
government of the region of origin, representing that the veterinarian 
issuing the certificate was authorized to do so, that states that the 
conditions of paragraphs (c)(1) and (c)(2) of this section have been 
met;
    (4) The sheep or goats must be imported only through a port of 
entry listed in Sec.  93.403(b) or as provided for in Sec.  93.403(f) 
and must be moved directly as a group from the port of entry to a 
recognized slaughtering establishment for slaughter as a group 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 the recognized 
slaughtering establishment by a USDA representative; and
    (5) The shipment must be accompanied from the port of entry to the 
recognized slaughtering establishment by APHIS Form VS 17-33.
    (d) Sheep or goats for feeding. Sheep and goats from a region 
listed in Sec.  94.18(a)(3) of this subchapter may be imported under 
the following conditions:
    (1) The sheep or goats must be less than 12 months of age when 
imported into the United States;
    (2) The sheep or goats must not have been known to have been fed 
ruminant protein, other than milk protein, during their lifetime;
    (3) The inside of one ear on each animal must be permanently and 
legibly tattooed with letters identifying the exporting country. 
Animals from Canada must be tattooed with the letters ``CAN'';
    (4) The sheep or goats must be accompanied by a certificate issued 
in accordance with Sec.  93.405(a) that states, in addition to the 
statements required by Sec.  94.405(a), that the conditions of 
paragraphs (d)(1) through (d)(3) of this section have been met;
    (5) The sheep or goats may be imported only through a port of entry 
listed in Sec.  93.403(b) or as provided for in Sec.  93.403(f) and 
must be moved directly as a group from the port of entry to a 
designated feedlot;
    (6) The shipment must be accompanied from the port of entry to the 
designated feedlot by APHIS Form VS 1-27;
    (7) The sheep or goats must be moved directly from the designated 
feedlot to a recognized slaughtering establishment for slaughter;
    (8) The shipment must be accompanied from the designated feedlot to 
the recognized slaughtering establishment by APHIS Form VS 1-27; and
    (9) The sheep and goats must be less than 12 months of age when 
slaughtered.
    (e) Cervids for immediate slaughter. Cervids from a region listed 
in Sec.  94.18(a)(3) of this subchapter may be imported for immediate 
slaughter under the following conditions:
    (1) The cervids must have been members of a herd in which 
surveillance for transmissible spongiform encephalopathies was 
conducted by appropriate authorities according to national standards or 
standards of the region itself if the region is a jurisdiction that has 
effective oversight of normal animal movements into, out of, or within 
the region and that, in association with national authorities if 
necessary, has the

[[Page 62403]]

responsibility for controlling animal disease locally;
    (2) The cervids must have been members of a herd not known to be 
infected with or exposed to a transmissible spongiform encephalopathy;
    (3) The cervids must have been born after a ban on the feeding of 
ruminant protein to ruminants was implemented;
    (4) The cervids must not have been known to have been fed ruminant 
protein, other than milk protein, during their lifetime;
    (5) The cervids must be accompanied by a certificate issued by a 
full-time salaried veterinary officer of the national government of the 
region of origin, or issued by a veterinarian designated or accredited 
by the national government of the region of origin and endorsed by a 
full-time salaried veterinary officer of the national government of the 
region of origin, representing that the veterinarian issuing the 
certificate was authorized to do so, that states the conditions of 
paragraphs (e)(1) through (e)(4) of this section have been met;
    (6) The cervids must be imported only through a port of entry 
listed in Sec.  93.403(b) or as provided for in Sec.  93.403(f) and 
must be moved directly from the port of entry as a group to a 
recognized slaughtering establishment for slaughter as a group 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 the recognized 
slaughtering establishment by a USDA representative; and
    (7) The shipment must be accompanied from the port of entry to the 
recognized slaughtering establishment by APHIS Form VS 17-33.

PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL 
PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL 
SWINE FEVER, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND 
RESTRICTED IMPORTATIONS

    4. The authority citation for part 94 would continue to read as 
follows:

    Authority: 7 U.S.C. 450, 7701-7772, and 8301-8317; 21 U.S.C. 136 
and 136a; 31 U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, 
and 371.4.

    5. Section 94.0 would be amended by adding new definitions of 
bovine spongiform encephalopathy (BSE) minimal-risk region, and 
personal use, in alphabetical order, to read as follows:


Sec.  94.0  Definitions.

* * * * *
    Bovine spongiform encephalopathy (BSE) minimal-risk region. A 
region that:
    (1) Maintains, and, in the case of regions where BSE was detected, 
had in place prior to the detection of BSE, risk mitigation measures 
adequate to prevent widespread exposure and/or establishment of the 
disease. Such measures include the following:
    (i) Restrictions on the importation of animals sufficient to 
minimize the possibility of infected ruminants being imported into the 
region, and on the importation of animal products and animal feed 
containing ruminant protein sufficient to minimize the possibility of 
ruminants in the region being exposed to BSE;
    (ii) Surveillance for BSE at levels that meet or exceed OIE 
recommendations for surveillance for BSE; and
    (iii) A ban on the feeding of ruminant protein to ruminants that 
appears to be an effective barrier to the dissemination of the BSE 
infectious agent, with no evidence of significant noncompliance with 
the ban.
    (2) In regions where BSE was detected, conducted an epidemiological 
investigation following detection of BSE sufficient to confirm the 
adequacy of measures to prevent the further introduction or spread of 
BSE, and continues to take such measures.
    (3) In regions where BSE was detected, took additional risk 
mitigation measures, as necessary, following the BSE outbreak based on 
risk analysis of the outbreak, and continues to take such measures.
* * * * *
    Personal use. Only for personal consumption or display and not 
distributed further or sold.
* * * * *


Sec.  94.1  [Amended]

    6. In Sec.  94.1, paragraph (b)(4) and the introductory text to 
paragraph (d) would be amended by removing the reference to ``Sec.  
94.21'' each time it appears and replacing it with a reference to 
``Sec.  94.22''.
    7. Section 94.18 would be amended as follows:
    a. Paragraph (a)(3) would be redesignated as paragraph (a)(4) and 
revised to read as set forth below.
    b. A new paragraph (a)(3) would be added, and paragraph (b) and the 
introductory text of paragraph (c) would be revised, to read as set 
forth below.


Sec.  94.18  Restrictions on importation of meat and edible products 
from ruminants due to bovine spongiform encephalopathy.

    (a) * * *
    (3) The following are minimal-risk regions with regard to bovine 
spongiform encephalopathy: Canada.
    (4) A region may request at any time that the Administrator 
consider its removal from a list in paragraphs (a)(1) or (a)(2) or this 
section, or its addition to or removal from the list in paragraph 
(a)(3) of this section, by following the procedures in part 92 of this 
subchapter.
    (b) Except as provided in paragraph (d) of this section or in Sec.  
94.19, the importation of fresh (chilled or frozen) meat, meat 
products, and edible products other than meat (except for gelatin as 
provided in paragraph (c) of this section, milk, and milk products), 
from ruminants that have been in any of the regions listed in paragraph 
(a) of this section is prohibited.
    (c) Gelatin. The importation of gelatin derived from ruminants that 
have been in any region listed in paragraph (a) of this section is 
prohibited unless the following conditions, or the conditions of Sec.  
94.19(j), have been met:
* * * * *
    8. Sections 94.19 through 94.24 would be redesignated as Sec. Sec.  
94.20 through 94.25, respectively.
    9. A new Sec.  94.19 would be added to read as follows:


Sec.  94.19  Restrictions on importation from BSE minimal-risk regions 
of meat and edible products from ruminants.

    Except as provided in Sec.  94.18 and this section, the importation 
of fresh (chilled or frozen) meat, meat products, and edible products 
other than meat (excluding gelatin, milk, and milk products), from 
ruminants that have been in any of the regions listed in Sec.  
94.18(a)(3) is prohibited. The commodities listed in paragraphs (a) 
through (j) of this section may be imported from a region listed in 
Sec.  94.18(a)(3) if the conditions listed are met and if, except for 
the commodities described in paragraph (g), the commodities are 
accompanied by an original certificate of such compliance issued by a 
full-time salaried veterinary officer of the national government of the 
region of origin, or issued by a veterinarian designated or accredited 
by the national government of the region of origin and endorsed by a 
full-time salaried veterinary officer of the national government of the 
region of origin, representing that the veterinarian issuing the 
certificate was authorized to do so.
    (a) Fresh (chilled or frozen) meat from bovines less than 30 months 
of age. The

[[Page 62404]]

meat is derived from bovines that were less than 30 months of age when 
slaughtered and that are not known to have been fed ruminant protein, 
other than milk protein, during their lifetime, and meets the following 
conditions:
    (1) The bovines from which the meat is derived were slaughtered at 
a facility that either slaughters only bovines less than 30 months of 
age or complies with a segregation process approved by the national 
veterinary authority of the region of origin and the Administrator as 
adequate to prevent contamination or commingling of the meat with 
products not eligible for importation into the United States.
    (2) The intestines of the bovines were removed at slaughter; and
    (3) The product qualifies as meat under the definition of meat in 
USDA's Food Safety and Inspection Service's regulations at 9 CFR 301.2.
    (b) Fresh (chilled or frozen) whole or half carcasses of bovines 
less than 30 months of age. The carcasses are derived from bovines that 
meet the following conditions:
    (1) The bovines were less than 30 months of age when slaughtered;
    (2) The bovines are not known to have been fed ruminant protein, 
other than milk protein, during their lifetime;
    (3) The intestines of the bovines were removed at slaughter; and
    (4) The bovines were slaughtered at a facility that either 
slaughters only bovines less than 30 months of age or complies with a 
segregation process approved by the national veterinary authority of 
the region of origin and the Administrator as adequate to prevent 
contamination or commingling with products not eligible for importation 
into the United States.
    (c) Fresh (chilled or frozen) bovine liver. The commodity is liver 
containing no other product and is derived from bovines for which an 
air-injected stunning process was not used at slaughter.
    (d) Fresh (chilled or frozen) bovine tongues. The tongues are 
derived from bovines that were born after the region implemented an 
effective ban on the feeding of ruminant protein to ruminants, that are 
not known to have been fed ruminant protein, other than milk protein, 
during their lifetime, and from which the tonsils of each animal were 
removed at slaughter.
    (e) Fresh (chilled or frozen) meat of sheep or goats or other 
ovines or caprines. The meat is from sheep or goats or other ovines or 
caprines that were less than 12 months of age when slaughtered and that 
are not known to have been fed ruminant protein, other than milk 
protein, during their lifetime, and meets the following conditions:
    (1) The meat is derived from sheep or goats or other ovines or 
caprines that were slaughtered at a facility that either slaughters 
only sheep and/or goats or other ovines and caprines less than 12 
months of age or complies with a segregation process approved by the 
national veterinary authority of the region of origin and the 
Administrator as adequate to prevent contamination or commingling of 
the meat with products not eligible for importation into the United 
States; and
    (2) The product qualifies as meat under the definition of meat in 
USDA's Food Safety and Inspection Service's regulations at 9 CFR 301.2.
    (f) Fresh (chilled or frozen) carcasses of ovines and caprines. The 
carcasses are derived from ovines or caprines that were less than 12 
months of age when slaughtered, that are not known to have been fed 
ruminant protein, other than milk protein, during their lifetime, and 
that were slaughtered at a facility that either slaughters only ovines 
and/or caprines less than 12 months of age or complies with a 
segregation process approved by the national veterinary authority of 
the region of origin and the Administrator as adequate to prevent 
contamination or commingling of the carcasses with products not 
eligible for importation into the United States.
    (g) Fresh (chilled or frozen) meat or dressed carcasses of hunter-
harvested wild sheep, goats, cervids, or other ruminants. The meat or 
dressed carcass (eviscerated and the head is removed) is derived from a 
wild sheep, goat, cervid, or other ruminant and meets the following 
conditions:
    (1) The meat or dressed carcass is intended for personal use and is 
derived from an animal that has been legally harvested in the wild, as 
verified by proof such as a hunting license, tag, or the equivalent 
that the hunter must show to the United States Customs and Border 
Protection official; and
    (2) The animals from which the meat is derived were harvested 
within a jurisdiction specified by the Administrator for which the game 
and wildlife service of the jurisdiction has informed the Administrator 
either that the jurisdiction conducts no type of game feeding program, 
or has complied with, and continues to comply with, the ban on the 
feeding of ruminant protein to ruminants in the BSE minimal-risk 
region.
    (h) Fresh (chilled or frozen) meat of cervids either farm-raised or 
harvested on a game farm or similar facility. The meat is derived from 
cervids that were born after the region of origin implemented an 
effective ban on the feeding of ruminant protein to ruminants, that are 
not known to have been fed ruminant protein, other than milk protein, 
during their lifetime, and that were members of a herd not known to be 
infected with or exposed to a transmissible spongiform encephalopathy, 
and, if ground meat or sausage, is either all cervine meat or cervine 
meat mixed with nonruminant meat.
    (i) Fresh (chilled or frozen) meat from wild-harvested caribou, 
musk ox, or other cervids. The meat is derived from wild caribou, musk 
ox, or other cervids and meets the following conditions:
    (1) The animals from which the meat is derived were harvested 
within a jurisdiction specified by the Administrator for which the game 
and wildlife service of the jurisdiction has informed the Administrator 
either that the jurisdiction conducts no type of game feeding program, 
or has complied with, and continues to comply with, the ban on the 
feeding of ruminant protein to ruminants in the BSE minimal-risk 
region; and
    (2) The meat is derived from cervids that were slaughtered at a 
facility that either slaughters only cervids eligible for entry into 
the United States or complies with a segregation process approved by 
the national veterinary authority of the region of origin and the 
Administrator as adequate to prevent contamination or commingling of 
the meat with products not eligible for importation into the United 
States.
    (j) Gelatin. The gelatin is derived from the bones of bovines less 
than 30 months of age when slaughtered and that are not known to have 
been fed ruminant protein, other than milk protein, during their 
lifetime.
    (k) Ports. All products to be brought into the United States under 
this section must, if arriving at a land border port, arrive at one of 
the following ports: Eastport, ID; Houlton, ME; Detroit (Ambassador 
Bridge), Port Huron, and Sault St. Marie, MI; International Falls, MN; 
Sweetgrass, MT; Alexandria Bay, Buffalo (Lewiston Bridge and Peace 
Bridge), and Champlain, NY; Pembina and Portal, ND; Derby Line and 
Highgate Springs, VT; and Blaine (Pacific Highway and Cargo Ops), 
Lynden, Oroville, and Sumas (Cargo), WA.

[[Page 62405]]

PART 95--SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS), 
AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES

    10. 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.

    11. Section 95.1 would be amended by adding a new definition of 
offal, in alphabetical order, to read as follows:


Sec.  95.1  Definitions.

* * * * *
    Offal. The parts of a butchered animal that are removed in 
dressing, consisting largely of the viscera and the trimmings, which 
may include, but are not limited to, brains, thymus, pancreas, liver, 
heart, kidney.
* * * * *
    12. Section 95.4 would be amended as follows:
    a. In paragraph (a), the words ``paragraphs (c) through (f)'' would 
be removed and the words ``paragraphs (c) through (h)'' would be added 
in their place.
    b. In paragraph (b), the words ``paragraphs (d) and (f)'' would be 
removed and the words ``paragraphs (d) and (h)'' would be added in 
their place.
    c. In paragraph (c)(4), the first sentence would be revised and a 
new sentence would be added after the final sentence to read as set 
forth below.
    d. Paragraph (c)(6) would be revised to read as set forth below.
    e. Paragraph (f) would be redesignated as paragraph (h).
    f. New paragraphs (f) and (g) would be added to read as set forth 
below:


Sec.  95.4  Restrictions on the importation of processed animal 
protein, offal, tankage, fat, glands, certain tallow other than tallow 
derivatives, and serum due to bovine spongiform encephalopathy.

* * * * *
    (c) * * *
    (4) Except for facilities in regions listed in Sec.  94.18(a)(3) of 
this subchapter, if the facility processes or handles any material 
derived from mammals, the facility has entered into a cooperative 
service agreement executed by the operator of the facility and APHIS. * 
* * In facilities in regions listed in Sec.  94.18(a)(3) of this 
subchapter, the inspections that would otherwise be conducted by APHIS 
must be conducted at least annually by a representative of the 
government agency responsible for animal health in the region.
* * * * *
    (6) Each shipment to the United States is accompanied by an 
original certificate signed by a full-time, salaried veterinarian of 
the government agency responsible for animal health in the region of 
export certifying that the conditions of paragraph (c)(1) through 
(c)(3) of this section have been met, except that, for shipments of 
animal feed from a region listed in Sec.  18(a)(3) of this subchapter, 
the certificate may be signed by a person authorized to issue such 
certificates by the veterinary services of the national government of 
the region of origin.
* * * * *
    (f) Tallow otherwise prohibited importation under paragraph (a)(1) 
of this section may be imported into the United States if it meets the 
following conditions:
    (1) The tallow is composed of less than 0.15 percent protein;
    (2) The tallow is derived from bovines that have not been in a 
region listed in Sec.  94.18(a)(1) or (a)(2) of this subchapter:
    (3) The bovines were less than 30 months of age when slaughtered 
and were born after the region of origin implemented an effective ban 
on the feeding of ruminant protein to ruminants;
    (4) The bovines are not known to have been fed ruminant protein, 
other than milk protein, during their lifetime;
    (5) The intestines were removed from each bovine at slaughter.
    (6) The tallow is not derived from an animal that died otherwise 
than by slaughter;
    (7) 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 and endorsed by a full-time salaried veterinary 
officer of the national government of the region of origin, 
representing that the veterinarian issuing the certificate was 
authorized to do so. The certificate must state that the requirements 
of paragraphs (f)(1) through (f)(6) of this section have been met; and
    (8) The shipment, if arriving at a U.S. land border port, arrives 
at a port listed in Sec.  94.19(k) of this subchapter.
    (g) Offal derived from cervids that is otherwise prohibited 
importation under paragraph (a)(1) of this section may be imported if 
the following conditions are met:
    (1) The offal is derived from cervids that were born after the 
region of origin implemented an effective ban on the feeding of 
ruminant protein to ruminants, that are not known to have been fed 
ruminant protein, other than milk protein, during their lifetime, and 
that were members of herd not known to be infected with or exposed to a 
transmissible spongiform encephalopathy;
    (2) 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 and endorsed by a full-time salaried veterinary 
officer of the national government of the region of origin, 
representing that the veterinarian issuing the certificate was 
authorized to do so. The certificate must state that the requirements 
of paragraph (g)(1) of this section have been met; and
    (3) The shipment, if arriving at a U.S. land border port, arrives 
at a port listed in Sec.  94.19(k) of this subchapter.
* * * * *

    Done in Washington, DC, this 29th of October 2003.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 03-27611 Filed 10-31-03; 2:30 pm]
BILLING CODE 3410-34-P