[Federal Register: November 4, 2003 (Volume 68, Number 213)]
[Proposed Rules]
[Page 62386-62405]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no03-5]
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Proposed Rules
Federal Register
________________________________________________________________________
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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[[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 regulations@aphis.usda.gov. 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