Federal Register, Volume 77 Issue 52 (Friday, March 16, 2012)

[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Proposed Rules]
[Pages 15848-15913]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6151]

[[Page 15847]]

Vol. 77

Friday,

No. 52

March 16, 2012

Part II

Department of Agriculture

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Animal and Plant Health Inspection Service

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9 CFR Parts 92, 93 et al.

Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine
Products; Proposed Rule

Federal Register / Vol. 77 , No. 52 / Friday, March 16, 2012 /
Proposed Rules

[[Page 15848]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 92, 93, 94, 95, 96, and 98

[Docket No. APHIS-2008-0010]
RIN 0579-AC68

Bovine Spongiform Encephalopathy; Importation of Bovines and
Bovine Products

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the regulations that govern the
importation of animals and animal products to revise the conditions for
the importation of live bovines and products derived from bovines with
regard to bovine spongiform encephalopathy (BSE). We are proposing to
base importation conditions on the inherent risk of BSE infectivity in
specified commodities, as well as on the BSE risk status of the region
from which the commodities originate. We are proposing to establish a
system for classifying regions as to BSE risk that is consistent with
the system employed by the World Organization for Animal Health (OIE),
the international standard-setting organization for guidelines related
to animal health. The conditions we are proposing for the importation
of specified commodities are based on internationally accepted
scientific literature and, except in a few instances, are consistent
with guidelines set out in the OIE's Terrestrial Animal Health Code. We
are also proposing to classify certain specified countries as to BSE
risk and are proposing to remove BSE restrictions on the importation of
cervids and camelids and products derived from such animals. We are
proposing to make these amendments after conducting a thorough review
of relevant scientific literature and a comprehensive evaluation of the
issues and concluding that the proposed changes to the regulations
would continue to guard against the introduction of BSE into the United
States, while allowing the importation of additional animals and animal
products into this country. In this document we are also affirming the
position we took in removing the delay of applicability of certain
provisions of the rule entitled ``Bovine Spongiform Encephalopathy;
Minimal-Risk Regions and Importation of Commodities,'' published in the
Federal Register on January 4, 2005 (70 FR 460-553). The delay of
applicability was removed in a final rule entitled ``Bovine Spongiform
Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and
Products Derived from Bovines,'' published in the Federal Register on
September 18, 2007 (72 FR 53314-53379).

DATES: We will consider all comments that we receive on or before May
15, 2012.

ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2008-0010-0001.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2008-0010, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
Supporting documents and any comments we receive on this docket may
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2008-
0010 or in our reading room, which 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.

FOR FURTHER INFORMATION CONTACT: For information concerning live
ruminants, contact Dr. Betzaida Lopez, Import Animal Staff
Veterinarian, Technical Trade Services, Animals, Organisms and Vectors,
and Select Agents, National Center for Import and Export, VS, APHIS,
4700 River Road Unit 39, Riverdale, MD 20737-1231; (301) 851-3364.
For information regarding ruminant products and for other
information regarding this proposed rule, contact Dr. Christopher
Robinson, Assistant Director, Technical Trade Services, Animal
Products, National Center for Import and Export, VS, APHIS, 4700 River
Road Unit 38, Riverdale, MD 20737-1231; (301) 734-3277.

SUPPLEMENTARY INFORMATION:

I. Overview

Background

In order to guard against the introduction of animal diseases, the
Animal and Plant Health Inspection Service (APHIS) of the U.S.
Department of Agriculture (USDA or Department) regulates the
importation of animals and animal products into the United States. The
regulations in parts 92, 93, 94, 95, 96, and 98 of the U.S. Code of
Federal Regulations (CFR) (referred to below as the regulations) govern
the importation of certain animals, birds, poultry, meat, other animal
products and byproducts, hay, and straw into the United States in order
to prevent the introduction of various animal diseases, including
bovine spongiform encephalopathy (BSE), a chronic degenerative disease
that affects the central nervous system of cattle. In this document we
are proposing to amend the import regulations related to BSE.

Nature of BSE

BSE belongs to the family of diseases known as transmissible
spongiform encephalopathies (TSEs). All TSEs affect the central nervous
system of infected animals. However, the distribution of infectivity in
the body of the animal and mode of transmission differ according to the
species and the TSE agent. In addition to BSE, TSEs include, among
other diseases, scrapie in sheep and goats, chronic wasting disease in
deer and elk, and Creutzfeldt-Jakob disease in humans.
The agent that causes BSE has yet to be fully characterized. The
theory that is most accepted in the international scientific community
is that the agent is an abnormal form of a normal protein known as
cellular prion protein. The BSE agent does not evoke a traditional
immune response or inflammatory reaction in host animals. BSE is
confirmed by post-mortem examination of an animal's brain tissue, which
may include detection of the abnormal form of the prion protein in the
brain tissues. The pathogenic form of the protein is both less soluble
and more resistant to degradation than the normal form. The BSE agent
is resistant to heat and to normal sterilization processes.
BSE is not a contagious disease, and therefore is not spread
through casual contact between animals. Scientists believe that
transmission is through ingestion of feed that has been contaminated
with a sufficient amount of tissues or organs containing the BSE agent
from an infected animal. This route of transmission can be prevented by
excluding from ruminant feed tissues or organs that could potentially
carry the BSE agent.
Other characteristics of the BSE agent, as evidenced by
epidemiology, transmission studies, and pathogenesis are discussed in
detail in a final rule APHIS published in the Federal Register on
September 18, 2007 (72 FR 53314-53379, Docket No. APHIS-2006-0041) and
in the supporting scientific

[[Page 15849]]

documentation that was prepared for this proposed rule. (The supporting
scientific documentation can be accessed at the APHIS Web site at
http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/RiskAssessment06-041-1%20.pdf).

Roles of Different Agencies

APHIS, an animal health agency within USDA, promulgates its
regulations regarding BSE under the authority of the Animal Health
Protection Act (7 U.S.C. 8301 et seq.), which gives the Secretary broad
discretion to regulate the importation of animals and animal products
if necessary to protect the health of U.S. livestock.
Because variant Creutzfeldt-Jakob Disease (vCJD) in humans has been
linked to exposure to the BSE agent, APHIS collaborates with other
Federal agencies with regulatory responsibility for assuring food
safety and the protection of human health to implement a comprehensive
coordinated U.S. response to BSE. Within USDA, protecting human health
from the risks of BSE is carried out by the Food Safety and Inspection
Service (FSIS), the agency charged with responsibility for
administering the Federal Meat Inspection Act, which was enacted to
ensure that meat and meat food products distributed in commerce are
wholesome, not adulterated, and properly marked, labeled, and packaged.
The USDA agencies carry out their programs in close coordination with
the following Centers of the Food and Drug Administration (FDA) of the
U.S. Department of Health and Human Services: The Center for Veterinary
Medicine regarding animal feed and veterinary pharmaceuticals; the
Center for Food Safety and Applied Nutrition regarding foods other than
meat, poultry, and egg products; and other Centers regarding drugs,
biologics, and devices containing bovine material. These agencies
collaborate, issuing regulations under their respective authorities.
Imported products must meet all relevant agency requirements. Each
agency has the capability to deny imports based on their individual
authorities and concerns.

Rulemaking Regarding BSE

The protective measures the Federal Government has taken have
evolved over the years, as scientific understanding of the disease has
increased. In 1989, APHIS prohibited the importation of live cattle and
other ruminants and certain ruminant products, including most rendered
protein products, into the United States from countries where BSE is
known to exist, and codified this prohibition in the CFR on April 30,
1991 (56 FR 19794-19796, Docket No. 90-252). The list of regions in
which BSE is known to exist is set out in the current regulations in
Sec. 94.18(a)(1).
In June 1997, FDA prohibited the use of all mammalian protein--with
the exception of pure pork and pure equine protein from single species
processing plants and certain other materials--in animal feeds given to
cattle and other ruminants, and established measures to protect against
the contamination of ``allowable'' feed material with materials that
could contain the BSE agent. We discuss this and other FDA actions
regarding BSE in this document under the heading ``Evolution of U.S.
Regulatory Response to BSE.''
In rulemaking made effective December 12, 1997, and published in
the Federal Register on January 6, 1998, APHIS added to the regulations
a category of regions that pose an undue risk of introducing BSE into
the United States. In the rulemaking document establishing that
category (63 FR 406-408, Docket No. 97-127-1), we explained that our
decision to add the category was based on developments that led us to
believe that, at the time, the BSE agent might have been present but as
yet undetected throughout Europe. We noted that the Netherlands,
Belgium, and Luxembourg had recently reported their first case of BSE
in native-born cattle. Additionally, we noted that Belgium and
Luxembourg had reported that cattle diagnosed with BSE had
inadvertently been processed into the animal food chain. We concluded
that, because of the movement of ruminants and ruminant products within
Europe, the possibility existed that this potentially contaminated
animal feed might have been moved to other European countries.
In our 1997 rulemaking, we applied the same import prohibitions and
restrictions to regions of undue risk for BSE that were being applied
to regions listed as those in which BSE is known to exist. The list of
regions of undue risk for BSE is set out in the current regulations in
Sec. 94.18(a)(2). Imports from any region not listed in either of
those two categories were not subject to any BSE prohibitions or
restrictions.
In December 2000, APHIS expanded its prohibitions on imports of
rendered ruminant protein products from BSE-restricted regions to
include rendered protein products of any animal species because of
concern that cattle feed supposedly free of ruminant protein may have
been cross-contaminated with the BSE agent (66 FR 42595-42601, Docket
No. 00-121-1). FDA also issued import alerts on animal feed ingredients
for APHIS-listed countries.
On November 4, 2003, APHIS published a proposed rule in the Federal
Register (68 FR 62386-62405, Docket No. 03-080-1) in which we proposed
to establish a category of regions that present a minimal risk of
introducing BSE into the United States via live ruminants and ruminant
products and byproducts, and to add Canada to this category. The
proposal also set forth conditions for the importation of certain live
ruminants and ruminant products and byproducts from BSE minimal-risk
regions.
In the November 2003 proposal, we set forth factors that would be
taken into account in determining whether a country qualified as a BSE
minimal-risk region. According to our proposed definition of a BSE
minimal-risk region, such measures would include importation
restrictions, surveillance, and a feed ban. With regard to a feed ban,
we proposed that, to be recognized as a BSE minimal-risk region, a
country must have in place 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.
On December 25, 2003, less than 2 weeks before the close of the
comment period for the proposed rule, a case of BSE in a dairy cow of
Canadian origin in Washington State was verified by an international
reference laboratory. Subsequently, both FSIS and FDA implemented
significant additional measures in the United States to protect human
health. In addition, APHIS commenced an enhanced BSE surveillance
program to determine the incidence of the disease in the United States.
The measures taken by Federal agencies in January 2004 led to a
change in APHIS' November 2003 proposed rule. Among the actions taken
by FSIS to supplement its measures to prevent the BSE agent from
entering the human food supply was to designate as specified risk
materials (SRMs) certain tissues from cattle 30 months of age and
older, and the tonsils and distal ileum of the small intestine of all
cattle, and to prohibit their use as human food. FSIS also required all
slaughtering and processing establishments to develop, implement, and
maintain written procedures for the removal, segregation, and
disposition of SRMs. FSIS did not restrict the age of cattle eligible
for slaughter, because the removal of SRMs effectively mitigates the
BSE risk to humans associated with cattle that pass

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both ante-mortem and post-mortem inspections (i.e., apparently healthy
cattle). (We discuss below additional BSE-related regulatory actions
taken by FSIS and FDA under the heading ``Evolution of U.S. Regulatory
Response to BSE.'')
The risk mitigation measures that FSIS implemented regarding
slaughtered cattle had ramifications for the importation of bovine-
derived meat from other countries. Pursuant to the Federal Meat
Inspection Act, countries that export meat to the United States must
implement food safety requirements that are equivalent to those in
place in the United States. To be eligible to export beef to the United
States, a country must have in place a system to effectively keep SRMs
out of the production chain and to prevent cross-contamination of beef
with SRMs. FSIS determined the SRM requirements implemented by Canada
in July 2003 to be equivalent to FSIS' requirements. Additionally,
FDA's feed ban prohibits most mammalian protein, including ruminant
protein, from entering the ruminant feed chain in the United States.
On March 8, 2004, APHIS published a document in the Federal
Register (69 FR 10633-10636, Docket No. 03-080-2) explaining the
effects on our proposed rule of the detection of BSE in the State of
Washington in a cow imported from Canada and of the additional measures
taken by FSIS, APHIS, and FDA. That document explained why the
detection of an imported BSE-infected cow did not alter the conclusions
we had reached in our original risk assessment. It explained further
that, in fact, the resulting additional measures put in place by FSIS
provided a basis for removing from the proposed provisions an age
restriction on cattle from which meat would be derived for export to
the United States. Accordingly, we proposed to allow the importation of
beef derived from cattle of any age. To give the public additional time
to comment on the proposal in light of these developments, we reopened
and extended the comment period for an additional 30 days.
On January 4, 2005, APHIS published in the Federal Register (70 FR
460-553, Docket No. 03-080-3) a final rule that established the
criteria for BSE minimal-risk regions, listed Canada as a BSE minimal-
risk region, and specified importation requirements for live animals,
and meat products and byproducts. The final rule allowed the
importation of meat from bovines of any age, as we had proposed on
March 8, 2004. The final rule was scheduled to become effective on
March 7, 2005.\1\
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\1\ On March 2, 2005, Judge Richard F. Cebull of the U.S.
District Court for the District of Montana ordered that the
implementation of APHIS' January 4, 2005, final rule be
preliminarily enjoined. On July 14, 2005, the U.S. States Court of
Appeals for the Ninth Circuit ordered that the preliminary
injunction order be vacated and the case remanded to the District
Court.
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In January 2005, BSE was confirmed in two cows in Canada.
On March 11, 2005, APHIS published a document in the Federal
Register (70 FR 12112-12113, Docket No. 03-080-6) that, pursuant to an
announcement by the Secretary of Agriculture on February 9, 2005,
delayed the applicability of the provisions of the January 2005 final
rule as they applied to the importation from Canada of certain
commodities, including meat, meat food products, and meat byproducts
other than liver when derived from bovines 30 months of age or older
when slaughtered. We discuss the delay of applicability in more detail,
below.
On August 18, 2005, APHIS published in the Federal Register (70 FR
48494-48500, Docket No. 05-004-1) a proposed rule to amend the
regulations by allowing, under certain conditions, the importation of
whole cuts of boneless beef from Japan.
On November 28, 2005, APHIS published in the Federal Register an
interim rule (70 FR 71213-71218, Docket No. 03-080-8) that amended
certain provisions established by the January 2005 final rule. The
interim rule broadened the list of who is authorized to break seals on
conveyances and allows transloading under supervision of products
transiting the United States.
On December 14, 2005, APHIS published a final rule in the Federal
Register (70 FR 73905-73919, Docket No. 05-004-2) that made final its
August 2005 proposed rule regarding certain cuts of boneless beef from
Japan. The risk assessment conducted for that rulemaking examined the
evidence supporting the safety of this commodity. This evidence and
APHIS' conclusions were consistent with those of the World Organization
for Animal Health (OIE) for trade in meat derived from cattle from
regions of controlled risk for BSE. (The risk document, ``Analysis of
Bovine Spongiform Encephalopathy (BSE) Risk to the U.S. Cattle
Population from Importation of Whole Cuts of Boneless Beef from
Japan,'' can be accessed at http://www.regulations.gov/#!documentDetail;D=APHIS-2005-0073-0002). The OIE is the international
standard-setting organization for guidelines related to animal health.
On March 14, 2006, APHIS published in the Federal Register a
technical amendment (71 FR 12994-12998, Docket No. 03-080-9) that
clarified our intent with regard to certain provisions in the January
2005 final rule and corrected several inconsistencies within the rule.
On August 9, 2006, APHIS published in the Federal Register a
proposed rule (71 FR 45439-45444, Docket No. APHIS-2006-0026) that
proposed to amend the provisions established by the January 2005 final
rule by removing several restrictions regarding the identification of
animals and the processing of ruminant materials from BSE minimal-risk
regions, and by relieving BSE-based restrictions on hide-derived
gelatin from BSE minimal-risk regions. We solicited comments concerning
our proposal for 60 days ending October 10, 2006. On November 9, 2006,
we published a document in the Federal Register (71 FR 65758-65759,
Docket No. APHIS-2006-0026) reopening and extended the comment period
until November 24, 2006.
On January 9, 2007, APHIS published a proposed rule in the Federal
Register (72 FR 1101-1129, Docket No. APHIS-2006-0041) that proposed to
establish conditions for the importation of the following commodities
from BSE minimal-risk regions: Live bovines for any use born on or
after a date determined by APHIS to be the date of effective
enforcement of a ruminant-to-ruminant feed ban in the region of
export;\2\ blood and blood products derived from bovines; and casings
and part of the small intestine derived from bovines.
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\2\ Requiring that live bovines exported to the United States
from BSE minimal-risk regions be born after the date of effective
enforcement of a ruminant-to-ruminant feed ban is consistent with
the OIE standards for the exportation of live bovines from countries
classified by the OIE as having either a negligible or a controlled
BSE risk. We consider effective enforcement to have been achieved
after completion of the initial (or practical) period of
implementation of a feed ban and after sufficient time has elapsed
to allow most feed products to cycle through the system. The
practical implementation period, which begins when the regulations
are initially put in place, can be determined by evaluating
implementation guidance and policies, such as allowing grace periods
for certain aspects of the industry. In addition, the time necessary
for initial education of industry and training of inspectors must be
considered. After the practical implementation period is defined, we
then consider the time necessary subsequent to practical
implementation to allow most feed products to cycle through the
system, given the management practices in the country. Effective
enforcement does not necessarily mean that 100 percent compliance
with the feed ban requirements will be achieved.
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On September 18, 2007, APHIS published in the Federal Register (72
FR 53314-53379, Docket No. APHIS-2006-0041) a final rule that adopted
the

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changes to the regulations we had proposed in January 2007.
Additionally, the September 2007 final rule removed the partial delay
of applicability of the January 2005 final rule with respect to meat
and certain meat products and byproducts derived from cattle over 30
months of age.
On January 18, 2008, APHIS published in the Federal Register a
final rule (73 FR 3379-3385, Docket No. APHIS-2006-0026) that made
final the provisions of our August 9, 2006, proposed rule, with some
changes.
On July 3, 2008, Judge Lawrence L. Piersol of the U.S. District
Court for the District of South Dakota, in response to a motion filed
in that Court, ordered USDA to provide the public with notice and a
further opportunity to comment on the provisions of our January 2005
final rule regarding the importation of beef from bovines 30 months of
age or older when slaughtered, to consider comments made by interested
parties, and to revise the rule as USDA deems necessary.
On September 18, 2008, APHIS published a request for comments in
the Federal Register (73 FR 54083-54089), in which we provided the
public with such notice and further opportunity to comment. We
solicited comments for 60 days ending November 17, 2008.
In this document, we discuss the issues raised by commenters in
response to our September 2008 request for comments and provide our
responses to those comments. Following that discussion, we describe and
discuss changes we are proposing to make to the APHIS BSE regulations.
However, in order to present our responses to the comments and the
changes we are proposing in the context of the available scientific
research and empirical data regarding the transmission of BSE, we
consider it necessary to first discuss what is known regarding SRMs and
the role of feed bans in reducing BSE risk.

Tissue Localization

Some bovine tissues have demonstrated infectivity, whereas others
have not. Most of the information on the development and distribution
of tissue infectivity in BSE-infected cattle has been derived from
experimental pathogenesis studies conducted in the United Kingdom and
Germany (Wells, et al., 1994; 1996; 1998; 1999; 2005; EFSA 2007;
Hoffman 2007; Hoffman 2011). In these studies, cattle were deliberately
infected with BSE through oral exposure to the brain tissue of cattle
with confirmed BSE. Subsets of the experimentally infected cattle were
killed at regular intervals as the disease progressed. At each
interval, the tissues of the infected cattle were examined for
histopathological changes consistent with BSE and for abnormal prion
proteins. Also, at each interval, a mouse assay was done--i.e., tissues
of the BSE-infected cattle were injected intracerebrally and
intraperitoneally into different types of mice (e.g., wild mice and
mice genetically altered to be highly susceptible to BSE) to identify
those tissues of cattle containing infectivity.
The first United Kingdom pathogenesis studies involved 30 animals,
each of which received a single dose of 100g of infected brain at 4
months of age (Wells, et al., 1994; 1996; 1998; 1999; 2005). This dose
is probably 10-100 times greater than that associated with field
exposure via feed (DEFRA, 2006). The studies demonstrate that in cattle
infected with BSE, the total amount of infectivity in the animal, as
well as the distribution of infectivity in the animal's body, changes
over time (Wells, et al., 1994; 1996; 1998; 1999; 2005). The highest
levels of infectivity were detected in the brain and spinal cord at the
end stages of disease. Some cattle exhibited clinical signs of BSE as
early as 35 months after oral exposure to the BSE agent. By 37 months
after oral exposure, all five animals that were still alive
demonstrated clinical evidence of BSE. Infectivity was found in cattle
with clinical signs of BSE in the brain, spinal cord, DRG,\3\
trigeminal ganglia, and the distal ileum of the small intestine.
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\3\ DRG are clusters of nerve cells attached to the spinal cord
that are contained within the bones of the vertebral column. ``DRG''
as used in this document has the same meaning as the term ``dorsal
spinal nerve root ganglia.'' Trigeminal ganglia are clusters of
nerve cells connected to the brain that lie close to the exterior of
the skull.
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BSE infectivity was demonstrated in the brain, spinal cord, and DRG
as early as 32 months after oral exposure to the BSE agent in some
cattle (Wells, et al., 1994; 1996; 1998; 1999; 2005). Infectivity was
demonstrated in these tissues 3 months before animals began to develop
clinical signs of the disease. Infectivity was demonstrated in the
distal ileum of cattle 6 to 18 months after oral exposure to the BSE
agent and again at 38 months and 40 months after oral exposure. A
similar study (Espinosa, et al., 2007) examined the infectivity of
tissues from these same animals by intracerebral inoculation of highly
sensitive transgenic mice overexpressing bovine PrP (prion protein).
This study's findings were similar to those of Wells, et al., described
above. In addition, infectivity in the sciatic nerve was found at low
levels only after 30 months from exposure. No detectable infectivity
was found in the spleen, skeletal muscle, blood, or urine of
asymptomatic cattle.
As explained by the United Kingdom's Department for Environment,
Food and Rural Affairs (DEFRA) and by the European Commission's
Scientific Steering Committee, a second phase of the pathogenesis
studies, which used a cattle bioassay as an endpoint, was conducted to
ensure that low levels of infectivity that may not have been detected
in the first phase using the mouse bioassay were not missed (DEFRA,
2006; EC SSC 2002). This second phase of the study was completed in
March 2007 (Gerald Wells, personal communication, 2008).
In the cattle bioassay, tissues from the same cattle orally exposed
to BSE in the earlier pathogenesis studies were injected directly into
the brain of BSE-free cattle (DEFRA, 2006). This method is considered
to be several hundred-fold more sensitive in detecting BSE infectivity
than the mouse bioassay (DEFRA, 2006). Preliminary results from the
cattle bioassay study demonstrate that, in addition to the materials
that were found to contain infectivity when the mouse bioassay was
used, the tonsils of calves 10 months after oral exposure to the BSE
agent also contain infectivity. However, because only one of five
animals injected with tonsil material from infected animals developed
clinical BSE at 45 months post-inoculation, the level of infectivity in
the tonsils appears to be very low.
BSE infectivity has not been demonstrated in the muscle tissue of
BSE-infected cattle examined in these studies through either the mouse
bioassay or the cattle assays (Wells 1996; 2005; personal communication
2008). All assays of the skeletal muscle pools were completed in March
2007 (Wells, personal communication 2008).
A larger pathogenesis study conducted in Germany involved calves
that were orally challenged with macerated brainstems from BSE-positive
cattle (EFSA 2007; Hoffman 2007). Every 4 months, randomly selected
animals are euthanized and necropsied, and more than 150 tissue and
bodily fluid samples are collected from each animal and analyzed by
immunohistochemistry, pure-tone average Western blot, and transgenic
mouse bioassay (TgbovXV). The initial results from the German BSE
pathogenesis study demonstrate that BSE prions can reach the brain as
soon as 24 months after a massive oral challenge (Hoffman 2007).
In addition to these studies on experimentally infected cattle,

[[Page 15852]]

distribution of tissue infectivity has also been studied in cattle
exposed to BSE under field conditions. In these animals, at the end
stages of the incubation period with demonstrated clinical signs, BSE
infectivity has been confirmed by mouse bioassay only in the brain,
spinal cord, and retina of the eye (EC SSC 2001).
In a 2005 study, mice genetically engineered to be highly
susceptible to BSE and to overexpress the bovine prion protein were
inoculated with tissues from an end-stage clinically affected BSE-
infected cow (Buschmann and Groschup, 2005). The sensitivity of these
mice to infection is significantly greater than other mice panels used
in bio-assays, and the sensitivity is even greater than that of cattle
by approximately tenfold. Using these highly sensitive mice, this study
demonstrated low levels of infectivity in the facial and sciatic nerves
of the peripheral nervous system of the cow. While this study, and the
2007 study by Espinosa, et al., produced interesting findings that can
help further characterize the pathogenesis of BSE, they cannot be
extrapolated into the context of the risk presented by natural (i.e.,
field) exposure pathways. The findings may be influenced by the
overexpression of prion proteins in these genetically engineered mice.
Any apparent levels of infectivity are low in these extremely sensitive
mice and would be even lower in other species such as cattle. Moreover,
the route of administration to the mice was both intraperitoneal and
intracerebral, both of which are very efficient routes of infection as
compared to oral consumption.
Tissues that have demonstrated infectivity, and thus are likely to
contain the infectious BSE agent in infected cattle, are brain, tonsil,
spinal cord, eyes, trigeminal ganglia, DRG, and distal ileum.
Approximately 90 percent of the infectivity is associated with the
brain, spinal column, DRG, and trigeminal ganglia. The remaining 10
percent is associated with the infectivity in the distal ileum. In BSE,
as with other TSEs, the total amount of infectivity in an animal
increases throughout the incubation period, reaching the highest load
at the end of that period, very close to the death of the animal.
Infectivity is considered to increase exponentially, reaching 4.5 logs
less than a clinical case at 50 percent of the incubation period and 3
logs less than a clinical case by 70 percent of the incubation period
(Comer and Huntly, 2003).
All of this research has contributed to the definition of which
tissues should be considered SRMs. Both the types of tissues and the
understanding of the progression of the infectivity throughout the
incubation period contribute to the definition of SRMs. Affiliated
tissues or structures such as skull or vertebral column are also
considered risk materials because of the difficulty in separating out
small tissues such as DRG from the vertebral column. The risks
associated with tissue localization can be mitigated by excluding SRMs
from the food or feed chain or by excluding them completely from
importation. FSIS and FDA regulations regarding SRMs, which we discuss
below under the heading ``Evolution of U.S. Regulatory Response to
BSE,'' are based on this scientific knowledge and an understanding of
the mitigative effects of exclusion of SRMs (FSIS, 2004; 2004a; 2004b;
2005; 2007; FDA, 2004; 2005; 2007; 2008).
The measures taken by FSIS included declaring SRMs to be inedible
and requiring their removal from cattle at slaughter. As noted above,
even if a BSE-infected cow 30 months or older that was presented for
slaughter were not exhibiting clinical signs of the disease and passed
ante-mortem and post-mortem inspections, the removal of SRMs from the
cow would effectively mitigate the BSE risk to humans.
Within USDA, APHIS and FSIS review and consider carefully, on an
ongoing basis, all BSE research regarding the definition of SRMs, as do
other countries that participate in the OIE. U.S. regulations regarding
SRM removal are consistent with international guidelines.

Feed Bans

As noted, scientists believe that the route of field transmission
in animals is through ingestion of feed that has been contaminated with
tissues or organs containing the BSE agent from an infected animal.
This route of transmission can be prevented by excluding potentially
contaminated materials from ruminant feed.
Experience internationally in countries with BSE has demonstrated
that feed bans are effective control measures and that the incidence of
BSE worldwide continues to decline because of these measures (OIE,
2010). In the United States, prohibitions on the use of ruminant
protein in ruminant feed are imposed by FDA to mitigate the risk of BSE
transmission.
Because of the demonstrated efficacy of an effectively enforced
feed ban in reducing the possibility of exposure of cattle to the BSE
agent, the OIE provides guidelines for trade in live cattle from
regions that have reported BSE if such regions have an effective feed
ban in place, provided the cattle were born after the date when the
feed ban was effectively enforced.
By eliminating transmission, an effective feed ban reduces the
possibility of the existence of infected animals in a given cattle
population, which in turn reduces further the chances of healthy
animals being exposed to the BSE agent via subsequent recycling of
infectivity.

September 2008 Request for Comments

As we discussed earlier in this document, the final rule that APHIS
published in January 2005 to establish criteria for BSE minimal-risk
regions, list Canada as a BSE minimal-risk region, and specify
importation requirements for live animals, and meat products and
byproducts was the outcome of a rulemaking process that APHIS initiated
in 2003 to update its BSE regulations to reflect the latest scientific
data and knowledge of the disease.
As discussed above, in our November 2003 proposal, we set forth
factors that would be taken into account in determining whether a
country qualified as a BSE minimal-risk region. According to our
proposed definition of a BSE minimal-risk region, such measures would
include importation restrictions, surveillance, and a feed ban. With
regard to a feed ban, we proposed that, to be recognized as a BSE
minimal-risk region, a country must have in place 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.
We explained the role a feed ban plays in reducing BSE risk,
stating that the primary source of BSE infection is feed contaminated
with the infectious agent, that scientific evidence shows that feed
contamination results from the incorporation of ingredients that
contain abnormal ruminant protein derived from specific tissues from
infected animals, and that bans prohibiting incorporation of ruminant
protein into ruminant feed are imposed to mitigate risk (Wilesmith, et
al., 1988; 1991; 1992).
In subsequent rulemaking documents, we elaborated further on the
role and effect of a feed ban. In our January 2007 proposed rule, which
we described earlier in this document, we discussed data associated
with a ruminant-to-ruminant feed ban in the United Kingdom and
indicated that experience in the United Kingdom demonstrates that
implementation of a ruminant-to-ruminant feed ban causes BSE

[[Page 15853]]

prevalence to decrease. We noted that as a result of reducing the
recycling of infectivity in the United Kingdom, the annual incidence of
BSE fell by 99.4 percent, from 36,680 animals in 1992 to 203 in 2005
(DEFRA 2006a) and concluded that there is every reason to expect
downward pressure on the prevalence of BSE in any country that
implements a feed ban.
The conditions for the importation of ruminant products and
byproducts from BSE minimal-risk regions that we proposed in November
2003 were proposed as changes to parts 94 and 95 of the regulations.
The commodities addressed by the proposed changes to part 94 included
meat and other edible products derived from ruminants. Part 95
addressed the importation of byproducts derived from ruminants.

Changes Regarding the Importation of Meat From Bovines Proposed in
November 2003

As set forth in our November 2003 proposed rule, the provisions in
part 94 for the importation of meat derived from bovines from BSE
minimal-risk regions required that the following conditions be met:
The 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;
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 APHIS
Administrator as adequate to prevent contamination or commingling of
the meat with products not eligible for importation into the United
States;
The intestines of the bovines were removed at slaughter;
and
The product qualifies as meat under the definition of meat
in the FSIS regulations at 9 CFR 301.2.
As noted, one of the conditions for the importation of bovine-
derived meat from BSE minimal-risk regions was that the bovines from
which the meat is derived be less than 30 months of age when
slaughtered. The relevance of the age of the animal to the risk of BSE,
which we explained earlier in this document under the heading ``Tissue
Localization,'' pertains to which tissues in a BSE-infected bovine have
been demonstrated to contain BSE infectivity and the age at which a
BSE-infected animal has been found to show infectivity in those
tissues. In essence, as we stated in our November 2003 proposed rule,
the proposed restriction on the age of the animals from which the
commodity was derived was a measure to guard against the importation
of, or contamination of meat through contact with, SRMs.
As noted above, after a BSE-infected cow of Canadian origin was
discovered in Washington State in December 2003, both FSIS and FDA
implemented significant additional measures in the United States to
protect human health. Among the measures taken by FSIS and FDA was to
declare SRMs to be inedible and require their removal from cattle at
slaughter. FSIS designated as SRMs the brain, skull, eyes, trigeminal
ganglia, spinal cord, vertebral column (excluding the vertebrae of the
tail, the transverse process of the thoracic and lumbar vertebrae, and
the wings of the sacrum), and DRG of cattle 30 months of age or older,
and the tonsils and distal ileum of the small intestine of all cattle.
To ensure effective removal of the distal ileum, FSIS also required all
slaughtering and processing establishments to develop, implement, and
maintain written procedures for the removal, segregation, and
disposition of SRMs. Establishments were specifically required to
implement procedures to address the potential contamination of edible
materials with SRMs before, during, and after entry into the
establishment. As noted above, FSIS did not restrict the age of cattle
eligible for slaughter. Even if a BSE-infected cow 30 months or older
that was presented for slaughter were not exhibiting clinical signs of
the disease and passed ante-mortem and post-mortem inspections, the
removal of SRMs from the cow would effectively mitigate the BSE risk to
humans.
As discussed above, pursuant to the Federal Meat Inspection Act,
implementation in the United States of those mitigation measures by
FSIS meant that any country seeking to export beef to the United States
would have to have equivalent mitigation measures in place. FSIS
determined the SRM requirements implemented by Canada in July 2003 to
be equivalent to FSIS' requirements.
As noted above, in March 2004, APHIS published a proposed rule and
reopening of comment period in the Federal Register in which we
explained why the detection of an imported BSE-infected cow did not
alter the conclusions we had reached in the assessment of risk on which
our November 2003 proposed rule was based. We explained further that,
in fact, the resulting additional measures put in place by FSIS (i.e.,
declaring SRMs to be inedible and requiring their removal from cattle
at slaughter) provided a basis for our removing from the provisions we
had proposed in November 2003 the age restriction on cattle from which
meat could be derived for export to the United States. In the March
2004 proposed rule and reopening of comment period, we stated that we
did not believe it was necessary to require that beef imported from BSE
minimal-risk regions be derived only from cattle less than 30 months of
age, provided measures equivalent to those established by FSIS in the
United States to ensure that SRMs are removed when the animals are
slaughtered are in place in the exporting country and that such other
measures as are necessary are in place.
As noted above, in January 2005 we published in the Federal
Register a final rule that established the criteria for BSE minimal-
risk regions, listed Canada as a BSE minimal-risk region, and specified
conditions for the importation from BSE minimal-risk regions for live
animals and meat, meat byproducts, and meat food products. For the
reasons we discussed in our March 8, 2004, Federal Register document,
the final rule did not limit the importation of bovine-derived meat
from Canada to that derived from cattle younger than 30 months of age.
In the final rule, we set forth in part 94 the following conditions for
the importation from BSE minimal-risk regions of meat, meat byproducts,
and meat food products derived from bovines:
The bovines from which the meat, meat byproduct, or meat
food product is derived have been subject to a ruminant feed ban
equivalent to the requirements established by the U.S. Food and Drug
Administration at 21 CFR 589.2000;
The meat, meat byproduct, or meat food product is derived
from bovines for which an air-injected stunning process was not used at
slaughter; and
The SRMs and small intestine of the bovines were removed
at slaughter.
As noted above, in March 2005, APHIS published a document in the
Federal Register that, pursuant to an announcement by the Secretary of
Agriculture on February 9, 2005, delayed the applicability of the
provisions of the January 2005 final rule as they applied to the
importation from Canada of the following commodities when derived from
bovines 30 months of age or older when slaughtered: (1) Meat, meat food
products, and meat byproducts other than liver; (2) whole or half
carcasses; (3) offal; (4) tallow composed of less than 0.15 percent
insoluble impurities that is not otherwise eligible for importation
under 9 CFR 95.4(a)(1)(i); and (5) gelatin

[[Page 15854]]

derived from bones of bovines that is not otherwise eligible for
importation under 9 CFR 94.18(c).
In his February 9, 2005, announcement, the Secretary stated that,
because ongoing investigations into the January 2005 finds of BSE in
Canada in animals over 30 months of age were not complete, he felt it
prudent to delay the effective date for allowing imports of meat from
bovines 30 months of age and over. He also indicated that the delay of
applicability would address concerns that the January 2005 final rule
allowed the importation of meat from bovines 30 months of age or older
while continuing to prohibit the importation of live cattle 30 months
of age or older for processing in the United States. The Secretary
stated that the Department would consider and develop a plan--based on
the latest scientific information and with the protection of public and
animal health as the highest priority--to allow imports of live bovines
30 months of age or older.
As discussed earlier in this document, in January 2007 we published
a proposed rule in the Federal Register to, among other things,
establish conditions for the importation from BSE minimal-risk regions
of live bovines for any use born on or after a date determined by APHIS
to be the date of effective enforcement of a ruminant-to-ruminant feed
ban in the region of export.
As noted above, in September 2007, we published a final rule in the
Federal Register that adopted the changes to the regulations we had
proposed in January 2007. Additionally, the September 2007 final rule
removed the partial delay of applicability of the January 2005 final
rule with respect to meat and certain meat products and byproducts
derived from cattle over 30 months of age that we addressed in our
March 2005 notice. In our September 2007 final rule, we stated that,
subsequent to implementation of the partial delay of applicability,
``we [had] obtained additional information regarding all aspects of the
issues that prompted the delay of applicability and [had] conducted
additional analyses'' as indicated by the Secretary in February 2005 to
allow imports of live bovines 30 months of age or older (72 FR 53316).
As we concluded in our September 2007 final rule, the risk
assessment for that final rule demonstrates the negligible BSE risk
from the importation of additional classes of live bovines, including
those 30 months of age or older.

II. Issues Raised in Response to Request for Comments

The September 2007 final rule, which included the removal of the
partial delay of applicability of the provisions of the January 2005
rule relating to meat derived from cattle 30 months of age or older,
became effective on November 19, 2007.
As noted above, on September 18, 2008, we published in the Federal
Register a document that provided the public with notice and further
opportunity to comment on the provisions of our January 2005 final rule
regarding the importation from BSE minimal-risk regions of beef from
bovines 30 months of age or older when slaughtered, for which the delay
of applicability was removed in our September 2007 final rule. We
solicited comments for 60 days ending November 17, 2008.
We received 12 comments by that date, including one submission that
included a compilation of comments from a large number of individuals.
The comments were from individual private citizens; associations of
producers of livestock and other agricultural commodities, both in the
United States and Canada; associations of meat processors; a consumer
organization; and the Government of Canada. We carefully considered all
comments received and we discuss in the following section the issues
raised by the commenters and our response to those issues.

Comments in Support of the Removal of the Delay of Applicability

Five of the comments expressed support for the removal of the delay
of applicability of provisions of our January 2005 final rule.
The remainder of the commenters opposed the removal of delay of
applicability. Of those commenters, several provided no information to
support their opposition. Others expressed general concern that
allowing the importation of bovines and commodities derived from
bovines from BSE minimal-risk regions would create an unacceptable
disease risk. We discuss in the following section specific issues
raised by commenters who opposed the removal of delay of applicability.

Meat Derived From Bovines Less Than 30 Months of Age

As noted above, one of the import conditions in the November 2003
proposed rule was that meat imported from bovines slaughtered in BSE
minimal-risk regions be derived from bovines less than 30 months of age
when slaughtered. Also as noted, in March 2004 we published a proposed
rule and a reopening of the comment period for the November 2003
proposed rule. We explained in that document that we believed BSE risk
mitigation measures implemented by FSIS subsequent to our November 2003
proposed rule provided a basis for removing from the proposed
provisions the requirement that beef imported from BSE minimal-risk
regions be derived only from cattle less than 30 months of age, with
the provision that equivalent measures are in place to ensure that SRMs
are removed when the animals are slaughtered and that such other
measures as are necessary are in place.
Issue: In our September 2008 request for comments, we included a
chronology of the relevant rulemaking documents that had preceded the
request for comments and referenced our March 2004 proposed rule and
reopening of the comment period for the November 2003 proposed rule.
One commenter stated that, in our September 2008 document, we
mischaracterized our March 2004 proposed rule and reopening of the
comment period as proposing to allow the importation from BSE minimal-
risk regions of beef derived from cattle of any age. The commenter
stated that the March 2004 proposed rule and reopening of the comment
period contained no reference to the importation of beef from cattle of
any age and instead continued to propose a restriction on the age of
cattle by retaining the requirement contained in the November 2003
proposed rule that the beef be derived from animals that are not known
to have been fed ruminant protein, other than milk protein, during
their lifetime.
Response: When we stated in our September 2008 request for comments
that our March 2004 proposed rule and reopening of the comment period
proposed to allow the importation of beef derived from cattle of any
age, our intent was to explain that, under the provisions of the March
2004 proposed rule and reopening of the comment period, the fact that
bovines from which meat and meat products intended for importation into
the United States from a BSE minimal-risk region were 30 months of age
or older when slaughtered would not in itself preclude the commodities
from being imported. We were not referring to any effect the feed ban
requirement might have on the import eligibility of the commodities.
The terminology regarding ``cattle of any age'' that we used in our
September 2008 request for comments was

[[Page 15855]]

consistent with that which we used in the risk analysis for our January
2005 final rule (APHIS, 2004).
Issue: One commenter noted that the risk assessment APHIS conducted
for its January 2005 final rule identified as a requirement for the
importation of bovine-derived meat and meat products from a BSE
minimal-risk country that veterinary officials in the exporting country
certify that the animals from which the meat and meat products were
derived were subject to a feed ban considered equivalent to that in
place in the United States. The commenter also noted that APHIS'
November 2003 proposed rule included a requirement that bovine-derived
meat imported from a BSE minimal-risk region be derived from bovines
that were not known to have been fed ruminant protein, other than milk
protein, during their lifetime.
The commenter noted, further, that, in APHIS' September 2008
request for comments, we stated that, with respect to the importation
of meat, the 30-month age restriction contained in our November 2003
proposed rule was a measure to guard against the importation of, or
contamination of meat through contact with, tissues other than meat
that have the potential of containing high levels of BSE infectivity.
According to the commenter, that wording mischaracterized APHIS'
rationale in the November 2003 proposed rule regarding the 30-month age
restriction on bovines from which meat and meat products were derived.
The commenter stated that APHIS' true intention regarding the 30-month
age restriction was to prevent the importation of products derived from
Canadian cattle that had been exposed to BSE infectivity.
The commenter cited text from the risk assessment conducted for
APHIS' 2005 final rule that stated that the risk of introducing BSE
infectivity can be reduced by requiring that animals presented for
export and animals from which meat or meat products intended for export
were derived were subject to a ruminant feed ban. Additionally, the
commenter cited text from (1) APHIS' November 2003 proposed rule that
stated that animals, and the products derived from those animals, will
present a lower risk if the animals were born after the implementation
of an effective feed ban and (2) from the risk assessment APHIS
conducted for its January 2005 final rule that stated that, in
addition, Canadian cattle less than 30 months of age would have been
born and raised during a time when the Canadian feed ban had been in
place for more than 5 years, and, based on evidence of a high level of
compliance with the feed ban, are unlikely to have been exposed to the
BSE agent.
The commenter discussed APHIS' provisions regarding two specific
products derived from bovines--tongues and liver--to support the
commenter's contention that APHIS' true intent regarding the 30-month
age restriction on bovines from which meat and meat products are
derived was to prevent the importation of products derived from
Canadian cattle that had been exposed to BSE infectivity, rather than
to guard against the importation of, or contamination of meat through
contact with, tissues other than meat that have the potential of
containing high levels of BSE infectivity.
With regard to tongues, the commenter stated that APHIS' November
2003 proposed rule would have allowed the importation of bovine
tongues, even tongues derived from cattle 30 months of age or older,
despite the fact that APHIS acknowledged that tongues are connected to
and bear the risk of contamination by tonsils, which the commenter
stated have the potential of containing high levels of BSE infectivity.
The commenter stated that, to mitigate this risk, APHIS proposed to
require that tongues be derived from cattle from which the tonsils were
removed at slaughter and that were born after the implementation of an
effective feed ban and were not known to have been fed ruminant
protein, other than milk protein, during their lifetime.
The commenter pointed to a similar situation regarding bovine-
derived liver from BSE minimal-risk regions. The commenter stated that
APHIS' November 2003 proposed rule would have allowed the importation
of liver that was not subject to the 30-month age restriction, even
though, according to APHIS, it was susceptible to contamination by
brain emboli, tissues that have the potential of containing high levels
of BSE infectivity. The commenter noted that, in APHIS' November 2003
proposed rule, the only mitigation of the potential for the
contamination of liver by the BSE agent was the requirement that the
liver not be derived from cattle for which an air-injected stunning
process was used at slaughter. The commenter noted that in APHIS'
January 2005 final rule, however, the importation of liver from BSE
minimal-risk regions was governed by the same conditions as those set
forth for other types of meat from bovines, including the requirement
that liver be derived from bovines that were subject to a ruminant feed
ban.
Response: We consider the commenter's assertion to be inconsistent
with APHIS' stated intent in its rulemaking documents and supporting
risk analyses, with the regulatory provisions of previous rulemaking
documents, and with internationally accepted scientific literature.
In presenting the issues noted above, the commenter seems to be
incorrectly concluding that two separate risk mitigation measures we
included in our November 2003 proposed rule--(1) a prohibition on the
importation from BSE minimal-risk regions of bovine-derived meat and
meat products from animals that were 30 months of age or older when
slaughtered, and (2) a requirement that the animals from which the
commodities were derived were subject to a ruminant feed ban--were
intended to mitigate BSE risk in the same way, i.e., by preventing the
importation of products derived from Canadian cattle that had been
exposed to BSE infectivity.
The commenter's characterization of APHIS' rationale for the 30-
month age restriction is inconsistent with the explanation we provided
in our November 2003 proposed rule. In the November 2003 proposed rule,
we explained in detail the likelihood that specific tissues in a BSE-
infected bovine of a certain age will contain the disease agent and how
that likelihood influences the risk of BSE transmission from an
infected animal. We stated in the proposed rule that ``levels of
infectious agent in certain tissues vary with the age of an animal, so
the age of the animal influences risk'' (68 FR 62390), then discussed
in detail the research findings supporting that statement. We concluded
our discussion of the influence of the age of the animal on BSE risk by
stating that ``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.'' (62 FR 62391)
As we discuss earlier in this document, in our March 2004 proposed
rule and reopening of the comment period, we explained that, in light
of the SRM removal requirements implemented in the United States by
FSIS following the diagnosis of BSE in Washington State in December
2003 in a cow imported from Canada, we did not believe it would be
necessary to require that beef imported from BSE minimal-risk regions
be derived only from cattle less than 30 months of age, provided
equivalent measures are in place to ensure that SRMs are removed

[[Page 15856]]

when the animals are slaughtered, and that such other measures as are
necessary are in place. In our September 2007 final rule, we emphasized
that the removal and disposal of SRMs is the key factor in the food
safety of products from bovines used for human consumption.
The ``other measures'' regarding the importation of bovine-derived
meat, meat byproducts, and meat food products and meat products from
BSE minimal-risk regions set forth in our January 2005 final rule were
that (1) the commodity be derived from bovines that have been subject
to a ruminant feed ban equivalent to the requirements established by
FDA in the United States and (2) the commodity be derived from bovines
for which an air-injected stunning process was not used at slaughter.
As the commenter noted, effective enforcement of a ruminant-to-
ruminant feed ban reduces the risk that an animal will be exposed to
the BSE agent. However, the removal of SRMs from bovines is an
effective means of mitigating the risk of BSE transmission to humans
from meat, meat products, and meat byproducts derived even from an
exposed animal. In comparison, the BSE regulations for live bovines
imported from a BSE minimal-risk region require that the animals were
born after the date of effective enforcement of a ruminant-to-ruminant
feed ban to reduce the likelihood that a BSE-infected live animal is
imported into the United States.
Requiring that SRMs be removed from bovines from which meat and
meat products are derived, as is required in both the United States and
Canada, ensures that tissues containing BSE infectivity are removed
even from a BSE-infected animal that might be presented for slaughter
showing no visible signs of BSE. We note that the OIE Code for trade in
fresh meat and meat products from cattle from countries of controlled
BSE risk (both Canada and the United States are classified as countries
of controlled BSE risk by the OIE) recognizes the negligible risk
presented by such products as long as SRMs are removed. Therefore, the
Code does not recommend that the date of birth of the animal from which
the commodity was derived be a condition for such trade, or that the
commodity be accompanied by certification that the animal was subject
to a feed ban.
APHIS' confidence in the effectiveness of SRM removal in reducing
BSE risk was demonstrated in a final rule that APHIS published in
December 2005 to allow the importation, under certain conditions, of
boneless beef from Japan. Although that rulemaking differs from the
rulemaking APHIS conducted regarding BSE minimal-risk regions in the
sense that the only commodity addressed in the Japan rulemaking was
boneless beef--whereas a more extensive list of commodities was made
eligible for importation into the United States from BSE minimal-risk
regions--it is significant to note that the conditions in Sec. 94.27
of the regulations for the importation of boneless beef from Japan do
not include the requirement that the bovines from which the beef was
derived were subject to a feed ban. The requirements for the
importation of boneless beef from Japan are that it be prepared in an
establishment eligible to have its products imported into the United
States under the Federal Meat Inspection Act and the FSIS regulations
in 9 CFR 327.2, that it meet all other applicable requirements of the
Federal Meat Inspection Act and regulations thereunder (9 CFR chapter
III), including the requirements for the removal of SRMs and the
prohibition on the use of air-injection stunning devices prior to
slaughter on cattle from which the beef is derived, and that it be
derived from cattle that were not subjected to a pithing process at
slaughter.
Although a ruminant-to-ruminant feed ban reduces the possibility of
exposure of bovines to the BSE agent and is an important measure in
mitigating the risk that BSE will be transmitted in a region, it serves
a different role in BSE mitigation than does SRM removal.
Issue: One commenter stated that APHIS, in its September 2008
request for comments, explained that the conclusion reached in the risk
assessment for the September 2007 final rule regarding the negligible
BSE risk from the importation of cattle from Canada, even those 30
months of age older, gave further support to the conclusion of the risk
analysis conducted for APHIS' 2005 final rule that the importation of
meat and meat products derived from bovines from BSE minimal-risk
regions posed a low BSE risk, provided certain conditions were met.
The commenter stated that both the risk assessment for APHIS' 2007
final rule regarding the importation of live older bovines and the risk
assessment for APHIS' 2005 final rule were predicated on a bovine's
being subject to a feed ban during its entire lifetime and that neither
the January 2005 final rule nor the risk analysis that accompanied that
rule addressed the risk of BSE contamination in meat or meat products
derived from cattle that were born prior to the date of effective
enforcement of Canada's feed ban. Therefore, stated the commenter,
APHIS had no basis to lift its restriction on the importation of beef
from Canadian cattle that were over 30 months of age when slaughtered.
The commenter stated further that APHIS, in its September 2007
final rule, deleted from the regulations without explanation the
requirement that bovine-derived meat and meat products imported from a
BSE minimal-risk region be derived from an animal that had been subject
to a feed ban.
Response: The commenter is incorrect in stating that the September
2007 final rule removed the requirement that bovine-derived meat and
meat products, and certain byproducts, imported from a BSE minimal-risk
region be derived from animals that had been subject to a feed ban.
With regard to the commenter's discussion of the wording we used in
our September 2008 request for comments in referring to our risk
assessments, although we acknowledge that the wording we used in that
document could be interpreted in several ways, our intent was to
compare the likelihood of BSE introduction into the United States
through the importation of live bovines from Canada with the likelihood
of BSE introduction through the importation of bovine-derived meat and
meat products from Canada. In making such a comparison, we referred to
the risk assessments for our January 2005 and September 2007 final
rules, in which we explained in detail the role of SRMs in BSE
transmission and the effectiveness of reducing the likelihood of BSE
transmission through the removal of SRMs at slaughter. Our point was
that, if, as we concluded in our September 2007 final rule, the risk of
BSE exposure in the United States from the importation of live
bovines--with SRMs intact--from Canada is negligible, then the
importation of bovine-derived meat and meat products from Canada would
present even less of a risk, because the SRMs from the bovines from
which the meat and meat products were derived would have been left
behind in Canada.

Effectiveness of Canadian Inspection System

As discussed above, one of the required risk mitigation measures
for bovine-derived meat and meat products imported from Canada is that
the SRMs of the bovines from which the commodities are derived were
removed at slaughter.

[[Page 15857]]

Issue: Several commenters expressed concern about the ability of
Canadian food inspectors to ensure that meat products are free from
SRMs. One commenter stated that, in a 2007 audit of Canadian food
establishments eligible to export to the United States, FSIS reported
the following: ``Inspection system controls at all levels were not
fully developed and implemented. There were many instances of
deficiencies both in the documentation reviews and in the operations
audits that should have been addressed prior to the FSIS audit. Some
inspection personnel were not well-trained in the performance of their
inspection tasks.'' (The commenter cited ``Food Safety and Inspection
Service, United States Department of Agriculture, ``Final Report of an
Audit Carried Out in Canada Covering Canada's Meat, Poultry, and Egg
Products Inspection System, May 1 through June 6, 2007'', http://
www.fsis.usda.gov/OPPDE/FAR/Canada/Canada2007.pdf.'')
Response: In addressing this issue, FSIS has stated that, with
respect to the FSIS audit of Canada in 2007, FSIS specifically assessed
controls for SRM removal in Canada and identified no related
deficiencies. With regard to the other deficiencies identified in the
2007 audit, FSIS stated that none caused FSIS to question whether the
Canadian inspection system was adequate with regard to SRM control.
FSIS has included a review of controls for SRM removal in its audits
since 2005. In each review--including audits conducted in February
2005, April-May 2006, May-June 2007, and May-June 2008--no deficiencies
were noted in relation to SRM removal and other BSE-related
requirements.
Issue: One commenter stated that the Canadian Food Inspection
Agency (CFIA) is considering weakening government food inspection and
turning the inspection process over to industry and that further
deregulation of meat inspection in Canada would endanger U.S. public
health.
Response: In addressing this issue, FSIS has informed APHIS that
FSIS has been in contact with CFIA, including follow-up discussions
about possible changes to the inspection system in Canada. FSIS is not
aware of any substantive planned changes at this time. Any changes
affecting meat, poultry, or processed egg product destined for the
United States would require discussion related to equivalency to the
U.S. inspection system.
Issue: One commenter stated that, although APHIS' September 2008
request for comments indicated that FSIS has determined that Canada has
implemented food safety requirements that are equivalent to those in
the United States, including Canada's July 2003 requirements regarding
SRMs, there is a disparity between what FSIS is supposed to require of
foreign plants that ship products to the United States and what is
actually practiced.
Response: In 2005, FSIS conducted an enforcement audit to evaluate
Canada's implementation of SRM controls for products destined for the
United States. FSIS concluded that SRM controls had been effectively
implemented, in accordance with FSIS regulatory requirements, in
Canadian establishments certified to export beef to the United States.
The audit led to no delistments of eligible establishments, nor to any
notices of intent to delist eligible establishments.\4\
---------------------------------------------------------------------------

\4\ Delistment of an establishment removes it from the list of
establishments authorized to export meat and meat products to the
United States. A notice of intent to delist is issued to an
establishment that conducts marginally acceptable practices, and
puts it on notice that it will be delisted unless specified
improvements are made.
---------------------------------------------------------------------------

Issue: One commenter cited a December 2005 report by the USDA's
Office of Inspector General (OIG) that stated, in part:

In July 2003, FSIS found that Canadian inspection officials were
not enforcing pathogen reduction and HACCP system regulations. These
same types of concerns were identified again in June 2005, almost 2
years later. However, as of September 2005, FSIS has not made a
determination whether the identified concerns are serious enough to
limit the import of Canadian products. As a result, FSIS has allowed
the importation of almost 700 million pounds of meat and poultry
from plants that did not receive daily inspection, a requirement for
all U.S. meat and poultry plants. Additionally, FSIS allowed the
import of over 261 million pounds of ready-to-eat meat and poultry
that had not been subjected to finished product testing for Listeria
monocytogenes, as is required of U.S. plants. (The commenter cited
``Audit Report Food Safety and Inspection Service Assessment of the
Equivalence of the Canadian Inspection System, U.S. Department of
Agriculture, Office of Inspector General, Northeast Region, Report
No. 24601-05-Hy, December 2005, at 4.'')

The commenter stated that, according to the OIG, FSIS does not have
protocols or guidelines for evaluating deficiencies in a country's
inspection system that could jeopardize a country's overall equivalence
determination and that FSIS did not institute compensating controls to
ensure that public health was not compromised while deficiencies were
present.
Response: As noted in the OIG report, FSIS addressed audit
deficiencies with CFIA officials during and immediately following the
2003 and 2005 audits. For those deficiencies that had potential impact
on public health, FSIS auditors required the establishments to take
immediate corrective actions. In some instances, FSIS also required
enforcement action to be taken by Canadian authorities. These
enforcement actions included immediate delistment of the establishment
or the issuance of a warning letter requiring specific corrective
actions within 30 days. FSIS' analysis of the audit reviews have
identified and resolved all potential public health concerns.
Issue: One commenter stated that, in a follow-up report issued by
the OIG in August 2008, the OIG reported that FSIS could not
demonstrate that the number of intensified inspections for physical and
laboratory failures provided the appropriate level of protection to
ensure the safety and wholesomeness of imported products.
Response: In response to Recommendation 8 of OIG audit
24601-08-Hy, FSIS agreed with OIG's findings and stated that FSIS would
determine the appropriate number of intensified inspections needed
following physical and laboratory failures to ensure the safety and
wholesomeness of imported products.\5\ After further analysis of
available data, FSIS determined that the current number of intensified
inspections for laboratory and physical failures is sufficient and
appropriately established. Thus, according to FSIS, further revisions
to the FSIS procedures for intensified inspections are unnecessary.
---------------------------------------------------------------------------

\5\ Intensified inspections are triggered after a product fails
to pass reinspections for physical and laboratory testing. If the
level of inspection is increased, FSIS management officials have
decided to perform reinspection activities above the normal level of
inspection for a lot, based on problems associated with the specific
product, foreign establishment, or country.
---------------------------------------------------------------------------

Issue: One commenter stated that the OIG found that FSIS could not
demonstrate that it performed an adequate sampling of foreign
establishments to validate that the country's inspection system is
equivalent to that in the United States. The commenter stated, further,
that the OIG found that FSIS did not visit the minimum number of
establishments necessary to validate that inspection systems were
equivalent to that in the United States in three of the four countries
it reviewed and questioned whether FSIS had sufficient data to conclude
that these countries' inspection systems were equivalent to the U.S.
system.

[[Page 15858]]

Response: In response to Recommendation 2 of OIG audit
24601-08-Hy, FSIS has developed and implemented a process to document
the reasons for the number of establishments selected for an on-site
country audit as part of the agenda for the pre-audit conference
between FSIS and the foreign country. In addition, FSIS has implemented
a statistically based sampling plan using a country's recent history of
overall compliance with FSIS requirements, as well as information
provided by the country on a continuous basis, in determining that the
foreign country's inspection system is performing adequately.

Efficacy of SRM Removal in Mitigating the Risk of BSE

Issue: One commenter stated that the risk modeling the commenter
said APHIS relies on to support its claim that SRM removal alone is
sufficient to mitigate the potential BSE risk to humans shows
otherwise. The commenter stated that the risk modeling shows that there
are two significant factors that contribute to the reduction in
potential BSE risk to humans: (1) The amount of BSE infectivity in
circulation (based on the number of BSE-infected cattle), and (2)
compliance with SRM removal requirements. The commenter stated that the
influence of the amount of BSE infectivity is demonstrated by the fact
that when the 2005 risk model was updated to include the presence of
BSE-contaminated poultry litter, resulting in more BSE-infected cattle,
the effectiveness of SRM removal in reducing potential BSE risk to
humans was decreased by nearly half (from 20 oral ID50s to
11oral ID50s) \6\ even with perfect compliance with SRM
removal requirements.\7\ (BSE infectivity is expressed in terms of
cattle oral ID50s. A cattle oral ID50 is defined
as the amount of infectivity required to cause infection in 50 percent
of an exposed cattle population).
---------------------------------------------------------------------------

\6\ BSE infectivity is expressed in terms of cattle oral
ID50s. A cattle oral ID50 is defined as the
amount of infectivity required to cause infection in 50 percent of
an exposed cattle population.
\7\ The commenter cites Harvard Risk Assessment of Bovine
Spongiform Encephalopathy Update, Phase IA, Supplemental Simulation
Results, December 26, 2006, Appendix 2A, Section 2.1.2c, line 15 (AR
17464); see also Harvard Risk Assessment of Bovine Spongiform
Encephalopathy Update, Phase IA, October 31, 2005, Appendix 2A,
Section 2.1.2, line 15 (AR 17109).
---------------------------------------------------------------------------

The commenter stated that the authors of the risk models further
substantiated that the amount of circulating infectivity impacts human
health even with perfect compliance by explaining why the potential
risk to humans was reduced following a simulation that prohibited SRMs
from being used in both human food and animal feed. The commenter
quoted the authors of the risk model as stating:

Removing infectious tissues from both human food and animal
feed, assuming that the ban effectively covers dead stock, and
assuming perfect compliance, together have a substantial impact on
both the potential human exposure and the spread of BSE * * *.
Potential human exposure decreases both because there are fewer BSE
cases and because the measures remove infectious tissues from the
human food supply. Average human exposure decreases by more than 99
percent from 3,800 cattle oral ID50s to 10 oral
ID50s.'' \8\
---------------------------------------------------------------------------

\8\ The commenter cites the Harvard Risk Assessment of Bovine
Spongiform Encephalopathy Update, Phase IA, October 31, 2005, at 29
(AR 17086).

Response: The commenter appears to be attempting to use various
model results to suggest that the SRM restrictions simulated in the
models are not sufficient to mitigate the public health risk when there
are higher numbers of infected animals present. However, the model
results themselves do not support this conclusion. To discuss the
commenter's statements in meaningful context, it is necessary to first
provide a history of the models and model runs referred to.
In 2001, Harvard University provided USDA with the results of an
extensive model that simulated the results of introducing BSE-infected
cattle into the United States. This model has since been used and
updated by both FSIS and APHIS at various times. These uses and updates
include the following that are of significance and/or referenced in
this docket:
2004--FSIS used model runs as part of their ``Preliminary
Analysis of Interim Final Rules and an Interpretive Rule to Prevent the
BSE Agent from Entering the U.S. Food Supply.''
October 2005--FSIS asked Harvard to update the model and
run several simulations, and these were published for public comment
``Harvard Risk Assessment of BSE Update; Phase IA, October 31, 2005.''
December 2006--FSIS/Harvard incorporated changes based on
public comment from the October 2005 simulations. This was made public,
along with the responses to the public comments as ``Harvard Risk
Assessment of BSE Update; Phase IA; Supplemental Simulation Results,
December 26, 2006.''
September 2007--APHIS used the model, with amendments, as
part of the risk assessment supporting its September 2007 final rule.
The quantitative model was used to support the exposure assessment of
the risk assessment.
In each of these instances, the assumptions used, the scenarios
examined, and even the model itself differed from those in the others.
It is therefore challenging to compare results from different instances
of using the model without understanding the changes in the assumptions
and the simulations. In the following paragraphs, we summarize these
different model runs in chronological order and provide selected
results from each, to help clarify the interpretation of the results.
2004: In this instance, FSIS used a modified version of the 2001
Harvard BSE risk assessment model (as revised by Harvard in response to
peer review comments). The baseline estimate assumed that five BSE-
infected animals were imported into the United States in 2003. The
model then simulated the spread of BSE infectivity until 2020. The
analysis assumed that measures implemented in the United States to
prevent the spread of BSE--e.g., the FDA feed ban--were in place at the
time that infectivity was introduced. FSIS simulated the introduction
of public health risk mitigation options--i.e., restrictions on SRMs
and advanced meat recovery (AMR)--and assumed that these were
implemented in 2004, 1 year after the infectivity was introduced.
Therefore, because of these assumptions, the simulated mitigation
options could never remove all of the infectivity that could be
available for human consumption over the model simulation timeframe. In
other words, BSE infectivity could enter the human food supply for 1
year before FSIS mitigations took effect. In the baseline analysis,
with five infected animals introduced into the United States, over the
17-year simulation a mean of slightly less than two additional animals
were affected. The baseline level of potential human exposure for the
introduction of 5 infected animals--with no SRM risk mitigation options
in place during the 17-year simulation--was an average of 22 cattle
oral ID50s over the 17-year timeframe. With the introduction
of SRM and AMR requirements (essentially the same requirements as those
established by the FSIS regulations), the potential human exposure was
an average of 7.5 cattle oral ID50s over the 17-year
simulation. This was an 80 percent reduction in this simulation. Again,
it is important to note that the public health assumptions used in
these simulations could never remove more than 90 percent of the
potential human exposure from the simulation.

[[Page 15859]]

In 2005 and 2006, FSIS again used the model to simulate a variety
of risk mitigation options. The original simulations were published in
October 2005 and public comment on the model and the assumptions used
was invited. In response to the public comments received, some changes
were made to the model and the assumptions, and the final results were
published in December 2006. The base case in each of these simulations
represented the circumstances in the United States prior to December
2003--i.e., with an FDA feed ban in place prior to the introduction of
infected animals. In each scenario, 500 infected animals were
introduced at one time and the model ran a total of 50,000 simulation
runs for each scenario. The scenarios considered included various food
safety measures, animal health measures (changes to the feed ban), and
combinations of both.
The October 2005 model included the following results. The results
of the base case simulation--500 infected animals and a simulation
timeframe of 20 years--indicated a mean of 680 total infected animals
over the 20 years (500 imported animals and 180 domestic animals) and a
mean of 3,800 cattle oral ID50s potentially available for
human consumption. In comparison, the scenario that modeled a
comprehensive ban from human food of SRMs from cattle 30 months of age
or older (which we refer to below as ``30-month SRM restrictions'')
yielded similar results for the number of infected animals, but with a
mean of only 11 cattle oral ID50s potentially available for
human consumption over the entire 20-year timeframe. The authors noted
that they found that the food safety measures enacted by USDA all
reduce potential human exposure to BSE infectivity but have little
effect on spread of BSE in the cattle population. They also
specifically noted that the results of the food safety measures enacted
were relative reductions to what is already a small risk in absolute
terms, especially in light of the fact that these simulations reflect
the assumed introduction of 500 infected cattle into the United States.
One other scenario modeled in this report was a removal of SRMs of
animals 12 months and older (which we refer to below as a ``12-month
SRM restrictions'') from both the human and the animal food chain. This
scenario decreased the number of infected animals to a mean of 540
total infected animals over the 20 years (including both imports and
domestic cases) and indicated a mean of 9.8 cattle oral
ID50s potentially available for human consumption. The
authors conclude that this scenario indicates potential human exposure
decreases both because there are fewer BSE cases and because the
measures remove infectious tissues from the human food supply, although
the amount of infectivity potentially available for human consumption
(9.8 oral ID50s) was not significantly different from the
simulation that modeled SRM removal (30 months of age and older) from
only the human food supply. In other words, the number of BSE cases
(680 total in the simulation with SRM removal from only human food as
compared to 540 total in the simulation with SRM removal from both
human and animal food chain) did not appear to significantly impact the
potential human exposure.
The December 2006 model provided similar results in many ways. This
report included a change to explicitly model contamination of cattle
feed as a result of the recycling of poultry litter. The base case
again simulated 500 infected animals introduced, with 50,000 simulation
runs of 20-year timeframes. The base case results indicated a mean of
700 total infected animals over the 20 years (500 imported animals and
200 domestic animals), with a mean of 6,600 cattle oral
ID50s potentially available for human consumption. Modeling
a requirement for removal from the human food supply of SRMs from
cattle 30 months of age or older, with 100 percent compliance,
indicated a mean of 20 oral ID50s potentially available for
human consumption over the 20-year time period. This same requirement,
with an assumption of 99 percent compliance, indicated a mean of 83
oral ID50s potentially available for human consumption.
APHIS used a modified version of the Harvard model as part of the
risk assessment that supported the September 2007 final rule.
Specifically, we used the quantitative model in our exposure assessment
to consider less likely scenarios. The model simulated BSE release and
exposure in the United States over 20 years, with the introduction of
infected animals from Canada at a constant rate over the entire period.
We assumed that the existing FDA feed ban requirements were in place
throughout the 20 years, and that FSIS and FDA restrictions on SRMs in
human food were the same as implemented in 2004. The base case scenario
results indicated that the importation of approximately 19 infected
animals leads to approximately 2 U.S. cases as secondary spread, for a
total of 21 infected animals over the 20-year period. The base case
indicated a mean of 45 cattle oral ID50s potentially
available for human consumption.
As noted above, the model results themselves do not support what
seems to be the commenter's conclusion that the SRM restrictions
simulated are not sufficient to mitigate the public health risk when
there are higher numbers of infected animals present. Specifically, in
the October 2005 model, both the base case and the 30-month SRM
restrictions from human food indicated the same number of total
infected animals--680 infected animals over the 20-year timeframe. Yet,
the simulation modeling the 30-month SRM restrictions from human food
reduced the mean amount of cattle oral ID50s available for
human consumption from 3,800 to 11. In the scenario where 12-month SRM
restrictions were applied in both human and animal food, although the
number of total BSE cases changed (540 total infected animals), the
amount of oral ID50s potentially available for human
consumption (9.8 oral ID50s) stayed essentially the same as
those in the 30-month SRM restriction scenario (11 oral
ID50s). It should be noted that the assumptions used in the
APHIS base case exposure assessment provided a total of only 21
infected animals over a 20 year time period--significantly less than
the approximately 700 total infected animals in the FSIS simulations.
It is important to place some context around the results of the
amount of infectivity potentially available for human consumption. The
significance of cattle oral ID50s to human exposure and
susceptibility is not known; however, various studies suggest that the
infectious agent may be 10 to 10,000 times less pathogenic in humans
than in cattle because of a species barrier (EC SSC, 2000). Thus, if
the cattle-human species barrier were 100, it would mean that 100 times
more infective material would be required in order to have a similar
probability of infecting a human as a bovine. Comer and Huntly (2003)
estimated, after an evaluation of available literature, that 54,000,000
(54 million) bovine oral ID50s were available for human
consumption in Great Britain from 1980 to 2003. This extremely large
amount of available infectivity has resulted in 168 cases of vCJD
identified or suspected in the United Kingdom through March 2009, plus
a few additional cases identified in other countries but attributed to
exposure in the United Kingdom. When compared to the United Kingdom's
BSE experience and the associated estimate of available bovine oral
ID50s, the mean values of 11 potentially available cattle
oral ID50s--

[[Page 15860]]

or even 20 oral ID50s or 83 oral ID50s--over a
20-year period are miniscule.
Issue: One commenter stated that the prevalence of BSE in Canada is
significantly higher than BSE prevalence in the United States and that
APHIS has no basis to claim that measures implemented in the United
States to mitigate the prevalence of BSE in this country are sufficient
to mitigate a much higher prevalence in Canada. The commenter
referenced a statement by the Centers for Disease Control (CDC) that
the prevalence of BSE in Canada has been 90 percent likely to be
between 18-fold and 48-fold higher than the previously published best
estimate of the prevalence of BSE in the United States. The commenter
stated that CDC notes that, nonetheless, a BSE prevalence in Canada 23-
fold higher than that in the United States continues to be used in the
Harvard Risk Assessments' ``worst case'' analysis when evaluating the
risk of imported Canadian cattle's causing BSE to spread among U.S.
animals.
Response: In comparing the estimate of the prevalence of BSE in the
United States with the estimated prevalence of BSE in Canada, it should
be noted that the estimated number of BSE-infected animals per million
is very low in either case--0.167 cases per million in the United
States and 3 to 8 cases per million in Canada.
The commenter states that prevalence of disease has a significant
impact on the effectiveness of mitigation measures, but provides no
evidence to support this claim. Evidence in countries with significant
outbreaks of BSE indicates that the animal health and public health
mitigation measures are effective, even in the face of significantly
higher prevalence levels. The primary animal health mitigation measure
is a feed ban to prevent the inclusion of potentially infective tissues
from being fed to cattle. This measure has demonstrably worked in the
United Kingdom, a country with a significantly higher prevalence level
relative to other countries. The number of BSE cases identified in
birth year cohorts (all cattle born in a given year) in the United
Kingdom has continued to decline since peaking in 1987. The United
Kingdom established its initial feed ban requirement in 1988. This
continuous decline clearly demonstrates the effectiveness of a feed ban
as an animal health mitigative measure in the face of an outbreak with
high prevalence. Similarly, on the public health side, SRM restrictions
are an effective public health measure, even in a high prevalence
situation. Experience in the United Kingdom and elsewhere in Europe
demonstrates this effectiveness. The models used by FSIS that are
discussed above continue to indicate the effectiveness of this measure,
even when simulating relatively high numbers of infected animals
present in the system. Given all of these points, APHIS has no reason
to believe that the effectiveness of these mitigation measures is
impacted by differences in prevalence levels.
Issue: One commenter stated that it is important to note that
APHIS' estimate of the prevalence of BSE in Canada is based on the
detection of 11 cases of BSE, and that since that estimate was made,
additional cases of BSE in Canadian cattle have been diagnosed. The
commenter stated that APHIS should not rely on outdated prevalence
estimates to evaluate Canada's BSE risk.
Response: In conducting our assessment of the risk of importing
live bovines from Canada under the provisions of the 2007 final rule,
we took into account, among other factors, the estimated prevalence of
BSE in Canada. In discussing our estimate of BSE prevalence in Canada
in that final rule, we explained that the number of BSE cases detected
through surveillance understates the disease prevalence because exposed
animals may be incubating disease and carrying infectious material in
their tissues without presenting clinical symptoms. We noted,
additionally, that surveillance will miss a proportion of detectable
cases. Therefore, as we explained in our 2007 final rule, we applied
statistical methods to the available epidemiologic and surveillance
data to estimate, with attendant uncertainty, the prevalence of BSE in
Canada. Even taking into account this attendant uncertainty, our
qualitative and quantitative assessments of release of BSE into the
United States via the import of live bovines from Canada demonstrate an
extremely low likelihood of release, and that, because of the
comprehensive mitigations already in place in the U.S., the likelihood
of establishment is negligible.
Issue: One commenter noted that the epidemiological investigation
conducted by Canada regarding an animal born in 2003 indicated that the
most likely source of infection was consumption of commercial cattle
feed produced in Canada. The commenter concluded that such information
demonstrates that what the commenter termed ``Canada's widespread BSE
exposure'' occurred because the August 1997 feed ban in Canada failed
to address the cross-contamination of cattle feed with feed produced
for other animals.
The commenter stated that APHIS' statement that its 2005 evaluation
of the feed ban in Canada revealed that overall compliance with the
feed ban is good and that the feed ban was reducing the risk of
transmission of BSE in the Canadian cattle population has been
disproven by subsequent outbreaks of BSE in cattle that were born years
after the implementation of Canada's feed ban. The commenter stated
further that the CDC has reported that occurrence of BSE in Canada has
risen in recent years.
The commenter stated that there is no evidence that the prevalence
of BSE in Canada is decreasing at this time. The commenter noted that
most of the animals diagnosed with BSE in Canada were born after Canada
implemented its 1997 feed ban and that over half of those cases were
born after March 1, 1999, the date that APHIS determined to be the date
of effective enforcement of the feed ban in Canada. The commenter also
noted that more animals determined to be infected with BSE--two--were
born in 2000 than in any other year. Other commenters also expressed
opposition to the removal of the delay of applicability of the
provisions described above because of the diagnosis of BSE in a number
of Canadian-born cows since the diagnosis of BSE in a Canadian-born cow
in May 2003. Some commenters expressed particular concern regarding the
discovery of BSE in Canadian cattle within the past several years. One
commenter stated that Canada's feed ban was not made whole until July
2007, when Canada took steps to ban ruminant protein from all animal
feed and fertilizer. The commenter concluded that USDA should withdraw
the September 2007 final rule and initiate a rulemaking to determine if
Canada's feed ban is likely to have become effectively enforced after
July 2007.
Response: We disagree with the commenters' conclusions. The
commenters suggest that, in order for the Canadian feed ban to be
considered effective, BSE surveillance data would have to demonstrate
that the likelihood of BSE transmission in that country has been
eliminated. However, as noted in the risk assessment for our September
2007 final rule, Canadian BSE surveillance data do not provide a
statistical basis for distinguishing BSE prevalence among birth year
cohorts (APHIS, 2007); the overall prevalence is so low that
distinguishing any difference is nearly impossible. In other words, the
data cannot distinguish any significant difference in prevalence among
animals born in different years, which would have been one way to
demonstrate the effect of a feed ban

[[Page 15861]]

(e.g., if the feed ban were implemented at the beginning of 1997,
surveillance data showing a higher BSE prevalence in animals born in
1996 than in animals born in 1997 would support the effectiveness of
the feed ban). However, in the absence of a feed ban that reduced
exposure to BSE, we would expect the prevalence of the disease to
increase over time. We have no evidence that such an increase has
occurred but we do have data that the feed ban is being enforced.
Furthermore, as we discussed in the risk assessment for our
September 2007 final rule, detection of BSE in an animal born after the
date a feed ban was implemented does not indicate an overall failure of
the measures in place to stem transmission of the disease in that
country. Most other countries that have experienced cases of BSE have
reported similar cases. Human error is expected, which is why the feed
ban is comprised of a number of interrelated measures that have a
cumulative effect. Our risk assessment does not assume 100 percent
compliance with all measures all of the time. We discussed factors
related to the feed ban in Canada since before its implementation in
1997. We considered activities related to inspection and compliance
with the feed ban, the rendering industry, the risk of cross-
contamination, education activities and industry awareness, and on-farm
practices that might contribute to the efficacy of the feed ban. In
addition, we highlighted the fact that since the implementation of the
feed ban on August 4, 1997, Canada has continued to revise and
strengthen its processes and procedures to further enhance the
effectiveness of the feed ban.
With regard to the commenter's recommendation that a date in July
2007 be considered as the date of effective enforcement of a feed ban
in Canada, as we discussed in our September 2007 final rule, we
consider the July 2007 expansion of the Canadian feed ban to be an
enhancement of an already effective ban. In July 2007, Canada modified
its feed ban to remove SRMs from all animal feeds, pet food, and
fertilizer. CFIA, in explaining its rationale for the enhanced ban,
emphasizes that although surveillance results and investigations of BSE
cases indicate that the feed ban in Canada has effectively reduced the
spread of BSE since being implemented in 1997, even compliance with the
ban's requirements left limited opportunities for contamination during
manufacture, transportation, and storage that CFIA considered worth
eliminating. In addition, the accidental misuse of feed on farms with
multiple species could not be discounted. With the enhanced ban, CFIA
projects that the eradication of BSE in Canada will be accelerated.
Following such a regulatory path does not indicate that the feed ban in
Canada prior to July 2007 was not effective or effectively enforced.
Issue: One commenter stated that APHIS, in its September 2007 final
rule, established that SRM removal requirements are approximately 19
percent less effective in preventing human exposure to the BSE agent
when those requirements are applied to cattle born before effective BSE
mitigation measures were in place, such as in cattle born before the
Canadian feed ban became effective.
The commenter discussed analyses that were conducted by FSIS to
estimate the likely reduction of potential human exposure to BSE given
the SRM removal requirements established by that Agency. The commenter
stated that, in its 2004 evaluation, FSIS estimated that the SRM
removal policy adopted by that Agency could reduce potential human
exposure to BSE by 80 percent, based on the assumption that five BSE-
infected animals had been introduced into the United States 12 months
before FSIS implemented its BSE mitigation measures, including SRM
removal. In 2005, stated the commenter, FSIS re-analyzed the likely
reduction in potential human exposure, this time assuming that U.S.
risk mitigation measures were implemented before the introduction of
BSE-infected cattle in the United States. Using that assumption, said
the commenter, FSIS indicated that the mitigation measures implemented
by FSIS in 2004 would reduce potential human exposure by more than 99
percent on average. APHIS discussed the results of this re-analysis in
its September 2007 final rule, stating:

``Since all scenarios [evaluated by FSIS] included at least some
time in which the mitigations were not implemented, under the
simulations, a certain amount of potential infectivity was allowed
into inappropriate channels, such as human food. Because none of
these scenarios incorporated the more realistic assumption that the
mitigations were implemented (even imperfectly) throughout the
simulation period, it is inappropriate to use this analysis as a
citation for the level of public health protection provided by risk
mitigation measures in place in the United States.
A more appropriate analysis for understanding the role of SRM
removal in potential human exposure to BSE infectivity would be the
FSIS update of the same Harvard simulation model that was available
for public comment in 2006 * * *. This updated model used the ``base
case'' as the circumstances in the United States prior to December
2003, and simulated the response of the U.S. system for 20 years
following the import of BSE-infected cattle. FSIS' updated model
estimated the impact of various risk management measures, including
measures that were adopted, considered, or proposed by various
agencies and groups. These simulations, where the risk mitigation
was applied during the entire simulation, as opposed to the
simulation in the [2004] analysis * * * (in which it was not),
indicated that removing SRMs, as currently defined by FSIS, reduced
potential human exposure by more than 99 percent, on average. This
report also stated that ``[i]t is worth noting that these measures
reduce what is already a small exposure in absolute terms.'' (72 FR
53335-53336)

The commenter stated that the latter FSIS analysis is irrelevant to
the issue of risk related to the importation of beef from Canada
derived from cattle 30 months of age or older, because Canada is known
to have had at least three generations of BSE infectivity in its native
cattle herd prior to the time that Canada implemented its BSE
mitigation measures, including SRM removal.
Response: The commenter states that APHIS established that SRM
removal requirements are approximately 19 percent less effective in
preventing human exposure to the BSE agent when those requirements are
applied to cattle born before effective BSE mitigation measures were in
place, such as in cattle born before the Canadian feed ban became
effective. However, APHIS did not establish or suggest such a
conclusion. In our September 2007 final rule, we responded to a
commenter who raised the issue of the FSIS 2004 model, where the
potential human exposure was reduced by only 80 percent. APHIS
explained that this specific use of the model was not appropriate in
completely evaluating the role of SRM removal in potential human
exposure and noted that the FSIS 2005/2006 simulations provided a
better analysis for understanding potential human exposure. APHIS noted
that the FSIS 2004 model included ``* * * at least some time in which
the mitigations were not implemented * * *'' (72 FR 53336). The
commenter appears to have interpreted this to include all mitigations,
including animal health mitigations such as the feed ban. This is
inaccurate, as the FSIS 2004 model assumed that the feed ban
requirements were in place throughout the 17-year time period of the
simulations.
The commenter suggests that use of the FSIS 2005 model is
inappropriate in an evaluation of the risk of imported beef from
Canada, because Canada had infectivity in its cattle herd for at least
three generations prior to implementing SRM restrictions. The commenter
is

[[Page 15862]]

correct that the timeframe of implementing SRM restrictions is
important for public health considerations. However, the commenter's
conclusion that the presence of infectivity in animals prior to the
implementation of SRM restrictions affects the effectiveness of those
SRM restrictions is inaccurate. Requirements to prevent the inclusion
of SRMs in the human food supply provide an immediate public health
impact, regardless of the length of time infectivity may have been
present in animals. These restrictions prevent infectious tissues from
any animal--born before or after a feed ban--from entering the human
food supply. As demonstrated in the FSIS 2005 and 2006 models, they
provide significant public health protection, even over a 20-year
timeframe.
Issue: The commenter stated that APHIS has provided no basis for an
assertion that the rate of compliance with SRM removal requirements for
Canadian cattle slaughtered in either the United States or Canada is
adequate to protect human health. The commenter stated that the
influence of the extent of compliance with SRM removal requirements is
demonstrated by that fact that, all else being equal, when compliance
with SRM removal requirements drops by only 1 percent, the potential
risk to human health is more than quadrupled (increasing from 20 oral
ID50s to 83 oral ID50s).
Response: We disagree that APHIS has not provided a basis for its
conclusion that SRM removal in the United States or Canada constitutes
an effective safeguard of human health with regard to BSE. In our
September 2007 final rule, we established conditions for the
importation into the United States of live bovines born on or after the
date of effective enforcement of a ruminant-to-ruminant feed ban in a
BSE minimal-risk region, as well as conditions for the importation of
other bovine-derived commodities. As part of that rulemaking, we
conducted an assessment of the potential BSE risk of implementing the
provisions of the final rule. The exposure model used for the risk
assessment assumed that SRMs are effectively removed 99 percent of the
time in the United States. This assumption was based on FSIS summaries
of Noncompliance Records performed from January 2004 to May 2005 in
about 6,000 federally inspected meat and poultry establishments. Based
on these records, FSIS estimated that noncompliance with respect to
SRM-related regulations had a frequency of less than 1 percent.
In our September 2007 final rule, we explored the possible impact
of assuming an arbitrary decrease (compared to the results of our
exposure model) in SRM removal compliance in the United States on the
availability of infectivity for human consumption. The model was for
the United States, not Canada, but based on similarities in
slaughterhouse practices in the United States and Canada, we can make a
broad general assumption that the results in Canada would be the same
as those in the United States. As discussed earlier in this document,
in a 2007 audit in Canada, FSIS specifically assessed controls for SRM
removal in Canada and identified no related deficiencies.
In our September 2007 final rule, we discussed the significance of
an order-of-magnitude increase in available infectivity compared to our
model's findings. First, we considered the results of that model, which
uses the unlikely assumption that prevalence in Canada (and thus the
proportion of infected animals imported from Canada) remains constant
over the next 20 years. In the model's scenario, the total amount of
infectivity potentially available for human consumption over the 20
years of the analysis is 45 cattle oral ID50s.
As discussed above, if the cattle-human species barrier were 100,
it would mean that 100 times more infective material would be required
in order to have a similar probability of infecting a human as a
bovine. As noted, the extremely large amount of infectivity available
for human consumption in Great Britain from 1980 to 2003--estimated by
Comer and Huntly (2003) as 54 million bovine oral ID50s--
resulted in 168 cases of vCJD identified in the United Kingdom through
March 2009, plus a few additional cases identified in other countries
but attributed to exposure in the United Kingdom. As discussed above,
when compared to the United Kingdom's BSE experience and the associated
estimate of available bovine oral ID50s, the expected or
average value of 45 cattle oral ID50s indicates that only a
miniscule amount of the BSE infective agent could possibly be available
for potential human exposure in the United States over a 20-year
period. (The potential for human exposure under this scenario is
estimated at 1,200,000 times less in the United States than what the
United Kingdom experienced during its BSE epidemic.) Even if compliance
with the SRM ban were not as high as the 99 percent estimated in our
exposure model, and we were to assume that the infectivity available
for human consumption were increased by an order of magnitude (10x), it
would still be far less than that estimated to have circulated in the
United Kingdom and, we conclude, not be of significance to human
health.
Issue: One commenter noted that APHIS stated in its September 2007
final rule that effective enforcement of a ruminant-to-ruminant feed
ban does not necessarily mean 100 percent compliance with the feed ban
will be achieved. The commenter stated that, although APHIS concludes
that removal of SRMs effectively mitigates the BSE risk to humans
associated with cattle that pass both ante-mortem and post-mortem
inspections, FSIS states that this conclusion regarding the
effectiveness of SRM removal is valid only if compliance is perfect.
The commenter stated that it is arbitrary and capricious for APHIS to
conclude that a feed ban is effective and effectively enforced even
without perfect compliance, while at the same time concluding that SRM
removal requirements provide effective mitigation to human health, even
though such a level of protection is predicated on perfect compliance.
Response: We disagree with the commenter's logic. There are
multiple mitigation measures that contribute to reduction of BSE risk.
Each has its own degree of importance in a systemic reduction in risk.
As we discuss above, enforcement of an effective feed ban in a region
has the effect of reducing the amount of circulating BSE infectivity in
that region. This makes it less likely that any one animal in that
region will be infected with BSE. SRM removal is a method of removing
and disposing of tissues that present a high likelihood of containing
BSE infectivity if an animal were infected. In effect, countries such
as the United States, Canada, and other countries worldwide that
require SRM removal are making the assumption that any one animal
presented for slaughter could be infected with BSE, even though the
presence of an effective feed ban in that country reduces the
likelihood of that to a minimal level.
With regard to the text from the FSIS document regarding perfect
compliance, it is important to review the wording cited by the
commenter in context. In the FSIS interim rule referred to by the
commenter, FSIS refers to the December 2006 model we describe above,
and states the following:

However, although both the number of BSE cases and the level of
human exposure increased in the post-public comment runs,
conclusions with regard to prohibiting the use of SRMs for human
food remain the same. More specifically, even with the revised base
case, the post-public comment

[[Page 15863]]

runs show that excluding the materials designated as SRMs in this
final rule almost completely eliminates potential human exposure to
the BSE agent if compliance is perfect. Similarly, the post-public
comment runs found that neither lowering the age classification for
SRMs from cattle 30 months of age and older to 12 months of age and
older, nor from 30 months of age and older to 24 months of age and
older, provides additional benefits in reducing the level of
potential human exposure to the BSE agent. Thus, the results of the
2005 model, regardless of the base case used, have not led the
Agency to change its conclusion that the measures adopted in this
final rule are prudent for preventing potential human exposure to
the BSE agent. (72 FR 38726)

In addition, in the same rule, FSIS refers to the October 2005
model we described above, and states the following: ``The pre-public
comment runs found that removing SRMs from cattle 30 months of age and
older almost completely eliminates potential human exposure, reducing
it to 11 cattle oral ID50s * * *. It is worth noting that
these are relative reductions to what is already a small risk in
absolute terms, especially in light of the fact that these simulations
reflect the assumed introduction of 500 infected cattle into the U.S.''
(72 FR 38725)
FSIS considered all of the information from the modeling
simulations, including those runs where compliance was assumed to be
less than 100 percent. Evaluating all of these results and statements
together demonstrates the overall conclusion that SRM removal
effectively mitigates the BSE risk to humans.
We also note that APHIS did not assume 100 percent compliance with
SRM removal in the exposure assessment of our risk assessment. As noted
elsewhere, we assumed a 99 percent compliance rate, acknowledging that
no regulatory effort can ever ensure 100 percent compliance.

Specified Risk Materials

One of the requirements for the importation of meat, meat
byproducts, and meat food products derived from bovines in BSE minimal-
risk regions is that the SRMs of the bovines were removed at slaughter.
In Sec. Sec. 94.0 and 95.1 of the regulations, SRMs are defined as
``[t]hose bovine parts considered to be at particular risk of
containing the bovine spongiform encephalopathy (BSE) agent in infected
animals, as listed in the FSIS regulations at 9 CFR 310.22(a).'' With
some limited exceptions, the FSIS regulations list the following
tissues as SRMs: (1) The brain, skull, eyes, trigeminal ganglia, spinal
cord, vertebral column (excluding the vertebrae of the tail, the
transverse processes of the thoracic and lumbar vertebrae, and the
wings of the sacrum), and DRG from cattle 30 months of age and older,
and (2) the distal ileum of the small intestine and the tonsils from
all cattle. If the small intestine is to be used for human food, the
distal ileum must be removed by a procedure that removes at least 80
inches of the uncoiled and trimmed small intestine as measured from the
ceco-colic junction and progressing proximally towards the jejunum, or
must be otherwise removed by a procedure that the establishment
demonstrates is effective in ensuring complete removal of the distal
ileum.
Issue: One commenter stated that central to APHIS' September 2008
request for comments is the Agency's assumption that SRM removal will
effectively protect consumers from exposure to BSE. The commenter
stated that such an assumption is called into question by numerous
studies demonstrating the limitations on mitigating the risk of BSE
exposure via SRM removal. The commenter stated that the CDC has
acknowledged that the risk of humans developing vCJD from eating muscle
meat from cattle potentially infected with BSE cannot be precisely
determined. The commenter stated that APHIS should have, but has not,
explained why this uncertainty does not undermine what the commenter
termed APHIS' almost-exclusive reliance on SRM removal requirements to
protect American public health from potentially hazardous Canadian
imports.
The commenter stated that the current inability to detect BSE
prions in certain tissues does not mean that there is insufficient
infectivity to be a hazard and that, while BSE prions have been found
only in a solitary bovine muscle of a single cow, that likely is a
function of the current limited analytical sensitivity of the test. The
commenter stated that all the other information points to the
likelihood that prions are present in such tissues.
The commenter stated that APHIS ignores the significance of
recently detected BSE variations and dismisses the relevance of new
studies that have detected BSE infectivity in new tissues. The
commenter stated that in its September 2008 request for comments, APHIS
stated that the new findings could be the result of more sensitive
tests and of detection tools that may over-express the BSE agent. The
commenter stated that APHIS incorrectly argued in its September 2008
request for comments that, because demonstrating the presence of PrP
does not necessarily indicate the presence of BSE infectivity, studies
that have detected abnormal PrP in the facial and sciatic nerves do not
warrant new mitigation measures. The commenter stated that the World
Health Organization (WHO) has found both the presence of Prp\TSE\ and
BSE infectivity in the peripheral nerves of cattle. The commenter
stated that the WHO has identified two classifications of BSE tissue
infectivity, ``high infectivity'' and ``lower infectivity,'' and that
the WHO includes peripheral nerves (e.g. sciatic and facial nerves) in
the category of lower infectivity.
The commenter stated that, in its request for comments, APHIS
specifically cited research that detected BSE infectivity in the
sciatic nerve of cattle, but only after 30 months after exposure.
Despite this, stated the commenter, APHIS does not require mitigation
measures regarding the sciatic nerve in cattle 30 months of age or
older. The commenter stated that facial and sciatic nerves are the only
bovine tissues scientifically determined by multiple studies to harbor
BSE infectivity for which APHIS requires no risk mitigations, not even
the mitigation of requiring that beef imported from Canada be derived
only from cattle that were subject to a feed ban during their
lifetimes. The commenter stated that this policy is inconsistent with
APHIS' consideration of tonsils in cattle of any age as an SRM tissue,
even though APHIS cites only one study that found what appears to be a
very low level of infectivity in the tonsils of BSE-infected cattle.
The commenter disagreed with this policy, stating that (1) BSE
infectivity is known to exist in non-SRM tissues; (2) BSE infectivity
is known to have been circulating in Canadian cattle for years, leading
up to and including 2003; and (3) APHIS does not know the minimum
dosage necessary to cause BSE infectivity in either humans or cattle.
The commenter cited 2006 WHO guidelines as stating: ``It remains
unknown whether tissues containing such very small amounts of
infectious material [detected by novel techniques] would transmit
infection to humans.'' (The commenter cites WHO Guidelines on Tissue
Infectivity Distribution in Transmissible Spongiform Encephalopathies,
World Health Organization, 2006, at 10.) Based on this uncertainty,
stated the commenter, APHIS should take precautionary steps to avoid
human exposure to meat and meat products from Canadian cattle that pose
the highest risk of infection-- cattle 30 months of age or older--
particularly those born before the Canadian feed ban was effective.

[[Page 15864]]

Response: A similar issue was raised by the commenter in response
to our January 2007 proposed rule. We are aware of the studies cited by
the commenter and do not agree that they question the efficacy of SRM
removal. In our September 2007 final rule, we acknowledged that studies
using new methods that provide increased sensitivity will probably
demonstrate the presence of PrP\BSE\ (the abnormal form of the prion
protein) in various tissues. However, demonstrating the presence of
PrP\BSE\ does not necessarily indicate the presence of BSE infectivity,
especially if no infectivity is demonstrated via the most sensitive
method available: Cattle-to-cattle exposure via intracerebral
transmission. Therefore, one cannot automatically assume that a finding
of PrP\BSE\ in a tissue means the tissue should be defined as an SRM.
The OIE made this particular point in the Terrestrial Animal Health
Standards Commission Report, October 2006--Supporting Document for
Chapter 2.3.13. Of the Terrestrial Animal Health Code on Bovine
Spongiform Encephalopathy, as follows:

The availability of experimental infectivity data has
significantly increased in recent years. During the same interval,
extremely sensitive tests have been developed, including those
employing highly sensitive transgenic mice strains and potentially
more sensitive laboratory PrP detection methods. With the
development of such highly sensitive methods, the probability of
detection of PrP\BSE\ in tissues that are not currently listed as
infectious is increasing. However, such findings need to be
considered in context, and their relevance to establishing risk to
consumers evaluated carefully when the quantity of PrP\BSE\ detected
is potentially below the limit of detection of intracerebral (i.c.)
cattle to cattle bioassay. By April 2007, 165 variant Creutzfeldt-
Jakob Disease (vCJD) cases had been detected in the United Kingdom,
a country where most probably the majority of the population was
exposed to the BSE-agent. The latest models of the vCJD epidemic
estimate that the potential scale of the clinical epidemic arising
from food-borne exposure is unlikely to exceed 400 future cases in
the United Kingdom (Clarke and Ghani, 2005). The relatively low
number of predicted vCJD cases in relation to the massive exposure
to the BSE agent is suggested to be due mainly to a significant
species barrier between cattle and humans (Comer and Huntley, 2004;
Bishop et al., 2006).

APHIS is familiar with the results of the study (Buschmann, 2005)
in which tissues from a BSE-diseased cow were inoculated into
genetically engineered (transgenic) mice that are highly susceptible to
BSE and that overexpress the bovine prion protein. Using this extremely
sensitive mouse assay, the study demonstrated low levels of infectivity
in the peripheral nervous system (e.g., facial and sciatic nerves) of
the infected cow. APHIS discussed these findings in the risk assessment
it made available with its September 2007 final rule and concluded that
``[g]iven all these factors there is not sufficient information to
alter our understanding of the epidemiologically significant
distribution of BSE infectivity in cattle.'' (APHIS, 2007). APHIS also
acknowledges the results of Japanese studies in which PrP\BSE\ has been
reported in the peripheral nerves of a case of BSE (Iwamaru et al.,
2005) and in some peripheral nerves of cattle slaughtered at abattoirs
in Japan (Iwata et al., 2006) by Western blot analyses. APHIS has also
reviewed the German study in which infectivity was detected in the
brainstem of an animal at 24 months post-infection (Hoffman, 2007). We
have carefully considered all of these findings. USDA reviews and takes
into consideration all BSE research for the definitions of SRMs, as do
Canada and other countries internationally. As noted in the quote
above, international policies regarding SRM removal have not changed
based on the results of the studies discussed. Both the U.S. and
Canadian policies regarding SRM removal are consistent with
international standards.
Finally, we consider the quote the commenter provides from the WHO
2006 report to be of little use when presented out of context. In the
report referenced by the commenter, the WHO was discussing in a
hypothetical fashion the possibility of advances in techniques to
detect PrP^TSE not limited to PrP^BSE. The WHO
statement reads as follows:

Several new methods attempting to detect PrP^TSE using
novel techniques * * * if successfully developed, might eventually
offer sufficient sensitivity to demonstrate amounts of agent below
the level of detection of currently validated tests. It has been
speculated that such methods might find small amounts of agent in
some tissues currently thought to be free of infectivity. It remains
unknown whether tissues containing such very small amounts of
infectious material would transmit infection to humans. (WHO, 2006)

Issue: One commenter stated that APHIS' assumption that removal of
the tonsils removes the potential for BSE transmission is unjustified
given that APHIS has not evaluated the potential for contamination of
tongue with tonsil tissue. The commenter stated that, although APHIS
claims the possibility of such contamination is eliminated by current
slaughter techniques, scientists who examined over 250 bovine tongues
intended for human consumption found tonsillar tissue in the vast
majority; in some cases, even after the most rigorous trimming of the
root of the tongue.\9\
---------------------------------------------------------------------------

\9\ The commenter cites Wells, G., Spiropoulos, J., Hawkins, S.,
and Ryder, S., Pathogenesis of Experimental Bovine Spongiform
Encephalopathy; Preclinical Infectivity in Tonsil and Observations
on the Distribution of Lingual Tonsil in Slaughtered Cattle,
Veterinary Record (2005) 156, 401-407.
---------------------------------------------------------------------------

Response: We are making no changes based on the comment. As we
discussed in our September 2007 final rule, Wells et al. (2005) state
the following:

However, the trace level of infectivity so far detected in
tonsillar tissue and the localization of the lingual tonsillar
lymphoid tissue, together with the current SRM legislation for the
removal of tonsil from cattle carcasses and the low and diminishing
prevalence of BSE in the UK suggest that the risk of human exposure
to infected tonsil is now remote. It seems likely that under these
circumstances any additional trimming of the tongue would result in
an immeasurable reduction in the risk * * *
In other words, the study cited by the commenter does not present a
strong case for additional risk measures, and, in fact, points to the
opposite conclusion.
Moreover, even before the SRM requirements were implemented in
January 2004, FSIS did not consider tonsil to be edible tissue--it was
previously required to be removed. As noted in FSIS Notice 50-04:

In the preamble to 9 CFR 310.22, FSIS stated that tonsils of all
livestock species, including cattle, were already required to be
removed and were prohibited for use as ingredients in meat food
products under 9 CFR 318.6(b)(6). The accepted practice for removing
the tonsils from livestock has been to remove all visible tonsils.
In cattle, this includes separation of the palatine tonsils and
lingual tonsils from the tongue (in establishments that harvest the
tongue for human food) by a transverse cut caudal (just behind) the
last vallate papillae * * * FSIS expected that establishments would
continue to remove tonsils from cattle in accordance with the
procedures that they had implemented to comply with 9 CFR
318.6(b)(6) * * * Establishments that slaughter cattle should have
been following these practices before tonsils were designated as
SRMs. (FSIS, 2004c).

APHIS' quantitative exposure model conducted for the September 2007
final rule included an update that acknowledged the potential
infectivity in tonsils and clearly added these as an SRM, with the
acknowledgment that they could still be potentially available for human
consumption. In fact, the output tables from the model runs show the
potential oral ID50s derived from tonsils and available for
human consumption over the 20-year period of

[[Page 15865]]

the analysis. These values are obviously very low, ranging from 0.026
oral ID50s in the base case scenario to 0.16 oral
ID50s in sensitivity analysis 6 (in which all uncertain
parameters were simultaneously set to their corresponding pessimistic
level). Such very small values are not surprising given the low
likelihood of infectivity in the tissue itself. Moreover, although our
model predicts a vanishingly low level of possible human exposure via
tonsils, we have not stated that the risk is ``eliminated,'' as was
suggested in the comment.
Issue: One commenter stated that it is not yet possible to
demonstrate how effective SRM removal is in mitigating the risk of BSE,
because SRM removal requirements have not been in place long enough for
an effect to be evident, particularly in light of the lengthy
incubation periods assumed for vCJD in humans. The commenter stated
that any human who consumed beef from a BSE-infected animal slaughtered
after SRM removal requirements were implemented would not be expected
to show signs of vCJD for about 17 years. The commenter stated that, if
there has been a reduction in the number of cases of vCJD infection--
which the commenter said is unclear--it is much more likely that that
the reduction resulted from decreases in the number of infected cattle
in the past decade due to feed bans, rather than to what the commenter
termed the much more recent implementation of SRM removal.
Response: The commenter raised a similar issue in response to our
January 2007 proposed rule. In response to the comment, we acknowledged
in our September 2007 final rule that there has been no specific
controlled study that clearly and unequivocally demonstrates the
effectiveness of SRM restrictions on protecting public health. However,
the absence of such a study does not negate the fact that substantial
epidemiological and case evidence clearly indicate the success of such
control measures. As we stated in our September 2007 final rule, it is
widely and generally accepted internationally, including by such
international bodies as the WHO and the OIE, that the primary public
health protective measure regarding BSE is the removal of SRMs from the
human food supply (WHO, 2002).
The OIE Scientific Revue notes the following: ``Excluding SRM from
the human food chain effectively minimizes the risk of human exposure
and is the most important measure taken to protect consumers. Failure
to remove SRMs would probably expose a large number of consumers to an
unnecessary risk.'' (Heim and Kihm, 2003). This point is also widely
acknowledged in scientific literature. For example, Bradley and
Liberski (2004) conclude that ``risks to humans from infected cattle
are now remote so long as the [bans on the use of SRMs in human food]
are rigorously enforced.'' Fox and Peterson (2004) conclude that
``[a]doption of the human [specified bovine offal] ban in the United
Kingdom in 1989 is probably the only example in the BSE story of a
government going beyond expert opinion in taking a precautionary
measure. It turned out to be the correct decision, and likely saved
thousands of people from exposure to the disease.''
Simulation models and analysis conducted in the United Kingdom
support the assumption that primary exposure sources for people were
SRMs in the food supply prior to imposed restrictions. These models
have been updated and revised repeatedly since the original
identification of vCJD and the link to BSE in cattle (Ghani et al.,
1998, 2000, 2001, 2003). They incorporate assumptions for all the
parameters that could influence the course of vCJD in the United
Kingdom--including assumptions about primary exposure from dietary
sources, calculations about how many infected cattle may have been
slaughtered at different points in time, what tissues from those
animals were available for consumption, and what restrictions were
imposed on the tissues and types of products available for consumption.
The models are updated routinely to incorporate new information about
vCJD cases as they are reported.
These models have been used to predict the course of the vCJD
epidemic in the United Kingdom. Initially, the projections were fairly
high with considerable uncertainty. As more information is incorporated
into the models, these projections continue to decline and the
uncertainty levels also decrease. The number of clinical cases of vCJD
in the United Kingdom has continued to decline since an apparent peak
in 2000 (Andrews, 2007). This decline is consistent with projections
made from the models, thus validating some of the assumptions used in
the models. As an example, Cooper and Bird (2003) assume that the
primary sources of exposure are the consumption of meat products--
including mechanically separated meat and head meat-that were most
likely contaminated with SRMs such as spinal cord, DRG, and brain.
Restrictions on the inclusion of spinal cord and brain, among other
tissues, were initially imposed in the United Kingdom in 1989.
Restrictions on the production of mechanically separated meat, which
included a significant level of infectivity from DRG, were imposed in
the United Kingdom in 1995. Cooper and Bird (2003) concluded that
``[t]here is remarkable similarity between the age distribution and
gender of simulated and observed vCJD patients, which supports (but
does not prove) our assumption about the primary sources of exposure to
BSE.''
The commenter noted the ``exceedingly long incubation periods
assumed for humans.'' More recent updates of the models described
previously have included estimates of the mean incubation period for
vCJD (Ghani et al., 2003), estimating the mean incubation period at
12.6 years when using the accumulated case data from confirmed vCJD
cases. When additional information was added from results of a
screening study performed on appendix and tonsil tissues, the mean
incubation period was 16.7 years when fitted to this data. From this
evidence, we can conclude that even the longer mean incubation period
of 16.7 years would allow sufficient time to demonstrate the effect of
SRM restrictions on the outbreak, since the initial SRM restrictions
were imposed in 1989. We note that all vCJD cases that have been
genotyped to date, with one exception, have been of the homozygous
methionine (MM) genotype at codon 129 of the human prion protein gene.
In describing the methodology used for their 2003 update of projections
of future vJCD cases in the United Kingdom, Ghani et al. indicated that
approximately 40 percent of the Caucasian population is homozygous
methionine, with approximately 10 percent valine homozygous, and the
remaining 50 percent heterozygous. While the effect of genotype on vCJD
is still unknown, we can evaluate scenarios in the MM genotype as an
example of epidemic progression, because this genotype may be the most
susceptible and/or have shorter incubation periods than other
genotypes.
Issue: One commenter stated that, in its September 2008 request for
comments, APHIS misguidedly relied on OIE recommendations to justify
its decision not to strengthen SRM removal requirements and to allow
the importation from Canada of live cattle 30 months of age or older.
The commenter stated that APHIS should base its assessment of the
effectiveness of BSE mitigation measures on empirical data from
countries that have imposed BSE restrictions, rather than on
empirically unproven standards such as those recommended by the OIE.

[[Page 15866]]

The commenter stated that Japan allows the importation of beef only
from cattle 20 months of age or younger and that the European Union
limits imports of beef to that derived from cattle under 30 months of
age.
The commenter stated that all countries in which BSE has been
diagnosed, except for Canada, remove the brain, spinal column, etc., at
slaughter from all bovines 12 months and over, rather than just from
all bovines 30 months of age or older, as is required by APHIS for the
importation of meat, meat byproducts, and meat food products from BSE
minimal-risk regions. The commenter noted that Japan requires the
removal of SRMs from cattle of any age. Therefore, stated the
commenter, the experience with SRM removal in those countries is
inapplicable for predicting risk in the United States and APHIS lacks a
basis for stating that the SRM removal it requires has been
demonstrated to be highly effective.
Response: We disagree with the commenter in several ways. First,
contrary to the commenter's statement, the European Union has
determined that its policies regarding the importation of beef are
consistent with the OIE Code. Second, the commenter failed to list the
United States as a country in which BSE has been diagnosed in a native
animal that requires removal of the brain, spinal column, etc., at
slaughter from bovines 30 months of age or older. Finally, the
commenter's recommendations are inconsistent with scientific findings
regarding BSE transmission generally accepted internationally.
As we noted in our September 2007 final rule, in the past few
years, significant consideration has been given to the age limits on
SRMs and their appropriateness. Additional information obtained from
new research findings has contributed to these evaluations. Scientists
in Europe have specifically examined these findings as part of their
consideration of the age limit in cattle for the removal of SRMs (EFSA
Journal, 2005; 2007). In each of these opinions, they conclude that any
likely detectable infectivity in the central nervous system (CNS)--
including the SRMs in question--appears at about 75 percent of the
incubation time. These opinions also note that the experimental low-
dose scenarios are more likely to resemble the actual field exposure.
The low-dose research scenarios are those in which calves were exposed
orally to 1 gram of highly infective brain tissue, rather than the 100
grams used in the high-dose scenario. Experimental attack rate studies
indicate that the incubation period for the low-dose scenario has a
mean of 60 months, with a range of 45 to 73 months (Wells et al.,
2007). Using the low end of this range of incubation period, and
assuming that infectivity is present in the CNS at 75 percent of the
incubation period, they predict that infectivity would be sub-
detectable or still absent in CNS in cattle aged 33 months.
In the United Kingdom, even including cases from the height of the
BSE epidemic there, which are believed to have had shorter incubation
periods than more recent cases, the peak age at onset of clinical signs
was 5 to 6 years. This age of clinical onset is consistent with an
assumption that the average incubation period in the United Kingdom has
been about 60 months. The average age of animals identified with
disease in the European Union is higher than this-the average was 86
months in 2001 and has increased since then. This evidence indicates
that considering certain tissues in bovines 30 months of age or older
to be SRMs, and removing and disposing of those tissues, would
eliminate the majority of infectivity present, and removing and
disposing of these same tissues from bovines between 12 and 30 months
of age would not provide any significant additional protection.
This same point is illustrated in various models. Comer and Huntly
(2003) modeled the potential human exposure available in the United
Kingdom from 1980 through 2002. They concluded that an estimated total
of 54 million bovine oral ID50 units could have been
consumed in that timeframe. This period included both the beginning of
the epidemic in cattle, before the disease was recognized and public
health control measures were established, and later in the epidemic
when control measures were developed and instituted. Comer and Huntly
also concluded that 99.4 percent of this estimated exposure was from
animals older than 30 months of age. Therefore, SRM restrictions from
animals greater than 30 months would reduce the vast majority of
potential exposure.
Also, as discussed above in this document, in 2006, FSIS/Harvard
incorporated changes based on public comment on an October 2005
simulation that used a modified version of the 2001 Harvard BSE risk
assessment model. This was made available to the public, along with the
responses to the public comments, as ``Harvard Risk Assessment of BSE
Update; Phase IA; Supplemental Simulation Results, December 26, 2006.''
The base case simulated 500 infected animals introduced, with 50,000
simulation runs of 20-year timeframes. The base case results, which
assumed no removal of SRMs, indicated a mean of 700 total infected
animals over the 20 years (500 imports and 200 domestic), with a mean
of 6,600 cattle oral ID50s potentially available for human
consumption. In comparison, modeling a requirement for removal from the
human food supply of SRMs from cattle 30 months of age or older,
assuming 100 percent compliance, indicated a mean of 20 oral
ID50s potentially available for human consumption over the
20-year time period. The update also modeled requirements for removal
from the human food supply of SRMs from cattle 12 months of age and
older and 24 months of age and older. There was no significant
difference between the results of those models and that which modeled a
requirement for removal from the human food supply of SRMs from cattle
30 months of age and older--viz., 17 oral ID50s each when
SRM removal from cattle 12 months of age and older and 24 months of age
and older were modeled, compared to 20 oral ID50s when
removal of SRMs from cattle 30 months of age was modeled.
In summary, we agree with the conclusion that has been widely
reached and that has generally been accepted internationally, that the
primary public health protective measure regarding BSE is the removal
of SRMs from the human food supply, and we concur that the OIE
recommendations address those tissues that have been shown to contain
BSE infectivity.
Issue: Several commenters stated that our September 2007 final rule
should be withdrawn because the USDA's OIG reported in 2008 that APHIS'
import controls are not sufficient to prevent, detect, or address the
entry of animals that do not meet import requirements. The commenters
expressed concern about APHIS' ability to prevent the introduction of a
BSE-infected animal from Canada and concluded that the OIG report
demonstrates that APHIS is incapable of adequately enforcing import
restrictions necessary to protect the health of U.S. cattle and U.S.
consumers.
One commenter stated that the OIG report dealt with, among other
things, APHIS' enforcement of requirements in its January 2005 final
rule during the period between August 2006 and July 2007. The commenter
stated that the report concluded that APHIS' import procedures were not
sufficient to prevent unauthorized shipments of live animals into the
United States. The commenter stated, further, that according to the OIG
report, the

[[Page 15867]]

problems that the OIG found regarding compliance with APHIS' January
2005 final rule raise concerns with APHIS' controls over live animal
imports and whether the controls are adequate to ensure compliance with
import restrictions contained in APHIS' September 2007 final rule. The
commenter stated that the OIG audit also referenced other findings
regarding APHIS enforcement of its regulations.
The commenter stated that the OIG report contradicts APHIS'
statement in its September 2007 final rule that there were only
individual instances of errors or violations regarding the provisions
of APHIS' January 2005 final rule. The commenter stated that OIG found
the errors and violations to be pervasive and stated that the OIG
report concluded that problems associated with inaccurate health, age,
identification, and pregnancy status on Canadian cattle certificates
that were used to import more than 7,000 cattle were not isolated
occurrences because they involved at least 52 different Canadian
veterinarians and 40 CFIA officials. The commenter stated that APHIS
was aware, while preparing its September 2007 final rule, that OIG was
auditing its import controls and finding what the commenter termed
serious violations of APHIS' enforcement of the January 2005 final
rule.
Response: We agree that the OIG audit referenced by the commenter
identified several areas where APHIS could improve its management
controls and documentation regarding import procedures. Our response to
the audit agrees with many of the recommendations and identifies
actions to address them. In many instances, these actions will assist
APHIS in documenting issues to provide sufficient information for an
analysis to determine the true significance of the reported issues. The
report itself acknowledges that OIG had ``difficulty assessing the
significance of import noncompliance * * *.'' (Audit Report, USDA's
Controls Over the Importation and Movement of Live Animals, Department
of Agriculture, Office of Inspector General, Midwest Region, Report No.
50601-0012-Ch, March 2008). The commenter stated that OIG found errors
in certificates to be pervasive, yet the report does not reach this
conclusion. OIG identified a total of 211 cattle that were imported
with inaccuracies on the health certificate--86 animals inaccurately
certified for pregnancy status, 105 animals allegedly inaccurately
certified for age, and 21 with inaccurate identification. These
inaccuracies are out of a total of 1.1 million animals imported in that
year. While we agree with the recommendations in the report and are
taking actions to improve our processes, we disagree with the
commenter's conclusion that this level of inaccuracies is pervasive and
that this demonstrates that APHIS is incapable of enforcing its import
regulations.
Issue: One commenter stated that, in its September 2007 final rule,
APHIS relied on disproven findings to support its decision to remove
the delay of applicability of those provisions of its January 2005
final rule governing the importation of meat and meat byproducts from
BSE minimal-risk regions. The commenter stated that, as justification
for its decision to lift the ban on the importation of such commodities
from Canada, APHIS asserted that its 2005 evaluation of the
epidemiology of BSE cases identified at that time suggested that
Canada's BSE outbreak was only a local exposure, based on the
relatively small geographical location, temporal association, and the
clustering of cases. The commenter stated that this conclusion has been
disproven by subsequent outbreaks of BSE that occurred prior to APHIS'
publication of its September 2007 final rule.
Response: The commenter is incorrect that, in its September 2007
final rule, APHIS cited the results of the 2005 evaluation of the
epidemiology of BSE cases identified in Canada as justification for
lifting the delay of applicability of certain provisions of its January
2005 final rule. In its September 2007 final rule, APHIS explained its
rationale for the lifting of the delay of applicability as follows:

Since the date of the partial delay of applicability of our
January 2005 final rule, we have obtained additional information
regarding all aspects of the issues that prompted the delay of
applicability and have conducted additional analyses in line with
the plan as described. The risk assessment for this final rule
demonstrates the negligible BSE risk from the importation of
additional classes of live cattle, including those 30 months of age
or older. This includes acknowledging the potential risk pathway
that could be available if the SRMs from infected imported cattle
entered the ruminant feed supply in contravention of current feed
regulations. The negligible risk from the importation of live older
cattle therefore gives further support to the conclusion of the risk
analysis conducted for our January 2005 final rule regarding meat
and meat products derived from bovines of any age in BSE minimal-
risk regions. Specifically, the risk is even lower for the
importation of meat and meat products, as the SRMs will be removed
in accordance with the regulations, than for live bovines. (72 FR
53316)

APHIS' description of the 2005 epidemiological investigation
referred to by the commenter appeared in its September 2008 request for
comments on the removal of the delay of applicability, and was
included, for the sake of completeness, in a chronological list of
events that occurred since APHIS' November 2003 proposal to establish
the category of BSE minimal-risk regions. In the September 2008 request
for comments, APHIS did not point to the 2005 epidemiological
investigation as the rationale for removing the delay of applicability.
Issue: One commenter stated that, in its September 2007 final rule,
APHIS projected that 75,000 cull cattle 30 months of age and older
would be imported from Canada. However, stated the commenter, USDA data
showed that by November 8, 2008, the United States had imported
approximately 167,224 cull cattle 30 months of age or older from
Canada. The commenter stated that APHIS has explained that projected
imports are a key component of the likelihood of BSE infectivity. Thus,
stated the commenter, APHIS' estimate that the implementation of the
September 2007 final rule could lead to the introduction of between 19
and 105 BSE-infected cattle into the United States--which could, in
turn, produce BSE infections in 2 to 75 U.S.-born cattle, lasting over
a 20-year period--understates the actual level of BSE infectivity that
has likely entered the United States in 2008.
Response: The commenter is correct that, in analyzing the potential
economic effects of its September 2007 final rule, APHIS projected that
75,000 cull cattle 30 months of age and older would be imported into
the United States from Canada in 2008. That number was a decrease from
the 657,000 head that APHIS had originally projected in its January
2007 proposed rule, and took into account information supplied by
commenters on the proposed rule. However, the risk analysis for the
September 2007 final rule continued to use a projected importation of
657,000 head. Therefore, the number of cull cattle actually imported
under the provisions of the final rule was less than that assumed in
the risk analysis.
Issue: One commenter stated that APHIS' promulgation of its
September 2007 final rule violates the Agency's Congressional mandate
to take the action necessary to prevent the introduction into or
dissemination within the United States and to take the steps necessary
to detect, control, and eradicate animal disease. The commenter stated
that APHIS acknowledged that the September 2007 final rule could result
in the importation

[[Page 15868]]

of some BSE-infected cattle from Canada. For this reason, stated the
commenter, APHIS should withdraw its September 2007 final rule.
Response: We disagree that the Secretary acted outside his broad
authority under the Animal Health Protection Act (AHPA) (7 U.S.C. 8301
et seq.) in promulgating the September 2007 final rule. The applicable
section of the AHPA provides that ``the Secretary may prohibit or
restrict * * * the importation or entry of any animal, article, or
means of conveyance * * * if the Secretary determines that the
prohibition or restriction is necessary to prevent the introduction
into or dissemination within the United States of any pest or disease
of livestock'' (7 U.S.C. 8303 (a)(1)). The United States Court of
Appeals for the Ninth Circuit held that this section confers ``wide
discretion'' on the Secretary in dealing with imports and ``does not
impose any requirement on USDA that all of its actions carry no
associated increased risk of disease'' (R-CALF v. USDA, 415 F.3d 1078,
1094). The court found that open borders are a default under the AHPA
and that the Secretary can close them only when he has determined that
it is necessary. The court noted that the statute's use of the word
``may'' suggests that the Secretary has broad discretion to decide
whether to close the borders at all (id. at 1094-1095). We do not
believe that the September 2007 final rule violates our statutory
mandate and we deny the commenter's request to withdraw the rule on
this basis.
Issue: One commenter stated that the United States should prohibit
the importation of beef or cattle from any country known to have BSE.
Another commenter stated that beef and cattle trade with Canada should
not be expanded until, among other actions pertaining just to live
animals, Canada can verify 100 percent compliance with its ruminant
feed ban and that its cattle herd and beef products are BSE-free.
Response: The actions recommended by the commenter are not
supported by scientific evidence or empirical data, nor are they
consistent with internationally accepted animal health standards. Such
action, if taken in turn by U.S. trading partners with regard to U.S.
beef and cattle, would eliminate the export of beef and cattle from the
United States.
In a series of documents published from November 2003 through
September 2008, which we discuss above in this document, APHIS provides
the scientific rationale for classifying Canada as a BSE minimal-risk
region and allowing the importation of certain ruminants and ruminant
products from Canada under specified conditions.
The regulatory conditions for the importation into the United
States of beef and cattle from a BSE minimal-risk region such as Canada
are consistent with the OIE Code for trade in beef and live animals
from a country recognized by the OIE as having controlled risk for BSE.
Both Canada and the United States are recognized as BSE controlled risk
countries.
The OIE, of which the United States is a Member country, is the
internationally recognized standard-setting body that develops science-
based recommendations for the safe trade of animals and animal
products. The World Trade Organization has recognized the OIE as the
international forum for setting animal health standards, reporting
global animal disease events, and presenting guidelines and
recommendations on sanitary measures relating to animal health.
The OIE facilitates intergovernmental cooperation to prevent the
spread of contagious diseases in animals by sharing scientific research
among its members. The major functions of the OIE are to collect and
disseminate information on the distribution and occurrence of animal
diseases and to ensure that science-based standards govern
international trade in animals and animal products. The OIE carries out
its function through the development and revision of international
standards for diagnostic tests, vaccines, and the safe international
trade of animals and animal products.
The OIE develops risk-based standards, which, if agreed upon by
Member countries through consensus, are published in the OIE
Terrestrial Animal Health Code (Code). However, each OIE Member country
is obligated to review and comment on proposed OIE standards, and make
decisions regarding the adoption of those standards, strictly on their
scientific merits.
As an OIE Member country, the United States reviews and, where
appropriate, comments on all draft OIE chapters and revisions. As part
of the U.S. consideration of OIE drafts, APHIS distributes these drafts
to the U.S. livestock and aquaculture industries, veterinary experts in
various U.S. academic institutions, and other interested persons for
review and comment.
In addition, each year, prior to formulating its comments for the
OIE annual meeting, APHIS makes available on its Web site those
potential changes to the Code that the OIE has submitted to Member
countries for comment, and accepts information and recommendations from
the public regarding those proposed changes. Through its OIE Reference
Laboratories and Collaborating Centers, APHIS also provides OIE Member
countries with technical assistance and expert advice on disease
surveillance and control and risk analysis, as well as diagnostic
assistance, evaluation, and consultation.
Over the years, the OIE Member countries, including the United
States, have agreed by consensus to amend the OIE Code based on
increased scientific evidence regarding the disease. The OIE Code
reflects the current understanding that, depending on multiple factors,
there can be gradations in the risk of the BSE agent being moved from
one country to another, and gradations in the risk of BSE transmission
and amplification within any particular country. As a member of the
OIE, the United States, represented by APHIS, has been actively
involved in the development of the OIE Code and fully supports the OIE
position that gradations in BSE risk among regions should be recognized
and that trade should be commensurate with risk.
Issue: One commenter stated that beef and cattle trade with Canada
should not be expanded until U.S. international beef export markets are
firmly established. The commenter also urged that, if the restrictions
on importations from Canada are removed, American cattle producers be
compensated for economic disadvantages that might arise from such
importations. Another commenter stated that U.S. exports are suffering
because the United States requirements for imports from Canada are
consistent with OIE standards but less stringent than the requirements
imposed by other countries for the importation into those countries of
beef from the United States.
Another commenter stated that, as noted above, in its September
2007 final rule, APHIS projected that 75,000 cull cattle 30 months of
age older would be imported from Canada. However, stated the commenter,
USDA data showed that by November 8, 2008, the United States had
imported approximately 167,224 cull cattle 30 months of age or older
from Canada. The commenter stated that although APHIS had projected
revenue losses of over $66 million for U.S. cattle producers due to the
importation from Canada of cattle 30 months of age or older, the larger
number of such cattle actually imported will make those losses
significantly higher.
Response: As we stated in our September 2007 final rule, APHIS does

[[Page 15869]]

not have the statutory authority to restrict trade based purely on its
potential economic impact, market access effects, or quantity of
products expected to be imported. Under the AHPA, the Secretary of
Agriculture may prohibit or restrict the importation or entry of any
animal or article when the Secretary determines it is necessary to
prevent the introduction or dissemination of a pest or disease of
livestock. This authority has been delegated to APHIS.
We note that neither our January 2005 final rule nor our September
2007 final rule made any commodities eligible for importation from
Canada that were not already allowed importation prior to May 2003,
when a BSE-infected cow was diagnosed in Canada. One difference between
the current situation and pre-May 2003, however, is that certain of the
commodities that are now eligible for importation are subject to risk-
mitigating importation conditions appropriate to the fact that BSE has
been detected in Canada and that we consider that country a minimal-
risk region for BSE. Both Canada and the United States have been
classified as controlled-risk countries for BSE under the OIE Code.
Nonetheless, there are some commodities (e.g., cattle born before March
1, 1999) that continue to be ineligible for importation into the United
States. Even taking into account such restrictions, however, the
current regulations represent to a great extent a return to trade
patterns that existed between the United States and Canada for many
years previously.
Issue: One commenter stated that during the period 2004-2007 the
United States lost a total of $11 billion in the sale of U.S. beef
abroad, including $5.7 billion in lost sales to Japan and $3.7 billion
in lost sales to Korea. The commenter stated that restrictions on the
importation of U.S. beef by other countries shows that those countries
view OIE BSE risk mitigation standards--which the commenter stated the
United States applies to imports of Canadian cattle and beef--as
inadequate to protect their consumers from exposure to BSE.
Response: The reduction in export sales that the commenter cites
occurred during a 3-year period that began following the diagnosis of
BSE in a cow of Canadian origin in Washington State in December 2003,
prior to the publication of APHIS' final rule recognizing the category
of BSE minimal-risk regions. As we stated in our September 2007 final
rule, U.S. Government agencies are actively negotiating with trading
partners to reestablish our export markets. After the December 2003
detection of an imported BSE-infected cow in Washington State, many of
the 114 nations that imported U.S. beef banned our beef and live
animals, despite the apparent lack of scientific basis for such
measures. The efforts of multiple U.S. Government agencies have
succeeded in removing bans in over half of those markets, including our
largest export market, Japan. U.S. Government agencies continue to work
to reopen or further open markets where restrictions remain.
Issue: One commenter stated that beef and cattle trade with Canada
should not be expanded until mandatory country of origin labeling
(COOL) is fully implemented and enforced.
Response: On May 13, 2002, President Bush signed into law the Farm
Security and Rural Investment Act of 2002, more commonly known as the
2002 Farm Bill. One of its many initiatives requires country of origin
labeling (COOL) for beef, lamb, pork, fish, perishable agricultural
commodities and peanuts. The COOL program became fully effective as of
March 16, 2009. However, as USDA's Agricultural Marketing Service noted
in its October 30, 2004 proposal in discussing Section 10816 of Public
Law 107-171 (7 U.S.C. 1638-1638d), the ``intent of the law is to
provide consumers with additional information on which to base their
purchasing decisions. It is not a food safety or animal health measure.
COOL is a retail labeling program and as such does not address food
safety or animal health concerns.''

Affirmation of Position Regarding Removal of Delay of Applicability

After closely considering the issues raised by commenters in
response to our September 2008 request for comments, for the reasons
given in our September 2007 final rule and in this document we are
affirming the position we took in removing the delay of applicability
of certain provisions of our January 2005 final rule.

III. Proposed Changes

Although APHIS has amended its BSE regulations in recent years
consistent with increased scientific understanding of the disease, we
believe that the regulations contain certain provisions that are not
yet fully consistent with the latest scientific literature. Therefore,
in this document we are proposing to establish conditions for the
importation of live bovines and products derived from bovines that we
believe are more reflective of current scientific understanding of BSE.
We are proposing to base importation conditions on the inherent
risk of BSE infectivity in specified commodities, as well as on the BSE
risk status of the region from which the commodities originate. We are
proposing to establish a system for classifying regions as to BSE risk
that is consistent with the system employed by the OIE. The conditions
we are proposing for the importation of specified commodities are based
on internationally accepted scientific literature and, except in a few
instances, are consistent with the OIE Code. We are also proposing to
classify certain specified countries as to BSE risk and are proposing
to remove BSE restrictions on the importation of cervids and camelids
and products derived from such animals. We are proposing to make these
amendments after conducting a thorough review of relevant scientific
literature and a comprehensive evaluation of the issues and concluding
that the proposed changes to the regulations would continue to guard
against the introduction of BSE into the United States, while allowing
the importation of additional animals and animal products into this
country.

Evolution of U.S. Regulatory Response to BSE

As discussed earlier in this document, the Federal Government
conducts a coordinated response to protect humans and livestock from
BSE. The protective measures APHIS has taken have evolved over the
years, as scientific understanding of the disease has increased. From
1997 until 2005, the only two categories of regions listed in the CFR
with regard to BSE were regions in which BSE is known to exist and
regions of undue risk for BSE. The regulations prohibit the importation
from such regions of live cattle and other ruminants and certain
ruminant products, including most rendered protein products. Imports
from any region not listed in either of those two categories are not
subject to any BSE prohibitions or restrictions. While this approach
has been successful in protecting against the risk of BSE, advances in
scientific understanding of the disease now allow the United States to
take a more focused approach.
In terms of method of transmission, BSE differs from most other
livestock diseases. Oral ingestion of feed contaminated with the BSE
agent is the only documented route of field transmission of the
disease. This understanding of the disease made it increasingly evident
that preventing material potentially infected with the BSE agent from
being fed to ruminants is a key to preventing introduction and
amplification of the disease within a

[[Page 15870]]

livestock population. Scientific research also found that some bovine
tissues have demonstrated infectivity, whereas others have not, and
that levels of infectious agent in certain tissues vary with the age of
an animal.
This scientific evidence regarding the most likely method of
transmission of BSE was the basis for measures taken by Federal
agencies to protect the U.S. human and livestock populations from BSE.
As noted above under the heading ``Rulemaking Regarding BSE,'' in June
1997 FDA prohibited the use of all mammalian protein, with the
exception of pure pork and pure equine protein from single species
processing plants, in animal feeds given to cattle and other ruminants,
and established measures to protect against the contamination of
``allowable'' feed material with materials that could contain the BSE
agent (62 FR 30936; codified at 21 CFR 589.2000). The rule also allows
exceptions for certain products believed to present a low risk of
transmitting BSE: blood and blood products; gelatin; inspected meat
products that have been cooked and offered for human food and further
heat processed for feed (such as plate waste and used cellulosic food
casings, referred to below as ``plate waste''); and milk products (milk
and milk protein).
FSIS, in a series of three interim final rules published in the
Federal Register on January 12, 2004, established provisions to
supplement its measures to prevent the BSE agent from entering the
human food supply. As discussed above, in one of the interim final
rules (FSIS Docket No. 03-025IF; 69 FR 1861-1874), FSIS, among other
actions, designated the brain, skull, eyes, trigeminal ganglia, spinal
cord, vertebral column (excluding the vertebrae of the tail, the
transverse process of the thoracic and lumbar vertebrae, and the wings
of the sacrum) and DRG of cattle 30 months of age and older, and the
tonsils and distal ileum of the small intestine of all cattle as SRMs,
and prohibited their use as human food. To ensure effective removal of
the distal ileum, the SRM rule required establishments to remove the
entire small intestine and dispose of it as inedible. FSIS also
required all slaughtering and processing establishments to develop,
implement, and maintain written procedures for the removal,
segregation, and disposition of SRMs. Establishments were specifically
required to implement procedures to address the potential contamination
of edible materials with SRMs before, during, and after entry into the
establishment. FSIS did not restrict the age of cattle eligible for
slaughter, because the removal of SRMs effectively mitigates the BSE
risk to humans associated with cattle that pass both ante-mortem and
post-mortem inspections (i.e., apparently healthy cattle). The rule
also declared mechanically separated beef (MS beef)) to be inedible and
prohibited its use for human food, and prohibited all non-ambulatory
disabled cattle for use as human food.
The second interim final rule (FSIS Docket No. 03-038IF; 69 FR
1874-1885) prohibited products produced by advanced meat recovery
systems from being labeled as ``meat'' if, among other things, they
contain central nervous system (CNS) tissue.
The third interim final rule (FSIS Docket No. 01-0331IF; 69 FR
1885-1891) prohibited the use of penetrative captive bolt stunning
devices that deliberately inject air into the cranial cavity of cattle
because they may force large fragments of CNS tissue into the
circulatory system of stunned cattle where they may become lodged in
edible tissues.
On July 14, 2004, FDA published in the Federal Register an interim
final rule (69 FR 42255-42274, Docket No. 2004N-0081), consistent with
the January 2004 FSIS rulemaking, that prohibited the use of certain
cattle material in human food, including dietary supplements, and
cosmetics.
On September 7, 2005, FSIS published in the Federal Register an
interim final rule (70 FR 53043-53050, Docket No. 03-025IFA) that
allowed for use as human food, under certain conditions, beef small
intestine, excluding the distal ileum, derived from cattle slaughtered
in official U.S. establishments or in certified foreign establishments
in countries listed by FSIS in 9 CFR 327.2(b) as eligible to export
meat products to the United States.
Also on September 7, 2005, FDA published an interim final rule (70
FR 53063-53069, Docket No. 2004N-0081) and request for comments in
which it provided that small intestine is not considered a prohibited
cattle material if the distal ileum is removed by a qualifying
procedure. FSIS imposed a similar requirement in its interim rule.
On July 13, 2007, FSIS published an interim final rule (72 FR
38199-38730, Docket No. 03-025F) that affirmed its January 2004 interim
final rules with some changes.
In its September 2007 final rule (discussed above under the heading
``Rulemaking Regarding BSE,'') APHIS, among other things, made its BSE
regulations consistent with the FSIS and FDA changes regarding the
small intestine.
On April 25, 2008, FDA published a final rule (73 FR 22718-22758,
Docket No. 2002N-0273) to prohibit the following in the food or feed of
all animals: The entire carcass of BSE-positive cattle; the brains and
spinal cord from cattle 30 months of age and older; the entire carcass
of cattle not inspected and passed for human consumption that are 30
months of age or older from which brains and spinal cords were not
removed; tallow that is derived from BSE-positive cattle; tallow that
is derived from other materials prohibited by the April 2008 final rule
that contains more than 0.15 percent insoluble impurities; and
mechanically separated beef that is derived from the materials
prohibited by the April 2008 final rule.

International Standards

The science upon which U.S. Federal agencies have based their
rulemaking has also been the basis for internationally accepted BSE-
related standards governing the trade of ruminants and ruminant
products. Much of the information that follows regarding the OIE and
the United States' role in international standard setting is set out
above in our response to a comment from the public on our September
2008 request for comments. We repeat it here because of its relevance
to the changes we are proposing in this document. As noted above, the
OIE, of which the United States is a Member country, is the
internationally recognized standard-setting body that develops science-
based recommendations for the safe trade of animals and animal
products. The OIE is currently composed of 174 Member nations, each of
which is represented by a delegate who, in most cases, is the chief
veterinary officer of that country. The World Trade Organization has
recognized the OIE as the international forum for setting animal health
standards, reporting global animal disease events, and presenting
guidelines and recommendations on sanitary measures related to animal
health.
As noted above, the OIE facilitates intergovernmental cooperation
to prevent the spread of contagious diseases in animals by sharing
scientific research among its members. The major functions of the OIE
are to collect and disseminate information on the distribution and
occurrence of animal diseases and to ensure that science-based
standards govern international trade in animals and animal products.
The OIE aims to achieve these through

[[Page 15871]]

the development and revision of international standards for diagnostic
tests, vaccines, and the safe international trade of animals and animal
products.
The OIE develops risk-based standards, which, if agreed upon by
Member countries through consensus, are published in the OIE
Terrestrial Animal Health Code (Code). The OIE Code chapters are
drafted (or revised) by either the Terrestrial Animal Health Standards
Commission or by ad hoc groups composed of technical experts nominated
by the Director General of the OIE by virtue of their subject-area
expertise. Once a new chapter is drafted or an existing one is revised,
the chapter is distributed to Member countries for review and comment.
Generally, if a country has concerns with a particular draft
standard, and supports those concerns with sound technical information,
the pertinent OIE Code Commission will revise that standard
accordingly, circulate the revised standard to OIE Member countries for
comment, and present the revised draft for adoption at the General
Session in May. In the event that a country's concerns regarding a
draft standard are not taken into account, that country may refuse to
support the standard when it comes up for adoption at the General
Session. However, each Member country is obligated to review and
comment on proposed standards, and make decisions regarding the
adoption of those standards, strictly on their scientific merits.
Through APHIS, the United States plays on ongoing role in the
development and revision of the OIE Code. The science upon which APHIS
has based its regulations has also been the basis for APHIS'
recommendations regarding and response to BSE-related changes in the
OIE Code. APHIS maintains a data base of disease and subject matter
experts to review specific Code chapters; monitors and evaluates
reports and scientific data produced by the OIE; and conducts meetings
with staff members, pertinent industry groups, and subject matter
experts to review and develop positions for the safe movement of animal
and animal products.
As an OIE Member country, the United States reviews and, where
appropriate, comments on all draft OIE chapters and revisions. As part
of the U.S. consideration of OIE drafts, APHIS distributes these drafts
to the U.S. livestock and aquaculture industries, veterinary experts in
various U.S. academic institutions, and other interested persons for
review and comment.
In addition, each year, prior to formulating its comments for the
OIE annual meeting, APHIS makes available on its Web site those
potential changes to the Code that the OIE has submitted to Member
countries for comment, and accepts information and recommendations from
the public regarding those proposed changes. (The proposed changes can
be accessed at http://www.aphis.usda.gov/import_export/animals/oie/).
Through its OIE Reference Laboratories and Collaborating Centers, APHIS
also provides OIE Member countries with technical assistance and expert
advice on risk analysis and disease surveillance and control, as well
as diagnostic assistance, evaluation, and consultation.
Over the years, the OIE Member countries, including the United
States, have agreed by consensus to amend the OIE Code based on
increased scientific evidence regarding the disease. The OIE Code
reflects the current understanding that, depending on multiple factors,
there can be gradations in the risk of the BSE agent being moved from
one country to another, and gradations in the risk of BSE transmission
and amplification within any particular country. As a member of the
OIE, the United States, represented by APHIS, has been actively
involved in the development of the OIE Code and fully supports the OIE
position that gradations in BSE risk among regions should be recognized
and that trade should be commensurate with risk.
This recognition of varying levels of BSE risk is the underpinning
for OIE's system of classifying countries according to different levels
of BSE risk. Currently, the OIE categorizes countries as either
negligible risk, controlled risk, or undetermined risk for BSE. For
live cattle and for many products derived from cattle, the trade
conditions recommended by the OIE Code are based on the BSE risk
classification of the exporting country.

Changes to APHIS' Regulations Regarding BSE

In recent years, APHIS has amended its regulations consistent with
scientific evidence and BSE risk management that allow the United
States to take a more focused approach to categorizing regions and
establishing import prohibitions and restrictions with regard to BSE.
As discussed above, in January 2005, APHIS amended its regulations to
recognize a category of regions that present a minimal risk of
introducing BSE into the United States, even though BSE may have been
diagnosed in the region. In evaluating the BSE risk from a region to
determine whether to classify it as a minimal-risk region, APHIS
considers a combination of 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). In its 2005
rule, APHIS also established conditions for the importation of certain
live ruminants and ruminant products and byproducts from such regions
and recognized Canada as a BSE minimal-risk region. We based our
recognition of Canada as a BSE minimal-risk region 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, ``Analysis of Risk--Update for the
Final Rule: Bovine Spongiform Encephalopathy; Minimal Risk Regions and
Importation of Commodities.'' which also identified measures necessary
to mitigate any BSE risk that specific commodities imported from Canada
might present to the United States, can be accessed at http://www.aphis.usda.gov/peer_review/downloads/risk_assessment_final9-2007.pdf)
As noted above, in December 2005, APHIS amended its regulations to
allow the importation of certain cuts of boneless beef from Japan. The
risk assessment conducted for that rulemaking examined the evidence
supporting the safety of this commodity. This evidence and APHIS'
conclusions were consistent with OIE for trade in meat derived from
cattle from regions of controlled risk for BSE. (The risk document,
``Analysis of Bovine Spongiform Encephalopathy (BSE) Risk to the U.S.
Cattle Population from Importation of Whole Cuts of Boneless Beef from
Japan,'' can be accessed at http://www.regulations.gov/#!documentDetail;D=APHIS-2005-0073-0002).
As discussed above, in September 2007, APHIS again amended the BSE
regulations to allow the importation of additional commodities from BSE
minimal-risk regions. As part of this rulemaking, APHIS conducted a
risk assessment that was peer reviewed by recognized experts in the
field. (The risk assessment, peer review, and APHIS responses to peer
review comments can be accessed at http://www.aphis.usda.gov/peer_review/downloads/risk_assessment_%20final9-2007.pdf).

BSE Categories in Current APHIS Regulations

With the 2005 addition to the regulations of the BSE minimal-risk
category, the three categories of regions

[[Page 15872]]

with regard to BSE set forth in APHIS' regulations became: (1) Those in
which BSE is known to exist (listed in Sec. 94.18(a)(1) of the
regulations); (2) those that present an undue risk of introducing BSE
into the United States because their import requirements are less
restrictive than those that would be acceptable for import into the
United States and/or because the regions have inadequate surveillance
(listed in Sec. 94.18(a)(2) of the regulations); and (3) those that
present a minimal risk of introducing BSE into the United States via
live ruminants and ruminant products and byproducts (listed in Sec.
94.18(a)(3) of the regulations). These are the categories set forth in
the current regulations.
How APHIS categorizes a region with regard to BSE risk determines
which ruminants and products derived from ruminants from that region
are eligible for importation into the United States. Of the three
categories listed in Sec. 94.18(a), those regions listed in Sec.
94.18(a)(1) (regions in which BSE is known to exist) and in Sec.
94.18(a)(2) (regions that present an undue risk of introducing BSE into
the United States) are subject to the most restrictive BSE-related
regulatory provisions. The prohibitions and restrictions on the
importation of live ruminants and commodities derived from ruminants
are the same for regions in either of those categories.
The importation of live ruminants of any kind is prohibited from
regions listed in either Sec. 94.18(a)(1) or Sec. 94.18(a)(2).
Additionally, with certain exceptions, regions listed in either Sec.
94.18(a)(1) or Sec. 94.18(a)(2) are not eligible to import into the
United States the following commodities derived from ruminants that
have been in the regions: Meat; meat products; and edible products
other than meat. Also, with certain limited exceptions, the following
commodities are prohibited importation into the United States if they
are derived from ruminants that have been in any region listed in Sec.
94.18(a)(1) or Sec. 94.18(a)(2), or if the commodities themselves have
been in such regions (and, in some cases, if they are derived from
nonruminant species that might have been commingled with products
derived from ruminants): Processed animal protein; tankage; offal;
tallow other than tallow derivatives (unless, in the opinion of the
Administrator, the tallow cannot be used in feed); glands and
unprocessed fat tissue; processed fats and oils; derivatives of
processed animal protein, tankage, and offal; derivatives of glands;
casings, other than stomachs; and serum and related materials.
Under the regulations regarding BSE minimal-risk regions, specified
live ruminants and products derived from ruminants are eligible for
importation from such regions, provided certain conditions are met.
Factors governing the eligibility of and conditions for importation of
such commodities from BSE minimal-risk regions include the following:
The species of animal intended for importation or from which products
were derived; whether an animal intended for importation has been
properly identified; whether the animal had been subject to a ruminant-
to-ruminant feed ban; and, in the case of products derived from
bovines, whether specified BSE risk materials were removed from the
animal at slaughter.
APHIS does not restrict the importation into the United States of
ruminants and ruminant products from any region that is not listed in
one of the three categories included in Sec. 94.18(a) (regions in
which BSE is known exists, regions of undue risk for BSE, and regions
of minimal risk for BSE), but their importation might be prohibited or
restricted due to other animal diseases.

Proposed Changes

Refining science-based regulations for safe trade in bovines and
meat and other products derived from bovines has been and continues to
be a high priority for APHIS. As noted above, although APHIS'
regulatory changes in recent years with regard to BSE have been
consistent with increased scientific understanding of the disease, we
believe that further refinement of the regulations is in order given
the latest scientific literature regarding BSE. In this document, we
are proposing to amend the regulations to establish importation
requirements based on our current scientific understanding of the risk
of BSE. In many instances these changes, while still protecting
livestock in the United States from BSE, would allow the importation
into the United States of additional commodities. In a few cases, this
proposal would make BSE-related import conditions more restrictive.\10\
---------------------------------------------------------------------------

\10\ For example, ruminant-derived MBM and greaves, and products
containing such, sourced from regions of controlled and undetermined
risk would be prohibited.
---------------------------------------------------------------------------

OIE Code

APHIS is closely familiar with the development of the OIE Code and
considers it to be based on sound science. The scientific literature
upon which we are basing our proposed regulations includes literature
that has been considered by OIE subject matter experts and Member
countries in developing and updating the OIE Code, as well as other
scientific literature reviewed by APHIS. One result of implementing
these science-based changes would be to make the APHIS regulations more
consistent with the 2010 OIE Code. In those few instances where our
proposed provisions differ from the guidelines in the 2010 OIE Code, we
provide a science-based rationale for those differences, either in this
document or in the supporting scientific documentation.
The OIE Code reflects the scientific understanding of the nature of
BSE and appropriate risk mitigation measures. Two of the most important
risk mitigation measures are the control of SRMs and feed bans. Most of
the OIE guidelines rest on these two significant mitigation measures.
An additional risk mitigation measure can be the application of certain
production processes that can achieve a level of inactivation of the
BSE agent. In some instances, industrial production methods--such as
those for gelatin production--are sufficient to provide varying levels
of inactivation of the BSE agent. These are described in more detail in
this document in the relevant sections for these products. The use of
these mitigation measures as outlined in the OIE Code significantly
reduces the risk that the BSE agent might be present in the animals or
products presented for trade.
The same mitigation measures are applied domestically, thus
minimizing the risk that BSE will become established in the United
States if the BSE agent is present in an imported animal or product.
Using the importation of live cattle as an example, we can consider the
risk pathway for transmission of BSE. Several steps must take place for
BSE to be transmitted to cattle in the United States from a bovine
imported live from another country. A BSE-infected bovine must be
imported into the United States; the infected bovine must die or be
slaughtered; tissues from that animal that contain sufficient levels of
the infectious agent must be sent to a rendering facility; the
infectivity present in these tissues must survive inactivation in the
rendering process; the resulting processed animal protein containing
the abnormal prion protein must be incorporated into feed; and this
feed must be fed to cattle at a level adequate to infect the cattle.
(The amount of infectious material required in feed for cattle to
become infected is dependent on the age of the cattle; younger cattle
are more susceptible to BSE and require less BSE-contaminated feed to
become infected.) The nature

[[Page 15873]]

and likelihood of these pathways depend in large part on mitigations--
such as SRM controls and a feed ban--acting in series and in parallel
that reduce the likelihood that BSE will be established in the United
States.
The combined OIE requirements and additional APHIS requirements
would serve to prevent the introduction and spread of the BSE agent
from imported commodities regardless of a country's BSE prevalence.

Classification of Regions as to BSE Risk

One of the structural changes this proposed rule would make to the
current BSE regulations would be to change the current Sec. 94.18(a)
categories of regions in which BSE is known to exist, regions of undue
risk for BSE, and BSE minimal-risk regions to the system used by the
OIE of classifying areas as being either of negligible risk, controlled
risk, or undetermined risk for BSE.\11\ Whether a live bovine or a
bovine-derived product would be eligible for importation into the
United States, and under what conditions, would in many cases be
determined by the BSE category of the region from which the animal or
product originates.\12\
---------------------------------------------------------------------------

\11\ Although the OIE Code refers to categorization of
``countries, zones, or compartments,'' the only areas that have been
classified by OIE with regard to BSE risk to date have been entire
countries. In discussing animal diseases in its regulations, APHIS
uses the term ``region'' to refer to foreign areas. Under the APHIS
regulations, a region can consist of any of the following: (1) A
national entity (country); (2) part of a national entity (zone,
county, department, municipality, parish, Province, State, etc.);
(3) parts of several national entities combined into an area; or (4)
a group of national entities combined into a single area. In our
proposed rule, we would continue to use the term ``region'' in order
to be consistent with our current animal import regulations, and
will refer to the geographic and political entities considered by
the OIE as ``regions.'' However, when considering BSE risk
classification, we do not anticipate dealing with any entities other
than individual countries in their entirety. Considering the BSE
risk status of entire individual countries would be consistent with
past APHIS practice, as well as OIE practice.
\12\ The current regulations regarding BSE minimal-risk regions
apply to bison as well as cattle. In current Sec. Sec. 93.400,
94.0, and 95.1 of the regulations, bovine is defined as Bos taurus,
Bos indicus, and Bison bison. Although the research and other data
cited in this proposed rule refer to bovines other than bison (i.e.,
to ``cattle''), there is no evidence to indicate that the BSE
susceptibility of bison differs from that of cattle. We therefore
assume that our conclusions based on cattle-specific evidence
discussed in this proposed rule are also applicable to bison. The
provisions of this proposed rule would apply to bovines as defined
in the current regulations, which include bison.
---------------------------------------------------------------------------

BSE Classification of Regions

We are proposing to base APHIS' classification of the BSE risk
status of a region on the results of an evaluation of BSE risk posed by
that region. Under this proposed rule, that evaluation could have been
conducted either by APHIS or by the OIE. The process the OIE uses in
conducting such an evaluation and the information it considers are
equivalent to the process and information APHIS considers necessary to
arrive at an appropriate determination of BSE risk. The process and
information considered are discussed at greater length, below, under
the heading ``Process for Determining BSE Risk Classification.''

Scope of This Proposed Rule

The current APHIS regulations regarding BSE encompass all ruminants
and products from all ruminants. Under the current regulations in 9 CFR
parts 93, 94, and 98, ruminants are defined as ``all animals that chew
the cud, such as cattle, buffaloes, sheep, goats, deer, antelopes,
camels, llamas and giraffes.'' Included among ruminants are bovines
(e.g., cattle), ovines (e.g. sheep), caprines (e.g., goats), cervids
(e.g., deer and elk), and camelids (e.g., llamas and alpacas). Bovines
are defined in the regulations as bos taurus, bos indicus, and bison
bison--cattle and bison. In the following paragraphs, we discuss how
this proposed rule applies to each of these groups of ruminants.
Cervids and Camelids
In prohibiting the importation of all ruminants from regions listed
in Sec. 94.18(a)(1) and (a)(2), the current regulations prohibit the
importation from such regions of cervids and camelids, and products
derived from such animals, from such regions. However, live cervids and
camelids and products derived from cervids and camelids are eligible
for importation from BSE minimal-risk regions without restriction
regarding BSE.
In this document, we are proposing to remove all restrictions with
regard to BSE from the importation of live cervids and camelids and
their products from any region of the world. Although BSE has been
shown to be naturally and experimentally transmitted to a wide range of
ruminants, natural transmission of BSE has not been reported in cervids
or camelids. One ongoing study shows that red deer (cervus elaphus)
developed clinical signs similar to chronic wasting disease upon
intracerebral inoculation of BSE-infected brain (Martin, et al., 2007);
however red deer challenged intra-gastrically with BSE-infected brain
developed neither clinical signs of disease nor presence of PrPsc at
post-mortem examination. In addition, surveillance in the United
Kingdom and European cervid population did not show any evidence of any
TSEs (http://www.cdc.gov/Ncidod/eid/vol12no02/pdfs/05-0970.pdf; http://www.defra.gov.uk/animalh/bse/othertses/index.html). Therefore, APHIS
considers the BSE risk from removing import restrictions on cervids and
camelids and their products to be very low. The OIE Code with respect
to BSE does not address trade in cervids or camelids.
Ovines and Caprines
In this proposal, we continue to apply the current import
prohibitions and restrictions regarding ovines and caprines (e.g.,
sheep and goats) and their products. We are in the process of
developing a proposal to amend the BSE regulations as they affect the
importation of ovines and caprines and products derived from such
animals. Upon completion of such a proposal, we will publish it in the
Federal Register for public comment.
Because this proposed rule contains no substantive changes to the
import regulations regarding ovines and caprines, any comments we
receive in response to this proposed rule that pertain to ovines and
caprines will not be addressed in this rulemaking, but will be
considered as we develop our proposed rule regarding the importation of
ovines and caprines and products from such animals.
Although we are not proposing at this time to make any substantive
changes to the regulations regarding the importation of ovines and
caprines and products derived from such animals with regard to BSE, we
are proposing certain formatting and wording changes to those
regulations. We discuss these proposed changes below under the heading
``Provisions Regarding Ovines and Caprines.''
Bovines
As noted above, we are proposing to amend our import regulations
with regard to bovines and BSE in a way that would result in our
regulations being more consistent with the current scientific
understanding of BSE, which is also reflected in the recommendations
regarding trade in cattle and cattle products set forth in Chapter 11.5
of the OIE Code.\13\
---------------------------------------------------------------------------

\13\ The current regulations regarding BSE minimal-risk regions
apply to bison as well as cattle. In current Sec. Sec. 93.400,
94.0, and 95.1 of the regulations, bovine is defined as Bos taurus,
Bos indicus, and Bison bison. Although the research and other data
cited in this proposed rule refer to bovines other than bison (i.e.,
to ``cattle''), there is no evidence to indicate that the BSE
susceptibility of bison differs from that of cattle. We therefore
assume that our conclusions based on cattle-specific evidence
discussed in this proposed rule are also applicable to bison. The
provisions of this proposed rule would apply to bovines as defined
in the current regulations, which include bison.

---------------------------------------------------------------------------

[[Page 15874]]

As discussed above, commodities from regions not listed in any of
the categories set forth in Sec. 94.18(a) (regions in which BSE is
known to exist, regions of undue risk for BSE, and regions of minimal
risk for BSE) are currently not subject to import restrictions because
of BSE. Imports from BSE-affected regions and those that present an
undue risk are governed by the same set of restrictions, which prohibit
the importation of live ruminants and most products derived from
ruminants. Imports from BSE minimal-risk regions are governed by their
own set of restrictions, which allow for the importation of more
commodities than do the regulations regarding BSE-affected regions and
those that present an undue risk.
As noted above, the 2010 OIE Code chapter regarding BSE provides
for three possible BSE risk classifications: Negligible risk,
controlled risk, and undetermined risk. APHIS has thoroughly reviewed
the peer-reviewed scientific literature on BSE that the OIE uses to
support its guidelines for risk evaluations (discussed in ``Supporting
document for Chapter 2.3.13 of the Terrestrial Animal Health Code on
Bovine Spongiform Encephalopathy'' (OIE TAHSC, 2006)) and, with certain
limited exceptions, agrees with the OIE's recommendations and
guidelines. We discuss below the factors the OIE takes into account in
making its classifications.
Under the OIE Code for live cattle and many products derived from
cattle, many of the recommended measures to mitigate any BSE risk from
the trade of such commodities depend on the risk classification of an
exporting region. The OIE takes many factors into account in
determining whether the BSE risk in a particular country is negligible,
controlled, or undetermined. These factors include: The history of BSE
in the country; whether BSE-infected animals in the country were
imported or were indigenous; if indigenous, how long ago an infected
animal was born; identification and destruction of infected animals and
potentially exposed animals; the level of surveillance for BSE carried
out in the country and the length of time the surveillance has been
carried out; whether, and for how long, appropriate awareness and
notification programs and laboratory diagnostic procedures have been in
place; whether, and for how long, a ban on the feeding of ruminant
materials to other ruminants has been effectively enforced. These are
the same factors that APHIS took into account when determining that
Canada qualified as a BSE minimal-risk region.
In this proposal, we are proposing to amend our BSE regulations to
structure classification of regions for BSE risk in the same way as
does the OIE. Such classification is based on an overall evaluation of
the BSE risk of a region, including a risk assessment. Because the data
and process for a BSE risk evaluation that APHIS would conduct are
equivalent to those employed by the OIE in making its own evaluations,
we are proposing that APHIS' classification of the BSE risk status of
an exporting region could be based on either an evaluation of the BSE
risk of a country that is conducted by the OIE, or, for regions not yet
classified by OIE, on an evaluation conducted by APHIS following a
request.

Definitions of Regions of Negligible Risk, Controlled Risk, and
Undetermined Risk for BSE

We are proposing to add definitions of a region of negligible risk
for BSE, a region of controlled risk for BSE, and a region of
undetermined risk for BSE to the regulations in Sec. 92.1. The
definitions we are proposing to add are substantively the same as those
used by the OIE in its Code. However, stylistically, our proposed
definitions are, in some places, worded differently from the wording
used in the OIE Code.
Regions of Negligible Risk for BSE
There are multiple criteria that must be met for a region to
qualify as a region of negligible risk for BSE. Our proposed definition
of a region of negligible risk for BSE appears in Sec. 92.1 and
includes the following conditions. We are proposing that a region of
negligible risk for BSE is one for which a risk assessment has been
conducted that is sufficient to identify the historical and existing
BSE risk factors in the region and that:
Has demonstrated that appropriate BSE risk mitigation
measures have been taken for at least as long as indicated in this
definition;
Has demonstrated that Type B surveillance in accordance
with Article 11.5.22 of the OIE Code, or with equivalent guidelines
recognized by the Administrator, is in place and the relevant points
target, in accordance with Table 1 of Article 11.5.22 of the OIE Code,
or with equivalent guidelines recognized by the Administrator, has been
met (OIE guidelines for surveillance are discussed below under the
heading ``Epidemiological situation concerning BSE in the country.'')
Has, for at least the past 7 years:
1. Conducted an ongoing awareness program for veterinarians,
farmers, and workers involved in the transportation, marketing and
slaughter of bovines to encourage reporting of all bovines showing
clinical or behavioral signs that could be indicative of BSE.
2. Required notification and investigation of all bovines showing
clinical signs consistent with BSE; and
3. Carried out the examination, in accordance with internationally
accepted diagnostic tests and procedures and in approved laboratories,
of brain or other tissues collected as part of the required
surveillance and monitoring system;
Has demonstrated through an appropriate level of control
and audit that, for at least the past 8 years, neither meat-and-bone
meal (MBM) nor greaves derived from ruminants have been fed to
ruminants. In the OIE Code, the 8-year requirement regarding a feed ban
applies to MBM and greaves derived from ruminants. Even though the OIE
recommends that regions that are considered controlled risk or
undetermined risk should not trade in MBM and greaves derived from
ruminants, or in any commodities containing such, APHIS is proposing
that the recommendation apply to processed animal protein derived from
ruminants or commodities containing processed animal protein derived
from ruminants. In part 95 of the current regulations, processed animal
protein is defined as ``meat meal, bone meal, MBM, blood meal, dried
plasma and other blood products, hydrolyzed proteins, hoof meal, horn
meal, poultry meal, feather meal, fish meal, and any other similar
products.'' Like MBM, each of the other products in the definition is a
rendered product, and, except for blood and blood products, we have not
yet done an assessment of the BSE risk of the products. Additionally,
we believe it is necessary to take into account the risk that the other
products could become commingled with MBM, which, if derived from
infected ruminants, may contain the infectious agent. APHIS would allow
the importation of those processed animal proteins derived from
ruminants or commodities containing such after an assessment of the
risk has determined that these products are not commingled or
contaminated with ruminant MBM or greaves.
In addition to meeting the criteria listed above, for a region to
qualify as a region of negligible risk for BSE, one of the following
conditions must apply; either:
There has been no case of BSE in the region; or

[[Page 15875]]

There have been one or more cases, but each case has been
demonstrated to have been imported and has been completely destroyed;
or
There has been at least one indigenous case, but every
indigenous case was born more than 11 years ago. If there has been one
or more indigenous cases, all bovines included in either of the
following two categories must, if still alive, be officially identified
with unique individual identification that is traceable to the premises
of origin of the animal, have their movements controlled, and, when
slaughtered or at death, be completely destroyed:
1. All bovines that, during their first year of life, were reared
with a bovine determined to be infected with BSE during its first year
of life, and that investigation showed consumed the same feed that
potentially contained SRM material as the infected animal during that
period; or
2. If the investigation was unable to determine whether the feed
source that was used to feed the bovine known to be infected was also
used to feed other bovines in the herd of the infected animal, all
bovines born in the same herd as a BSE-infected bovine either within 12
months before or 12 months after the birth of the infected animal.
Regions of Controlled Risk for BSE
If a region does not qualify as a region of negligible risk for
BSE, we are proposing that it could be classified as a region of
controlled risk for BSE if specified conditions are met, as set forth
in Sec. 92.1 of this proposed rule and described below. We are
proposing that a region of controlled risk for BSE is one for which a
risk assessment has been conducted sufficient to identify the
historical and existing BSE risk factors in the region and that:
Has demonstrated that appropriate mitigations are being
taken to manage all identified risks, but has not taken every
mitigation measure for the length of time that would be necessary to
qualify as a region of negligible risk for BSE;
Has demonstrated that Type A surveillance in accordance
with Article 11.5.22 of the OIE Code, or with equivalent guidelines
recognized by the Administrator, is in place and the relevant points
target, in accordance with Table 1 of Article 11.5.22 of the OIE Code
or equivalent guidelines recognized by the Administrator has been met.
Type B surveillance, or equivalent surveillance recognized by the
Administrator, is sufficient in place of Type A surveillance once the
relevant points target for Type A surveillance has been met;
Meets the conditions of one of the two following sets of
conditions:
Conditions Set 1. There has been no case of BSE in the region, or,
if there have been one or more cases of BSE, every case has been
demonstrated to have been imported and has been destroyed. In addition,
both of the following conditions apply:
The following conditions have been met and continue to be
met:
a. The region has conducted an ongoing awareness program for
veterinarians, farmers, and workers involved in transportation,
marketing and slaughter of bovines to encourage reporting of all
bovines showing clinical signs that could be indicative of BSE;
b. The region has required notification and investigation of all
bovines showing clinical signs consistent with BSE; and
c. The region has carried out the examination, in accordance with
internationally accepted diagnostic tests and procedures and in
approved laboratories, of brain or other tissues collected as part of
the required surveillance and monitoring system;

and:

The feeding to ruminants of MBM and greaves derived from
ruminants is prohibited in the region.
However, the requirements described above regarding awareness,
notification, and examination have not been met for at least the past 7
years and/or it cannot be demonstrated that controls over the feeding
of ruminant protein to ruminants have been in place for at least the
past 8 years.
Conditions Set 2. There has been an indigenous case of BSE, and
either or both of the following applies; either:
The following conditions have been met and continue to be
met, but not for at least the past 7 years:
a. The region has conducted an ongoing awareness program for
veterinarians, farmers, and workers involved in transportation,
marketing and slaughter of bovines to encourage reporting of all
bovines showing clinical signs that could be indicative of BSE;
b. The region has required notification and investigation of all
bovines showing clinical signs consistent with BSE;
c. The region has carried out the examination, in accordance with
internationally accepted diagnostic tests and procedures and in
approved laboratories, of brain or other tissues collected as part of
the required surveillance and monitoring system;

or:

The feeding to ruminants of MBM or greaves derived from
ruminants is prohibited in the region, but it cannot be demonstrated
through an appropriate level of control and audit that the prohibited
material has not been fed to ruminants for at least the past 8 years.
Additionally, in either of the situations described in
this second set of conditions, for a region to qualify as a region of
controlled risk for BSE, the following condition must be met: If alive
in the region, bovines that are included in either of the following
categories are officially identified with unique individual
identification that is traceable to the premises of origin of the
animal, have their movements controlled, and, when slaughtered or at
death, are completely destroyed:
a. All bovines that, during their first year of life, were reared
with a bovine determined to be infected with BSE during its first year
of life, and that investigation showed consumed the same feed that
potentially contained SRM material as the infected animal during that
period; or
b. If the investigation was unable to determine whether the feed
source that was used to feed the bovine known to be infected was also
used to feed other bovines in the herd of the infected animal, all
bovines born in the same herd as the BSE-infected bovine either within
12 months before or 12 months after the birth of the infected animal.
Regions of Undetermined Risk for BSE
A region of undetermined risk for BSE is defined by the OIE, and
would be defined by APHIS in Sec. 92.1, as a region that does not meet
the criteria for being classified as either a region of negligible risk
for BSE or a region of controlled risk for BSE.
Incorporation by Reference of OIE Code Standards for BSE Surveillance
The proposed definitions of region of negligible risk for BSE and
region of controlled risk for BSE include the criteria that the region
has demonstrated that specified surveillance in accordance with Article
11.5.22 of the OIE Code, or with equivalent guidelines recognized by
the Administrator, is in place and that the relevant points target, in
accordance with Table 1 of Article 11.5.22 of the OIE Code or
equivalent guidelines recognized by the Administrator has been met.
As discussed above, the OIE, of which the United States is a member
country, is the internationally recognized standard-setting body that
develops science-based recommendations for the safe trade of animals
and animal products. We are proposing to incorporate into the
regulations by reference at Sec. 92.7 Article 11.5.22 of the

[[Page 15876]]

OIE Code. The OIE surveillance standards are discussed in more detail,
below, under the heading ``Epidemiological situation concerning BSE in
the country.'' Section 92.7 would also state that the incorporation by
reference was approved by the Director of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and that the OIE
maintains a copy of its standards on its internet homepage at http://www.oie.int/eng/normes/Mcode/en_sommaire.htm. Additionally, Sec. 92.7
would state that copies of the OIE standards are available for
inspection at the National Archives and Records Administration (NARA)
and that information on the availability of this material at NARA can
be obtained by calling 202-741-6030 or by going to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Process for Determining BSE Risk Classification

In the following paragraphs, we discuss the process followed by the
OIE in conducting its evaluation of a country for BSE risk. As noted
above, APHIS recognizes the scientific validity of the process used by
the OIE and employed an equivalent process in classifying Canada as a
BSE minimal-risk region and, in subsequent rulemaking, allowing
additional imports of live bovines and bovine products from Canada.
In carrying out its evaluation process, the OIE refers to risk
factors as they involve ``cattle.'' Therefore, when discussing the OIE
process in this proposed rule, we use the term ``cattle.'' However, as
we note above in this document, the provisions of this proposed rule
would apply to bovines as defined in the current regulations, which
include bison.
As described in the questionnaire for BSE status recognition
(http://www.oie.int/fileadmin/Home/eng/Animal_Health_in_the_World/docs/pdf/A_BSE quest.pdf) that is based on Articles 11.5.3 and 11.5.4
of the OIE Code, countries requesting classification from the OIE as a
country of negligible risk for BSE or a country of controlled risk for
BSE must submit a dossier containing BSE historical data to support a
risk assessment and overall evaluation. The information in the dossier
is evaluated by BSE experts who are leading specialists regarding the
disease.
In the following paragraphs we discuss the OIE procedure for
recommending the BSE classification of a country and the rationale
behind the considerations taken. As noted above, APHIS considers the
approach taken by the OIE to be based on the current scientific
understanding of BSE. In its own evaluations of the BSE risk in other
countries, APHIS has taken, and will continue to take, an equivalent
approach.
For purposes of discussion of the classification process, we will
follow the OIE terminology in discussing the country being evaluated
for BSE risk as the exporting country or exporting region. In proposed
Sec. Sec. 92.1, 93.400, 94.0, and 95.1, we define exporting region as
a region from which shipments are sent to the United States.
The risk classification of an exporting country may be influenced
by commodities the country has imported from another country. For
purposes of discussion, we will follow the OIE terminology and refer to
a country that sends commodities to the ``exporting country'' as a
``country of origin.''

Components of a Risk Assessment

A risk assessment is the primary tool used by the OIE in
determining whether to recognize a country as either a country of
negligible risk for BSE or a country of controlled risk for BSE, and
would be the primary tool used by APHIS in making such a determination.
An assessment of BSE risk includes at least two components: A release
assessment and an exposure assessment. A release assessment assesses
the likelihood that BSE has been introduced into the exporting country
through live animals, processed animal protein, or other animal
products. An exposure assessment assesses the likelihood that cattle
within the exporting country could have been exposed to the BSE agent.
Under the OIE Code, in addition to the information necessary to
allow OIE to conduct a risk assessment, a country requesting OIE
classification as a country of negligible risk or controlled risk for
BSE must also submit information regarding the country's BSE awareness
program, its notification requirements for BSE, its diagnostic
capabilities, and its BSE surveillance program. This type of
information was also considered by APHIS in conducting its evaluation
of the BSE disease risk of Canada.

Release Assessment Component of a Risk Assessment

As noted above, a release assessment assesses the likelihood of
release of the BSE agent into a country through the importation of
potentially infected live cattle, processed animal protein, or other
products of animal origin potentially infected with BSE. In the
following paragraphs, we discuss the significance of these commodities
with regard to BSE risk.
Potentially Infected Live Cattle
An assessment of the risk of the release of the BSE agent in the
exporting country includes consideration of whether potentially
infected live cattle were imported into that country. The risk of the
release of the BSE agent in the exporting country is dependent on:
The BSE status of the country of origin of the potentially
infected live cattle;
The feeding and management of the cattle in the country of
origin;
Whether the cattle are dairy or beef breeds, if there are
differences in exposure due to feeding practices in the country of
origin;
The date at which imports occurred, relative to the BSE
mitigation in the country of origin; and
The volume of potentially contaminated imports.
Products of Animal Origin That Could Pose a BSE Risk
A release assessment also considers the importation of animal
products that could pose a BSE risk. As with importation of potentially
infected live cattle, there are various factors that can affect the
potential risk presented by products of animal origin.
The risk of the release of the BSE agent in the exporting
country due to the importation of animal products is dependent on:
Whether products from cattle contain tissues of the type
known to contain BSE infectivity (i.e., SRMs);
The country of origin of the products and the BSE status
of that country;
The feeding and management of the animals in the country
of origin;
Whether the cattle from which the products are derived in
the country of origin are dairy or beef breeds, if there are
differences in exposure due to feeding practices in the country of
origin; and
The age at which the cattle from which the products were
derived were slaughtered in the country of origin.
For both live animals and animal products, some of the risk factors
identified can be mitigated through import requirements. These are
evaluated as part of the OIE process. For example, if a country
prohibited the importation of any cattle products containing or derived
from SRMs, the risk would be mitigated. Therefore, imports meeting
those conditions would not necessarily result in an elevated risk as
noted in the risk assessment.

[[Page 15877]]

For most animal products, the OIE evaluates the information
described above regarding products of animal origin that have been
imported during the previous 7 years into the potential exporting
country (i.e., the country seeking a BSE risk classification from the
OIE).
Of the types of animal products derived from bovines, processed
ruminant protein that either contains or has been contaminated by the
BSE agent is the means of transmission of BSE. Therefore, in conducting
an assessment of the BSE risk in a country, it is important to know the
origin of processed animal protein, or feedstuffs containing processed
animal protein, that have been imported into the country. Processed
animal protein originating from high-risk countries for BSE presents a
higher release risk than if originating from low-risk countries.
Because of the relatively greater BSE risk posed by processed
ruminant protein compared to other animal products, the required
reporting period for MBM and greaves is greater than for other animal
products, and countries seeking BSE risk classification must inform the
OIE whether MBM, greaves, or feedstuffs containing either, have been
imported into that country within the past 8 years, and, if so, from
what country and in what quantities. (In the OIE Code, MBM is defined
as ``the solid protein products obtained when animal tissues are
rendered, including any intermediate protein product other than
peptides of a molecular weight less than 10,000 daltons and amino
acids.'' Greaves are the protein-containing residue obtained after the
partial separation of fat and water during the rendering process.)
Eight years are associated with the incubation period of BSE, and
represent a time period longer than the one representing the 95th
percentile of the normal distribution of the age of clinical BSE cases
detected at the peak of the United Kingdom and Swiss epidemic--i.e., 95
percent of clinical cases of BSE would be expected to be detected in
some period of time less than 8 years after exposure to MBM or greaves
contaminated with the BSE agent.

Exposure Assessment of the Exporting Country

The exposure assessment assesses the likelihood of exposure to the
BSE agent of cattle in the exporting country, given the release of the
BSE agent into the country. The exposure assessment evaluates the
entire risk pathway for the transmission of BSE in the country. This
includes all aspects of the cattle feed production and management
systems.
Evidence indicates that field transmission of BSE requires that
cattle ingest feed that has been contaminated with tissues or organs
containing the BSE agent from an infected animal. Several steps in the
risk pathway must take place consecutively for this to happen. An
infected animal, carrying significant amounts of the infectious agent,
must die or be slaughtered; tissues from that animal that contain the
infectious agent must be sent to a rendering facility; the infectivity
present in these tissues must survive inactivation in the rendering
process; the resulting protein must be incorporated into feed, and this
feed must be fed to at least one bovine at an adequate level.
The exposure assessment conducted by the OIE carefully evaluates
all of these steps in the pathway as they consider the potential for
the exposure of cattle to the BSE agent through consumption of MBM or
greaves of bovine origin. This incorporates an evaluation of the
implementation and enforcement of feed bans, including measures to
prevent cross-contamination of animal feed. It includes all aspects of
the potential for recycling and amplification of the BSE agent--whether
the origin and use of bovine carcasses (including fallen stock),
byproducts, and slaughterhouse waste presented a risk of recycling or
amplification of the BSE agent; the parameters of the rendering
processes; and the methods of producing feed for cattle and other
animals. The OIE evaluates information addressing each of the factors
listed above.
The rendering industry is crucial in reducing the risk of
transmitting BSE infectivity, not only because of its role in
inactivation of the BSE agent, but also because it serves as a critical
control point for the redirection of ruminant protein away from cattle
feeds. The OIE evaluates all aspects of the rendering industry. These
include what types of tissues and/or carcasses are used as inputs in
the rendering process. If SRMs are excluded from the input tissues or
carcasses, this reduces the risk. It also includes the parameters of
the rendering processes. Certain rendering processes can inactivate a
proportion of the BSE agent present. If a fraction of the BSE
infectivity were to escape in activation at the rendering facility, it
would need to bypass controls imposed to prevent cross-contamination
and ensure proper labeling of rendered materials (at the renderer) and
feeds produced using prohibited MBM (at the feed mill).
The OIE also evaluates any feed ban or feed controls that are in
place in the country. As noted above, it is widely accepted that BSE is
caused by the consumption of processed animal protein of ruminant
origin carrying and/or contaminated with the BSE agent. For potential
exporting countries requesting a classification of BSE risk, the OIE
evaluates information on whether MBM or greaves of ruminant origin have
been fed to cattle in the country within the previous 8 years,
including information regarding the implementation and enforcement of a
feed ban and measures to prevent cross-contamination of animal feed.
This evaluation includes consideration of the regulations imposing a
feed ban, the veterinary infrastructure used to enforce and audit all
aspects of the feed ban, and results of all audits or enforcement
activities.
The overall risk of BSE in the cattle population of a country is
proportional to the level of known or potential exposure to BSE
infectivity and the potential for recycling and amplification of the
infectivity through livestock feeding practices. For a risk assessment
to conclude that the cattle population of a country is of negligible or
controlled risk for BSE, it must have been demonstrated that
appropriate measures have been taken for a set period of time to manage
any risks identified. The risk assessment evaluates information, within
the context of the risk described above, regarding all aspects of the
feeding practices over the previous 8 years in the country.

Additional Factors To Be Considered in the Determination of BSE Risk
Status

Epidemiological Situation Concerning BSE in the Country
Surveillance programs generate a picture of the epidemiological
situation of BSE in a country. The more targeted the surveillance
activities, the greater the power of the information. Surveillance
targeted at high-risk populations for BSE provides more powerful
information than generic animal disease surveillance for the entire
cattle population.
Depending on the characteristics of the country, the goal of BSE
surveillance could be to:
Detect cases at a predetermined design prevalence;
Monitor the evolution of the disease (i.e., introduction
and/or spread);
Monitor the effectiveness of a feed ban and/or other risk
mitigation measures; or
Provide supporting evidence for claimed BSE status or for
maintaining status or advancing to a higher BSE status.
Targeted sampling for BSE surveillance focuses on two factors that

[[Page 15878]]

have been shown to be relevant to determining the risk for BSE:
Clinical presentation and age. For the purpose of disease detection, it
is most efficient to collect as many samples as possible from the
surveillance stream that has the greatest likelihood of finding the
disease--cattle displaying clinical signs consistent with BSE. This is
referred to as targeted surveillance.
The OIE Code provides guidelines for surveillance programs based on
a weighted point system (Article 11.5.22). This system reflects
international scientific consensus that the best BSE surveillance
programs focus on obtaining quality samples from targeted
subpopulations, rather than looking at the entire adult cattle
population.
OIE has identified the following four subpopulations of cattle for
surveillance purposes:
1. Clinical suspects: Cattle over 30 months of age that display
behavioral or clinical signs consistent with BSE.
2. Casualty slaughter: Cattle over 30 months of age that are
nonambulatory, recumbent, unable to rise or to walk without assistance,
sent for emergency slaughter, or condemned at ante-mortem inspection.
3. Fallen stock: Cattle over 30 months that are found dead on-farm
or during transport to or at an abattoir.
4. Healthy slaughter: Cattle over 36 months that exhibit no
clinical signs consistent with BSE or other diseases.
The number of points a sample receives correlates directly to an
animal's clinical presentation at the time of sampling. The highest
point values are assigned to those samples from the subpopulation of
animals with classic clinical signs of the disease. The lowest point
values correspond to animals from the subpopulation of clinically
normal animals tested at routine slaughter. This weighted approach
allows countries the flexibility to sample readily available
surveillance streams, while taking into account the differences in the
statistical value of samples from different streams. As a result,
countries have the option of using varying approaches that can provide
equal levels of assurance in defining the level of disease.
Type A Surveillance
Type A surveillance is recommended for countries that would like to
meet the controlled-risk status. The OIE BSE surveillance guidelines
recommend a target number of surveillance points for Type A
surveillance based on the size of a country's cattle population. For
instance, a country with an adult cattle population of 800,000 to 1
million should collect samples whose total point value equals 240,000
points. These points are accrued over 7 consecutive years, and are
weighted according to the surveillance stream and age of the animal
sampled.
Type B Surveillance
Type B surveillance may be carried out by countries of negligible
BSE risk status to confirm the conclusions of the risk assessment
(e.g., by demonstrating the effectiveness of the measures mitigating
any risk factors identified, through surveillance targeted to maximize
the likelihood of identifying failures of such measures).
Type B surveillance may also be carried out by countries of
controlled BSE risk status (OIE Code, Article 11.5.4) following the
achievement of the relevant points target using Type A surveillance, to
maintain confidence in the knowledge gained through Type A
surveillance. As with Type A surveillance, the recommended number of
points for Type B surveillance is based on the size of a country's
cattle population. For instance, a country with a cattle population of
800,000 to 1 million should collect samples whose total point value
equals 120,000.
Presence of a BSE Awareness Program
The OIE will evaluate information about the existence of any
awareness programs; the target audience; the curriculum; how long the
program has been in place; and any contingency and/or preparedness
plans that address BSE.
Compulsory Notification and Investigation
Proper management of the disease requires that there be incentives
and/or obligations to report and investigate suspect BSE cases.
Therefore, the OIE will evaluate information about any guidance given
to veterinarians, producers, workers at auctions, slaughterhouses,
etc., with regard to the criteria that would initiate the investigation
of an animal as a BSE suspect; whether these criteria have changed over
time; the date and content of the legal act making notification of BSE
suspects compulsory; and any measures in place to stimulate
notification, such as compensation payments or penalties for not
reporting a suspect.
Sample Testing
For a country's BSE surveillance system to be recognized by the
OIE, samples must be tested in accordance with the OIE's Manual of
Diagnostic Tests and Vaccines for Terrestrial Animals. The OIE
evaluates whether countries seeking BSE classification uses diagnostic
procedures and methods that are consistent with those described in
OIE's disease diagnostic manual and whether these diagnostic procedures
and methods have been applied throughout the entire surveillance
period.
BSE History of the Country
It is important to note that in order to retain classification by
OIE as a country of negligible risk or controlled risk for BSE, a
country must continue to observe OIE's guidelines and report any
significant events that might change that status. The OIE reserves the
right to revoke the given disease status of any country that fails to
comply with this process. In order to retain classification, Member
countries are obligated to notify the OIE in writing that the
epidemiological situation with respect to each of the diseases for
which the OIE has classified the country has remained unchanged in
order to retain classification. APHIS also believes that it is
essential to have periodically updated information from a country that
APHIS recognizes as either negligible risk or controlled risk for BSE,
and are including a requirement for such updated information in this
proposed rule, as discussed below under the heading ``Requirement for
Updated Information.''

The Process for APHIS Recognition of the BSE Risk Classification of a
Region

Under this proposed rule, each country of the world will be
considered by APHIS to be in the BSE undetermined risk category, unless
APHIS has recognized that country as either a region of negligible risk
for BSE or a region of controlled risk for BSE.
APHIS recognition of a region as a region of negligible risk or
controlled risk for BSE could be achieved in one of two ways.
If the OIE has classified a country as either BSE
negligible risk or BSE controlled risk, APHIS would seek information to
support concurrence with the OIE classification. This information could
be publicly available information, or APHIS could request that
countries supply the same information given to the OIE. APHIS would
announce in the Federal Register, subject to public comment, our intent
to concur with an OIE classification. APHIS would also post the summary
of the BSE OIE ad hoc group conclusions for review during the comment
period. The summaries would be available for review on the APHIS Web
site. Following review of any comments received, the Administrator
would announce his or her final

[[Page 15879]]

determination regarding classification of the country in the Federal
Register, along with a discussion of and response to pertinent issues
raised by commenters. If APHIS recognizes a country as either
negligible risk or controlled risk for BSE, the Agency would include
that country in a list of regions of negligible risk or controlled risk
for BSE, as applicable, that APHIS would make available to the public
on the Agency's Web site.
A region that has not received categorization by OIE as
either negligible risk or controlled risk for BSE and that wishes to be
recognized by USDA as negligible risk or controlled risk could submit
to the Administrator a request for such classification, along with
documentation sufficient to allow the USDA to conduct an evaluation of
whether the region meets the criteria for such classification. If,
following such evaluation, the Administrator determines that the region
meets the criteria for negligible or controlled risk, APHIS would
announce that determination in the Federal Register and would make
available to the public the evaluation conducted by APHIS, as well as
the information provided by the requesting region. APHIS would accept
public comment on its intent. Following review of any comments
received, the Administrator would announce his or her final
determination regarding classification of the region in the Federal
Register, along with a discussion of and response to pertinent issues
raised by commenters.

Requirement for Updated Information

As required by the OIE for countries classified as either
negligible risk or controlled risk by the OIE, regions evaluated by
APHIS and classified as negligible or controlled risk would need to
submit updated information to APHIS each year. The required information
includes documentation of the following:
Relevant changes in BSE legislation, compared to the
previous year;
The importation into the region during the year of cattle,
processed animal protein and products containing such material;
Audit findings in rendering plants and feed mills that
process ruminant material or material from mixed species that contains
ruminant material, related to the prohibition of the feeding of MBM or
greaves to ruminants;
Audit findings in rendering plants and feed mills that
process nonruminant material, related to the prohibition of the feeding
to ruminants of ruminant-derived MBM and greaves;
Infractions at the types of facilities listed above;
If and why, in light of the audit findings, there has been
no significant exposure of cattle to the BSE agent through consumption
of ruminant-derived MBM and greaves;
Surveillance efforts;
All clinical BSE suspects;
Any new cases of BSE.
If APHIS at any time determines that a region no longer meets the
criteria for the risk classification it had previously received, APHIS
would remove it from its list of regions so classified. If the OIE
determines the region no longer meets the criteria for the risk
classification it had previously received, APHIS may concur with the
OIE determination or may request updated information from the region
and determine whether to concur with the OIE decision. APHIS will
announce its intent in the Federal Register and accept public comment
regarding that intent. Following review of any comments received, the
Administrator will announce in the Federal Register his or her final
determination regarding classification of the region, along with a
discussion of and response to pertinent issues raised by commenters.

Conditions for Importation of Commodities

The BSE-related importation conditions we are proposing for live
bovines and products derived from bovines are based on internationally
accepted data and research. These same data and research are used by
the OIE in formulating its recommendations regarding trade in cattle
and products derived from cattle with regard to BSE, and include
experimental data, epidemiological data, information about risk
mitigation strategies regarding processing, and data from risk
assessment studies.
In the following section, we discuss the pertinent scientific
information regarding each type of commodity considered for importation
and explain APHIS' conclusions regarding mitigation measures, if any,
that we consider necessary to safely allow for the importation of that
type of commodity, taking into account the BSE risk classification of
the region of export. In most cases, the conclusions we have reached
are consistent with those reached by the OIE. In those few cases where
our conclusions regarding mitigation measures differ from that of the
OIE, we note the differences and explain our rationale for differing
with the OIE Code. If the information we considered is based on
research or other data concerning cattle and products from cattle, we
discuss the information as it applies to cattle. However, for the
reason we stated above in footnote 3 of this document, where we propose
to modify our regulations based on that information, we propose to
apply the amendments to bovines, rather than just to cattle. In the
sections that follow, we discuss the OIE recommendations regarding
trade of specific types of bovine commodities.

Live Bovines

The OIE Code recommends that trade in live cattle be allowed from
regions of negligible, controlled, and undetermined risk for BSE under
the following conditions.
From regions of negligible risk and regions of controlled risk for
BSE: The bovines are accompanied by an international veterinary
certificate attesting to the BSE risk classification of the region of
export. Additionally, for exports of live cattle from regions of
negligible risk for BSE that have had an indigenous case of BSE and
from regions of controlled risk for BSE, the following conditions must
be met and attested to on the certificate: The cattle intended for
export were born after the date a ban on the feeding of MBM and greaves
of ruminant origin to ruminants was effectively enforced, and are
identified with a permanent identification system that enables them to
be identified if they are birth or feed cohorts of an infected animal.
From regions of undetermined risk for BSE: The bovines were born at
least 2 years after a ban on the feeding of MBM and greaves of ruminant
origin to ruminants was effectively enforced, and are identified by a
permanent identification system in such a way that enables them to be
identified if they are birth or feed cohorts of an infected animal. In
addition, the region must demonstrate that, if alive in the region,
bovines that are included in either of the following two categories are
officially identified with unique individual identification that is
traceable to the premises of origin of the animal, their movements are
controlled, and, when slaughtered or at death, they are completely
destroyed:
1. All bovines that, during their first year of life, were reared
with a bovine determined to be infected with BSE during its first year
of life, and that investigation showed consumed the same feed that
potentially contained SRM material as the infected animal during that
period;
2. If the investigation was unable to determine whether the feed
source that was used to feed the bovine known to be infected was also
used to feed other

[[Page 15880]]

bovines in the herd of the infected animal, all bovines born in the
same herd as a BSE-infected bovine either within 12 months before or 12
months after the birth of the infected animal.

APHIS' Proposed Provisions Regarding the Importation of Live Bovines
With Regard to BSE Risk

In this proposed rule, we concur with the conclusions reached by
the OIE regarding import conditions for cattle from regions of
negligible risk and controlled risk with regard to BSE, but differ from
the OIE Code regarding the importation of bovines from regions of
undetermined BSE risk. We discuss our proposed provisions regarding
importations from undetermined risk regions, below. With regard to
importations of live bovines from regions of negligible or controlled
risk for BSE, we are proposing in Sec. 93.436(a) and (b) that bovines
may be imported under the following conditions:
The bovines are accompanied by an original certificate
that indicates the APHIS BSE risk classification of the region of
export and states that the following conditions, where applicable, have
been met.
From regions of negligible risk for BSE that have had an
indigenous case of BSE and from regions of controlled risk for BSE,
before the animals' arrival at the port of entry into the United
States, each bovine imported into the United States is officially
identified with unique individual identification that is traceable to
the premises of origin of the animal. We consider this requirement
necessary for us to determine the likelihood of exposure to potentially
contaminated materials. We would provide that no person may alter,
deface, remove, or otherwise tamper with the official identification
while the animal is in the United States or moving into or through the
United States, except that the identification may be removed at
slaughter.
From regions of negligible risk for BSE that have had an
indigenous case of BSE and from regions of controlled risk for BSE, the
bovines are permanently and humanely identified before arrival at the
port of entry with a distinct and legible mark identifying the
exporting country. Acceptable means of permanent identification include
the following:
1. A mark properly applied with a freeze brand, hot iron, or other
method, and easily visible on the live animal and on the carcass before
skinning. Such a mark must be not less than 2 inches nor more than 3
inches high, and must be applied to each animal's right hip, high on
the tail-head (over the junction of the sacral and first coccygeal
vertebrae);
2. A tattoo with letters identifying the exporting country must be
applied to the inside of one ear of the animal;
3. Other means of permanent identification upon request if deemed
adequate by the Administrator to humanely identify the animal in a
distinct and legible way as having been imported from the BSE minimal-
risk exporting region.
From regions of negligible risk for BSE that have had an
indigenous case of BSE and from regions of controlled risk for BSE, the
bovines were born after the date from which the ban on the feeding of
ruminants with processed ruminant proteins has been effectively
enforced.
Additionally, if there has been an indigenous case of BSE in the
region, the following restrictions would apply:
Bovines that, during their first year of life, were reared
with a bovine determined to be infected with BSE during its first year
of life, and that an investigation showed consumed the same feed that
potentially contained SRM material as the infected animal during that
period would not be eligible for importation to the United States; and
If the investigation was unable to determine whether the
feed source that was used to feed the bovine known to be infected was
also used to feed other bovines in the herd of the infected animal, no
bovine born in the same herd as a BSE-infected bovine either within 12
months before or 12 months after the birth of the infected animal would
be eligible for importation into the United States.

Date of Effective Enforcement of a Feed Ban

As noted, for the importation of cattle from certain risk
classifications of countries, one of the OIE-recommended mitigations is
that the animals were born after the date a feed ban was effectively
enforced. The primary source of BSE infection, and the only documented
route of field transmission of the disease, is commercial feed
contaminated with ruminant protein derived from infected animals
(Wilesmith, et al., 1988; 1991; 1992; Prince, et al., 2003). Bans that
prohibit incorporation of mammalian or ruminant protein into ruminant
feed have been shown to be effective in mitigating the risk of BSE
transmission and are an integral factor in evaluating the BSE risk of a
region. The experience regarding BSE in the United Kingdom, which was
discussed in detail in the risk assessment we conducted for our
September 2007 final rule, demonstrated the effectiveness of a
ruminant-to-ruminant feed ban in reducing the prevalence of BSE (APHIS,
2007).
Although, in evaluating a country for BSE risk classification, the
OIE examines whether the country has an effectively enforced ban on the
feeding of ruminant-derived processed animal protein to other
ruminants, and although some of the trade conditions recommended by the
OIE with regard to BSE are dependent on when a country achieved
effective enforcement of such a feed ban, the OIE does not provide
specific recommendations for determining the date of effective
enforcement of a feed ban. For a country that wishes to export live
bovines to the United States and that is classified by APHIS as
controlled risk for BSE or as negligible risk for BSE and the country
has reported an indigenous case of BSE, APHIS would need to determine
the date a feed ban was effectively enforced in the country.
It is important to note that the existence of an effectively
enforced feed ban does not mean there will be no instances of
contravention of the feed ban, either accidentally or intentionally,
just as isolated transgressions of U.S. laws do not necessarily
constitute ineffective enforcement of those laws. Nor does it mean that
BSE will never be detected in a bovine born after the date from which a
feed ban is considered to have been effectively enforced. Human error
is expected, and no regulatory effort can ensure 100 percent
compliance, which is why a feed ban is comprised of a number of
interrelated measures that have a cumulative effect.
In our September 2007 final rule to allow additional live bovines
and certain bovine products from BSE minimal-risk regions (72 FR 53314-
53379, Docket No. APHIS-2006-0041), we explained the considerations and
process used by APHIS to determine the date of effective enforcement of
a ruminant-to-ruminant feed ban in Canada. In this proposal, we are
proposing to base our determination of the date of effective
enforcement of a ruminant-to-ruminant feed on similar considerations.
The information would include, but not necessarily be limited to:
Policies and infrastructure for feed ban enforcement,
including an awareness program for producers and farmers;
Livestock and husbandry practices;
Disposition of processed animal protein produced from
domestic bovines, including the feeding of any animal species;

[[Page 15881]]

Measures taken to control cross-contamination and
mislabeling of feed intended for bovines with processed animal protein;
Monitoring and enforcement of the ruminant feed ban,
including audit findings in rendering plants and feed mills that
process ruminant material.
Additionally, in determining the date of effective enforcement of a
country's feed ban, APHIS may conduct a site visit to the requesting
country to complement and verify the information provided by the
country.
After receiving and evaluating the necessary information, APHIS
would publish in the Federal Register for public comment the date APHIS
considers to be the date of effective enforcement of a ruminant-to-
ruminant feed ban in the requesting region, and would make available to
the public the evaluation conducted by APHIS, as well as the supporting
documentation. Following review of any comments received, the
Administrator would announce his or her final determination in the
Federal Register, along with a discussion of and response to pertinent
issues raised by commenters.

Live Bovines From Regions of Undetermined Risk for BSE

With regard to the importation of live bovines, we propose allowing
the importation of live bovines from regions of undetermined risk for
BSE only in very limited situations.
We believe that the nature of a region that is classified as
undetermined with regard to BSE risk is such that making a general
determination in this regulation that the conditions recommended by the
OIE have been met could not be made with a sufficient degree of
confidence. When it comes to the overall BSE risk of an exporting
region, factors in addition to a feed ban--such as veterinary
infrastructure, surveillance, and import controls--play a role. Such
factors are taken into consideration when determining whether to
classify a region as negligible or controlled risk for BSE. If enough
evidence has been evaluated to conclude that a region of undetermined
risk for BSE has in place an effectively enforced feed ban--upon which
importation of live bovines would be dependent--and that the region can
demonstrate that the other conditions have been met, APHIS believes the
region would qualify as at least controlled risk. We believe that the
fact that a region is in the BSE undetermined-risk category argues
against a generalized determination by way of this proposed rule that
the OIE-recommended conditions have been met.
For the reasons discussed above, we are proposing to allow the
importation of live bovines from regions of undetermined risk for BSE
only in very limited situations. In Sec. 93.436(c) of this proposed
rule, we provide that, with regard to BSE, live bovines may be imported
from regions of undetermined risk for BSE for specific limited uses,
such as movement to exhibitions and zoos, under specified conditions on
a case-by-case basis, if the Administrator determines that the bovines
can be imported under conditions that will prevent the introduction of
BSE into the United States. Instructions for applying for a permit for
the importation of live ruminants are included in current Sec. 93.404.

Provisions Regarding the Importation of Live Bovines From Canada

Canada is classified by the OIE as a region of controlled risk for
BSE and, under our proposal, live bovines from Canada would be subject
to all of the import requirements we are proposing for regions of
controlled risk for BSE. However, Canada is currently singular in the
APHIS BSE regulations in that it is the only region recognized by APHIS
as a BSE minimal-risk region. As a BSE minimal-risk region, Canada is
eligible to import live bovines into the United States that are
prohibited importation from other regions listed in Sec. 94.18(a).
Under the current regulations, live bovines are eligible for
importation from Canada if the conditions in Sec. 93.436 and related
sections are met.
Some of the requirements that are included in current Sec. 93.436
would continue to apply to imports from Canada, in some cases for
reasons other than BSE risk, but would not apply as a general rule to
every region of controlled risk for BSE. These include the requirement
in current Sec. 93.436(a)(4) that bovines from Canada intended for
immediate slaughter be moved from the port of entry to a slaughtering
establishment in a sealed means of conveyance, which we are proposing
to include in Sec. 93.420 of this proposal for the importation of all
ruminants imported from Canada for immediate slaughter. This provision
exists as a safeguard against diseases other than BSE.
Certain of the requirements in current Sec. 93.436 for the
importation of live bovines from Canada are substantively the same as
the requirements we are proposing for the importation of live bovines
from any region of controlled risk for BSE--such as the requirement
that live bovines intended for importation be permanently identified--
by branding, tattooing, or some other method--as to country of export,
and the requirement that the bovines were born on or after the date of
effective enforcement of a ruminant-to-ruminant feed ban in the region
of origin. However, the provisions in current Sec. 93.436 include
specifics as to how those general requirements apply to Canada. For
instance, the regulations in current Sec. 93.436 specify the lettering
that must be used for a brand or tattoo to identify the bovines as
being of Canadian origin and specify that APHIS recognizes March 1,
1999, as the date of effective enforcement of a ruminant-to-ruminant
feed ban in Canada.
Because this proposed rule would retain these specifics, we are
proposing to set forth the importation requirements for live bovines
from Canada in sections of the CFR that would be dedicated to imports
from Canada, specifically Sec. Sec. 93.418 and 93.420.

Commodities Recommended for Unrestricted Trade With Regard to BSE

A review of scientific literature (discussed in the ``Supporting
document for Chapter 2.3.13 of the Terrestrial Animal Health Code on
Bovine Spongiform Encephalopathy'' (OIE TAHSC, 2006)) (the contents of
Chapter 2.3.13 have been updated and currently appear in Chapter 11.5)
has led the OIE to recognize certain products as safe for trade with
regard to BSE, regardless of the BSE status of the exporting region.
Bovine-derived commodities that the OIE recommends be allowed to be
traded without any restrictions for BSE include:
Milk and milk products;
Semen and in vivo derived embryos;
Hides and skins;
Gelatin and collagen from hides and skins;
Tallow with a maximum level of insoluble impurities of
0.15 percent in weight; and
Dicalcium phosphate with no trace of protein or fat.
APHIS has reached the same conclusions. Some of the commodities
listed above are already eligible for importation without BSE-related
restrictions from regions listed in Sec. 94.18(a) of the regulations.
These are milk and milk products, semen, and hides and skins. For these
commodities, we are proposing no changes to their importation status
with regard to BSE. The rationale for allowing their importation has
been discussed in previous rulemaking and is not addressed in this
document.

[[Page 15882]]

The remaining commodities listed above--those that are not
currently eligible for unrestricted importation into the United States
with regard to BSE--would become so under the provisions of this
proposed rule.

Commodities Recommended for Trade Under the Same Conditions, Regardless
of the Risk Classification of the Exporting Region

The OIE recommends that several other types of bovine commodities
be eligible for trade without ``any BSE-related conditions, regardless
of the BSE risk status of the cattle population of the exporting
country, zone, or compartment'' (OIE Code Article 11.5.1). Although the
OIE Code refers to an absence of ``BSE-related conditions'' for these
commodities, the OIE recommendations do include qualifying conditions
regarding the processing of such commodities, in order to guard against
the contamination of the commodities by other materials that might
contain BSE infectivity. These commodities are:
Boneless skeletal muscle meat (excluding mechanically
separated meat \14\) from cattle, provided (1) the cattle were not
subjected to air injected stunning before slaughter or to pithing, (2)
the cattle passed ante-mortem and post-mortem inspections, and (3) the
product has been prepared in a manner that avoids contamination with
SRMs;
---------------------------------------------------------------------------

\14\ Mechanically separated meat is a finely comminuted product
resulting from the mechanical separation and removal of most of the
bone from attached skeletal muscle of bovine carcasses that meets
the FSIS specifications contained in 9 CFR 319.5. A definition of
mechanically separated meat is included in Sec. 94.0 of this
proposed rule.
---------------------------------------------------------------------------

Blood and blood byproducts from cattle that were not
subjected, prior to slaughter, to air-injected stunning or to pithing.
We are proposing to allow the importation of these commodities \15\
from any region under the same conditions recommended by the OIE, with
one exception. With regard to blood and blood products, we are
proposing some additional requirements regarding the collection of
blood and blood products to guard against contamination. We reference
the scientific rationale for allowing such importation in a discussion
of each type of commodity, below, and explain as well our rationale for
proposing several risk mitigation measures slightly different from
those recommended by the OIE.
---------------------------------------------------------------------------

\15\ Additionally, the FSIS regulations in 9 CFR 327.2 provide
that, to be eligible to export meat and meat products to the United
States for human consumption, a foreign country must be able to
certify that it meets FSIS requirements. Therefore, prior to
exporting meat and meat products to the United States, countries are
required to be approved by FSIS as having an inspection system
equivalent to that in the United States.
---------------------------------------------------------------------------

Specified Risk Materials

For some commodities, a condition for importation under this
proposed rule is that the commodity not contain or be potentially
contaminated with SRMs. Under this proposed rule, tissues from bovines
from regions of negligible risk for BSE are not considered SRMs and
what is considered an SRM in a region of controlled risk differs
somewhat from what is considered an SRM in a region of undetermined
risk.
Regions of Negligible Risk for BSE
By definition, in a region that has been evaluated and has been
determined to be a region of negligible animal health risk, there is a
negligible risk of circulating BSE infectivity. Consequently, we do not
believe it is necessary to consider any tissues from bovines from a
region of negligible risk for BSE to be SRMs. This conclusion is
consistent with internationally accepted BSE-related standards. It is
also consistent with the approach taken by FSIS in an affirmation of
interim final rules with amendments published on July 13, 2007 (72 FR
38199-38730, Docket No. 03-025F).
In that document, FSIS amended its September 7, 2005 interim final
rule to exclude from the FSIS definition of SRMs materials from cattle
from foreign countries that can demonstrate that their BSE risk status
can reasonably be expected to provide the same level of protection from
human exposure to the BSE agent as does prohibiting SRMs for use as
human food in the United States. In its document, FSIS stated that an
``evaluation of a country's BSE risk status would consider whether
appropriate measures are in place to manage identified risks. This
would include consideration of import policies and import history to
determine the likelihood of the introduction of BSE into the country.
It could also include (among other things) consideration of any of the
following: Effective surveillance efforts; measures to identify and
effectively control pathways for the amplification of BSE; appropriate
awareness programs; effective epidemiological investigations as
necessary, with appropriate tracing, control and destruction of risk
animals; continuing risk considerations with corresponding revisions of
existing mitigations; appropriate public health control measures
commensurate with risk; and the infrastructure sufficient to define and
implement any of the above.'' (72 FR 38718) FSIS stated further that
evaluation of a country's measures would be conducted by FSIS officials
with technical program expertise along with, where appropriate,
technical experts from other agencies, such as APHIS and FDA, with FSIS
making the final determination.
Regions of Controlled Risk and Negligible Risk
As noted above, in January 2004, FSIS regulations established as
SRMs the skull, brain, spinal cord, trigeminal ganglia, eyes, vertebral
column (excluding the vertebrae of the tail, the transverse processes
of the thoracic and lumbar vertebrae, and the wings of the sacrum), and
DRG of cattle 30 months of age or older, as well as the tonsils and
distal ileum of the small intestine of cattle of all ages.\16\ FSIS
designates potentially infective materials, as well as certain
materials that are closely associated with potentially infective
materials, from cattle 30 months of age or older as SRMs. Although the
skull and vertebral column of cattle infected with BSE have not
demonstrated infectivity, the skull contains the eyes, trigeminal
ganglia, and brain, and the vertebral column contains DRG and spinal
cord. Thus, because they contain high-risk tissues, skulls and
vertebral column are included in FSIS' definition of SRMs. Unlike other
parts of the vertebral column, the vertebrae of the tail, the
transverse processes of the thoracic and lumbar vertebrae, and the
wings of the sacrum do not contain spinal cord or DRG. Therefore, FSIS
excludes these parts of the vertebral column from the materials
designated as SRMs. Under FSIS regulations, head meat, cheek meat, and
tongue may be used for human food, provided they are not contaminated
with SRMs.
---------------------------------------------------------------------------

\16\ On July 13, 2007, FSIS published an affirmation with
amendments (72 FR 38700, Docket No. 03-025F) of its January 2004
interim final rule. Among the amendments included in July 2007 was a
provision that excludes from the definition of SRMs materials from
cattle from countries that can demonstrate that their BSE risk
status can reasonably be expected to provide the same level of
protection from human exposure to the BSE agent as prohibiting SRMs
for use as human food does in the United States.
---------------------------------------------------------------------------

In Sec. Sec. 92.1, 94.0, and 95.1 of this proposed rule, APHIS
defines SRMs from regions of controlled risk for BSE and undetermined-
risk regions as the same tissues considered by FSIS to be SRMs, with
one exception. For regions of undetermined risk for BSE, APHIS is
consistent with OIE in considering the tissues that FSIS considers to
be SRMs in animals 30 months of age or older to be SRMs if the tissues
come from animals over 12 months of age. Research demonstrates that the
incubation period

[[Page 15883]]

for BSE is apparently linked to the infectious dose received, i.e., the
larger an infectious dose received, the shorter the incubation period
(EC SSC, 2002). While some cases have been found in animals less than
30 months of age, these have been relatively few and have occurred
primarily in countries with significant levels of circulating
infectivity. Specifically, BSE was found in animals less than 30 months
of age in the United Kingdom in the late 1980s to early 1990s, when the
incidence of BSE was extremely high (the youngest case, detected in
1989, was 21 months). The exceptional detection of BSE in young animals
during the peak of the BSE epidemic in the United Kingdom supports a
cautious approach in defining SRMs for regions of undetermined risk for
BSE. Theoretically, in such regions, high levels of circulating
infectivity could exist if the region is not implementing BSE risk
management measures.
Because BSE infectivity is detectable in central nervous system
tissue at three-quarters of the incubation period, the 12-month
provision would ensure the removal of tissues potentially containing
infectivity from even the single youngest animal observed since the
start of BSE surveillance in the United Kingdom.

Other Bovine Commodities

According to the OIE recommendations, certain bovine commodities
may or may not be eligible for importation, depending on the BSE risk
classification of the country that would be exporting the commodity and
on whether specified conditions have been met to mitigate BSE risk
based on the country's risk classification.
These commodities include:
Meat that does not meet the conditions, described above,
for boneless skeletal muscle meat;
Gelatin and collagen prepared from bones;
Tallow, tallow derivatives, and dicalcium phosphate (other
than tallow with a maximum level of insoluble impurities of 0.15
percent in weight and dicalcium phosphate with no trace of protein or
fat); and
MBM and greaves.
Although APHIS' proposed provisions regarding these commodities are
broadly based on OIE recommendations, we are also proposing some
modifications to those guidelines, where necessary, to reflect APHIS'
interpretation of the scientific literature and current USDA
regulations and policies.
In the sections that follow, we discuss the science that supports
the OIE recommendations and the import conditions we are proposing, and
present the rationale for the few instances where our proposed
provisions differ from OIE recommendations.

Meat, Meat Byproducts, and Meat Food Products

In our discussion, where we refer to meat, meat byproducts, and
meat food products, we consider those commodities to be as defined in
the FSIS regulations in 9 CFR 301.2.
As noted earlier in this document, BSE infectivity has not been
demonstrated in the muscle tissue of BSE-infected cattle examined in
either mouse bioassay studies (in which different bovine tissues are
inoculated into mice to determine which tissues carried infectivity) or
in cattle assays in the United Kingdom pathogenesis study (Wells, et
al., 1996; 2005; Wells, personal communications, 2008). Some reports
have identified the presence of prions in muscle tissue from rodents,
humans, and small ruminants infected with TSEs other than BSE (Bosque
et al., 2002). Those findings are consistent with differences in the
transmission, host range, genetic susceptibility, infectivity
distribution, and epidemiology found in different TSEs that affect
animals and humans. In the transgenic mice over-expressing the bovine
PrP gene (Tg bov XV), infectivity was detected in one muscle
(semitendinosus) from a single clinical case of BSE in Germany
(Buschmann and Groschup, 2005). The sensitivity of these mice to
infection is significantly greater than that of the mice used for the
United Kingdom pathogenesis study (10,000-fold) and even greater than
that of cattle (approximately tenfold).
From studies of the pathogenesis of experimental BSE in cattle, no
infectivity has been found in assays of skeletal muscle pools (triceps,
masseter, sternocephalicus and longissimus dorsi) completed in wild-
type mice bioassay and in cattle bioassay (masseter, semitendinosus and
longissimus dorsi) from selected kill time points of the oral exposure
study (Wells et al., 1996 and 2005). All assays of the skeletal muscle
pools were completed in March 2007 (Wells, personal communication,
2008).
Recent studies using tissues from asymptomatic cattle challenged
orally with BSE and culled at 20, 24, 27, 30, and 33 months, and
inoculated intracerebrally into BoPrP-Tg110 mice, have failed to detect
infectivity in muscle (Espinosa et al., 2007).
The United Kingdom's Spongiform Encephalopathy Advisory Committee
(SEAC, 2001) and the European Commission's (EC) Scientific Steering
Committee (SSC) evaluated the implications of the findings of the
presence of infectivity in muscle for other TSEs in different species
in relation to human food safety. EC SSC concluded that there was no
reason to revise its opinions regarding the safety of meat, given the
consistent negative results in BSE infectivity experiments (EC SSC,
2002a). SEAC concluded that the findings could not be directly applied
to BSE in cattle and did not change the assessment of the risk to
humans of consumption of beef. Updated opinions from the EC SSC are
consistent with its original reports.
Skeletal muscle meat in and of itself is regarded as safe with
regard to BSE, regardless of the BSE risk category of the region of
export and origin. Any blood that might be associated with the meat is
also, in and of itself, regarded as safe with regard to BSE, as
discussed below under the heading ``Blood and Blood Products.''
However, it is possible that, in regions in which there is some
circulating BSE infectivity, such meat could become contaminated with
the BSE agent unless certain measures are taken to preclude such
contamination. In this proposed rule, although we are proposing to
allow the importation of boneless skeletal muscle meat from any BSE
category of region, such importation would be contingent on the
necessary safeguards against contamination having been met in the
region of export.
One of these safeguards is that the bovines from which the meat was
derived were not subjected to a stunning process prior to slaughter
with a device injecting compressed air or gas into the cranial cavity,
or to a pithing process (EFSA Journal, 2004; TAFS, 2004). Several
studies have shown that penetrative captive bolt stunners that
incorporate air-injection can force visible pieces of brain and other
central nervous system tissue into the circulatory system of stunned
cattle (Anil, et al., 1999; Schmidt, et al., 1999). In addition, the
pithing process could cause dissemination of central nervous tissue
throughout the body.
Another safeguard is the removal of SRMs. Handling of SRMs in ways
that prevent contamination of the carcass is an important mitigation in
preventing contamination of edible meat with BSE infectivity (EFSA
Journal, 2005).
Therefore, with regard to BSE, we are proposing in Sec.
94.18(b)(2) to allow the importation of boneless skeletal muscle meat
from bovines, regardless of the BSE risk status of the region of
export, provided that (1) the cattle were not subjected to air injected
stunning before slaughter or to pithing, (2) the cattle

[[Page 15884]]

passed ante-mortem and post-mortem inspections, and (3) the meat has
been prepared in a manner that avoids contamination with SRM tissues.
Additionally, the shipment of such meat to the United States would
have to be accompanied by an original certificate stating that the
above conditions have been met. The certificate must be issued by a
full-time salaried veterinary officer of the national government of the
region of export, or be issued by a veterinarian designated by the
national government of the region of export and endorsed by a full-time
salaried veterinary officer of the region of export, representing that
the veterinarian issuing the certificate was authorized to do so. Our
listing of who would be eligible to issue a certificate differs
slightly from the list in Sec. 94.19 of the current regulations
regarding the importation of meat and other edible products from BSE
minimal-risk regions, in that we would not include veterinarians
accredited by the national government of the region of origin. We are
not including such individuals to avoid any situations where a
veterinarian employed by an exporter might issue a certificate for that
exporter's shipment.

Meat Other Than Boneless Skeletal Muscle Meat, Meat Food Products, and
Meat Byproducts Derived From Bovines

For meat other than the boneless skeletal meat described above,
meat food products, and meat byproducts, the conditions for importation
would depend on the BSE risk classification of the region of export.
These conditions are discussed in the following paragraphs.
Regions of Negligible Risk for BSE
With regard to regions of negligible risk for BSE, we are proposing
in Sec. 94.19 the conditions under which bovine meat that is not
boneless skeletal meat, meat food products, and meat byproducts would
be eligible for importation. These conditions are as follows; either:
1. The commodity is accompanied by certification that the region of
export is a region of negligible risk for BSE in which there has not
been an indigenous case of BSE, and that the commodity is derived from
bovines that passed ante-mortem and post-mortem inspection; or
2. If there has been an indigenous case of BSE in the region of
negligible risk, the commodity is accompanied by certification that the
region of export is a region of negligible risk for BSE and that the
commodity was derived from bovines that passed ante-mortem and post-
mortem inspection and were subject to a ban on the feeding to ruminants
of processed animal protein derived from ruminants.
Our proposed conditions for the importation of such commodities
from negligible risk regions that have had an indigenous case of BSE
are modified somewhat from those recommended by the OIE. The OIE
recommends that such commodities be sourced from animals born after the
date a ban on feeding ruminant MBM and greaves to ruminants had been
effectively enforced. The OIE also recommends this condition for the
importation of MBM and greaves derived from ruminants from such
regions. There is a wide range of bovine products that could fall under
these categories, including products that may have gone through
multiple processing steps after slaughter. APHIS recognizes the
difficulty in providing specific certification about the age of the
animal from which the products were derived, given these steps. This
difficulty, in combination with the overall low risk of such products
from a negligible risk region, is why we propose to modify the OIE
guidelines somewhat. We feel that because the criteria for this
particular risk categorization calls for any indigenous case to be born
more than 11 years ago and requires demonstration through an
appropriate level of control and audit that for at least 8 years
processed animal protein from ruminants has not been used in the
feeding of ruminants (these criteria are discussed above under the
heading ``Regions of Negligible Risk for BSE''), it is highly unlikely
that such products could contain or be contaminated with the BSE agent.
Taking these factors into consideration, APHIS concludes that the
commodities under consideration pose an extremely low risk for BSE, as
low as to be considered insignificant.
As noted above, in July 2007 FSIS amended its regulations to
exclude from the FSIS definition of SRMs materials from cattle from
foreign countries that can demonstrate that their BSE risk status can
reasonably be expected to provide the same level of protection from
human exposure to the BSE agent as does prohibiting SRMs for use as
human food in the United States. Our proposed provisions regarding the
importation of meat, meat byproducts, and meat food products from
regions of negligible risk for BSE are consistent with the FSIS
provisions. In this proposed rule we would add a note to Sec. 94.19 to
indicate that, to be eligible to export bovine meat, meat byproducts,
and meat food products to the United States under the provisions of
that section, a region recognized by APHIS as a one of negligible risk
for BSE would also need to be one that has demonstrated to FSIS that
its BSE risk status can reasonably be expected to provide the same
level of protection from human exposure to the BSE agent as does
prohibiting specified risk materials for use as human food in the
United States.
Regions of Controlled Risk for BSE
We are proposing in Sec. 94.20 that, in addition to boneless
skeletal muscle meat that meets the requirements listed above, bovine
meat, meat byproducts, and meat food products would be eligible for
importation from regions of controlled risk for BSE if the following
requirements are met:
The bovines from which the commodities were derived passed
ante-mortem and post-mortem inspections;
The bovines from which the commodities were derived were
not subjected to a stunning process with a device injecting compressed
air into the cranial cavity or to a pithing process;
The commodity does not contain mechanically separated meat
from the skull and vertebral column of bovines 30 months of age or
older;
The commodity was produced in a manner that ensures that
it does not contain and is not contaminated with SRMs, as defined in
Sec. 94.0 of this proposed rule for regions of controlled risk for
BSE;
The shipment is accompanied by an original certificate
stating that the above conditions have been met. The certificate must
be issued by a full-time salaried veterinary officer of the national
government of the region of export, or be issued by a veterinarian
designated by the national government of the region of export and
endorsed by a full-time salaried veterinary officer of the region of
export, representing that the veterinarian issuing the certificate was
authorized to do so.
Regions of Undetermined Risk for BSE
We are proposing in Sec. 94.21 that, in addition to boneless
skeletal muscle meat that meets the requirements listed above, bovine
meat, meat byproducts, and meat food products would be eligible for
importation from regions of undetermined risk for BSE if the following
requirements are met:
The bovines from which the commodities were derived have
never been fed processed animal protein derived from ruminants;
The bovines from which the commodities were derived passed
ante-mortem and post-mortem inspections;
The bovines from which the commodities were derived were
not subjected to a stunning process with a

[[Page 15885]]

device injecting compressed air into the cranial cavity or to a pithing
process; and
The commodities were produced in a manner that ensures
that such products do not contain and are not contaminated with: (1)
Mechanically separated meat from the skull and vertebral column of
bovines over 12 months of age; or (2) SRMs as defined for regions of
undetermined risk for BSE.
The shipment is accompanied by an original certificate
stating that the above conditions have been met. The certificate must
be issued by a full-time salaried veterinary officer of the national
government of the region of export, or be issued by a veterinarian
designated by the national government of the region of export and
endorsed by a full-time salaried veterinary officer of the region of
export, representing that the veterinarian issuing the certificate was
authorized to do so.

Offal

In this proposed rule, Sec. 95.6 contains provisions regarding BSE
and the importation of offal derived from bovines. In Sec. 95.1 of the
current regulations, offal is defined as the inedible parts of a
butchered animal that are removed in dressing, consisting largely of
the viscera and trimmings, which may include, but are not limited to,
brains, thymus, pancreas, liver, heart, or kidneys. We are proposing to
apply the same import requirements to bovine-derived offal as those
described above for bovine-derived meat, meat byproducts, and meat food
products, with one exception. The proposed provisions for the
importation of bovine-derived meat, meat byproducts, and meat food
products include the requirement that the bovines from which the
commodities were derived passed ante-mortem and post-mortem
inspections. That requirement is a safeguard for commodities intended
for human consumption. Because offal is, by definition, inedible, there
is no need to require that the offal was derived from bovines that
passed ante-mortem and post-mortem inspections.

Meat or Dressed Carcasses of Hunter-Harvested Bovines

In the current regulations, Sec. 94.19(e) contains provisions for
the importation into the United States of meat or carcasses of hunter-
harvested wild sheep, goats, or other ruminants other than cervids from
BSE minimal-risk regions (the importation of cervid meat from BSE
minimal-risk regions is unrestricted with regard to BSE). For hunter-
harvested meat or carcasses to be eligible for importation with regard
to BSE, the following conditions must be met:
The meat or dressed carcass 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
The animal from which the meat is derived was 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, a ruminant feed ban
equivalent to the requirements established by FDA at 21 CFR 589.2000.
Consistent with the approach we are taking in this document not to
propose any changes at this time to BSE regulations related to ovines
or caprines, in Sec. 94.25(c) of this proposed rule, we are retaining
the conditions described above as they apply to hunter-harvested wild
ovines or caprines from BSE minimal-risk regions. In Sec. 94.22 of
this proposed rule, we are including provisions for the importation of
hunter-harvested wild bovines from any region. Under those provisions,
the meat or carcass of a hunter-harvested wild bovine would be eligible
for importation into the United States if it is derived from a wild
bovine 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.
Additionally, the carcass of a hunter-harvested wild bovine would have
to be dressed (eviscerated and the head and spinal cord removed). We
are not including a requirement comparable to that described above for
ovines and caprines regarding the feeding of the wild bovines. BSE has
been detected in wild bovines kept in captivity but not in non-captive
wild bovines, and APHIS considers it very unlikely that wild bovines
could be exposed to processed animal protein.

Gelatin and Collagen

Gelatin is a highly purified protein manufactured from hides, skin,
and/or bones of animals using various refining processes in which each
step is able to significantly inactivate BSE infectivity. A similar
process, with similar inactivation results, is used in the production
of collagen.
Derived From Hides or Skins
Bovine hides have not demonstrated BSE infectivity, even in
infected animals. The safety of bovine hides with regard to BSE is
recognized internationally. The OIE Code recommends that gelatin
derived exclusively from the hides of bovines not be subject to trade
restrictions. The European Commission Scientific Steering Committee's
Updated Opinion on the Safety With Regard to TSE Risk of Gelatine
Derived From Ruminant Bones or Hides (adopted by the Scientific
Steering Committee at its December 5-6, 2002, meeting) states in
section B(c): ``When ruminant hides are used for the production of
gelatine, they are usually obtained from bovines. On the basis of
current knowledge, it can be considered that the parts of the bovine
hides used for the production of gelatine do not present a risk with
regard to TSE's [transmissible spongiform encephalopathies, which
include BSE], provided contamination with potentially infected
materials is avoided.''
Therefore, we believe there is no scientific basis for prohibiting
the importation of gelatin derived from the hides of bovines and are
proposing in Sec. 94.23(b) to allow the importation of gelatin derived
from the hides or skins of bovines, regardless of the BSE risk
classification of the region of origin, provided the gelatin has not
been commingled with materials ineligible for entry into the United
States. In Sec. 95.7(b), we are proposing equivalent provisions for
the importation of collagen derived from bovine hides or skins.
Derived From Bones
The different steps of the refining process in producing gelatin
from bones, as well as the resulting infectivity reduction, are
described below.
1. Degreasing: Before bone can be used to manufacture gelatin, fat
must be removed. This is done by crushing the bones, washing, and
degreasing the chips with hot water to remove fat residues. Studies
evaluating the efficiency of the degreasing process in decreasing the
amount of nervous tissues present in bones have shown that, during the
degreasing step, 98-99 percent of the proteins of nervous origin are
eliminated (Mantze, et al., 1996).
2. Acid treatment: The treatment consists of immersing the
degreased chip bone into hydrochloric acid (approximately 4 percent, <
pH 1.5) for a period of at least 2 days. This acid treatment changes
the structure of the

[[Page 15886]]

collagen protein and reduces the infectivity that might be present
(Grobben, et al., 2004).
3. Alkaline treatment: The materials are soaked in a saturated lime
solution (pH 12.5) for a period of 20 to 50 days. The alkaline
treatment changes the internal structure of the BSE protein, if
present. The combination of time, temperature, and concentration of the
alkaline treatments reduces the levels of BSE infectivity in the event
they were present in the raw materials (Grobben, et al., 2004).
4. Further acid treatments: In the event gelatin is produced from
ossein by an acid process, the ossein is immersed for 12 to 24 hours in
acid (pH 2-3.5).
5. Gelatin extraction: Once all the procedures are performed,
gelatin is extracted by a series of hot water steps. These include
purification by filtration and sterilization, both of which further
remove suspended materials and thus further reduce the level of any
remaining BSE infectivity, if present, which is unlikely at this stage
in the production.
Research studies mimicking the manufacturing process described
above were unable to show detectable levels of infectivity in the mouse
bioassay. The results are consistent with TSE infectivity reduction
capacity exceeding a factor of 30.000 (4.5 logs, although results from
most recent research indicate clearance factors exceeding 4.8 logs) (EC
SSC adopted at the 12-13 September 2002 meeting). These studies have
demonstrated that the common process of manufacturing bovine gelatin
provides significant assurance of gelatin safety.
Experimental studies have confirmed that the chemical processes
used in the manufacture of gelatin derived from bones are sufficient to
inactivate BSE infectivity that might have been present in the raw
material (EC SSC, 1998). These experimental studies were designed to
ensure that they accurately represented the ``lowest common
denominator'' of current manufacture practices.
A quantitative risk assessment (EFSA Journal, 2006) of the residual
risk in bone-derived gelatin, obtained from bones fit for human
consumption calculated different scenarios resulting in different risk
levels. The study did not take into consideration the sourcing of
bones. Results of the risk assessment indicate that the relevant
exposures are very small compared to the historical exposure of the
human population in the United Kingdom (1980-2001) due to meat and meat
products in its diet. The removal of skull and vertebral column from
the source materials results in only a very small risk reduction.
However, the input parameters to the supporting risk assessment model
sourced animals only from the healthy slaughter subpopulation and did
not address the scenario where material was sourced from cattle not
subject to ante- and post-mortem inspection.
Although this evidence points to the conclusion that gelatin
derived from bones that is produced using common manufacturing
processes could be considered safe regardless of the region from which
the bones originate, we believe that the limited parameters of the
input data in the European Food Safety Authority (EFSA) assessment make
it advisable to propose additional risk mitigations based on the BSE
risk classification of the region of origin. Therefore, we are
proposing in Sec. 94.23 to allow the importation of gelatin derived
from the bones of bovines under the following conditions:
Region of negligible risk: We are proposing in Sec. 94.23(c) for
gelatin and Sec. 95.7(c) for collagen that gelatin and collagen
derived from the bones of bovines would be eligible for importation
from a region of negligible risk for BSE, provided that the bovines
from which the gelatin was derived passed ante-mortem and post-mortem
inspection, and provided the shipment is accompanied by certification
as to the BSE risk classification of the region from which the gelatin
or collagen originates and that the conditions for import have been
met.
Region of controlled risk or undetermined risk: We are proposing in
Sec. 94.23(d) for gelatin and Sec. 95.7(d) for collagen that gelatin
and collagen derived from the bones of bovines would be eligible for
importation from a region of controlled risk or undetermined risk for
BSE provided that: (1) The bovines from which the gelatin was derived
passed ante-mortem and post-mortem inspection; (2) skulls from bovines
of any age have been excluded from the processing (due to the fact that
skull might still have pieces of brain attached), as has the vertebral
column from bovines 30 months of age or older; (3) and the bones are
subjected to a process that includes all of the following steps, or to
a process at least as effective in reducing BSE infectivity:
1. Degreasing;
2. Acid demineralization;
3. Acid or alkaline treatment;
4. Filtration; and
5. Sterilization at 138 [deg]C (280.4 [deg]F) or greater for a
minimum of 4 seconds.
Shipments of gelatin and collagen imported into the United States
under the above conditions would need to be accompanied by an original
certificate that indicates the BSE risk classification of the exporting
region and that states that the required conditions have been met.
We are proposing, additionally, in Sec. 94.23(f) for gelatin and
Sec. 95.7(f) for collagen, to allow the importation of gelatin and
collagen under conditions other than those described above if the
Administrator determines that the gelatin and collagen will not come
into contact with ruminants in the United States and that the
conditions under which it will be imported will prevent the
introduction of BSE into the United States. A United States Veterinary
Permit for Importation and Transportation of Controlled Materials and
Organisms and Vectors would need to be obtained. Application for a
permit would need to be filed on VS Form 16-3 (available from APHIS,
Veterinary Services, National Center for Import and Export, 4700 River
Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a
permit must state the intended use of the material and the name and
address of the consignee in the United States.

Dicalcium Phosphate

Considerable mineral content is recovered from the hydrochloric
acid treatment of bone chip used in the production of gelatin. As
stated earlier, before bones can be used in the manufacture of gelatin,
fat and other impurities must be removed by a process called
``degreasing.'' The bones are crushed to a small size and then washed
and degreased in a process that removes any residues of fat, marrow, or
other soft tissues. Before degreased bone chip material can be used to
produce gelatin, minerals--including calcium and phosphate--must be
removed. To remove minerals, the bone chip is soaked in hydrochloric
acid (approximately 4 percent, < pH 1.5) for a period of at least 2
days. The recovered minerals are further purified, followed by
precipitation and drying. The resultant product is dicalcium phosphate.
In 2003, the EC SSC stated that the residual risk in dicalcium
phosphate derived from bovine bones was negligible when the raw
material for the production of bovine bone dicalcium phosphate is
obtained from a country of any risk categorization if (1) the dicalcium
phosphate is derived from appropriate tissues (i.e., from animals fit
for human consumption, with SRMs--including skull and vertebrae--
excluded, and cross-contamination with these bones avoided) and (2)
submitted

[[Page 15887]]

to a production process that has a proven TSE infectivity reduction
capacity (EC SSC, 2003).
The same processing steps applied for the pretreatment of bones
used to produce bone-derived gelatin are followed for pretreatment of
bones for the production of dicalcium phosphate. Accordingly, studies
that demonstrate the safety of gelatin resulting from the pretreatment
of bone during degreasing and acid demineralization (Grobben, et al.,
2004; Manzke, et al., 1996) also indicate that a very safe dicalcium
phosphate is yielded as a byproduct of the gelatin manufacturing
process. Further, a significant reduction of TSE infectivity under
experimental conditions has been demonstrated for dicalcium phosphate
by a recent validation study in which dicalcium phosphate was prepared
from bone artificially contaminated with TSEs and assayed for the
presence of infectivity (Grobben, et al., 2006).
In addition, according to the EC SSC (EC SSC, 2003) a 2003
validation study by Groben, et al., shows that the acid process after
degreasing and demineralization (as described above under the heading
``Gelatin'') together result in a reduction of infectivity of 2.6 log
10. The production process as a whole reduces the infectivity further
up to 3.8 to 3.9 log 10.
Research indicates that dicalcium phosphate is not a risk factor
for the transmission of the BSE agent when the dicalcium phosphate
contains no traces of protein or fat. However, there is evidence that
dicalcium phosphate produced from bones under normal manufacturing
processes can contain a small residual proteinaceous fraction. Although
the scientific evidence points to a significant reduction in
infectivity during processing of dicalcium phosphate, there is a
potential that it will present higher risk when it contains traces of
protein or fat.
The OIE Code recommends no BSE-related restrictions for dicalcium
phosphate that contains no trace of protein or fat. However, the OIE
Code does recommend that dicalcium phosphate that is not free of
protein or fat should originate only from negligible or controlled risk
regions (OIE Code, 2010, Article 11.5.17), and that, if the material
originates from a region of controlled risk for BSE, additional risk
mitigation measures be applied. These additional measures are that the
dicalcium phosphate is derived from cattle that have passed ante-mortem
and post-mortem inspections and that the SRMs from cattle 30 months of
age or older at the time of slaughter have been excluded (OIE Code,
2010, Article 11.5.17).
Based on our review of the science regarding dicalcium phosphate,
we concur with the OIE's recommendations regarding trade of dicalcium
phosphate. Therefore, we are proposing in Sec. 95.10 to allow the
importation of bovine-derived dicalcium phosphate that contains no
trace of protein or fat from any region, regardless of the region's BSE
risk classification. We are proposing to provide in Sec. 95.10(b) to
allow the importation from a region of negligible risk for BSE of
bovine-derived dicalcium phosphate other than that with no trace of
protein or fat if the dicalcium phosphate is accompanied by
certification of the BSE classification of the exporting region. We are
proposing to provide in Sec. 95.10(c) to allow the importation from a
region of controlled risk for BSE of bovine-derived dicalcium phosphate
other than that with no trace of protein or fat if the dicalcium
phosphate is accompanied by certification that it is derived from
bovines that have passed ante-mortem and post-mortem inspection and was
produced in a manner that ensures that it does not contain and is not
contaminated with SRMs.
Bovine-derived dicalcium phosphate other than that with no trace of
protein or fat would not be eligible for importation from a region of
undetermined risk for BSE, except on a case-by-case basis as provided
in the next paragraph.
We are proposing in Sec. 95.10(e) to allow the importation of
dicalcium phosphate that is not protein free under conditions other
than those described above if the Administrator determines that the
derivatives will not come into contact with ruminants in the United
States and that the conditions under which it will be imported will
prevent the introduction of BSE into the United States. A United States
Veterinary Permit for Importation and Transportation of Controlled
Materials and Organisms and Vectors must be obtained. To apply for a
permit, file a permit application on VS Form 16-3 (available from
APHIS, Veterinary Services, National Center for Import and Export, 4700
River Road Unit 38, Riverdale, MD 20737-1231, or electronically at
http://www.aphis.usda.gov/animal_health/permits/). The application for
such a permit must state the intended use of the material and the name
and address of the consignee in the United States.

Tallow

Several studies have evaluated TSE infectivity in tallow that was
spiked with infected brain material and then subjected to rendering. In
two rendering studies, one with BSE (Taylor et al., 1995) and the other
with scrapie (Taylor, et al., 1997), no detectable infectivity from
either agent was demonstrated from any of the tallow samples when
assayed in mice. The BSE rendering study did not demonstrate any
infectivity in crude unfiltered tallow, although the same rendering
procedure produced MBM with almost the same infectivity levels as the
untreated raw material. These studies suggest that during the
manufacturing process of tallow, both BSE and scrapie agents do not
preferentially separate with tallow during rendering but tend to remain
with the MBM fraction.
A review of inactivation of TSE agents during rendering (Taylor and
Woodgate 2003) suggests that tallow is generally not considered to be
related to risk of BSE infection for two main reasons: (1) That the
BSE-spiked rendering studies confirmed the lack of detectable
infectivity of tallow through mice bioassay; and (2) because
epidemiological studies were not able to link the distribution and use
of tallow in cattle feed to the incidence of BSE in the United Kingdom.
Some countries (e.g., Denmark and Japan) have implicated tallow in
milk replacers as a potential source of BSE infection. A 2003
epidemiological report on BSE in Japan hypothesized tallow in calf milk
replacer as one possible source and route of infection. However,
statistical analysis of the data did not support the conclusion of any
correlation between the use of milk replacer and BSE incidence (BSE
Epidemiological Study Group report, 2003).
A quantitative risk assessment of BSE transmission through tallow-
based milk replacer (Paisley and Hostrup-Pedersen, 2004) modeled the
effects of level of impurities (0.02, 0.15, and 0.5 percent), inclusion
of SRMs, and other inputs on the probability of occurrence of BSE
cases. Although the results were associated with a high level of
uncertainty, the study found that, under certain scenarios, tallow-
based milk replacer could be associated with transmission of BSE to
calves. The simulations demonstrated the importance of SRM exclusion in
limiting the probability of BSE infection, particularly from tallow
with high impurity levels (0.5 percent). Uncertainty in the results
stemmed from infectivity in central nervous system tissue and from the
level of impurities in tallow.
A quantitative risk assessment on the residual BSE risk posed by
tallow (EFSA

[[Page 15888]]

Journal, 2005a) concluded that tallow was not a risk factor in
transmitting the BSE agent, if the tallow was derived from cattle that
have passed ante-mortem and post-mortem inspection. Likewise, while the
level of soluble impurities did not significantly affect the risk of
exposure, the assessment concluded that the source of raw material
warranted further consideration. In addition, removal of SRMs
corresponded to a 2 log reduction in potential BSE infectivity. The
EFSA Scientific Panel concluded that, for the scenarios evaluated in
the quantitative risk assessment, the exposure levels for tallow were
minimal, thereby posing no risk of transmission.
The OIE guidelines regarding tallow derived from bovines, and the
current APHIS regulations regarding the importation of tallow from BSE
minimal-risk regions are based on the conclusion that tallow with a
maximum level of insoluble impurities of 0.15 percent in weight and
derivatives made from this are not a risk factor in the transmission of
the BSE agent. APHIS concludes that such tallow and derivatives made
from this tallow can be imported without BSE restrictions, regardless
of the BSE risk classification of the region of origin. We are
proposing in Sec. 95.8(b) to allow such importation of tallow with a
maximum level of insoluble impurities of 0.15 percent in weight.
In addition, the evidence suggests that tallow other than tallow
with a maximum level of insoluble impurities of 0.15 percent in weight
is not a risk factor provided it is sourced from cattle that have
passed ante-mortem and post-mortem inspections and SRMs are excluded.
Therefore, we are proposing in Sec. 95.8 that tallow other than tallow
with a maximum level of insoluble impurities of 0.15 percent in weight
would be eligible for importation under the following conditions.
Either:
It is sourced from a region of negligible risk for BSE; or
If it is sourced from a region of controlled risk for BSE,
it was derived from bovines that have passed ante-mortem and post-
mortem inspections and has not been prepared using SRMs.
Additionally, to be eligible for importation, bovine-derived tallow
other than tallow with a maximum level of insoluble impurities of 0.15
percent in weight would need to be accompanied by certification of the
BSE risk classification of the exporting region and that the applicable
conditions, above, have been met.
Tallow other than tallow with a maximum level of insoluble
impurities of 0.15 percent in weight would not be eligible for
importation from a region of undetermined risk for BSE, except on a
case-by-case basis as provided in the next paragraph.
We are proposing in Sec. 95.8(f) to allow the importation of
tallow other than tallow with a maximum level of insoluble impurities
of 0.15 percent in weight under conditions other than those described
above if the Administrator determines that the tallow will not come
into contact with ruminants in the United States and that the
conditions under which it will be imported will prevent the
introduction of BSE into the United States. A United States Veterinary
Permit for Importation and Transportation of Controlled Materials and
Organisms and Vectors must be obtained. To apply for a permit, file a
permit application on VS Form 16-3 (available from APHIS, Veterinary
Services, National Center for Import and Export, 4700 River Road Unit
38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a
permit must state the intended use of the material and the name and
address of the consignee in the United States.

Tallow Derivatives Other Than Those Made From Tallow With a Maximum
Level of Insoluble Impurities of 0.15 Percent in Weight

In addition to tallow itself, derivatives of tallow are a
commercially traded commodity. Several studies have evaluated the
effects of various time, temperature, and pressure processes on prion
inactivation. The BSE-spiked tallow study (Taylor, et al., 1995) showed
that, while infectivity does not persist in tallow during rendering,
the level of infectivity of BSE subjected to a poorly inactivated
rendering process remained at almost the same level as the untreated
material.
The current APHIS regulations in Sec. 95.4 allow the importation
of derivatives from bovine-derived tallow without restriction with
regard to BSE. Under Sec. 95.9(b) of this proposal, derivatives from
bovine-derived tallow with a maximum level of insoluble impurities of
0.15 percent in weight would continue to be eligible for importation
into the United States without restriction due to BSE.
With regard to derivatives from bovine-derived tallow other than
tallow with a maximum level of insoluble impurities of 0.15 percent in
weight, the OIE Code recommends that trade be allowed in such a
commodity under any of the following conditions:
It originates from a country of negligible risk for BSE;
It originates from a country of controlled risk for BSE,
is derived from bovines that have passed ante-mortem and post-mortem
inspections, and does not contain SRMs; or
It originates from either a country of controlled risk for
BSE or a country of undetermined risk for BSE and was produced by
hydrolysis, saponification, or transesterification. Those processes
create conditions of high enough temperature and pressure to inactivate
the BSE agent.
The OIE Code does not define tallow derivative. However, in 21 CFR
589.2001, the FDA defines tallow derivative as follows: ``* * * [A]ny
chemical obtained through initial hydrolysis, saponification, or
transesterification of tallow; chemical conversion of material obtained
by hydrolysis, saponification, or transesterification may be applied to
obtain the desired product.'' According to the FDA definition, all
bovine-derived tallow derivatives would meet the guideline in the OIE
Code under which tallow derivatives from any country could be traded.
In this document, we are proposing in Sec. 95.1 to define tallow
derivative as FDA does. In Sec. 95.9, we are proposing to allow the
importation from any region of tallow derivatives that meet our
definition in Sec. 95.1. In Sec. 95.9 of this proposal, we are also
providing that if an importer wishes to import a commodity the importer
considers to be a tallow derivative, but that does not meet our
proposed definition of tallow derivative, and the commodity was not
derived from tallow with a maximum level of insoluble impurities of
0.15 percent in weight, it must meet one of the following conditions to
be eligible for importation:
It originates from a country of negligible risk for BSE;
It originates from a country of controlled risk for BSE,
is derived from bovines that have passed ante-mortem and post-mortem
inspections, and does not contain SRMs.
Additionally, to be eligible for importation, derivatives from
bovine-derived tallow other than tallow with a maximum level of
insoluble impurities of 0.15 percent in weight would need to be
accompanied by certification that the applicable conditions, above,
have been met.
We are proposing in Sec. 95.9(g) to allow the importation of
derivatives of tallow other than tallow with a maximum level of
insoluble impurities of 0.15 percent in weight under conditions other
than those described above if the Administrator determines that the
derivatives will not come into contact

[[Page 15889]]

with ruminants in the United States and that the conditions under which
it will be imported will prevent the introduction of BSE into the
United States. A United States Veterinary Permit for Importation and
Transportation of Controlled Materials and Organisms and Vectors must
be obtained. To apply for a permit, file a permit application on VS
Form 16-3 (available from APHIS, Veterinary Services, National Center
for Import and Export, 4700 River Road Unit 38, Riverdale, MD 20737-
1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a permit must state the intended
use of the material and the name and address of the consignee in the
United States.

In-Vivo-Derived Embryos

The current regulations in part 98 include BSE-related restrictions
on the importation of embryos from ruminants. The regulations in Sec.
98.15(a) provide that ruminant embryos may be imported into the United
States from regions in which foot-and-mouth disease or rinderpest
exists only if certain conditions apply with regard to BSE and other
diseases. Among the conditions related to BSE are the following:
During the year before embryo collection, no case of BSE
occurred in or within 5 kilometers of the embryo collection unit;
During the year before embryo collection, no case of BSE
occurred in any herd in which the donor dam was present;
Not less than 30 days nor more than 120 days after embryo
collection, the donor dam was examined by an official veterinarian and
was found free of clinical evidence of BSE;
Between the time the embryos were collected and all
required examinations and tests were conducted, no animals in the
embryo collection unit with the donor dam, or in the donor dam's herd
of origin, exhibited any clinical evidence of BSE.
We are proposing to remove the BSE-related restrictions in Sec.
98.15(a) on the importation of embryos derived from bovines, cervids,
or camelids. This change would be consistent with the OIE Code
regarding trade in in-vivo-derived embryos derived from bovines, and
would be consistent with our proposal, discussed above under the
heading ``Cervids and Camelids,'' to remove BSE-related import
restrictions on cervids and camelids.
No detectable infectivity has been found in susceptible mice fed
placenta from confirmed cases of BSE (Middleton and Barlow, 1993;
Barlow and Middleton, 1990; Bradley, 1990), nor in placenta, placental
fluids, or ovary or uterine caruncle following mouse inoculation
(Fraser and Foster, 1994; MAFF, 1997; EC SSC, 2000). Male reproductive
tissues (e.g., testis, epididymis, prostate, semen, seminal vesicle)
inoculated into mice showed no infectivity (Fraser and Foster, 1994;
MAFF, 1999). In addition, infectivity was not detected in the fetal
membranes and placenta of cattle with clinical BSE after cattle were
dosed oro-nasally with a pooled tissue homogenate from BSE cattle.
Animals were killed at 24 and 84 months post infection with no evidence
of disease (Bradley, 1996; EC SSC, 2000).
A different study examined the potential for washed embryos to
transmit BSE (Wrathall et al., 2002). In this study, semen from 13
bulls, 8 with clinical BSE, was used for artificial insemination (AI)
of 167 clinically affected cows in the terminal stages of BSE. The
resulting embryos were treated according to the recommendation of the
International Embryo Transfer Society. The embryos were always
transferred singly, but repeat transfers were done if returns to estrus
occurred within the particular transfer session. Five hundred eighty-
seven viable embryos were transferred into 347 recipient heifers
imported from New Zealand. A total of 266 live offspring were born, of
which 54.1 percent had a BSE-positive sire as well as a BSE-positive
dam. The recipient heifers were monitored for clinical signs of BSE for
7 years after transfer, and the offspring were also monitored for 7
years after birth. Twenty-seven heifers and 20 offspring died during
monitoring, but none showed signs of BSE. The brains of these animals,
in addition to the brains of animals killed, as scheduled, after 7
years were examined for BSE by histopathology, PrP
immunohistochemistry, and by electron microscopy for scrapie-associated
fibrils. All results were negative. In addition to the embryos
transferred into recipient heifers, 1,020 nonviable embryos were
sonicated and inoculated intracerebrally into susceptible mice (20
embryos per mouse) that were monitored for up to 700 days post
inoculation; their brains were then examined for spongiform lesions.
All results were negative. Additionally, uterine flush fluid samples
from 41 cows were tested for BSE infectivity by intracerebral and
intraperitoneal inoculation of 946 mice. One of these mice had some
vacuolar pathology, but its relevance proved difficult to determine,
since the putative incubation period was inconsistent with the survival
of remaining mice in the group. All other mice with injections of flush
fluids from the same cow were negative when finally killed and
examined. Results of the study indicate that embryos are unlikely to
carry BSE, and do not transmit the disease to recipients and their
embryo transfer offspring, even when they are collected from donor cows
at the end-stage, when the risk of maternal transmission (if it were to
exist) would potentially be the highest.
In a cohort study, 316 offspring of BSE confirmed cows (cases) and
316 offspring from cows over 6 years old and without BSE from the same
farm and age cohort (controls) have been observed under controlled
conditions over a 7-year period. The purpose of the study was to
determine whether maternal transmission occurs, and, if so, at what
level of incidence. There was a statistically significant risk
difference between the two cohorts examined (i.e., calves born to dams
with BSE and calves born to healthy dams more than 6 years old). This
difference was 9.7 percent, with a relative risk of 3.2 for offspring
of cows that developed clinical BSE. This enhanced risk for the
offspring of BSE dams appeared to decline the later the offspring were
born after the 1988 feed ban was in place, but increased the closer
that parturition was to the onset of clinical disease in the dam. The
results cannot distinguish between a genetic component and true
maternal transmission for which there is no other evidence. Instead, a
combination of a genetic cause (i.e., increased susceptibility to feed
exposure that could have occurred in any cattle in the study) and
genuine transmission fits the computer model of the epidemic best
(Donnelly, et al., 1997). Later studies by Donnelly, et al. (2002)
significantly reduced the estimated risk to offspring, although they
recognized that the introduction of culling of offspring of confirmed
cases made estimation of the risk impossible other than by back-
calculation methods. The route for the hypothetical maternal
transmission of BSE has not been established. Based on the modeling
study, given that less than 1 percent of the offspring of affected
cattle in the United Kingdom epidemic may succumb to this means of
exposure, it is likely to be difficult to determine the route. More
recent work on cases born after the 1996 feed ban fails to demonstrate
evidence of maternal transmission (Hill, 2005). Thus, although maternal
transmission may be possible, more recent epidemiologic

[[Page 15890]]

evidence suggests that maternal transmission of BSE is unlikely to
occur at any appreciable level, if at all.
For the reasons discussed above, we do not believe it is necessary
to retain the BSE-related restrictions in Sec. 98.15(a) on the
importation of embryos derived from bovines, cervids, or camelids.

Blood and Blood Products

Blood and blood products can be divided into two main groups: (1)
Whole blood and cellular derivatives such as red cell concentrate,
platelets, and other cellular elements; and (2) plasma-derived products
including serum (including fetal bovine serum (FBS), clotting factors,
immunoglobulins, and albumin (Farshid, et al., 2005)). Plasma is the
cell-free portion of the blood. Serum is plasma with fibrinogen and
clotting factors removed.
Transmission Studies
BSE infectivity has not been demonstrated in cattle blood or any
tested derivatives (EC SSC, 2002). This conclusion derives from studies
in which tissues from infected cattle were injected intracerebrally and
intraperitoneally into mice (the ``mouse bioassay''), or
intracerebrally into cattle (the ``cattle bioassay''). Mouse bioassays
were performed using buffy coat (the white cell fraction of centrifuged
whole blood), clotted blood, fetal calf blood, and serum from confirmed
clinical cases (Kimberlin, 1996 cited in EC SSC, 2002). Wild-type mouse
and cattle bioassays were performed on buffy coat from cattle
experimentally exposed orally to the BSE agent. In all cases, no
evidence of infectivity was detected. However, brain damage caused by
certain stunning techniques can produce central nervous system tissue
emboli in venous blood draining the head (EFSA Journal, 2004). A recent
study (Espinosa, et al., 2007), utilizing material derived from the
second United Kingdom Veterinary Laboratories Agency pathogenesis study
(cattle challenged orally with BSE and culled 20, 24, 27, and 30 months
post exposure), revealed no detectable blood infectivity by assay in
transgenic BoPrP-Tg110 mice.
Investigators have demonstrated that BSE can be transmitted to
sheep by transfusion of whole blood from sheep experimentally infected
with BSE (Houston, et al., 2000; Hunter, et al., 2002). In these
studies, a transfusion of 400 ml of whole blood, taken from clinically
normal infected sheep, caused disease in 2 of 24 recipients. Blood or
buffy coat taken from clinically ill animals, however, did not cause
disease in the four recipients. These same investigators also examined
scrapie in sheep. A total of 4 sheep out of 21 transfused with blood
from sheep naturally infected with scrapie developed disease. The
transfusion of buffy coat derived from a clinically ill animal caused
disease in the recipient. The EC SSC examined these studies and their
implications. They concluded that the finding of infectivity in the
blood of sheep could not be extrapolated to BSE in cattle (EC SSC,
2002b).
Brown, et al. (1999), using a human strain of TSE (Gerstmann-
Straussler-Scheinker) in mice inoculated intracerebrally, concluded
that infectivity was present in the buffy coat (platelets, white cells)
during the preclinical phase of TSE, but absent or in only trace
amounts in the plasma or plasma fractions. Following the onset of
clinical signs, increased infectivity of both buffy coat and plasma was
found, but still at very low levels compared to levels in the central
nervous system. As cited in a review of the relevant literature (Comer,
2004, p. II.18), most studies using a rodent model and adapted strains
of scrapie or CJD demonstrated that the fractions containing white
blood cells have the highest levels of infectivity.
In contrast to investigations of the natural distribution of
infectivity in rodent blood fractions, one ``spiking'' study added high
levels of hamster-adapted scrapie infectivity from brain homogenate to
normal human blood. Following fractionation by centrifugation into red
cells, white cells/platelets, and plasma components, titrations
indicated that the majority of infectivity was in the red cell
component (Brown, et al., 1998). These results, although not as
relevant to understanding the natural distribution of TSEs in blood,
may potentially apply to the distribution following cross-contamination
at blood collection. Therefore, if contrary to current research, or if
the proposed mitigations are not properly implemented, BSE infectivity
is present in bovine blood, either naturally or via cross-
contamination, it would likely be highest in the cellular components.
These fractions, both red and white cells, are excluded when harvesting
FBS and bovine serum albumin used in the preparation of vaccines and
drugs.
Further decrease in TSE infectivity occurs with fractionation of
plasma proteins. Fractionation is the process whereby specific
proteins, such as albumin, are separated out from other components of
the plasma. Infectivity in various fractions has been examined. For
example, using data from several cited studies, Comer (2004) estimated
that human albumin contains 3.1x10-5 vCJD ID50/gram.
Compared to Comer's estimates of infectivity in whole blood (2 iv vCJD
ID50/gram), this figure represents a dramatic decrease.
Although BSE has never been detected in any bovine blood, blood
product, or fetal blood, APHIS recognizes the possibility of cross-
contamination with SRMs at the time of collection, particularly in a
slaughter environment. Certain slaughterhouse stunning practices-
specifically the use of devices that inject compressed air or gas into
the cranial cavity or pithing processes--may introduce macro-emboli of
tissue from the central nervous system into the circulatory system
(Anil et al., 1999; Schmidt, et al., 1999). In addition, collection of
blood in an open manner may allow other tissues to contaminate the
blood.
In order to prevent contamination due to such potential sources of
infectivity, we are proposing in Sec. 95.12 to require mitigations to
decrease the risk of cross-contamination. For all blood and for
products derived from blood, a condition of importation eligibility
would be that the blood was collected in a hygienic manner, as
determined by the Administrator, that prevents contamination of the
blood with SRMs. For blood collected at slaughter and for products
derived from such blood, we would require that the slaughtered animal:
(1) Pass ante-mortem inspection; and (2) not be subjected to a stunning
process with a device injecting compressed air or gas into the cranial
cavity, or to a pithing process. For blood collected from live donor
bovines and for products derived from such blood, we would require that
the donor animal be free of clinical signs of disease. Although this
requirement regarding the disease status of live donor animals, which
is set forth in the Sec. 95.4(e) of the current regulations, is not
included in the OIE Code, we are including it here as an additional
precaution against BSE contamination of the blood collected.
Additionally, we would require that each shipment of blood and
blood products to the United States must be accompanied by
certification that the applicable requirements have been met.

Restrictions on Processed Animal Protein Derived From Nonruminants

Although materials derived from nonruminants do not pose a BSE risk
in and of themselves, the importation of such materials into the United
States could pose a BSE risk if the nonruminant materials are
commingled with materials from BSE-infected

[[Page 15891]]

ruminants. To guard against such a possibility, the current regulations
in Sec. 95.4 restrict the importation of certain animal materials,
regardless of the species from which it is derived, unless it can be
demonstrated that the nonruminant material (or ruminant material if the
ruminants are from a country not listed in Sec. 94.18(a)) has not been
commingled with ruminant materials that are prohibited entry into the
United States. The regulations in Sec. 95.4(c)(4) also contain
provisions under which a facility that wishes to export such material
to the United States from a region listed in Sec. 94.18(a), and that
process or handle any material derived from mammals, must allow for
periodic APHIS inspection of its facilities, records, and operations to
ensure there is no commingling. Facilities in regions listed in Sec.
94.18(a)(1) or (a)(2) that wish to export such material to the United
States are required to enter into a cooperative service agreement with
APHIS to provide for the payment of the costs of APHIS inspections.
This proposed rule would continue to include safeguards against the
commingling of nonruminant materials with materials that could contain
BSE infectivity. The non-commingling provisions in proposed Sec.
95.4(c) regarding materials derived from ovines and caprines would
continue to apply to a variety of materials--e.g., processed animal
protein, tankage, offal, tallow other than tallow derivatives,
processed fats and oils, and derivatives of processed animal protein,
tankage, and offal, pending any future rulemaking regarding ovines and
caprines. However, in proposed Sec. Sec. 95.13 and 95.14, which
address potential BSE contamination of nonruminant-derived materials
due to commingling with materials derived from bovines, the provisions
would apply only to processed animal protein, based on the scientific
evidence discussed above regarding the role of such material in BSE
transmission.
We are proposing in Sec. 95.13 that processed animal protein from
a region of negligible risk for BSE that is derived from animals other
than ruminants may not be imported into the United States unless the
following conditions are met:
The material is not otherwise prohibited under the
provisions in Sec. 95.4 regarding materials derived from ovines or
caprines;
The shipment of materials into the United States is
accompanied by an original certificate signed by a full-time salaried
veterinary officer of the national government of the exporting region,
or issued by a veterinarian designated by the national government of
the exporting region and endorsed by a full-time salaried veterinary
officer of the national government of the exporting region,
representing that the veterinarian issuing the certificate was
authorized to do so. The certificate must indicate the BSE risk
classification of the region of export;
The person importing the shipment has applied for and
obtained from APHIS a United States Veterinary Permit for Importation
and Transportation of Controlled Materials and Organisms and Vectors by
filing a permit application on VS Form 16-3. (VS Form 16-3 may be
obtained from APHIS, Veterinary Services, National Center for Import
and Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or
electronically at http://www.aphis.usda.gov/animal_health/permits/.)
We are proposing in Sec. 95.14 that processed animal protein from
a region of controlled risk or undetermined risk for BSE that is
derived from animals other than ruminants may not be imported into the
United States unless, in addition to the requirements for importation
listed above for importation from a region of negligible risk for BSE,
the following conditions are met:
Except as provided in the next bulleted condition for
blood and blood products, the processed animal protein does not contain
and was not commingled with material derived from ruminants originating
in a region of controlled risk or undetermined risk for BSE.
For blood meal, blood plasma, and other blood products,
the material does not contain and was not commingled with ruminant
blood or blood products prohibited importation into the United States.
Because, as noted above, BSE infectivity has not been demonstrated in
cattle blood or any tested derivatives (EC SSC, 2002), we do not
believe it is necessary to require that processed animal protein
derived from nonruminants not contain or be commingled with blood and
blood products derived from any ruminant from a BSE controlled- or
undetermined-risk region. However, because of the possibility that
blood derived from bovines could be contaminated with the BSE agent if
collected in a manner that does not ensure that it is not contaminated
with tissues containing the BSE agent, we consider it necessary to
prohibit the contamination or commingling of nonruminant processed
animal protein from controlled- or undetermined-risk regions with blood
or blood product that does not meet all the conditions (e.g.,
collection in a hygienic manner) necessary to make it eligible for
importation into the United States.
Inspection of the facility for compliance with the
provisions of this section is conducted at least annually by a
competent authority of the government agency responsible for animal
health in the region, unless the region chooses to have such
inspections conducted by APHIS. The inspections must verify either
that:
1. All steps of processing and storing the material are carried out
in a facility that has not been used for the processing or storage of
materials derived from ruminants originating in a BSE controlled- or
undetermined-risk region; or
2. The material is produced in a manner that prevents contamination
of the processed animal protein with materials prohibited importation
into the United States.
If APHIS conducts the required inspection, the facility
has entered into a cooperative service agreement executed by the
operator of the facility and APHIS. In accordance with the cooperative
service agreement, the facility must be current in paying all costs for
a veterinarian of APHIS to inspect the facility (it is anticipated that
such inspections will occur approximately once per year), including
travel, salary, subsistence, administrative overhead, and other
incidental expenses (including excess baggage provisions up to 150
pounds). In addition, the facility must have on deposit with APHIS an
unobligated amount equal to the cost for APHIS personnel to conduct one
inspection. As funds from that amount are obligated, a bill for costs
incurred based on official accounting records will be issued to restore
the deposit to the original level, revised as necessary to allow for
inflation or other changes in estimated costs. To be current, bills
must be paid within 14 days of receipt.

Processed Animal Protein Derived From Ruminants

Epidemiological evidence indicates the consumption by a susceptible
animal of processed animal protein of ruminant origin contaminated by
the BSE agent is the route by which BSE is transmitted. A region
recognized by APHIS as a region of negligible risk for BSE and in which
there has never been an indigenous case of BSE would have a negligible
likelihood of circulating BSE infectivity and, therefore, pose a
negligible risk that a BSE-infected animal would be incorporated into
rendered protein. Therefore, we are proposing in Sec. 95.5 to allow
the

[[Page 15892]]

importation of processed animal protein derived from ruminants from
such a region.
In the case of a region of negligible risk for BSE that has had an
indigenous case of the disease, we would require in Sec. 95.5 that the
product be derived from ruminants that were subject to a ruminant-to-
ruminant feed ban.
Under this proposal, processed animal protein derived from
ruminants would not be eligible for importation into the United States
from a region of controlled risk for BSE or a region of undetermined
risk. Because the primary source of BSE exposure has been shown to be
processed animal protein derived from ruminants contaminated with the
BSE agent, and because processed animal protein could potentially carry
or be contaminated with the BSE agent, we are proposing to prohibit the
importation of processed animal protein from regions of controlled risk
for BSE unless it can be demonstrated that such product has not been
commingled or contaminated with ruminant MBM or greaves. We would
prohibit the importation of processed animal protein derived from
ruminants from regions of undetermined risk for BSE because of the
possibility that such a region may not have adequate infrastructure and
the capability to implement BSE-related risk mitigations, including an
effectively enforced feed ban.

Transiting Provisions

In the current regulations, Sec. Sec. 94.18(d) and 95.4(h) provide
that articles that are otherwise prohibited importation into the United
States under the BSE regulations may transit air and ocean ports in the
United States for immediate export, provided certain conditions are
met. The requirements are that:
The person moving the articles has obtained an import
permit from APHIS;
The articles are sealed in leakproof containers bearing
serial numbers during transit, and each container remains sealed during
the entire time that it is in the United States;
The person moving the articles notifies, in writing, the
inspector at both the place in the United States where the articles
will arrive and the port of export before such transit. The
notification must include the import permit number; the times and dates
of arrival in the United States; the times and dates of exportation
from the United States; the mode of transportation; and the serial
numbers of the sealed containers; and
The articles transit the United States in Customs bond.
We are proposing in Sec. 94.27 and Sec. 95.15 to continue to
allow such transiting of articles otherwise prohibited importation by
the BSE regulations.
Sections 94.18(d) and 95.4(h) of the current regulations also allow
the overland transit through the United States of articles from BSE
minimal-risk regions, provided the requirements listed above are met,
and the following additional requirements are met:
The articles are eligible to enter the United States in
accordance with the BSE provisions in part 94 or part 95, as
applicable;
The shipment is exported from the United States within 7
days of its entry;
The commodities are not transloaded while in the United
States, except for direct transloading under the supervision of an
inspector, who must break the seals of the national government of the
exporting region on the means of conveyance that carried the
commodities into the United States and seal the means of conveyance
that will carry the commodities out of the United States with seals of
the U.S. Government; and
A copy of the required import permit is presented to the
inspector at the port of arrival and the port of export in the United
States.
In this document, we are proposing in Sec. 94.27 and Sec. 95.15
to allow the overland transit of products governed by the BSE
regulations, provided the same conditions for overland transit as those
listed above are met.

Certification of Certain Materials

Section 95.29 of the current regulations requires certification
regarding the source, processing, and storage of certain specified
animal materials imported from regions other than those listed in Sec.
94.18(a), which lists regions from which the importation of ruminants
and ruminant products are restricted because of BSE. The materials for
which certification is required are the following:
Processed animal protein, tankage, offal, and tallow other
than tallow derivatives, unless, in the opinion of the Administrator,
the tallow cannot be used in feed, regardless of the animal species
from which the material is derived;
Glands and unprocessed fat tissue from ruminants;
Processed fats and oils, and derivatives of processed
animal protein, tankage, and offal, regardless of the animal species
from which the material is derived;
Derivatives of glands from ruminants; and
Any product containing any of the listed materials.
We are proposing to amend the provisions of Sec. 95.29
(redesignated as Sec. 95.40 in this proposed rule) to make them apply
only to materials derived from ovines or caprines. As discussed above,
we are not at this time proposing to make any substantive changes to
the BSE regulations governing ovines or caprines or products from such
animals. The purpose of the provisions in current Sec. 95.29 as they
apply to materials from nonruminant animals and to ruminants other than
ovines and caprines--to ensure that materials eligible for entry into
the United States have not been commingled with materials ineligible
for entry because of their BSE risk--would be met by the provisions we
are proposing to set forth in new Sec. 95.13, which we discuss above
under the heading ``Restrictions on Processed Animal Protein Derived
from Nonruminants.''

Importation of Casings

Part 96 of the current regulations includes provisions regarding
the importation of animal casings into the United States. Current Sec.
96.2(b) prohibits the importation of casings, except stomachs, from
ruminants that originated in or were processed in any region listed in
Sec. 94.18(a) for BSE, unless specified conditions in Sec. 96.2(b)(1)
or (b)(2) are met. These provisions are as follows:
The casings are derived from sheep that were slaughtered
in a BSE minimal-risk region listed in Sec. 94.18(a)(3) (currently
only Canada) at less than 12 months of age and that were from a flock
subject to a ruminant feed ban equivalent to the requirements
established by the FDA at 21 CFR 589.2000; or
The casings are derived from bovines that were slaughtered
in a BSE minimal-risk region, provided, if the casings are derived from
the small intestine, the casings are derived from that part of the
small intestine that is eligible for use as human food in accordance
with the requirements established by FSIS at 9 CFR 310.22 and the FDA
at 21 CFR 189.5.
Casings that are imported in accordance under either of the above
scenarios must also be accompanied by certification that the applicable
conditions have been met.
In this document, we are proposing to amend Sec. 96.2(b) to
specify that the prohibitions in that paragraph that currently apply to
casings from all ruminants would apply only to casings derived from
ovines or caprines. We are proposing no changes to the current
provisions governing the importation of

[[Page 15893]]

casings derived from sheep from Canada.
We are proposing to amend the current Sec. 96.2 provisions
regarding casings derived from bovines to allow for the importation of
casing derived from bovines provided the following conditions are met:
If the casings are derived from bovines from a region of
negligible risk for BSE, the certification required under Sec. 96.3
indicates the APHIS BSE risk classification of the region in which the
bovines were slaughtered and the casing processed.
If the casings are derived from bovines from a region of
controlled risk for BSE or a region of undetermined risk for BSE, the
casings are not derived from the small intestine or, if the casings are
derived from the small intestine, the casings are derived from that
part of the small intestine that is eligible for use as human food in
accordance with the requirements established by FSIS at 9 CFR 310.22
and FDA at 21 CFR 189.5.
The casings are accompanied by a certification that the
required conditions have been met.

Provisions Regarding Ovines and Caprines

In this proposal, we retain the current import prohibitions and
restrictions regarding ovines and caprines (e.g., sheep and goats) and
their products. However, we are proposing to make formatting and
wording changes to the regulations regarding such animals, for several
reasons.
In many cases, the current import regulations regarding BSE apply
to all ruminants or to several types of ruminants. For instance, the
regulations in current Sec. 94.18 prohibit or restrict the importation
of most products derived from ruminants from regions in which BSE
exists (listed in current Sec. 94.18(a)(1)) or that pose an undue risk
of BSE (listed in current Sec. 94.18(a)(2)), whether the ruminant from
which the product is derived is a bovine, ovine, caprine, cervid, or
camelid. Similar blanket prohibitions or restrictions are set forth in
current part 93 with regard to live ruminants, in current part 95 with
regard to products derived from ruminants other than meat and other
edible products, and in current part 96, with regard to casings.
The current regulations apply no BSE prohibitions or restrictions
to live cervids and camelids from BSE minimal-risk regions (listed in
current Sec. 94.18(a)(3)) or to products derived from such animals.
The importation from BSE minimal-risk regions of live bovines, sheep,
and goats--and products derived from such animals--is allowed under
specified conditions.
Because, in this proposed rule, we would retain the current
importation provisions with regard to BSE as they apply to ovines and
caprines--but not as they apply to bovines, cervids, and camelids--it
is necessary to revise the current regulations to make them particular
to ovines and caprines, pending any future rulemaking regarding such
animals. Among the revisions we are proposing to the regulations
regarding ovines and caprines is the removal of the terminology
currently used in Sec. 94.18(a) to refer to the BSE risk status of a
region (i.e., regions in which BSE exists, regions of undue risk for
BSE, and regions of minimal-risk for BSE). In order to avoid confusion
as to our intent regarding our proposed BSE risk classification system
with regard to bovines (i.e., BSE negligible-, controlled-, and
undetermined-risk regions), when we refer to regions that are listed in
current Sec. 94.18(a) with regard to ovines and caprines, we simply
list the names of those regions.
In this proposed rule, the provisions in part 94 that are
particular to ovines and caprines are set forth in Sec. Sec. 94.24
through 94.27. The provisions in part 95 that are particular to ovines
and caprines are set forth in Sec. Sec. 95.4, 95.15, and 95.40. In
parts 93 and 96, the BSE import provisions related to ovines and
caprines and their products are set forth in the same regulatory
sections as in the current regulations.

Definitions

In addition to the definitions we are proposing to add to the
regulations that we discuss elsewhere in this document, we are
proposing to add to Sec. 92.1 definitions of approved laboratory, OIE,
OIE Code, and OIE Terrestrial Manual. Additionally, we are proposing to
amend the definition of recognized slaughtering establishment in Sec.
93.400 to mean a slaughtering establishment operating under the
provisions of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.)
or a State meat inspection act. This proposed definition is the same as
that currently contained in 9 CFR 78.1.

Miscellaneous Nonsubstantive Changes

We are also proposing to make nonsubstantive editorial and
formatting changes to parts 92, 93, 94, 95, and 96, in order to make
the text in those parts consistent with the changes that we discuss
above in this document. These nonsubstantive changes include
redesignation and reformatting of regulatory sections and amendment of
cross-references where necessary.
We are also proposing nonsubstantive editorial changes to Sec.
96.3 to reflect the changes we are proposing to make in Sec. 96.2.

APHIS Classification of BSE Risk Status of Countries That Have Received
Classification by the OIE

As we discussed above in this document under the heading ``The
Process for APHIS Recognition of the BSE Risk Classification of a
Region,'' if the OIE has classified a country as either BSE negligible
risk or BSE controlled risk, APHIS would give notice to the public that
the Agency considers such classification by the OIE to be a basis for
APHIS' recognition of the country as having the BSE risk classification
determined by the OIE, subject to public comment regarding that intent.
In accordance with that proposed process we are giving notice in
this document that APHIS gives preliminary concurrence to the OIE risk
classifications of the following countries:
Regions of negligible risk for BSE: Argentina, Australia,
Chile, Denmark, Finland, Iceland, New Zealand, Norway, Panama,
Paraguay, Peru, Sweden, and Uruguay.
Regions of controlled risk for BSE: Austria, Belgium,
Brazil, Canada, Colombia, Cyprus, Czech Republic, Estonia, France,
Germany, Greece, Hungary, Ireland, Italy, Japan, Latvia, Liechtenstein,
Lithuania, Luxembourg, Malta, Mexico, the Netherlands, Poland,
Portugal, Republic of Korea, Slovak Republic, Slovenia, Spain,
Switzerland, and the United Kingdom.\17\
---------------------------------------------------------------------------

\17\ The United States is also classified by the OIE as a region
of controlled risk for BSE.
---------------------------------------------------------------------------

The OIE recommendations regarding each of the above countries can
be viewed at http://www.oie.int/en/animal-health-in-the-world/official-disease-status/bse/list-of-bse-risk-status/.

Date of Effective Enforcement of Feed Ban in Mexico

As noted above, we are proposing to recognize Mexico as a country
of controlled risk for BSE. Also as discussed above, for a country
classified by APHIS as negligible-risk or controlled-risk for BSE that
wishes to export live bovines to the United States, APHIS would need to
determine the date a feed ban was effectively enforced in the country.
Consequently, we have conducted an evaluation to determine the date of
effective enforcement of a feed ban in Mexico. Based on that
evaluation, we consider the date of

[[Page 15894]]

effective enforcement of a feed ban in Mexico to be November 30, 2007.
Copies of our evaluation, as well as the supporting documentation, are
available by contacting the person listed under FOR FURTHER INFORMATION
CONTACT or on the Regulations.gov Web site (see ADDRESSES above for
instructions for accessing Regulations.gov).

Public Comment Regarding BSE Classification of Countries and Date of
Effective Enforcement of Feed Ban in Mexico

We will accept public comment on our preliminary BSE risk
classification of the countries listed above, as well as on our
preliminary determination of the date of effective enforcement of a
feed ban in Mexico, for the length of the comment period for this
proposed rule document. Any final classification of countries regarding
BSE risk would depend both on whether the classification system and
procedures we are proposing in this document are made final and on
comments received from the public regarding such classifications.
Following review of any comments received, we will inform the public in
the Federal Register of the Administrator's final determination
regarding classification of the countries listed above and the date of
effective enforcement of a feed ban in Mexico, along with a discussion
of and response to pertinent issues raised by commenters.

Provisions Regarding the Importation of Live Bovines From Mexico

As we discuss earlier in this document with regard to the
importation of live bovines from Canada, the provisions we are
proposing in Sec. 93.436 for the importation of live bovines from a
region of controlled risk are generic to any such region. For instance,
the provisions in Sec. 93.436 require that live bovines imported from
a controlled risk region for BSE must have been born after the date
from which the ban on the feeding of ruminants with MBM and greaves
derived from ruminants has been effectively enforced. Also, the
provisions in Sec. 93.436 require that live bovines intended for
importation be permanently identified--by branding, tattooing, or some
other method--as to the country of export. As noted above, in this
document we are proposing to recognize November 30, 2007, as the date
of effective enforcement of a feed ban in Mexico. Further, in this
document, we are proposing to specify that the letters ``MX'' be used
to identify sexually intact bovines as being of Mexican origin. (The
regulations already require that cattle from Mexico that are other than
sexually intact be identified as to country of origin, for diseases
other than BSE.) To make this specific information more easily
accessible in the regulations, we are proposing to set forth the
provisions regarding the importation of live bovines from Mexico with
regard to BSE in a new paragraph (f) in Sec. 93.427. Current Sec.
93.427 contains requirements governing the importation of cattle from
Mexico with regard to fever ticks, brucellosis, and tuberculosis.

Executive Orders 12866 and 13563 and Regulatory Flexibility Act

This proposed 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.
We have prepared an economic analysis for this rule. The economic
analysis provides a cost-benefit analysis, as required by Executive
Orders 12866 and 13563, which direct agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, and equity). Executive Order 13563 emphasizes the importance
of quantifying both costs and benefits, of reducing costs, of
harmonizing rules, and of promoting flexibility. The economic analysis
also examines the potential economic effects of this rule on small
entities, as required by the Regulatory Flexibility Act. The economic
analysis is summarized below. Copies of the full analysis are available
by contacting the person listed under FOR FURTHER INFORMATION CONTACT
or on the Regulations.gov Web site (see ADDRESSES above for
instructions for accessing Regulations.gov).
The proposed rule would make our bovine and bovine product import
restrictions related to bovine spongiform encephalopathy (BSE) more
reflective of current scientific thinking while continuing to guard
against the introduction of BSE. The proposed process for classifying
regions with respect to BSE risk would be based on the comprehensive
review of relevant, internationally accepted scientific literature and
would be consistent with the process employed by the World Organization
for Animal Health (OIE). The proposed rule would also remove BSE-
related restrictions on the importation of live cervids and camelids
and their products.
While benefits of the proposed rule are expected to exceed its
costs, effects on U.S. imports are expected to be minimal. Potential
impacts of the proposed rule on U.S. export markets, by influencing
trading partners' import policies, are not considered in this analysis.

Live Bovines (Cattle and Bison)

Canada and Mexico are the sources of nearly all U.S. bovine
imports. In the past 15 years, they have accounted for 99.9 percent of
all cattle and bison imported into the United States. APHIS is
proposing to classify Canada and Mexico as countries of controlled risk
for BSE (their classification by the OIE).
Imports from Canada are likely to be unaffected by this proposed
rule because the proposed requirements would cause no change in the
number or type of animals that are eligible for importation, based on
Canada's status as a BSE minimal-risk region. Imports from Mexico also
are likely to be largely unaffected, since nearly all cattle imported
from Mexico (98 to 99 percent) are estimated to be less than 24 months
of age and APHIS is proposing in this rule to establish November 30,
2007, as the date of effective enforcement of a ruminant-to-ruminant
feed ban in Mexico (the earliest date that bovines imported from Mexico
could be born).

Products Derived From Bovines

Six countries, Argentina, Australia, Brazil, Canada, New Zealand,
and Uruguay, accounted for 93 percent of all U.S. bovine product import
volume (and 92 percent of the import value) over the five-year period,
2006-2010. Imports from each of the six countries should continue
essentially unchanged and without interruption under the proposed rule,
because the protocols in place in these countries are already in full
compliance with the proposed criteria. Argentina, Australia, New
Zealand, and Uruguay are APHIS-proposed negligible risk regions for BSE
that have never reported a case of BSE. Canada and Brazil, as proposed
controlled risk regions for BSE, already satisfy FSIS inspection
requirements and prohibitions on certain animal stunning or pithing and
mechanically separated meat.
Imports from the 36 (primarily European) countries listed in 9 CFR
94.18 as prohibited from shipping bovine products to the United States
likely would be insignificant under the proposed rule. In none of the
years from 1990 through 1996, that is, prior to the prohibition on
ruminant product imports from all of Europe in 1997, did the volume of
U.S. bovine product

[[Page 15895]]

imports from the 36 countries account for more than 0.6 percent of
imports of these products. Nor does the current trade climate suggest a
significant volume of imports from the 36 countries in the future, at
least in the near term. U.S. imports of beef and other bovine products
have been in decline, a situation that makes it increasingly difficult
for foreign exporters to compete in the U.S. market. Second, while
bovine product exports by the European Union (EU-27) more than doubled
in nominal value in five years, from $0.43 billion in 2006 to $1.01
billion in 2010, the value of bovine product imports by EU-27 member
countries in 2010 ($2.1 billion) was twice the value of their bovine
product exports. The EU-27 continues to be a large net importer of
bovine products overall. Emerging markets, such as Russia, are likely
to take a growing share of Europe's bovine product exports.
Bovine product imports from other countries that are not currently
subject to BSE-related restrictions are not expected to be
significantly affected. Over the five years, 2006-2010, annual imports
from such countries as a group averaged 6 to 7 percent of all U.S.
bovine product imports by volume (7 to 8 percent by value), with
virtually all of the products coming from Mexico, Nicaragua, and Costa
Rica. Imports from Mexico already meet the proposed requirements of a
region of controlled risk for BSE largely by way of FSIS requirements.
The potential impact on imports from Nicaragua and Costa Rica, which
APHIS is proposing to recognize as regions of undetermined risk for
BSE, should be minimal at most. Almost all imports from those two
countries are of boneless beef that already satisfy the proposed rule's
requirements, again, largely by way of FSIS requirements.

Live Cervids and Camelids and Their Products

Removal of the prohibition on the importation of live cervids and
camelids and their products from the 36 countries listed in 9 CFR 94.18
would likely have little or no impact. The United States has not
imported any live cervids or camelids from these countries since at
least 1990. In none of the years from 1990 through 1996, before the
prohibition of ruminant meat, meat products, and other edible products
from all of Europe in 1997, did the volume of U.S. imports of meat and
edible offal of deer from the 36 countries account for more than 3.3
percent of total imports. Moreover, U.S. imports of meat and edible
offal of deer have declined since 2005, a situation that makes it
increasingly difficult for foreign exporters to compete in the U.S.
market. The volume of U.S. imports of camelid products is very small.
Their annual value averaged less than $50,000 over the five-year
period, 2006-2010, and 90 percent of those imports were supplied by
Canada and China.

Benefits, Costs, and Alternatives

Consumers benefit from imports to the extent that consumer choice
is broadened and the increased supply of the imported commodity leads
to a price decline. We anticipate that the proposed rule would have
little impact on consumer choice or import volumes. Likewise, we
anticipate little or no impact for U.S. businesses because of changes
in import volumes.
Although the impact of this proposed rule on U.S. consumers and
producers is expected to be minimal, the benefits of the rule are
expected to outweigh its costs. Leaving the bovine regulations
unchanged would be unsatisfactory, because it would perpetuate the
current situation in which our BSE-related import conditions are not
fully supported by scientific evidence. Additionally, maintaining the
status quo would not provide an opportunity to recognize a region's BSE
risk status in a more timely fashion than is possible under current
regulations. Another alternative, amending the BSE regulations related
to the importation of bovines and bovine-derived products to match
precisely the OIE Code without allowing for modification deemed
necessary by APHIS, would also be unsatisfactory, because it would not
allow APHIS to independently interpret the scientific literature and
findings that underlie OIE risk categorization recommendations. Making
no changes to the regulations that govern the importation of cervids
and camelids would also be unsatisfactory, because it would perpetuate
an unnecessary constraint on trade in those commodities.
Small entities are prevalent in industries potentially affected by
the proposed rule, but as described, we expect at most a minimal
economic impact for U.S. businesses. We invite public comment on the
rule's potential economic impact, including comment on the potential
impact on small entities.

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

Our affirmation of the position we took in removing the delay of
applicability of certain provisions of our January 2005 final rule
leaves those regulations unchanged. Therefore, we are also affirming
the overall conclusions we reached in the environmental assessments we
conducted for our January 2005 and September 2007 final rules.
To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts associated with the
proposed revision of the conditions for the importation of live bovines
and products derived from bovines with regard to BSE set forth in this
proposed rule, we have prepared an environmental assessment. The
environmental assessment was prepared in accordance with: (1) The
National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C.
4321 et seq.), (2) regulations of the Council on Environmental Quality
for implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4)
APHIS' NEPA Implementing Procedures (7 CFR part 372).
The environmental assessment may be viewed on the Regulations.gov
Web site or in our reading room. Instructions for accessing
Regulations.gov and information on the location and hours of the
reading room are provided under the heading ADDRESSES at the beginning
of this proposed rule. In addition, copies may be obtained by calling
or writing to the individuals listed under FOR FURTHER INFORMATION
CONTACT.

Paperwork Reduction Act

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. APHIS-
2008-0010. Please send a copy of your comments to: (1) Docket No.
APHIS-2008-0010, Regulatory Analysis and Development, PPD, APHIS,
Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238,
and (2) Clearance Officer,

[[Page 15896]]

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.
APHIS is proposing to revise the conditions for the importation of
live bovines and products derived from bovines with regard to BSE, and
is proposing to establish a system and process for classifying regions
as to BSE risk that is consistent with the system and process employed
by the OIE. For the most part, the changes made by this rule would
expand the number and types of commodities eligible for entry into the
United States with regard to BSE. However, in many cases, the
commodities would be eligible for entry into the United States only if
specified conditions have been met, and the commodities are accompanied
by certification that the required conditions have been met. In some
cases, the person seeking to import a commodity would need to apply for
an import permit from APHIS.
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 .3960737 hours per response.
Respondents: U.S. importers of regulated animal products; full-time
salaried veterinary officials of exporting regions; and foreign
exporters of edible and inedible products derived from bovines.
Estimated annual number of respondents: 784.
Estimated annual number of responses per respondent: 41.4528.
Estimated annual number of responses: 32,499.
Estimated total annual burden on respondents: 12,872 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)
851-2908.

E-Government Act Compliance

The Animal and Plant Health Inspection Service is committed to
compliance with the E-Government Act to promote the use of the Internet
and other information technologies, to provide increased opportunities
for citizen access to Government information and services, and for
other purposes. For information pertinent to E-Government Act
compliance related to this proposed rule, please contact Mrs. Celeste
Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

References

Andrews, N.J. (2007). Incidence of Variant Creutzfeldt-Jakob Disease
Deaths in the UK, January 1994-December 2006. National Creutzfeldt-
Jakob Disease Surveillance Unit, University of Edinburgh.
(www.cjd.ed.ac.uk/vcjdqdec06.htm)
Anil, M. H., S. Love, S. Williams, A. Shand, J. L. McKinstry, C. R.
Helps, A. Waterman-Pearson, J. Seghatchian, and D. A. Harbour.
(1999). Potential contamination of beef carcasses with brain tissue
at slaughter. Vet. Rec. 145:460-462.
Animal and Plant Health Inspection Service (APHIS). (2004). Analysis
of risk--update for the Final Rule: bovine spongiform
encephalopathy; minimal risk regions and importation of commodities,
page 15. December. (http://www.aphis.usda.gov/newsroom/hot_issues/bse/background)
Animal and Plant Health Inspection Service (APHIS). (2007). Revised
assessment of Bovine Spongiform Encephalopathy (BSE) risks
associated with the importation of certain commodities from BSE
minimal risk regions (Canada). (http://www.aphis.usda.gov/newsroom/hot_issues/bse/index.shtml)
Barlow, R.M. and D.J. Middleton. (1990). Dietary transmission of
bovine spongiform encephalopathy to mice. Vet. Rec. 126: 111-112.
Bishop, M., P. Hart, et al. (2006). Predicting susceptibility and
incubation time of human-to-human transmission of vCJD. Lancet
Neurology 5. pp. 393-398.
Bosque, P.J., C. Ryou, G. Telling, D. Peretz, G. Legname, S.J.
DeArmond, and S.B. Prusiner. (2002). Prions in skeletal muscle.
Proc. Natl. Acad. Sci. 99: 3812-3817.
Bradley, R. (1990). Editorial: Bovine Spongiform Encephalopathy: The
Need for Knowledge, Balance, Patience, and Action. J. Pathology.
160: 283-285.
Bradley, R. (1996). The research programme on transmissible
spongiform encephalopathies in Britain with special reference to
bovine spongiform encephalopathy. Dev. Biol. Scand. 80: 157-170.
Bradley, R. and P. Liberski. (2004). Bovine Spongiform
Encephalopathy (BSE): The end of the beginning or the beginning of
the end? Folia Neuropathologica Supplement A. (2004). pp. 55-68.
Brown, P., R.G. Rohwer, B.C. Dunstan, C. MacAuley, DC Gajdusek, and
W.N. Drohan. (1998). The distribution of infectivity in blood
components and plasma derivatives in experimental models of
transmissible spongiform encephalopathy. Transfusion 38: 810-816.
Brown, P., L. Cervenakova, L.M. McShane, P. Barber, R. Rubenstein,
and W.N. Drohan. (1999). Further studies of blood infectivity in an
experimental model of transmissible spongiform encephalopathy, with
an explanation of why blood components do not transmit Creutzfeldt-
Jakob disease in humans. Transfusion 39: 1169-1178. November/
December.
BSE Epidemiological Study Group. (2003). Investigation into
Infection Sources and Infection Routes of Bovine Spongiform
Encephalopathy (BSE)--Report on Results of Epidemiological Analysis
by the BSE Epidemiological Study Group. September. https://
web01.aphis.usda.gov/db/mtaddr.nsf/2f5c87c0140172cb852564bf0046d1e2/
c6db63c18fc53f028525708200631b10/$FILE/EpiInvestigation09.2003.pdf
Buschmann, A., and M. Groschup. (2005). Highly Bovine Spongiform
Encephalopathy-Sensitive Transgenic Mice Confirm the Essential
Restriction of Infectivity to the Nervous System in Clinically
Diseased Cattle. Journal of Infectious Diseases, 192: 934-42.
September 1.
Clarke, P. and A. Ghani. (2005). Projections of the future course of
the primary vCJD epidemic in the UK: inclusion of subclinical
infection and the possibility of wider genetic susceptibility.
Journal of the Royal Society Interface 2(2): 19-31. March 22.
Comer, P.J. and P.J. Huntly. (2003). Exposure of the human
population to BSE infectivity over the course of the BSE epidemic in
Great Britain and the impact of changes to the Over Thirty Month
Rule. Over Thirty Month Rule (OTMR) review paper. June. Accessed
September 7, 2007. (http://www.food.gov.uk/multimedia/pdfs/otmcomer.pdf)
Comer, P.J. (2004). Risk assessment of exposure to vCJD infectivity
in blood and blood products. Department of Health, U.K. April.
Cooper, J.D. and S.M. Bird. (2003). Predicting incidence of variant
Creutzfeldt-Jakob disease from UK dietary exposure to bovine
spongiform encephalopathy for the 1940 to 1969 and post-1969 birth
cohorts. International Journal of Epidemiology. Vol. 32 5;
784-791.
Department for Environment, Food and Rural Affairs (DEFRA), United
Kingdom. (2005). Transmissible Spongiform

[[Page 15897]]

Encephalopathies (TSEs) in Great Britain 2004--A Progress Report.
(http://www.defra.gov.uk/animalh/bse/publications/index.html)
Department of Environment Food and Rural Affairs (DEFRA), United
Kingdom. (2006). BSE: Science & research--Pathogenesis. Page last
reviewed October 10. (http://www.defra.gov.uk/animalh/bse/science-research/pathog.html)
Department for Environment Food and Rural Affairs (DEFRA), United
Kingdom. (2006a). BSE: Statistics--BSE--GB weekly cumulative
statistics; as of April 28, 2006.
Donnelly, C.A., S. Gore, R. Curnow, J.W. Wilesmith. (1997). The
Bovine Spongiform Encephalopathy Maternal Cohort Study: Its Purpose
and Findings. Applied Statistics. 46(3): 299-304.
Donnelly, C.A., N.M. Ferguson, A.C. Ghani and R.M. Anderson. (2002).
Implications of BSE infection screening data for the scale of the
British BSE epidemic and current European infection levels. Proc
Biol Sci. Nov 7; 269(1506):2179-90.
Espinosa, J.C., M. Morales, J. Castilla, M. Rogers, and J.M. Torres.
(2007). Progression of prion infectivity in asymptomatic cattle
after oral bovine spongiform encephalopathy challenge. Journal of
General Virology 88:1379-1383. April.
European Commission Scientific Steering Committee (EC SSC). (1998).
Opinion on the Safety of Gelatine Adopted at the Scientific Steering
Committee at its plenary meeting of 26-27 March 1998. Following a
public consultation on the preliminary opinion adopted on 19-20
February 1998. March. (http://ec.europa.eu/food/fs/sc/ssc/out09_en.pdf)
European Commission Scientific Steering Committee (EC SSC). (2000).
Opinion on the Safety of Ruminant Blood with Respect to TSE Risks.
Adopted by the Scientific Steering Committee at its meeting of 13-14
April 2000. (http://ec.europa.eu/food/fs/sc/ssc/out74_en.pdf)
European Commission Scientific Steering Committee (EC SSC). (2001).
``Opinion on TSE Infectivity Distribution in Ruminant Tissues (State
of Knowledge, December 2001)'' (Adopted January 10-11, 2002).
(http://europa.eu.int/comm/food/fs/sc/ssc/out241_en.pdf)
European Commission Scientific Steering Committee (EC SSC). (2002).
Update of the opinion on TSE infectivity distribution in ruminant
tissues. November. (http://www.europa.eu.int/comm/food/fs/sc/ssc/out296_en.pdf)
European Commission Scientific Steering Committee (EC SSC). (2002a).
Prions in muscle statement adopted by the scientific steering
committee at its meeting of 4-5 April 2002. Accessed December 5,
2007. (http://ec.europa.eu/food/fs/sc/ssc/out254_en.pdf)
European Commission Scientific Steering Committee (EC SSC). (2002b.)
Minutes of the Scientific Steering Committee Meeting of 12-13
September 2002. (http://ec.europa.eu/food/fs/sc/ssc/out293_en.pdf)
European Commission Scientific Steering Committee (EC SSC). (2003).
Updated Opinion and Report on the Safety of Dicalcium Phosphate
(DCP) and tricalcium phosphate (TCP) from Bovine Bones, used as an
Animal Feed Additive or as Fertiliser. Submitted to the Scientific
Steering Committee at its meeting of 6-7 March 2003. Accessed
December 20, 2007. (http://ec.europa.eu/food/fs/sc/ssc/out322_en.pdf)
European Food Safety Authority Journal (EFSA Journal). (2004).
Opinion of the European Food Safety Authority on BSE risk from
dissemination of brain particles in blood and carcass following
stunning. 123, 1-4.
European Food Safety Authority Journal (EFSA Journal). (2005).
Opinion on the assessment of the age limit in cattle for removal of
certain specified risk materials (SRM). 220: 1-21.
European Food Safety Authority Journal (EFSA Journal). (2005a).
Opinion on the assessment of the human and animal BSE risk posed by
tallow with respect to residual BSE risk. 221: 1-47.
European Food Safety Authority Journal (EFSA Journal). (2006).
Quantitative assessment of the human and animal BSE risk posed by
gelatine with respect to residual BSE risk. Adopted on 18 January
2006. 312: 1-29.
European Food Safety Authority Journal (EFSA Journal). (2007).
Opinion of the scientific panel on biological hazards on a request
from the European Commission on the infectivity in SRM derived from
cattle at different age groups estimated by back calculation
modeling. 476: 1-47.
Farshid, M., R.E. Taffs, D. Scott, D.M. Asher, and K. Brorson.
(2005). The clearance of viruses and transmissible spongiform
encephalopathy agents from biologicals. Current Opinion in
Biotechnology. 16: 561-567.
Food and Drug Administration (FDA). (2004). Federal Register Volume
69, Number 134, 42255-42274. Interim Final Rule, ``Use of Materials
Derived from Cattle in Human Food and Cosmetics.'' FDA Docket No.
2004N-0081. July 14. (http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15881.htm)
Food and Drug Administration (FDA). (2005). Federal Register Volume
70, Number 172, 533063-53069. Interim Final Rule, ``Use of Materials
Derived from Cattle in Human Food and Cosmetics.'' FDA Docket No.
2004N-0081. September 7. (http://www.fda.gov/OHRMS/DOCKETS/98fr/05-17693.pdf)
Food and Drug Administration (FDA). (2007). Federal Register Volume
72, Number 8, 1582-1619. Proposed Rule, ``Use of Material Derived
from Cattle in Medical Products Intended for Use in Humans and Drugs
Intended for Use in Ruminants.'' FDA Docket No. 2005N-0373. January
12. (http://edocket.access.gpo.gov/2008/pdf/E6-22329.htm)
Food and Drug Administration (FDA). (2008). Federal Register Volume
73, Number 81, 22718-22758. Final Rule, ``Substances Prohibited from
Use in Animal Food or Feed.'' FDA Docket No. 2002N-0273. April 25.
(http://edocket.access.gpo.gov/2007/pdf/08-1180.pdf)
Food Safety and Inspection Service (FSIS). (2004). Federal Register
Volume 69, No. 7, 1861-1874. Interim Final Rule, ``Prohibition of
the Use of Specified Risk Materials for Human Food and Requirements
for the Disposition of Non-Ambulatory Disabled Cattle,'' Docket No
03-025IF. January 12. (http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/03-025IF.pdf)
Food Safety and Inspection Service (FSIS). (2004a). Federal Register
Volume 69, No. 7, 1874-1885. Interim Final Rule, ``Meat Produced by
Advanced Meat/Bone Separation Machinery and Meat Recovery (AMR)
Systems,'' Docket No 03-0038IF. January 12. (http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/03-0038IF.pdf)
Food Safety and Inspection Service (FSIS). (2004b). Federal Register
Volume 69, No. 7, 1885-1891. Interim Final Rule, ``Prohibition of
the Use of Certain Stunning Devices Used To Immobilize Cattle During
Slaughter; Bovine Spongiform Encephalopathy Surveillance Program;
Interim Final Rule,'' Docket No. 01-033IF. January 12. (http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/01-033IF.pdf)
Food Safety and Inspection Service (FSIS). (2004c). FSIS Notice,
Bovine Spongiform Encephalopathy (BSE): Issues Related to Tonsils
and Brain Collection. October 7
Food Safety and Inspection Service (FSIS) (2005). Federal Register
Volume 70, No. 173, 53043-53050. Interim final rule, ``Prohibition
of the Use of Specified Risk Materials for Human Food and
Requirements for the Disposition of Non-Ambulatory Disabled
Cattle.'' Docket No. 03-025IFA. September 7. (http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?position=all&page=53043&dbname=2005_register)
Food Safety and Inspection Service (FSIS). (2007). Federal Register
Volume 72, No. 134, 38700-38730. Affirmation of Interim Final Rules
with Amendments, ``Prohibition of the Use of Specified Risk
Materials for Human Food and Requirements for the Disposition of
Non-Ambulatory Disabled Cattle; Prohibition of the Use of Certain
Stunning Devices Used to Immobilize Cattle During Slaughter.''
Docket No. 03-025F. July 13. (http://www.fsis.usda.gov/Regulations_&_Policies/federal_register_publications_&_related_documents/index.asp)
Fox, J. and H.H. Peterson. (2004). Risks and Implications of bovine
spongiform encephalopathy for the United States: Insights from other
countries. Food Policy 29 (2004): 45-60.
Fraser, H. And J.D. Foster. (1994). Transmission to mice, sheep and
goats and bioassay of bovine tissues. Transmissible Spongiform
Encephalopathies. Proceedings of a Consultation with the Scientific
Veterinary Committee of the CEC. Edited by R. Bradley & B. Marchant.
VI/413/94-EN Brussels, EC. pp 145-149.
Ghani, A.C., N.M. Ferguson, C.A. Donnelly, T.J. Hagenaars, and R.M.
Anderson. (1998). Epidemiological determinants of the pattern and
magnitude of the vCJD epidemic in Great Britain; Proc. R Soc. Lond.
B 265; 2443-2452.
Ghani, A.C., N.M. Ferguson, C.A. Donnelly, and R.M. Anderson.
(2000). Predicted vCJD mortality in Great Britain; Nature 406; 583-
584.

[[Page 15898]]

Ghani, A.C., C.A. Donnelly, N.M. Ferguson, and R.M. Anderson.
(2003). Updated projections of future vCJD deaths in the UK. BMC
Infect. Dis. 3; 4.
Grobben A., P. Steele, R. Somerville, and D.M. Taylor. (2004).
Inactivation of the bovine spongiform encephalopathy (BSE) agent by
the acid and alkaline processes used in the manufacture of bone
gelatine. Biotechnology and Applied Biochemistry. (39): 329-338.
Grobben A., P. Steele, R. Somerville, and D.M. Taylor. (2006).
Inactivation of transmissible spongiform encephalopathy agents
during the manufacture of dicalcium phosphate from bone. Vet. Rec.
158: 361-366.
Heim, D. and U. Kihm. (2003). Risk management of transmissible
spongiform encephalopathies in Europe. Rev. Sci. Tech. World
Organization for Animal Health; 22(1): 179-199.
Hill, W. (2005). Review of the Evidence for the Occurrence of `BARB'
BSE Cases in Cattle. July 5. Accessed September 7, 2007. (http://www.defra.gov.uk/animalh/bse/pdf/hillreport.pdf).
Hoffmann, C., U. Ziegler, A. Buschmann, A. Weber, L. Kupfer, A.
Oelschlegel, B. Hammerschmidt, and M. Groschup. (2007). Prions
spread via the autonomic nervous system from the gut to the central
nervous system in cattle incubating bovine spongiform
encephalopathy. J. Gen. Virol. 88: 1048-1055.
Hoffmann C, Eiden M, Kaatz M, Keller M, Ziegler U, Rogers R, Hills
B, Balkema-Buschmann A, van Keulen L, Jacobs JG, Groschup MH.
(2011). BSE infectivity in jejunum, ileum and ileocaecal junction of
incubating cattle. Vet Res. 2011 Feb 7;42(1):21
Houston, F., J. Foster, A. Chong, N. Hunter, and C. Bostock. (2000).
Transmission of BSE by blood transfusion in sheep. Research letter.
The Lancet. 356: 999-1000.
Hunter, N., J. Foster, A. Chong, S. McCutcheon, D. Parnham, S.
Eaton, C. MacKenzie, and F. Houston. (2002). Transmission of prion
diseases by blood transfusion. J. Gen. Vir. 83: Published ahead of
print (16 July 2002).
International Forum for Transmissible Animal Diseases and Food
Safety (TAFS). (2004). Position paper on slaughter practices and the
dangers of carcass contamination with BSE. (http://www.tseandfoodsafety.org/position_papers/TAFS_POSITION_PAPER_ON%20SLAUGHTER_.pdf)
Iwamaru, Y., Y. Okubo, T. Ikeda, H. Hayashi, M. Imamura, T.
Yokoyama, and M. Shinagawa. (2005). PrPSc distribution of a natural
case of bovine spongiform encephalopathy. Kitamoto T, ed. Prions:
Food and Drug Safety. Springer-Verlag, New York.
Iwata, N., Y. Sato, Y. Higuchi, K. Nohtomi, N. Nagata, H. Hasegawa,
M. Tobiume, Y. Nakamura, K. Hagiwara, H. Furuoka, M. Horiuchi, Y.
Yamakawa, and T. Sata. (2006). Distribution of PrP\Sc\ in Cattle
with Bovine Spongiform Encephalopathy Slaughtered at Abattoirs in
Japan. Jpn. J. Infect. Dis. 59(2): 100-107. (http://www.nih.go.jp/JJID/59/100.pdf)
Mantze, U., G. Schlaf, R. Poethke, K. Felgenhauer, and M.
M[auml]der. (1996). On the Removal of nervous Proteins from Material
Used for Gelatin Manufacturing During Processing. Pharm. Ind., Vol.
58: 837-841.
Martin, S., M. Jeffrey, M. Stack, M. Chapin,, H.W. Reid, P. Steele,
M.P. Dagleish, and A. Balachandran. (2007). Abstract from Pre-prion
2007, Chronic Wasting Disease Workshop, Edinburgh, September 25,
2007. IHC and WB characterization or experimental BSE and CWD in red
deer.
Middleton, D. and R. Barlow. (1993). Failure to transmit bovine
spongiform encephalopathy to mice by feeding them with extraneural
tissues of affected cattle. Vet Rec. 132: 545-547.
Ministry of Agriculture, Fisheries and Food (MAFF) (1997). Food
Safety Information Bulletin No. 85: Maternal Transmission. June.
(http://archive.food.gov.uk/maff/archive/food/bulletin/1997/no85/seac.htm)
Ministry of Agriculture, Fisheries and Food (MAFF) (1999). Bovine
spongiform encephalopathy in Great Britain. A progress report.
London. December.
Paisley, L. and J. Hostrup-Pedersen. (2004). Assessment of the risk
of BSE transmission by tallow based calf milk replacer. Prev. Vet.
Med. 63(1-2): 135-149.
Prince, M.J., J.A. Bailey, P.R. Barrowman, K.J. Bishop, G.R.
Campbell, and J.M. Wood. (2003). Bovine Spongiform Encephalopathy.
Rev. sci. tech. OIE; 22 (1): 37-60.
Prusiner, S.B. (1994). Biology and Genetics of prion diseases.
Annual review of Microbiology. 48: 655-86.
Schmidt, G.R., K.E. Hossner, R.S. Yemm, and D.H. Gould. (1999).
Potential for disruption of central nervous system tissue in beef
cattle by different types of captive bolt stunners. J. Food Prot.,
62:390-393.
Spongiform Encephalopathy Advisory Committee (SEAC). (2001). Minutes
of the 73rd meeting held on 10 April 2002 at DEFRA, the Department
for Environment, Food, and Rural Affairs, United Kingdom. Accessed
December 20, 2007. (http://www.seac.gov.uk/papers/mins10-04-02.pdf)
Taylor, D.M., S.L. Woodgate, and M.J. Atkinson. (1995). Inactivation
of the bovine spongiform encephalopathy agent by rendering
procedures. Vet. Rec. 137: 605-610.
Taylor, D.M., S.L. Woodgate, A.J. Fleetwood, and R.J.G. Cawthorne.
(1997). The effect of rendering procedures on scrapie agent. Vet.
Rec. 141: 643-649.
Taylor, D.M. and S.L. Woodgate. (2003). Rendering practices and
inactivation of transmissible spongiform encephalopathy agents. Rev.
sci. tech. Off. int. Epiz. 2003. 22(1): 297-310.
Wells, G.A.H., M. Dawson, S.A.C. Hawkins, R.B. Green, I. Dexter,
M.E. Francis, M.M. Simmons, A.R. Austin, and M.W. Horigan. (1994).
Infectivity in the ileum of cattle challenged orally with bovine
spongiform encephalopathy. Vet. Rec. 135(2): 40-41.
Wells, G.A.H., M. Dawson, S.A.C. Hawkins, A.R. Austin, R.B. Green,
I. Dexter, M.W. Horigan, and M.M. Simmons. (1996). Preliminary
observations on the pathogenesis of experimental bovine spongiform
encephalopathy. In: Bovine spongiform encephalopathy: the BSE
dilemma (Gibbs C.J. Jr., ed.). Springer-Verlag, New York.
Wells, G.A.H., S.A.C. Hawkins, R.B. Green, A.R. Austin, I. Dexter,
Y.I. Spencer, M.J. Chaplin, M.J. Stack, and M. Dawson. (1998).
Preliminary observations on the pathogenesis of experimental bovine
spongiform encephalopathy (BSE): an update. Vet. Rec. 142: 103-106.
Wells, G.A.H., S.A.C. Hawkins, R.B. Green, Y.I. Spencer, I. Dexter,
and M. Dawson. (1999). Limited detection of sternal bone marrow
infectivity in the clinical phase of experimental bovine spongiform
encephalopathy (BSE). Vet. Rec. 144: 292-294.
Wells, G.A.H., J. Spiropoulos, S.A.C. Hawkins, and S.J. Ryder.
(2005). Pathogenesis of experimental bovine spongiform
encephalopathy: preclinical infectivity in tonsil and observations
on the distribution of lingual tonsil in slaughtered cattle. Vet
Rec. Mar 26;156 (13):401-7. (http://www.ncbi.nlm.nih.gov/pubmed/15816193?ordinalpos= 7&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_
ResultsPanel.Pubmed--RVDocSum)
Wells, G.A.H., T. Konold, M.E. Arnold, A.R. Austin, S.A.C. Hawkins,
M. Stack, M.M. Simmons, Y.H. Lee, D. Gavier-Wid[eacute]n, M. Dawson,
and J.W. Wilesmith. (2007). Bovine spongiform encephalopathy: the
effect of oral exposure dose on attack rate and incubation period in
cattle. J. Gen. Virol. 88: 1363-1373.
Wells, G.A.H. (2008). Personal communication with APHIS. Email.
January 30.
Wilesmith, J.W., G.A.H. Wells, M.P. Cranwell, and J.B.M. Ryan.
(1988). Bovine spongiform encephalopathy epidemiological studies.
Vet. Rec. 123: 638-644.
Wilesmith, J.W., J.B.M. Ryan, and M.J. Atkinson. (1991). Bovine
spongiform encephalopathy: epidemiological studies of the origin.
Vet. Rec. 128: 199-203.
Wilesmith, J.W., J.B.M. Ryan, and W.D. Hueston. (1992). Bovine
spongiform encephalopathy: case-control studies of calf feeding
practices and meat-and-bone meal inclusion in proprietary
concentrates. Res. Vet. Sci. 52: 325-331.
World Health Organization (WHO). (2002). WHO Guidelines on Tissue
Infectivity Distribution in Transmissible Spongiform
Encephalopathies, World Health Organization (WHO). (www.who.int/mediacentre/factsheets/fs113/en)
World Organization for Animal Health Terrestrial Animal Health
Standards Commission (OIE TAHSC). (2006). Supporting document for
Chapter 2.3.13 of the Terrestrial Animal Health Code on Bovine
Spongiform Encephalopathy. Terrestrial Animal Health Standards
Commission Report. October. (http://www.aata-animaltransport.org/Publications/issues/4-GS75TAHSCBSEsupportdocOct2006.doc)
World Organization for Animal Health (OIE). (2010). Annual incidence
rate of bovine spongiform encephalopathy (BSE) in OIE Member
Countries that have reported cases, excluding the United Kingdom.

[[Page 15899]]

(http://www.oie.int/eng/info/en_esbincidence.htm)
Wrathall, A.K. Brown, A. Sayers, G.A.H. Wells, M. Simmons, S.
Farrelly, P. Bellerby, J. Squirrell, Y. Spencer, M. Wells, M. Stack,
B. Bastiman, D. Pullar, J. Scatcherd, L. Heasman, J. Parker, D.A.R.
Hannam, D. Helliwell, A. Chree, and H. Fraser. (2002). Studies of
embryo transfer from cattle clinically affected by bovine spongiform
encephalopathy (BSE). Vet Rec. 150(12): 365-378.

List of Subjects

9 CFR Part 92

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

9 CFR Part 93

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

9 CFR Part 94

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

9 CFR Part 95

Animal feeds, Hay, Imports, Livestock, Reporting and recordkeeping
requirements, Straw, Transportation.

9 CFR Part 96

Imports, Livestock, Reporting and recordkeeping requirements.

9 CFR Part 98

Animal diseases, Imports.

Accordingly, we are proposing to amend 9 CFR parts 92, 93, 94, 95,
96, and 98 as follows:

PART 92--IMPORTATION OF ANIMALS AND ANIMAL PRODUCTS: PROCEDURES FOR
REQUESTING RECOGNITION OF REGIONS

1. The authority citation for part 92 continues to read as follows:

Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a;
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

2. In Sec. 92.1, definitions of approved laboratory, bovine,
exporting region, OIE, OIE Code, OIE Terrestrial Manual, processed
animal protein, region of controlled risk for BSE, region of negligible
risk for BSE, region of undetermined risk for BSE, specified risk
materials (SRMs) from regions of controlled risk for BSE, and specified
risk materials (SRMs) from regions of undetermined risk for BSE are
added, in alphabetical order, to read as follows:

Sec. 92.1 Definitions.

* * * * *
Approved laboratory. A properly equipped institution in the
exporting region, approved by the official authority who is responsible
for animal health matters in that region, that is staffed by
technically competent personnel under the control of a specialist in
veterinary diagnostic methods who is responsible for the results.
* * * * *
Bovine. Bos taurus, Bos indicus, and Bison bison.
* * * * *
Exporting region. A region from which shipments are sent to the
United States.
* * * * *
OIE. The World Organization for Animal Health.
OIE Code. The Terrestrial Animal Health Code of the World
Organization for Animal Health.
OIE Terrestrial Manual. The Manual of Diagnostic Tests and Vaccines
for Terrestrial Animals of the World Organization for Animal Health.
* * * * *
Processed animal protein. Meat meal, bone meal, meat-and-bone meal,
blood meal, dried plasma and other blood products, hydrolyzed protein,
hoof meal, horn meal, poultry meal, feather meal, fish meal, and any
other similar products.
* * * * *
Region of controlled risk for bovine spongiform encephalopathy
(BSE).\1\ A region for which a risk assessment has been conducted
sufficient to identify the historical and existing BSE risk factors in
the region and that:
---------------------------------------------------------------------------

\1\ A list of regions classified by APHIS as regions of
controlled risk for BSE is available at [ADDRESS TO BE ADDED IN
FINAL RULE]
---------------------------------------------------------------------------

(1) Has demonstrated that appropriate mitigations are being taken
to manage all identified risks, but may not have been taken for the
periods of time necessary to be classified as a region of negligible
risk for BSE.
(2) Is a region in which it can be demonstrated through an
appropriate control and audit that neither meat-and-bone meal nor
greaves derived from ruminants has been fed to ruminants.
(3) Has demonstrated that Type A surveillance in accordance with
Article 11.5.22 of the OIE Code, incorporated by reference in Sec.
92.7, or with equivalent guidelines recognized by the Administrator is
in place and the relevant points target, in accordance with Table 1 of
Article 11.5.22 of the OIE Code, or with equivalent guidelines
recognized by the Administrator has been met. Type B surveillance in
accordance with Article 11.5.22 of the OIE Code, or with equivalent
guidelines recognized by the Administrator, is sufficient in place of
Type A surveillance or its equivalent once the relevant points target
for Type A surveillance or its equivalent has been met.
(4) Meets one of the following conditions:
(i) Has had no case of BSE in the region or every case has been
demonstrated to have been imported and has been completely destroyed;
or
(ii) Has had at least one indigenous case, and all bovines
described in either paragraph (4)(ii)(A) or (4)(ii)(B) of this
definition, if still alive, are officially identified with unique
individual identification that is traceable to the premises of origin
of the animal, have their movements controlled, and, when slaughtered
or at death, are completely destroyed:
(A) All bovines that, during their first year of life, were reared
with a bovine determined to be infected with BSE during its first year
of life, and that investigation showed consumed the same feed that
potentially contained SRM material as the infected animal during that
period; or
(B) If the investigation was unable to determine whether the feed
source that was used to feed the bovine known to be infected was also
used to feed other bovines in the herd of the infected animal, all
bovines born in the same herd as a BSE-infected bovine either within 12
months before or 12 months after the birth of the infected animal.
(5) Meets the conditions in one of or both paragraphs (5)(i) or
(5)(ii) of this definition:
(i) Has met the following conditions, but not for at least the past
7 years:
(A) Conducted an ongoing awareness program for veterinarians,
farmers, and workers involved in transportation, marketing, and
slaughter of bovines to encourage reporting of bovines showing clinical
signs that could be indicative of BSE;
(B) Required notification and investigation of all bovines showing
clinical signs consistent with BSE; and
(C) Has carried out the examination, in accordance with
internationally accepted diagnostic tests and procedures and in
approved laboratories, of brain or other tissues collected as part of
the surveillance and monitoring described in paragraphs (2) and
(5)(i)(A) and (5)(i)(B) of this definition; or
(ii) Has prohibited the feeding to ruminants in the region of meat-
and-

[[Page 15900]]

bone meal and greaves derived from ruminants, but it cannot be
demonstrated through an appropriate level of control and audit that the
prohibited materials have not been fed to ruminants in the region for
at least the past 8 years.
Region of negligible risk for bovine spongiform encephalopathy
(BSE).\2\ A region for which a risk assessment has been conducted
sufficient to identify the historical and existing BSE risk factors in
the region and that:
---------------------------------------------------------------------------

\2\ A list of regions classified by APHIS as regions of
negligible risk for BSE is available at [ADDRESS TO BE ADDED IN
FINAL RULE].
---------------------------------------------------------------------------

(1) Has demonstrated that appropriate mitigations to manage all
identified risks have been taken for each relevant period of time to
meet each identified risk, as set forth in this definition.
(2) Has demonstrated that Type B surveillance in accordance with
Article 11.5.22 of the OIE Code, incorporated by reference in Sec.
92.7, or with equivalent guidelines recognized by the Administrator is
in place and the relevant points target, in accordance with Table 1 of
Article 11.5.22 of the OIE Code, or with equivalent guidelines
recognized by the Administrator has been met.
(3) Meets one of the following conditions:
(i) Has had no case of BSE in the region or every case has been
demonstrated to have been imported and has been completely destroyed;
or
(ii) Has had at least one indigenous case, but every indigenous
case was born more than 11 years ago, and all bovines described in
either paragraph (3)(ii)(A) or (3)(ii)(B) of this definition, if still
alive, are officially identified with unique individual identification
that is traceable to the premises of origin of the animal, have their
movements controlled, and, when slaughtered or at death, are completely
destroyed:
(A) All bovines that, during their first year of life, were reared
with a bovine determined to be infected with BSE during its first year
of life, and that investigation showed consumed the same feed that
potentially contained SRM material as the infected animal during that
period; or
(B) If the investigation was unable to determine whether the feed
source that was used to feed the bovine known to be infected was also
used to feed other bovines in the herd of the infected animal, all
bovines born in the same herd as a BSE-infected bovine either within 12
months before or 12 months after the birth of the infected animal.
(4) Has, for at least the past 7 years:
(i) Conducted an ongoing awareness program for veterinarians,
farmers, and workers involved in transportation, marketing, and
slaughter of bovines to encourage reporting of bovines showing clinical
signs that could be indicative of BSE;
(ii) Required notification and investigation of all bovines showing
clinical signs consistent with BSE; and
(iii) Carried out the examination, in accordance with
internationally accepted diagnostic tests and procedures and in
approved laboratories, of brain or other tissues collected as part of
the required surveillance and monitoring described in paragraphs (2)
and (4)(i) and (4)(ii) of this definition.
(5) Has demonstrated through an appropriate level of control and
audit that, for at least the past 8 years, neither meat-and-bone meal
nor greaves derived from ruminants have been fed to ruminants in the
region.
Region of undetermined risk for bovine spongiform encephalopathy
(BSE). Any region that is not classified as either a region of
negligible risk for BSE or a region of controlled risk for BSE.
* * * * *
Specified risk materials (SRMs) from regions of controlled risk for
BSE. Those bovine parts considered to be at particular risk of
containing the BSE agent in infected animals, as listed in the FSIS
regulations at 9 CFR 310.22(a).
Specified risk materials (SRMs) from regions of undetermined risk
for BSE. Those bovine parts considered to be at particular risk of
containing the BSE agent in infected animals, as listed in the FSIS
regulations at 9 CFR 310.22(a), except that the following bovine parts
from regions of undetermined risk for BSE are considered SRMs if they
are derived from bovines over 12 months of age: Brain, skull, eyes,
trigeminal ganglia, spinal cord, vertebral column (excluding the
vertebrae of the tail, the transverse processes of the thoracic and
lumbar vertebrae, and the wings of the sacrum), and the dorsal root
ganglia.
* * * * *
3. A subpart heading is added after Sec. 92.1 to read as follows:

Subpart A--Procedures for Requesting Recognition of Regions Other
Than for BSE

4. A new Subpart B--Procedures for Requesting BSE Risk Status
Classification With Regard to Bovines, Sec. Sec. 92.5, 92.6, and 92.7,
is added to read as follows:

Subpart B--Procedures for Requesting BSE Risk Status Classification
With Regard to Bovines

Sec.
92.5 Determination of the BSE risk classification of a region.
92.6 Determination of the date of effective enforcement of a
ruminant-to-ruminant feed ban.
92.7 OIE Code standards for surveillance for BSE.

Subpart B--Procedures for Requesting BSE Risk Status Classification
With Regard to Bovines

Sec. 92.5 Determination of the BSE risk classification of a region.

All countries of the world are considered by APHIS to be in one of
three BSE risk categories--negligible risk, controlled risk, or
undetermined risk. These risk categories are defined in Sec. 92.1 of
this part. Any region that is not classified by APHIS as presenting
either negligible risk or controlled risk for BSE is considered to
present an undetermined risk. The listing of those regions classified
by APHIS as having either negligible risk or controlled risk can be
accessed on the APHIS Web site at [ADDRESS TO BE ADDED IN FINAL RULE].
The listing can also be obtained by writing to APHIS at [ADDRESS TO BE
ADDED IN FINAL RULE]. APHIS may classify a region for BSE according to
either paragraph (a) or paragraph (b) of this section.
(a) BSE risk classification based on OIE classification. If the OIE
has classified a country as either BSE negligible risk or BSE
controlled risk, APHIS will seek information to support concurrence
with the OIE classification. This information could be publicly
available information, or APHIS could request that countries supply the
same information given to the OIE. APHIS will announce in the Federal
Register, subject to public comment, each intent to concur with an OIE
classification. APHIS will also post the summary of the BSE OIE ad hoc
group conclusions for review during the comment period. The summaries
would be available for review on the APHIS Web site at [ADDRESS TO BE
ADDED IN FINAL RULE]. Following review of any comments received, the
Administrator will announce his or her final determination regarding
classification of the country in the Federal Register, along with a
discussion of and response to pertinent issues raised by commenters. If
APHIS recognizes a country as either negligible risk or controlled risk
for BSE, the Agency will include that country in a list of regions of
negligible risk or controlled risk for

[[Page 15901]]

BSE, as applicable, that APHIS will make available to the public on the
Agency's Web site at [ADDRESS TO BE ADDED IN FINAL RULE].
(b) Regions seeking classification as negligible or controlled risk
that have not been classified by the OIE. A region that has not
received classification by OIE as either negligible risk or controlled
risk for BSE and that wishes to be classified by APHIS as negligible
risk or controlled risk must submit to the Administrator a request for
such classification, along with documentation sufficient to allow APHIS
to conduct an evaluation of whether the region meets the criteria for
the classification. A list of the documentation required can be
accessed on the APHIS Web site at [ADDRESS TO BE ADDED IN FINAL RULE].
If, following evaluation of the information submitted, the
Administrator determines that the region meets the criteria for
classification as negligible risk or controlled risk, APHIS will
announce that determination in the Federal Register and will make
available to the public on the APHIS Web site the evaluation conducted
by APHIS, as well as the information provided by the requesting region.
APHIS will accept public comment on its intent. Following review of any
comments received, the Administrator will announce his or her final
determination regarding classification of the region in the Federal
Register, along with a discussion of and response to pertinent issues
raised by commenters.
(d) Retention of classification as either negligible risk or
controlled risk. (1) As required by the OIE for countries classified as
either negligible risk or controlled risk by the OIE, regions evaluated
by APHIS and classified as negligible or controlled risk would need to
submit updated information to APHIS each year. The required information
includes documentation of the following:
(i) Relevant changes in BSE legislation, compared to the previous
year;
(ii) The importation into the region during the year of cattle,
processed animal protein, and products containing processed animal
protein.
(iii) Audit findings in rendering plants and feed mills that
process ruminant material or material from mixed species that contains
ruminant material, related to the prohibition of the feeding to
ruminants of processed animal protein derived from ruminants;
(iv) Audit findings in rendering plants and feed mills that process
nonruminant material, related to the prohibition of the feeding to
ruminants of processed animal protein;
(v) Infractions at the types of facilities listed above;
(vi) If and why, in light of the audit findings, there has been no
significant exposure of cattle to the BSE agent through consumption of
processed animal protein of bovine origin;
(vii) Surveillance efforts;
(viii) All clinical BSE suspects;
(ix) Any new cases of BSE.
(2) If APHIS at any time determines that a region no longer meets
the criteria for the risk classification it had previously received,
APHIS will remove the region from its list of regions so classified. If
the OIE determines the region no longer meets the criteria for the risk
classification it had previously received, APHIS may concur with the
OIE determination or may request updated information from the region
and determine whether to concur with the OIE decision. APHIS will
announce its intent in the Federal Register and accept public comment
regarding that intent. Following review of any comments received, the
Administrator will announce in the Federal Register his or her final
determination regarding classification of the region, along with a
discussion of and response to pertinent issues raised by commenters.

Sec. 92.6 Determination of the date of effective enforcement of a
ruminant-to-ruminant feed ban.

(a) In order for APHIS to determine the eligibility of live bovines
for importation from a region classified as BSE negligible risk or BSE
controlled risk, APHIS must determine the date from which a ban on the
feeding of ruminant material to ruminants has been effectively enforced
in the region. APHIS will base its determination of the date of
effective enforcement on the information included in the dossier the
region submitted when it requested to be classified regarding BSE risk.
The information APHIS will consider will include, but not be limited
to:
(1) Policies and infrastructure for feed ban enforcement, including
an awareness program for producers and farmers;
(2) Livestock husbandry practices;
(3) Disposition of processed animal protein produced from domestic
bovines, including the feeding of such material to any animal species;
(4) Measures taken to control cross-contamination and mislabeling
of feed; and
(5) Monitoring and enforcement of the ruminant-to-ruminant feed
ban, including audit findings in rendering plants and feed mills that
process ruminant material.
(b) After conducting its evaluation, APHIS will announce in the
Federal Register for public comment the date APHIS considers to be the
date of effective enforcement of a ruminant-to-ruminant feed ban in the
requesting region, and will make available to the public the evaluation
conducted by APHIS, as well as the supporting documentation. Following
review of any comments received, the Administrator will announce his or
her final determination in the Federal Register, along with a
discussion of and response to pertinent issues raised by commenters.

Sec. 92.7 OIE Code standards for surveillance for BSE.

Article 11.6.22 of the OIE Code, effective 2009, are incorporated
by reference. This incorporation by reference was approved by the
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. The OIE maintains a copy of these standards on its
Internet homepage at http://www.oie.int/eng/normes/Mcode/en_sommaire.htm. Copies are available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, FISH, AND POULTRY,
AND CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR
MEANS OF CONVEYANCE AND SHIPPING CONTAINERS

5. The authority citation for part 93 continues to read as follows:

Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a;
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

6. Section 93.400 is amended by revising the definition of
recognized slaughtering establishment and adding definitions of
exporting region and processed animal protein, in alphabetical order,
to read as follows:

Sec. 93.400 Definitions.

* * * * *
Exporting region. A region from which shipments are sent to the
United States.
* * * * *
Processed animal protein. Meat meal, bone meal, meat-and-bone meal,
blood meal, dried plasma and other blood products, hydrolyzed protein,
hoof meal, horn meal, poultry meal, feather

[[Page 15902]]

meal, fish meal, and any other similar products.
* * * * *
Recognized slaughtering establishment. Any slaughtering
establishment operating under the provisions of the Federal Meat
Inspection Act (21 U.S.C. 601 et seq.) or a State meat inspection
act.\2\
---------------------------------------------------------------------------

\2\ See footnote 1.
---------------------------------------------------------------------------

* * * * *

Sec. 93.401 [Amended]

7. In Sec. 93.401, paragraph (a), the second sentence is amended
by adding the word ``non-bovine'' before the word ``ruminant'' and by
removing the citation ``Sec. 94.18(a)(1) or (a)(2)'' and adding the
citation ``Sec. 94.24(a)'' in its place.

Sec. 93.405 [Amended]

8. In Sec. 93.405, paragraph (a)(4) is amended by removing the
words ``bovines, sheep, or goats from regions listed as BSE minimal-
risk regions in 94.18(a)(3) of this subchapter'' and adding the words
``sheep or goats from Canada'' in their place and by removing the words
``and Sec. 93.436(a)(3) and (b)(4)''.
9. In Sec. 93.418, the section heading is revised and a new
paragraph (d) is added to read as follows:

Sec. 93.418 Cattle and other bovines from Canada.

* * * * *
(d) In addition to meeting the requirements of paragraphs (a)
through (c) of this section, bovines may be imported from Canada only
under the following conditions:
(1) The bovines are imported for immediate slaughter under Sec.
93.420; or
(2) The bovines are imported for other than immediate slaughter
under the following conditions:
(i) The bovines were born after March 1, 1999, the date determined
by APHIS to be the date of effective enforcement of a ruminant-to-
ruminant feed ban in Canada;
(ii) The bovines are imported only through a port of entry listed
in Sec. 93.403(b) or as provided for in 93.403(f);
(iii) The bovines were officially identified prior to arriving at
the port of entry in the United States with unique individual
identification that is traceable to each bovine's premises of origin.
No person may alter, deface, remove, or otherwise tamper with the
official identification while the animal is in the United States or
moving into or through the United States, except that the
identification may be removed at slaughter; and
(iv) The bovines are permanently and humanely identified using one
of the following additional methods:
(A) A ``C[caret]N'' mark properly applied with a freeze brand, hot
iron, or other method, and easily visible on the live animal and on the
carcass before skinning. Such a mark must be not less than 2 inches nor
more than 3 inches high, and must be applied to each animal's right
hip, high on the tail-head (over the junction of the sacral and first
coccygeal vertebrae); or
(B) A tattoo with the letters ``CAN'' applied to the inside of one
ear of the animal; or
(C) Other means of permanent identification upon request if deemed
adequate by the Administrator to humanely identify the animal in a
distinct and legible way as having been imported from Canada.
(3) The bovines are accompanied by a certificate issued in
accordance with Sec. 93.405 that states, in addition to the statements
required by Sec. 93.405, that the conditions of paragraph (d)(2) of
this section, as applicable, have been met.
10. Section Sec. 93.420 is revised to read as follows:

Sec. 93.420 Ruminants from Canada for immediate slaughter other than
sheep and goats.

(a) General requirements. The requirements for the importation of
sheep and goats from Canada for immediate slaughter are contained in
Sec. 93.419. There are no BSE-related restrictions on the importation
of cervids or camelids from Canada. All other ruminants imported from
Canada for immediate slaughter, in addition to meeting all other
applicable requirements of this part, may be imported only under the
following conditions:
(1) The ruminants 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 be
inspected at the port of entry and otherwise handled in accordance with
Sec. 93.408.
(2) The ruminants must be moved directly from the port of entry to
a recognized slaughtering establishment in conveyances that are sealed
with seals of the U.S. Government at the port of entry. The seals may
be broken only at the recognized slaughtering establishment by an
authorized USDA representative.
(3) The ruminants must be accompanied from the port of entry to the
recognized slaughtering establishment by APHIS Form VS 17-33, which
must include the location of the recognized slaughtering establishment.
(b) Bovines. In addition to meeting the requirements of paragraph
(a) of this section, bovines may be imported from Canada for immediate
slaughter only under the following conditions:
(1) The bovines must have been born after March 1, 1999, the date
determined by APHIS to be the date of effective enforcement of a
ruminant-to-ruminant feed ban in Canada.
(2) Before the animal's arrival at the port of entry into the
United States, each bovine imported into the United States from Canada
must be officially identified with unique individual identification
that is traceable to the premises of origin of the animal. No person
may alter, deface, remove, or otherwise tamper with the official
identification while the animal is in the United States or moving into
or through the United States, except that the identification may be
removed at slaughter;
(3) The bovines must be accompanied by a certificate issued in
accordance with Sec. 93.405 that states, in addition to the statements
required by Sec. 93.405, that the conditions of paragraphs (b)(1) and
(b)(2) of this section have been met.
11. In Sec. 93.423, a new paragraph (e) is added to read as
follows:

Sec. 93.423 Ruminants from Central America and the West Indies.

* * * * *
(e) In addition to meeting all other applicable requirements of
this part, bovines from Central America and the West Indies may be
imported only in accordance with Sec. 93.436.
* * * * *
12. In Sec. 93.427, the section heading is revised and a new
paragraph (e) is added to read as follows:

Sec. 93.427 Cattle and other bovines from Mexico.

* * * * *
(e) BSE. In addition to meeting the requirements of paragraphs (a)
through (d) of this section and all other applicable requirements of
this part, bovines may be imported from Mexico only under the following
conditions:
(1) The bovines were born after November 30, 2007, the date
determined by APHIS to be the date of effective enforcement of a
ruminant-to-ruminant feed ban in Mexico.
(2) The bovines were officially identified prior to arriving at the
port of entry in the United States with unique individual
identification that is traceable to each bovine's premises of origin.
No person may alter, deface, remove, or otherwise tamper with the
official identification while the animal is in the United States or
moving into

[[Page 15903]]

or through the United States, except that the identification may be
removed at slaughter.
(3) The bovines, if sexually intact, are permanently and humanely
identified using one of the following additional methods:
(i) An ``MX'' mark properly applied with a freeze brand, hot iron,
or other method, and easily visible on the live animal and on the
carcass before skinning. Such a mark must be not less than 2 inches nor
more than 3 inches high, and must be applied to each animal's right
hip, high on the tail-head (over the junction of the sacral and first
coccygeal vertebrae); or
(ii) A tattoo with the letters ``MX'' applied to the inside of one
ear of the animal; or
(iii) Other means of permanent identification upon request if
deemed adequate by the Administrator to humanely identify the animal in
a distinct and legible way as having been imported from Mexico.
(4) The bovines are accompanied by a certificate issued in
accordance with Sec. 93.405 that states, in addition to the statements
required by Sec. 93.405, that the conditions of paragraph (e)(1)
through (e)(3) of this section have been met.
13. In Sec. 93.432, the section heading is revised and a new
paragraph (e) is added to read as follows:

Sec. 93.432 Cattle and other bovines from the Republic of Ireland.

* * * * *
(e) In addition to meeting all other applicable requirements of
this part, bovines from the Republic of Ireland may be imported only in
accordance with Sec. 93.436.
14. Section Sec. 93.436 is revised to read as follows:

Sec. 93.436 Bovines from regions of negligible risk, controlled risk,
and undetermined risk for BSE.

The importation of bovines is prohibited, unless the conditions of
this section and any other applicable conditions of this part are met.
Once the bovines are imported, if they do not meet the conditions of
this section, they must be disposed of as the Administrator may direct.
(a) Bovines from a region of negligible risk for BSE in which there
has been no indigenous case of BSE. Bovines from a region of negligible
risk for BSE, as defined in Sec. 92.1 of this subchapter, in which
there has been no indigenous case of BSE, may be imported only if the
bovines are accompanied by an original certificate issued by a full-
time salaried veterinary officer of the national government of the
exporting region, or issued by a veterinarian designated or accredited
by the national government of the exporting region and endorsed by a
full-time salaried veterinary officer of the national government of the
exporting region, representing that the veterinarian issuing the
certificate was authorized to do so, and the certificate attests that
the exporting region of the bovines is classified by APHIS as a
negligible-risk region for BSE in which there has been no indigenous
case of BSE.
(b) Bovines from a region of negligible risk for BSE in which there
has been an indigenous case of BSE and bovines from a region of
controlled risk for BSE. Bovines from a region of negligible risk for
BSE, as defined in Sec. 92.1 of this subchapter, in which there has
been an indigenous case of BSE, and bovines from a region of controlled
risk for BSE, as defined in Sec. 92.1 of this chapter, may be imported
only under the following conditions:
(1) Prior to importation into the United States, each bovine is
officially identified with unique individual identification that is
traceable to the premises of origin of the animal. No person may alter,
deface, remove, or otherwise tamper with the official identification
while the animal is in the United States or moving into or through the
United States, except that the identification may be removed at
slaughter.
(2) The bovines are permanently and humanely identified before
arrival at the port of entry with a distinct and legible mark
identifying the exporting country. Acceptable means of permanent
identification include the following:
(i) A mark properly applied with a freeze brand, hot iron, or other
method, and easily visible on the live animal and on the carcass before
skinning. Such a mark must be not less than 2 inches nor more than 3
inches high, and must be applied to each animal's right hip, high on
the tail-head (over the junction of the sacral and first cocygeal
vertebrae);
(ii) A tattoo with letters identifying the exporting country must
be applied to the inside of one ear of the animal;
(iii) Other means of permanent identification upon request if
deemed adequate by the Administrator to humanely identify the animal in
a distinct and legible way as having been imported from the BSE
minimal-risk exporting region.
(3) The bovines were born after the date from which the ban on the
feeding of ruminants meat-and-bone meal or greaves derived from
ruminants has been effectively enforced.
(4) The bovines are accompanied by an original certificate issued
by a full-time salaried veterinary officer of the national government
of the exporting region, or issued by a veterinarian designated or
accredited by the national government of the exporting region and
endorsed by a full-time salaried veterinary officer of the national
government of the exporting region, representing that the veterinarian
issuing the certificate was authorized to do so, and the certificate
attests to the BSE risk classification of the exporting region and that
the conditions of paragraphs (b)(1) through (b)(3) of this section have
been met.
(5) If there has been an indigenous case of BSE in the exporting
region, the following restrictions apply:
(i) Bovines that, during their first year of life, were reared with
a bovine determined to be infected with BSE during its first year of
life, and that an investigation showed consumed the same feed that
potentially contained SRM material as the infected animal during that
period are not eligible for importation into the United States; and
(ii) If the investigation was unable to determine whether the feed
source that was used to feed the bovine known to be infected was also
used to feed other bovines in the herd of the infected animal, all
bovines born in the same herd as a BSE-infected bovine either within 12
months before or 12 months after the birth of the infected animal are
not eligible for importation into the United States.
(c) Bovines from a region of undetermined risk for BSE. Importation
of bovines from a region of undetermined risk for BSE, as defined in
Sec. 92.1 of this subchapter, is prohibited; Except that: The
Administrator may allow such imports on a case-by-case basis if the
live bovines are imported for specific uses, including, but not limited
to, show or exhibition, and under conditions determined by the
Administrator to be adequate to prevent the spread of BSE.

PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, EXOTIC NEWCASTLE
DISEASE, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, SWINE
VESICULAR DISEASE, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED
AND RESTRICTED IMPORTATIONS

15. The authority citation for part 94 continues to read as
follows:

Authority: 7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317;
21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

16. Section 94.0 is amended by removing the definitions of cervid
and

[[Page 15904]]

specified risk materials (SRMs) and adding definitions of exporting
region, mechanically separated meat, processed animal protein,
specified risk materials (SRMs) from regions of controlled risk for
BSE, and specified risk materials (SRMs) from regions of undetermined
risk for BSE, in alphabetical order, to read as follows:

Sec. 94.0 Definitions.

* * * * *
Exporting region. A region from which shipments are sent to the
United States.
* * * * *
Mechanically separated meat. A finely comminuted product resulting
from the mechanical separation and removal of most of the bone from
attached skeletal muscle of bovine carcasses that meets the FSIS
specifications contained in 9 CFR 319.5.
* * * * *
Processed animal protein. Meat meal, bone meal, meat-and-bone meal,
blood meal, dried plasma and other blood products, hydrolyzed protein,
hoof meal, horn meal, poultry meal, feather meal, fish meal, and any
other similar products.[.
* * * * *
Specified risk materials (SRMs) from regions of controlled risk for
BSE. Those bovine parts considered to be at particular risk of
containing the BSE agent in infected animals, as listed in the FSIS
regulations at 9 CFR 310.22(a).
Specified risk materials (SRMs) from regions of undetermined risk
for BSE. Those bovine parts considered to be at particular risk of
containing the BSE agent in infected animals, as listed in the FSIS
regulations at 9 CFR 310.22(a), except that the following bovine parts
from regions of undetermined risk for BSE are considered SRMs if they
are derived from bovines over 12 months of age: Brain, skull, eyes,
trigeminal ganglia, spinal cord, vertebral column (excluding the
vertebrae of the tail, the transverse processes of the thoracic and
lumbar vertebrae, and the wings of the sacrum), and the dorsal root
ganglia.
* * * * *

Sec. 94.1 [Amended]

17. In Sec. 94.1, paragraphs (b)(4) and (d) are amended by
removing the citation ``Sec. 94.22'' both times it appears and adding
the citation ``Sec. 94.28'' in their place.

Sec. 94.9 [Amended]

18. In Sec. 94.9, paragraph (c) is amended by removing the
citation ``Sec. 94.24'' and adding the citation ``Sec. 94.30'' in its
place.

Sec. 94.10 [Amended]

19. In Sec. 94.10, paragraph (c) is amended by removing the
citation ``Sec. 94.24'' and adding the citation ``Sec. 94.30'' in its
place.
20. Section 94.18 is revised to read as follows:

Sec. 94.18 Bovine spongiform encephalopathy; importation of edible
products derived from bovines.

(a) The importation of meat, meat products, and other edible
products derived from bovines is prohibited with regard to BSE, except
as provided in this section and in Sec. Sec. 94.19, 94.20, 94.21,
94.22, 94.23, and 94.27.
(b) The following commodities derived from bovines may be imported
into the United States without restriction regarding BSE, provided that
all other applicable requirements of this part are met:
(1) Milk and milk products;
(2) Boneless skeletal muscle meat (excluding mechanically separated
meat) that:
(i) Is derived from bovines that were not, prior to slaughter,
subjected to a pithing process or to stunning with a device injecting
compressed air or gas into the cranial cavity, and that passed ante-
mortem and post-mortem inspection;
(ii) Has been prepared in a manner to prevent contamination with
SRMs; and
(iii) Is accompanied to the United States by an original
certificate stating that the conditions of paragraphs (b)(2)(i) and
(b)(2)(ii) of this section have been met. The certificate must be
issued by a full-time salaried veterinary officer of the national
government of the exporting region, or issued by a veterinarian
designated by the national government of the exporting region and
endorsed by a full-time salaried veterinary officer of the exporting
region, representing that the veterinarian issuing the certificate was
authorized to do so.
21. Section 94.19 is revised to read as follows:

Sec. 94.19 Importation of meat, meat byproducts, and meat food
products derived from bovines from regions of negligible risk for BSE.

Meat, meat byproducts, and meat food products, as defined by FSIS
in 9 CFR 301.2--except that those terms as applied to bison shall have
a meaning comparable to those provided in 9 CFR 301.2 with regard to
cattle, and other than boneless skeletal meat that meets the conditions
of Sec. 94.18(b)(2)--may be imported from a region of negligible risk
for BSE, as defined in Sec. 92.1 of this subchapter, if the following
conditions and all other applicable requirements of this part are met:
(a) The commodities were derived from bovines that were born and
raised in a region of negligible risk for BSE.
(b) If BSE has been diagnosed in one or more indigenous bovines in
the region of negligible risk, the commodities were derived from
bovines subject to a ban on the feeding to ruminants of meat-and-bone
meal or greaves derived from ruminants.
(c) The commodities were derived from bovines that passed ante-
mortem and post-mortem inspections.
(d) The commodities are accompanied by an original certificate
stating that the exporting region is classified by APHIS as a region of
negligible risk for BSE and that the conditions of paragraphs (a)
through (c) of this section, as applicable, have been met. The
certificate must be issued by a full-time salaried veterinary officer
of the national government of the exporting region, or issued by a
veterinarian designated by the national government of the exporting
region and endorsed by a full-time salaried veterinary officer of the
exporting region, representing that the veterinarian issuing the
certificate was authorized to do so.

Note: To be eligible to export meat, meat byproducts, and meat
food products under the conditions of this section for human
consumption, a region must also be one that has demonstrated to FSIS
in accordance with 9 CFR 310.22 that its BSE risk status can
reasonably be expected to provide the same level of protection from
human exposure to the BSE agent as does prohibiting specified risk
materials for use as human food in the United States.

22. Section 94.20 is revised to read as follows:

Sec. 94.20 Importation of meat, meat byproducts, and meat food
products derived from bovines from regions of controlled risk for BSE.

[[Page 15905]]

(b) The commodities were derived from bovines that passed ante-
mortem and post-mortem inspections.
(c) The commodities were derived from bovines that were not
subjected to a stunning process, prior to slaughter, with a device
injecting compressed air or gas into the cranial cavity, or to a
pithing process.
(d) The commodities were produced and handled in a manner that
ensured that such commodities do not contain and are not contaminated
with either of the following:
(1) SRMs from regions of controlled risk for BSE; or
(2) Mechanically separated meat from the skull and vertebral column
from bovines 30 months of age or older.
(e) The commodities are accompanied by an original certificate
stating that the exporting region is classified by APHIS as a region of
controlled risk for BSE, and that the conditions of this section have
been met. The certificate must be issued by a full-time salaried
veterinary officer of the national government of the exporting region,
or issued by a veterinarian designated by the national government of
the exporting region and endorsed by a full-time salaried veterinary
officer of the exporting region, representing that the veterinarian
issuing the certificate was authorized to do so.
23. A new Sec. 94.21 is added to read as follows:

Sec. 94.21 Importation of meat, meat byproducts, and meat food
products derived from bovines from regions of undetermined risk for
BSE.

Meat, meat byproducts, and meat food products, as defined by FSIS
in 9 CFR 301.2--except that those terms as applied to bison shall have
a meaning comparable to those provided in 9 CFR 301.2 with regard to
cattle, and other than boneless skeletal meat that meets the conditions
of Sec. 94.18(b)(2)--may be imported from regions of undetermined risk
for BSE, as defined in Sec. 92.1 of this subchapter, if the following
conditions and all other applicable requirements of this part are met:
(a) The commodities were derived from bovines that have never been
fed meat-and-bone meal or greaves derived from ruminants.
(b) The commodities were derived from bovines that passed ante-
mortem and post-mortem inspections.
(c) The commodities were derived from bovines that were not
subjected to a stunning process, prior to slaughter, with a device
injecting compressed air or gas into the cranial cavity, or to a
pithing process.
(d) The commodities were produced and handled in a manner that
ensured that such commodities do not contain and are not contaminated
with any of the following.
(1) SRMs from regions of undetermined risk for BSE; or
(2) Mechanically separated meat from the skull and vertebral column
from bovines over 12 months of age.
(e) The commodities are accompanied by an original certificate
stating that the exporting region is a region of undetermined risk for
BSE and that the conditions of this section have been met. The
certificate must be issued by a full-time salaried veterinary officer
of the national government of the exporting region, or issued by a
veterinarian designated by the national government of the exporting
region and endorsed by a full-time salaried veterinary officer of the
exporting region, representing that the veterinarian issuing the
certificate was authorized to do so.

Sec. 94.27 [Removed]

24. Section 94.27 is removed.

Sec. Sec. 94.22 through 94.26 [Redesignated]

25. Sections 94.22 through 94.26 are redesignated as Sec. Sec.
94.28 through 94.32, respectively.
26. New Sec. Sec. 94.22 through 94.27 are added to read as
follows:

Sec. 94.22 Meat or dressed carcasses of hunter-harvested bovines.

(1) The meat or dressed carcass (eviscerated and the head is
removed) is derived from a wild bovine 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.

Sec. 94.23 Importation of gelatin derived from bovines.

(a) The importation of gelatin derived from bovines is prohibited
because of BSE, unless:
(1) The gelatin meets the requirements of either paragraph (b),
(c), or (d), as well as the requirements of paragraph (e) of this
section and all other applicable requirements of this part; or
(2) The gelatin is authorized importation under paragraph (f) of
this section and meets all other applicable requirements of this part.
(b) The gelatin is derived from hides and skins, provided the
gelatin has not been commingled with materials ineligible for entry
into the United States.
(c) The gelatin is derived from the bones of bovines and originates
in a region of negligible risk for BSE.
(d) The gelatin is derived from the bones of bovines, originates in
a region of controlled risk or undetermined risk for BSE, and meets the
requirements of paragraphs (d)(1) through (d)(4) of this section:
(1) The bones from which the gelatin was derived were derived from
bovines that passed ante-mortem and post-mortem inspection.
(2) The bones from which the gelatin was derived did not include
the skulls of bovines or the vertebral column of bovines 30 months of
age or older.
(3) The bones were subjected to a process that includes all of the
following steps, or to a process at least as effective in reducing BSE
infectivity:
(i) Degreasing;
(ii) Acid demineralization;
(iii) Acid or alkaline treatment;
(iv) Filtration; and
(v) Sterilization at 138 [deg]C (280.4 [deg]F) or greater for a
minimum of 4 seconds; and
(4) The gelatin has not been commingled with materials ineligible
for entry into the United States.
(e) The gelatin is accompanied to the United States by an original
certificate that indicates the BSE risk classification of the exporting
region and that the conditions of this section have been met. The
certificate must be issued by a full-time salaried veterinary officer
of the national government of the exporting region, or issued by a
veterinarian designated by the national government of the exporting
region and endorsed by a full-time salaried veterinary officer of the
exporting region, representing that the veterinarian issuing the
certificate was authorized to do so.
(f) The Administrator determines that the gelatin will not come
into contact with ruminants in the United States and can be imported
under conditions that will prevent the introduction of BSE into the
United States, and the person importing the gelatin has obtained a
United States Veterinary Permit for Importation and Transportation of
Controlled Materials and Organisms and Vectors. To apply for a permit,
file a permit application on VS Form 16-3 (available from APHIS,
Veterinary Services, National Center for Import and Export, 4700 River
Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a
permit must state the intended use of the gelatin and name and address
of the consignee in the United States.

Sec. 94.24 Restrictions on importation of meat and edible products
from ovines and caprines due to bovine spongiform encephalopathy.

(a) Except as provided in paragraph (b) of this section and in
Sec. 94.25, the

[[Page 15906]]

importation of meat, meat products, and edible products other than meat
(excluding milk and milk products) from ovines and caprines that have
been in any of the following regions is prohibited: Albania, Andorra,
Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Canada, Croatia, the
Czech Republic, Denmark, the Federal Republic of Yugoslavia, Finland,
France, Germany, Greece, Hungary, the Republic of Ireland, Israel,
Italy, Japan, Liechtenstein, Luxembourg, the Former Yugoslav Republic
of Macedonia, Monaco, Norway, Oman, the Netherlands, Poland, Portugal,
Romania, San Marino, Slovakia, Slovenia, Spain, Sweden, Switzerland,
and the United Kingdom.
(b) The importation of gelatin derived from ovines or caprines that
have been in any region listed in paragraph (a) of this section is
prohibited unless the following conditions have been met:
(1) The gelatin is imported for use in human food, human
pharmaceutical products, photography, or some other use that will not
result in the gelatin coming in contact with ruminants in the United
States.
(2) The person importing the gelatin obtains a United States
Veterinary Permit for Importation and Transportation of Controlled
Materials and Organisms and Vectors by filing a permit application on
VS Form 16-3. To apply for a permit, file a permit application on VS
Form 16-3 (available from APHIS, Veterinary Services, National Center
for Import and Export, 4700 River Road Unit 38, Riverdale, MD 20737-
1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a permit must state the intended
use of the gelatin and name and address of the consignee in the United
States.

Sec. 94.25 Restrictions on the importation from Canada of meat and
edible products from ovines and caprines other than gelatin.

The commodities listed in paragraphs (a) of this section may be
imported from Canada if the conditions of this section are met.
(a) Meat, carcasses, meat byproducts, and meat food products from
ovines or caprines. (1) The meat, carcass, meat byproduct, or meat food
product, as defined by FSIS in 9 CFR 301.2, is derived from ovines or
caprines that are from a flock or herd subject to a ruminant feed ban
equivalent to the requirements established by the U.S. Food and Drug
Administration at 21 CFR 589.2000, and the ovines or caprines:
(2) Were less than 12 months of age when slaughtered;
(3) Were slaughtered at a facility that either slaughters only
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;
(4) Did not test positive for and were not suspect for a
transmissible spongiform encephalopathy;
(5) Never resided in a flock or herd that has been diagnosed with
BSE; and
(6) Were not subject to any movement restrictions within Canada as
a result of exposure to a transmissible spongiform encephalopathy.
(b) The commodities listed in paragraph (a) of this section are
accompanied by an original certificate of such compliance issued by a
full-time salaried veterinary officer of Canada, or issued by a
veterinarian designated by the Canadian government and endorsed by a
full-time salaried veterinary officer of the government of Canada,
representing that the veterinarian issuing the certificate was
authorized to do so; and if all other applicable requirements of this
part are met.
(c) Meat or dressed carcasses of hunter-harvested ovines or
caprines. (1) The meat or dressed carcass (eviscerated and the head is
removed) is derived from a wild ovine or caprine 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 animal from which the meat is derived was 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, a ruminant feed ban
equivalent to the requirements established by the U.S. Food and Drug
Administration at 21 CFR 589.2000.
(d) 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.

Sec. 94.26 Gelatin derived from horses or swine or from ovines or
caprines that have not been in a region restricted because of BSE.

Gelatin derived from horses or swine or from ovines or caprines
that have not been in any region listed in Sec. 94.24(a) must be
accompanied at the time of importation into the United States by an
official certificate issued by a veterinarian employed by the national
government of the region of origin. The official certificate must state
the species of animal from which the gelatin is derived and, if the
gelatin is derived from ovines or caprines, certify that the gelatin is
not derived from ovines or caprines that have been in any region listed
in Sec. 94.24(a).

Sec. 94.27 Transit shipment of articles

Meat, meat products, and other edible products derived from
bovines, ovines, or caprines that are otherwise prohibited importation
into the United States in accordance with Sec. 94.18 through Sec.
94.26 may transit air and ocean ports in the United States for
immediate export if the conditions of paragraphs (a) through (d) this
section are met. Meat, meat products, and other edible products derived
from bovines, ovines, or caprines are eligible to transit the United
States by overland transportation if the requirements of paragraphs (a)
through (e) of this section are met:
(a) The person moving the articles must obtain a United States
Veterinary Permit for Importation and Transportation of Controlled
Materials and Organisms and Vectors by filing a permit application on
VS Form 16-3. To apply for a permit, file a permit application on VS
Form 16-3 (available from APHIS, Veterinary Services, National Center
for Import and Export, 4700 River Road Unit 38, Riverdale, MD 20737-
1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/).
(b) The articles must be sealed in leakproof containers bearing
serial numbers during transit. Each container must remain sealed during
the entire time that it is in the United States.
(c) The person moving the articles must notify, in writing, the
inspector at both the place in the United States where the articles
will arrive and the port of export before such transit. The
notification must include the:
(i) United States Veterinary Permit for Importation and
Transportation of

[[Page 15907]]

Controlled Materials and Organisms and Vectors permit number;
(ii) Times and dates of arrival in the United States;
(iii) Times and dates of exportation from the United States;
(iv) Mode of transportation; and
(v) Serial numbers of the sealed containers.
(d) The articles must transit the United States in Customs bond.
(e) The commodities must be eligible to enter the United States in
accordance with Sec. Sec. 94.18 through 94.26 and must be accompanied
by the certification required by that section. Additionally, the
following conditions must be met:
(i) The shipment must be exported from the United States within 7
days of its entry;
(ii) The commodities may not be transloaded while in the United
States, except for direct transloading under the supervision of an
authorized inspector, who must break the seals of the national
government of the region of origin on the means of conveyance that
carried the commodities into the United States and seal the means of
conveyance that will carry the commodities out of the United States
with seals of the U.S. Government;
(iii) A copy of the import permit required under paragraph (a) of
this section must be presented to the inspector at the port of arrival
and the port of export in the United States.

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

27. The authority citation for part 95 continues to read as
follows:

Authority: 7 U.S.C. 8301-8317; 21 U.S.C. 136 and 136a; 31
U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

28. Section 95.1 is amended by removing the definition of specified
risk materials (SRMs), and adding definitions of exporting region,
specified risk materials (SRMs) from regions of controlled risk for
BSE, specified risk materials (SRMs) from regions of undetermined risk
for BSE, and tallow derivative in alphabetical order, to read as
follows:

Sec. 95.1 Definitions.

* * * * *
Exporting region. A region from which shipments are sent to the
United States.
* * * * *
Specified risk materials (SRMs) from regions of controlled risk for
BSE. Those bovine parts considered to be at particular risk of
containing the BSE agent in infected animals, as listed in the FSIS
regulations at 9 CFR 310.22(a).
Specified risk materials (SRMs) from regions of undetermined risk
for BSE. Those bovine parts considered to be at particular risk of
containing the BSE agent in infected animals, as listed in the FSIS
regulations at 9 CFR 310.22(a), except that the following bovine parts
from regions of undetermined risk for BSE are considered SRMs if they
are derived from bovines over 12 months of age: Brain, skull, eyes,
trigeminal ganglia, spinal cord, vertebral column (excluding the
vertebrae of the tail, the transverse processes of the thoracic and
lumbar vertebrae, and the wings of the sacrum), and the dorsal root
ganglia.
* * * * *
Tallow derivative. Any chemical obtained through initial
hydrolysis, saponification, or transesterification of tallow; chemical
conversion of material obtained by hydrolysis, saponification, or
transesterification may be applied to obtain the desired product.
* * * * *
29. Section 95.4 is revised to read as follows:

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

(a) Except as provided in paragraphs (c), (d), (e), (f), or (g) of
this section or in Sec. 95.15, any of the materials listed in
paragraph (b) of this section derived from animals, or products
containing such materials, are prohibited importation into the United
States if paragraph (a)(1), (a)(2), or (a)(3) of this section applies:
(1) The animals have been in any region listed in paragraph (a)(4)
of this section;
(2) The materials have been stored, rendered, or otherwise
processed in a region listed in paragraph (a)(4) of this section; or
(3) The materials have otherwise been associated with a facility in
a region listed in paragraph (a)(4) of this section.
(4) Albania, Andorra, Austria, Belgium, Bosnia-Herzegovina,
Bulgaria, Canada, Croatia, the Czech Republic, Denmark, the Federal
Republic of Yugoslavia, Finland, France, Germany, Greece, Hungary, the
Republic of Ireland, Israel, Italy, Japan, Liechtenstein, Luxembourg,
the Former Yugoslav Republic of Macedonia, Monaco, Norway, Oman, the
Netherlands, Poland, Portugal, Romania, San Marino, Slovakia, Slovenia,
Spain, Sweden, Switzerland, and the United Kingdom.
(b) Restricted materials: (1) Processed animal protein, tankage,
offal, and tallow other than tallow derivatives, unless in the opinion
of the Administrator, the tallow cannot be used in feed;
(2) Glands, unprocessed fat tissue, and blood and blood products;
(3) Processed fats and oils, and derivatives of processed animal
protein, tankage, and offal; or
(4) Derivatives of glands and blood and blood products.
(c) The import prohibition in paragraph (a) of this section does
not apply if the following conditions are met prior to importation:
(1) The material is derived from one of the following:
(i) A nonruminant species and the material is not ineligible for
importation under Sec. 95.13 or Sec. 95.14;
(ii) Cervids or camelids;
(iii) Bovines, and the material is not ineligible for importation
under the conditions of Sec. 95.5, Sec. 95.6, Sec. 95.7, Sec. 95.8,
Sec. 95.9, Sec. 95.10, or Sec. 95.12; or
(iv) Ovines or caprines that have never been in any region listed
in paragraph (a)(4) of this section.
(2) In any region other than Canada that is listed in paragraph
(a)(4) of this section, all steps of processing and storing the
material are carried out in a facility that has not been used for the
processing and storage of materials derived from ovines or caprines
that have been in any region that is listed in paragraph (a)(4) of this
section.
(3) In Canada, all steps of processing and storing the material are
carried out in a facility that has not been used for the processing and
storage of materials derived from ovines and caprines that have been in
any region other than Canada that is listed in paragraph (a)(4) of this
section.
(4) The facility demonstrates to APHIS that the materials intended
for exportation to the United States were transported to and from the
facility in a manner that would prevent cross-contamination by or
commingling with prohibited materials.
(5) If the facility processes or handles any material derived from
mammals, inspection of the facility for compliance with the provisions
of this section is conducted at least annually by a representative of
the government agency responsible for animal health in the region,
unless the region chooses to have such inspection conducted by APHIS.
If APHIS conducts the inspections required by this section, the
facility has entered into a cooperative service agreement executed by
the

[[Page 15908]]

operator of the facility and APHIS. In accordance with the cooperative
service agreement, the facility must be current in paying all costs for
a veterinarian of APHIS to inspect the facility (it is anticipated that
such inspections will occur approximately once per year), including
travel, salary, subsistence, administrative overhead, and other
incidental expenses (including excess baggage provisions up to 150
pounds). In addition, the facility must have on deposit with APHIS an
unobligated amount equal to the cost for APHIS personnel to conduct one
inspection. As funds from that amount are obligated, a bill for costs
incurred based on official accounting records will be issued to restore
the deposit to the original level, revised as necessary to allow for
inflation or other changes in estimated costs. To be current, bills
must be paid within 14 days of receipt.
(6) The facility allows periodic APHIS inspection of its
facilities, records, and operations.
(7) 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 exporting
region certifying that the conditions of paragraphs (d)(1) through
(d)(5) of this section have been met.
(8) The person importing the shipment has applied for and obtained
from APHIS a United States Veterinary Permit for Importation and
Transportation of Controlled Materials and Organisms and Vectors by
filing a permit application on VS Form 16-3. (VS Form 16-3 may be
obtained from APHIS, Veterinary Services, National Center for Import
and Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or
electronically at http://www.aphis.usda.gov/animal_health/permits/.)
(d) Except as provided in paragraph (e) of this section and in
Sec. 95.15, serum from ovines or caprines that have been in any region
listed in paragraph (a)(4) of this section is prohibited importation
into the United States, except for scientific, educational, or research
purposes if the Administrator determines that the importation can be
made under conditions that will prevent the introduction of BSE into
the United States. Such serum must be accompanied by a permit issued by
APHIS in accordance with Sec. 104.4 of this chapter and must be moved
and handled as specified on the permit.
(e) The importation of serum albumin, serocolostrum, amniotic
liquids or extracts, and placental liquids derived from ovines or
caprines that have been in any region listed in paragraph (a)(4) of
this section, and collagen and collagen products that are derived from
ovines or caprines and that would otherwise be prohibited under
paragraphs (a) and (b) of this section, is prohibited unless the
following conditions have been met:
(1) The article is imported for use as an ingredient in cosmetics;
(2) The person importing the article has obtained a United States
Veterinary Permit for Importation and Transportation of Controlled
Materials and Organisms and Vectors by filing a permit application on
VS Form 16-3 (VS Form 16-3 may be obtained from APHIS, Veterinary
Services, National Center for Import and Export, 4700 River Road Unit
38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/); and
(3) The permit application states the intended use of the article
and the name and address of the consignee in the United States.
(f) Insulin otherwise prohibited under paragraphs (a) and (b) of
this section may be imported if the insulin is for the personal medical
use of the person importing it and if the person importing the shipment
has applied for and obtained from APHIS a United States Veterinary
Permit for Importation and Transportation of Controlled Materials and
Organisms and Vectors. To apply for a permit, file a permit application
on VS Form 16-3 (available from APHIS, Veterinary Services, National
Center for Import and Export, 4700 River Road Unit 38, Riverdale, MD
20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a permit must state the
intended use of the insulin and the name and address of the consignee
in the United States.
Note to Paragraph (f): Insulin that is not prohibited from
importation under this paragraph may be prohibited from importation
under other Federal laws, including the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. 321 et seq.
(g) Offal that is otherwise prohibited under paragraphs (a) and (b)
of this section because it is derived from ovines or caprines that have
been in a region listed in paragraph (a)(4) of this section may be
imported into the United States if the offal is derived from ovines or
caprines from Canada that have not been in a region listed in paragraph
(a)(4) of this section other than Canada, and the following conditions
are met:
(1) The offal:
(i) Is derived from ovines or caprines that were less than 12
months of age when slaughtered and that are from a flock or herd
subject to a ruminant feed ban equivalent to the requirements
established by the U.S. Food and Drug Administration at 21 CFR
589.2000;
(ii) Is not derived from ovines or caprines that have tested
positive for or are suspect for a transmissible spongiform
encephalopathy;
(iii) Is not derived from animals that have resided in a flock or
herd that has been diagnosed with BSE; and
(iv) Is derived from ovines or caprines whose movement was not
restricted in the BSE minimal-risk region as a result of exposure 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 exporting region, or issued by a
veterinarian designated by the exporting region and endorsed by a full-
time salaried veterinary officer of the national government of the
exporting region, 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. 94.25(d) of this subchapter.

Sec. Sec. 95.5 through 95.30 [Redesignated]

30. Sections 95.5 through 95.30 are redesignated as Sec. Sec.
95.16 through 95.41, respectively,
31. Sections 95.5 through 95.15 are added to read as follows:

Sec. 95.5 Processed animal protein derived from ruminants.

The importation of ruminant-derived processed animal protein, or
any commodities containing such products, is prohibited unless the
conditions of paragraph (a) and (b) of this section are met:
(a) The exporting region is a region of negligible risk for BSE, or
the product is derived from ruminants born and raised in a region of
negligible risk for BSE, or it has been demonstrated that the product
has not been commingled or contaminated with ruminant meat-and-bone
meal or greaves. Additionally, if either paragraph (a)(1) or (a)(2) of
this section applies, the product must be derived from ruminants that
were subject to a ban on the feeding of ruminants with meat-and-bone
meal or greaves derived from ruminants:
(1) The product is exported to the United States from a region of
negligible risk for BSE in which there has been at least one indigenous
case of BSE; or
(2) The product is derived from ruminants that were born or raised
in a region of negligible risk for BSE in

[[Page 15909]]

which there has been at least one indigenous case of BSE.
(b) 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 exporting region, or issued by a
veterinarian designated by the national government of the exporting
region and endorsed by a full-time salaried veterinary officer of the
national government of the exporting region, representing that the
veterinarian issuing the certificate was authorized to do so. The
certificate must state that the exporting region is a region of
negligible risk for BSE and that the requirements of paragraph (a) of
this section, as applicable, have been met.

Sec. 95.6 Offal derived from bovines.

Offal derived from bovines is prohibited importation into the
United States unless it meets the requirements for the importation of
meat, meat products, and meat byproducts in either Sec. 94.19, Sec.
94.20, or Sec. 94.21, with the exception of the requirements in Sec.
94.19(c), Sec. 94.20(b), and Sec. 94.21(b), respectively.

Sec. 95.7 Collagen derived from bovines.

(a) The importation of collagen derived from bovines is prohibited
because of BSE unless:
(1) The collagen meets the requirements of either paragraph (b),
(c), or (d), as well as the requirements of paragraph (e) of this
section and all other applicable requirements of this part; or
(2) The collagen is authorized importation under (f) of this
section and meets all other applicable requirements of this part:
(b) The collagen is derived from hides and skins, provided the
collagen has not been commingled with materials ineligible for entry
into the United States.
(c) The collagen is derived from the bones of bovines that
originated from a region of negligible risk for BSE.
(d) The collagen is derived from the bones of bovines that
originated from a region of controlled or undetermined risk for BSE and
meets the requirements of paragraphs (d)(1) through (d)(4) of this
section:
(1) The bones from which the collagen was derived were derived from
bovines that passed ante-mortem and post-mortem inspection;
(2) The bones from which the collagen was derived did not include
the skulls of bovines or the vertebral column of bovines 30 months of
age or older;
(3) The bones were subjected to a process that includes all of the
following steps, or to a process at least as effective in reducing BSE
infectivity:
(i) Degreasing;
(ii) Acid demineralization;
(iii) Acid or alkaline treatment;
(iv) Filtration; and
(v) Sterilization at 138 [deg]C (280.4 [deg]F) or greater for a
minimum of 4 seconds; and
(4) The collagen has not been commingled with materials ineligible
for entry into the United States.
(e) The collagen is accompanied to the United States by an original
certificate that indicates the BSE risk classification of the exporting
region and that the conditions of this section have been met. The
certificate must be issued by a full-time salaried veterinary officer
of the national government of the exporting region, or issued by a
veterinarian designated by the national government of the exporting
region and endorsed by a full-time salaried veterinary officer of the
exporting region, representing that the veterinarian issuing the
certificate was authorized to do so.
(f) The Administrator determines that the collagen will not come
into contact with ruminants in the United States and can be imported
under conditions that will prevent the introduction of BSE into the
United States, and the person importing the collagen has obtained a
United States Veterinary Permit for Importation and Transportation of
Controlled Materials and Organisms and Vectors. To apply for a permit,
file a permit application on VS Form 16-3 (available from APHIS,
Veterinary Services, National Center for Import and Export, 4700 River
Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a
permit must state the intended use of the collagen and the name and
address of the consignee in the United States.

Sec. 95.8 Tallow derived from bovines.

(a) The importation of bovine-derived tallow is prohibited unless:
(1) The requirements of either paragraph (b), (c), or (d), as well
as the requirements of paragraph (e) of this section are met; or
(2) The requirements of paragraph (f) of this section are met.
(b) The tallow is composed of a maximum level of insoluble
impurities of 0.15 percent in weight; or
(c) The tallow originates from a region of negligible risk for BSE;
or
(d) The tallow originates from a region of controlled risk for BSE,
is derived from bovines that have passed ante-mortem and post-mortem
inspections, and has not been prepared using SRMs as defined for
regions of controlled risk for BSE in Sec. 92.1 of this part.
(e) The tallow is accompanied to the United States by an original
certificate signed by a full-time salaried veterinary officer of the
national government of the exporting region, or issued by a
veterinarian designated by the national government of the exporting
region and endorsed by a full-time salaried veterinary officer of the
national government of the exporting region, representing that the
veterinarian issuing the certificate was authorized to do so. The
certificate must state that the requirements of paragraph (b), (c), or
(d) of this section, as applicable, have been met and, for tallow other
than that described in paragraph (b) of this section, must indicate the
BSE risk classification of the exporting region.
(f) The Administrator determines that the tallow will not come into
contact with ruminants in the United States and can be imported under
conditions that will prevent the introduction of BSE into the United
States, and the person importing the tallow has obtained a United
States Veterinary Permit for Importation and Transportation of
Controlled Materials and Organisms and Vectors. To apply for a permit,
file a permit application on VS Form 16-3 (available from APHIS,
Veterinary Services, National Center for Import and Export, 4700 River
Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a
permit must state the intended use of the tallow and the name and
address of the consignee in the United States.

Sec. 95.9 Derivatives of tallow derived from bovines.

(a) The importation of derivatives of tallow from bovines is
prohibited unless the commodity meets the conditions of either
paragraph (b), (c), (d), or (e) of this section as well as paragraph
(f) of this section, or, alternatively, meets the conditions of
paragraph (g) of this section.
(b) The commodity meets the definition of tallow derivative in
Sec. 95.1.
(c) The derivative is from tallow composed of a maximum level of
insoluble impurities of 0.15 percent in weight.
(d) The derivative is from tallow that originates from a region of
negligible risk for BSE.
(e) The derivative is from tallow that originates from a region of
controlled risk for BSE, is derived from bovines that have passed ante-
mortem and post-mortem inspections, and does not contain SRMs as
defined for regions of

[[Page 15910]]

controlled risk for BSE in Sec. 92.1 of this subchapter.
(f) The tallow derivative is accompanied to the United States by an
original certificate signed by a full-time salaried veterinary officer
of the national government of the exporting region, or issued by a
veterinarian designated by the national government of the exporting
region and endorsed by a full-time salaried veterinary officer of the
national government of the exporting region, representing that the
veterinarian issuing the certificate was authorized to do so. The
certificate must state that the requirements of paragraph (b), (c),
(d), or (e) of this section, as applicable, have been met and, for
tallow derivatives other than those described in paragraph (b) or (c)
of this section, must indicate the BSE risk classification of the
exporting region.
(g) The Administrator determines that the tallow derivative will
not come into contact with ruminants in the United States and can be
imported under conditions that will prevent the introduction of BSE
into the United States, and the person importing the tallow derivative
has obtained a United States Veterinary Permit for Importation and
Transportation of Controlled Materials and Organisms and Vectors. To
apply for a permit, file a permit application on VS Form 16-3
(available from APHIS, Veterinary Services, National Center for Import
and Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or
electronically at http://www.aphis.usda.gov/animal_health/permits/).
The application for such a permit must state the intended use of the
tallow derivative and the name and address of the consignee in the
United States.

Sec. 95.10 Dicalcium phosphate derived from bovines.

(a) The importation of dicalcium phosphate derived from bovines
(other than dicalcium phosphate with no trace of protein or fat) is
prohibited unless:
(1) The requirements of either paragraph (b) or (c), and the
requirements of paragraph (d) of this section are met; or
(2) The requirements of paragraph (e) of this section are met.
(b) The dicalcium phosphate originates from a region of negligible
risk for BSE; or
(c) The dicalcium phosphate originates from a region of controlled
risk for BSE, is derived from bovines that have passed ante-mortem and
post-mortem inspections, and does not contain SRMs as defined for
regions of controlled risk for BSE in Sec. 92.1 of this subchapter.
(d) The dicalcium phosphate is accompanied by an original
certificate signed by a full-time salaried veterinary officer of the
national government of the exporting region, or issued by a
veterinarian designated by the national government of the exporting
region and endorsed by a full-time salaried veterinary officer of the
national government of the exporting region, representing that the
veterinarian issuing the certificate was authorized to do so. The
certificate must indicate the BSE risk classification of the exporting
region and state that the requirements of paragraph (b) or (c) of this
section, as applicable, have been met.
(e) The Administrator determines that the dicalcium phosphate will
not come into contact with ruminants in the United States and can be
imported under conditions that will prevent the introduction of BSE
into the United States, and the person importing the dicalcium
phosphate has obtained a United States Veterinary Permit for
Importation and Transportation of Controlled Materials and Organisms
and Vectors. To apply for a permit, file a permit application on VS
Form 16-3 (available from APHIS, Veterinary Services, National Center
for Import and Export, 4700 River Road Unit 38, Riverdale, MD 20737-
1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a permit must state the intended
use of the dicalcium phosphate and the name and address of the
consignee in the United States.

Sec. 95.11 Specified risk materials.

Notwithstanding any other provisions of this part, the importation
of specified risk materials from controlled-risk regions or
undetermined-risk regions for BSE, and any commodities containing such
materials, is prohibited, unless the Administrator determines that the
materials or other commodities will not come into contact with
ruminants in the United States and can be imported under conditions
that will prevent the introduction of BSE into the United States, and
the person importing the materials or other commodities has obtained a
United States Veterinary Permit for Importation and Transportation of
Controlled Materials and Organisms and Vectors. To apply for a permit,
file a permit application on VS Form 16-3 (available from APHIS,
Veterinary Services, National Center for Import and Export, 4700 River
Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/). The application for such a
permit must state the intended use of the materials and other
commodities and the name and address of the consignee in the United
States.

Sec. 95.12 Blood and blood products derived from bovines.

The importation of bovine blood and products derived from bovine
blood is prohibited unless the following conditions and the conditions
of all other applicable parts of this chapter are met:
(a) For blood collected at slaughter and for products derived from
blood collected at slaughter:
(1) The blood was collected in a hygienic manner, as determined by
the Administrator, that prevents contamination of the blood with SRMs;
and
(2) The slaughtered animal passed ante-mortem inspection and was
not subjected to a pithing process or to a stunning process with a
device injecting compressed air or gas into the cranial cavity.
(b) For blood collected from live donor bovines and for products
derived from blood collected from live donor bovines:
(1) The blood was collected in a hygienic manner, as determined by
the Administrator, that prevents contamination of the blood with SRMs;
and
(2) The donor animal was free of clinical signs of disease.
(c) The blood and blood products are accompanied to the United
States by an original certificate that states that the conditions of
this section have been met. The certificate must be issued by a full-
time salaried veterinary officer of the national government of the
exporting region, or issued by a veterinarian designated by the
national government of the exporting region and endorsed by a full-time
salaried veterinary officer of the exporting region, representing that
the veterinarian issuing the certificate was authorized to do so.

Sec. 95.13 Importation from regions of negligible risk for BSE of
processed animal protein derived from animals other than ruminants.

The importation from regions of negligible risk for BSE of
processed animal protein derived from animals other than ruminants is
prohibited importation into the United States unless the following
conditions are met:
(a) The processed animal protein is not prohibited importation
under Sec. 95.4;
(b) The processed animal protein imported into the United States in
accordance with this section is

[[Page 15911]]

accompanied by an original certificate signed by a full-time salaried
veterinary officer of the national government of the exporting region,
or issued by a veterinarian designated by the national government of
the exporting region and endorsed by a full-time salaried veterinary
officer of the national government of the exporting region,
representing that the veterinarian issuing the certificate was
authorized to do so, that indicates that the material originates from a
region classified by APHIS as a region of negligible risk for BSE.
(c) The person importing the shipment has applied for and obtained
from APHIS a United States Veterinary Permit for Importation and
Transportation of Controlled Materials and Organisms and Vectors. To
apply for a permit, file a permit application on VS Form 16-3
(available from APHIS, Veterinary Services, National Center for Import
and Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or
electronically at http://www.aphis.usda.gov/animal_health/permits/).

Sec. 95.14 Importation from regions of controlled risk or
undetermined risk for BSE of processed animal protein derived from
animals other than ruminants.

The importation from regions of controlled risk or undetermined
risk for BSE of processed animal protein derived from animals other
than ruminants is prohibited importation into the United States unless
the following conditions are met:
(a) The processed animal protein is not prohibited importation
under Sec. 95.4;
(b) Except as provided in paragraph (c) of this section, the
processed animal protein does not contain and was not commingled with
material derived from ruminants originating in a BSE controlled- or
undetermined-risk region;
(c) For blood meal, blood plasma, and other blood products, the
material does not contain and was not commingled with ruminant blood or
blood products prohibited importation into the United States under this
part.
(d) Inspection of the facility for compliance with the provisions
of this section is conducted at least annually by a competent authority
of the government agency responsible for animal health in the region,
unless the region chooses to have such inspections conducted by APHIS.
The inspections must verify either that:
(1) All steps of processing and storing the material are carried
out in a facility that has not been used for the processing or storage
of materials derived from ruminants originating in a BSE controlled- or
undetermined-risk region; or
(2) The material is produced in a manner that prevents
contamination of the processed animal protein with materials prohibited
importation into the United States.
(e) If APHIS conducts the inspections required by paragraph (d) of
this section, the facility has entered into a cooperative service
agreement executed by the operator of the facility and APHIS. In
accordance with the cooperative service agreement, the facility must be
current in paying all costs for a veterinarian of APHIS to inspect the
facility (it is anticipated that such inspections will occur
approximately once per year), including travel, salary, subsistence,
administrative overhead, and other incidental expenses (including
excess baggage provisions up to 150 pounds). In addition, the facility
must have on deposit with APHIS an unobligated amount equal to the cost
for APHIS personnel to conduct one inspection. As funds from that
amount are obligated, a bill for costs incurred based on official
accounting records will be issued to restore the deposit to the
original level, revised as necessary to allow for inflation or other
changes in estimated costs. To be current, bills must be paid within 14
days of receipt.
(f) The facility allows periodic APHIS inspection of its
facilities, records, and operations.
(g) The processed animal protein imported into the United States in
accordance with this section is accompanied by an original certificate
signed by a full-time, salaried veterinary officer of the national
government of the exporting region, or issued by a veterinarian
designated by the national government of the exporting region and
endorsed by a full-time, salaried veterinary officer of the national
government of the exporting region, representing that the veterinarian
issuing the certificate was authorized to do so, that indicates the
APHIS BSE risk classification of the exporting region and states that
the conditions of this section have been met.
(h) The person importing the shipment has applied for and obtained
from APHIS a United States Veterinary Permit for Importation and
Transportation of Controlled Materials and Organisms and Vectors. To
apply for a permit, file a permit application on VS Form 16-3
(available from APHIS, Veterinary Services, National Center for Import
and Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or
electronically at http://www.aphis.usda.gov/animal_health/permits/).

Sec. 95.15 Transit shipment of articles.

Articles that are otherwise prohibited importation into the United
States in accordance with Sec. Sec. 95.4 through 95.14 may transit air
and ocean ports in the United States for immediate export if the
conditions of paragraphs (a) through (d) this section are met. Articles
are eligible to transit the United States by overland transportation if
the requirements of paragraphs (a) through (e) of this section are met.
(a) The person moving the articles must obtain a United States
Veterinary Permit for Importation and Transportation of Controlled
Materials and Organisms and Vectors. To apply for a permit, file a
permit application on VS Form 16-3 (available from APHIS, Veterinary
Services, National Center for Import and Export, 4700 River Road Unit
38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/).
(b) The articles must be sealed in leakproof containers bearing
serial numbers during transit. Each container must remain sealed during
the entire time that it is in the United States.
(c) Before such transit, the person moving the articles must
notify, in writing, the inspector at both the place in the United
States where the articles will arrive and the port of export. The
notification must include the:
(i) United States Veterinary Permit for Importation and
Transportation of Controlled Materials and Organisms and Vectors permit
number;
(ii) Times and dates of arrival in the United States;
(iii) Times and dates of exportation from the United States;
(iv) Mode of transportation; and
(v) Serial numbers of the sealed containers.
(d) The articles must transit the United States under Customs bond.
(e) The commodities must be eligible to enter the United States in
accordance with Sec. Sec. 95.4 through 95.14 and must be accompanied
by the certification required by that section. Additionally, the
following conditions must be met:
(i) The shipment must be exported from the United States within 7
days of its entry;
(ii) The commodities may not be transloaded while in the United
States, except for direct transloading under the supervision of an
authorized inspector, who must break the seals of the national
government of the exporting region on the means of conveyance that
carried the commodities into the United States

[[Page 15912]]

and seal the means of conveyance that will carry the commodities out of
the United States with seals of the U.S. Government; and
(iii) A copy of the import permit required under paragraph (a) of
this section must be presented to the inspector at the port of arrival
and the port of export in the United States.

Sec. 95.17 [Amended]

32. In newly redesignated Sec. 95.17, the introductory text is
amended by removing the citation ``Sec. 95.5'' and adding the citation
``Sec. 95.16'' in its place.

Sec. 95.18 [Amended]

33. In newly redesignated Sec. 95.18, the introductory text is
amended by removing the citation ``Sec. 95.8'' and adding the citation
``Sec. 95.19'' in its place, and footnote 1 to paragraph (c) is
amended by removing the citation ``Sec. 95.5'' and adding the citation
``Sec. 95.16'' in its place.

Sec. 95.19 [Amended]

34. In newly redesignated Sec. 95.19, the introductory text is
amended by removing the citation ``Sec. 95.7'' and adding the citation
``Sec. 95.18'' in its place.

Sec. 95.20 [Amended]

35. In newly redesignated Sec. 95.20, the introductory text is
amended by removing the citation ``Sec. 95.10'' and adding the
citation ``Sec. 95.21'' in its place, and footnote 1 to paragraph (c)
is amended by removing the citation ``Sec. 95.5'' and adding the
citation ``Sec. 95.16'' in its place.

Sec. 95.21 [Amended]

36. In newly redesignated Sec. 95.21, the introductory text is
amended by removing the citation ``Sec. 95.9'' and adding the citation
``Sec. 95.20'' in its place.

Sec. 95.23 [Amended]

37. In newly redesignated Sec. 95.23, the introductory text is
amended by removing the citation to ``Sec. 95.11'' and adding the
citation ``Sec. 95.22'' in its place.

Sec. 95.25 [Amended]

38. In newly redesignated Sec. 95.25, the introductory text is
amended by removing the citation ``Sec. 95.16'' and adding the
citation ``Sec. 95.27'' in its place.

Sec. 95.26 [Amended]

39. Newly redesignated Sec. 95.26 is amended by removing the
citation ``Sec. 95.16'' and adding the citation ``Sec. 95.27'' in its
place.

Sec. 95.27 [Amended]

40. In newly redesignated Sec. 95.27, the introductory text is
amended by removing the citation ``Sec. 95.15'' and adding the
citation ``Sec. 95.26'' in its place.

Sec. 95.29 [Amended]

41. Newly redesignated Sec. 95.29 is amended by removing the
citation ``Sec. 95.17'' and adding the citation ``Sec. 95.28'' in its
place.

Sec. 95.32 [Amended]

42. Newly redesignated Sec. 95.32 is amended by removing the
citation ``Sec. 95.28'' and adding the citation ``Sec. 95.39'' in its
place, and by removing the citation ``Sec. 95.22'' and adding the
citation ``Sec. 95.33'' in its place.

Sec. 95.33 [Amended]

43. Newly redesignated Sec. 95.33 is amended by removing the
citation ``Sec. 95.28'' and adding the citation ``Sec. 95.39'' in its
place, and by removing the citation ``Sec. 95.21'' and adding the
citation ``Sec. 95.32'' in its place.

Sec. 95.36 [Amended]

44. In newly redesignated Sec. 95.36, paragraphs (a) and (b) are
amended by removing the citation ``Sec. 95.26'' both times it appears
and adding the citation ``Sec. 95.37'' in their place.
45. Newly redesignated Sec. 95.40 is revised to read as follows:

Sec. 95.40 Certification for certain materials.

(a) In addition to meeting any other certification or permit
requirements of this chapter, the following articles, if derived from
ovines or caprines, may be imported into the United States from any
region not listed in Sec. 95.4(a)(4) only if they are accompanied by a
certificate, as described in paragraph (b) of this section:
(1) Processed animal protein, tankage, offal, and tallow other than
tallow derivatives, unless, in the opinion of the Administrator, the
tallow cannot be used in feed;
(2) Glands and unprocessed fat tissue;
(3) Processed fats and oils, and derivatives of processed animal
protein, tankage, and offal;
(4) Derivatives of glands; and
(5) Any product containing any of the materials listed in
paragraphs (a)(1) through (a)(4) of this section.
(b) The certificate required by paragraph (a) of this section must
be an original official certificate, signed by a full-time, salaried
veterinarian of the agency responsible for animal health in the
exporting region, that states the following:
(1) The animal species from which the material was derived;
(2) The region in which any facility where the material was
processed is located;
(3) That the material was derived only from animals that have never
been in any region listed in Sec. 95.4(a)(4), with the regions listed
in Sec. 95.4(a)(4) specifically named;
(4) That the material did not originate in, and was never stored,
rendered, or processed in, or otherwise associated with, a facility in
a region listed in Sec. 95.4(a)(4); and
(5) The material was never associated with any of the materials
listed in paragraph (a) of this section that have been in a region
listed in Sec. 95.4(a)(4).
(c) The certification required by paragraph (a) of this section
must clearly correspond to the shipment by means of an invoice number,
shipping marks, lot number, or other method of identification.

(Approved by the Office of Management and Budget under control
number 0579-0183)

PART 96--RESTRICTION OF IMPORTATIONS OF FOREIGN ANIMAL CASINGS
OFFERED FOR ENTRY INTO THE UNITED STATES

46. The authority citation for part 96 continues to read as
follows:

Authority: 7 U.S.C. 8301-8317; 21 U.S.C. 136 and 136a; 7 CFR
2.22, 2.80, and 371.4.

47. In Sec. 96.2, paragraph (b) is revised and paragraph (c) is
added to read as follows:

Sec. 96.2 Prohibition of casings due to African swine fever and
bovine spongiform encephalopathy.

* * * * *
(b) Casings from ovines or caprines. The importation of casings,
except stomachs, derived from ovines or caprines that originated in or
were processed in any region listed in Sec. 95.4(a)(4) are prohibited,
unless the following conditions are met:
(1) The casings are derived from sheep that were slaughtered in
Canada at less than 12 months of age and that were from a flock subject
to a ruminant feed ban equivalent to the requirements established by
the U.S. Food and Drug Administration at 21 CFR 589.2000; and
(2) The casings are accompanied by an original certificate that
meets the requirements of Sec. 96.3 and:
(i) States that the casings meet the conditions of this section;
(ii) Is written in English;
(iii) Is signed by an individual eligible to issue the certificate
required under Sec. 96.3; and
(iv) Is presented to an authorized inspector at the port of entry.

[[Page 15913]]

(c) Casings from bovines. The importation of casings derived from
bovines is prohibited, unless the following conditions are met:
(1) If the casings are derived from bovines from a region of
negligible risk for BSE, as defined in Sec. 92.1 of this subchapter,
the certificate required under Sec. 96.3 of this part indicates the
APHIS BSE risk classification of the region in which the bovines were
slaughtered and the casings were collected.
(2) If the casings are derived from bovines from a region of
controlled risk for BSE or a region of undetermined risk for BSE, as
defined in Sec. 92.1 of this subchapter, the casings are not derived
from the small intestine or, if the casings are derived from the small
intestine, the casings are derived from that part of the small
intestine that is eligible for use as human food in accordance with the
requirements established by the Food Safety and Inspection Service at 9
CFR 310.22 and the Food and Drug Administration at 21 CFR 189.5.
(3) The casings are accompanied by an original certificate that
meets the requirements of Sec. 96.3 and paragraphs (b)(2)(i) through
(b)(3)(iv) of this section.
* * * * *
48. In Sec. 96.3, paragraph (d) is revised to read as follows:

Sec. 96.3 Certificate for animal casings.

* * * * *
(d) In addition to meeting the requirements of this section, the
certificate accompanying sheep casings from Canada must state that the
casings meet the requirements of Sec. 96.2(b) and the certificate
accompanying bovine casings must state that the casings meet the
requirements of either Sec. 96.2(c)(1) or (c)(2) as applicable.
* * * * *

PART 98--IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN

49. The authority citation for part 98 continues to read as
follows:

Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a;
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

50. Section 98.11 is amended by adding definitions of camelid and
cervid, in alphabetical order, to read as follows:

Sec. 98.11 Definitions.

* * * * *
Camelid. All species of the family Camelidae, including camels,
guanacos, llamas, alpacas, and vicunas.
Cervid. All members of the family Cervidae and hybrids, including
deer, elk, moose, caribou, reindeer, and related species.
* * * * *
51. In Sec. 98.15, the introductory text of paragraph (a) is
revised to read as follows:

Sec. 98.15 Health requirements.

* * * * *
(a) The donor dam is determined to be free of communicable diseases
based on tests, examinations, and other requirements, as follows,
except that, with regard to bovine spongiform encephalopathy, the
following does not apply to bovines, cervids, or camelids.
* * * * *

Done in Washington, DC, this 8th day of March 2012.
Edward Avalos,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2012-6151 Filed 3-15-12; 8:45 am]
BILLING CODE 3410-34-P