[Federal Register Volume 73, Number 182 (Thursday, September 18, 2008)]
[Proposed Rules]
[Pages 54083-54089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-21786]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 94 and 95

[Docket No. APHIS-2008-0093]


Bovine Spongiform Encephalopathy; Minimal-Risk Regions and 
Importation of Meat, Meat Byproducts, and Meat Food Products Derived 
From Bovines 30 Months of Age or Older

AGENCY: Animal and Plant Health Inspection Service, USDA.

[[Page 54084]]


ACTION: Request for comments.

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SUMMARY: This document requests comment on the removal of 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 
November 17, 2008.

ADDRESSES: You may submit comments by either of the following methods:
    <bullet> Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0093 to submit or view comments and 
to view supporting and related materials available electronically.
    <bullet> Postal Mail/Commercial Delivery: Please send two copies of 
your comment to Docket No. APHIS-2008-0093, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. APHIS-2008-0093.
    Reading Room: You may read any comments that we receive on this 
docket, as well as APHIS supporting materials referenced in this 
docket, in our reading room. The reading room is located in room 1141 
of the USDA South Building, 14th Street and Independence Avenue, SW., 
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., 
Monday through Friday, except holidays. To be sure someone is there to 
help you, please call (202) 690-2817 before coming.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Lisa Ferguson, ASEP Director, 
National Center for Animal Health Programs, VS, APHIS, 4700 River Road 
Unit 46, Riverdale, MD 20737-1231; (301) 734-6188.

SUPPLEMENTARY INFORMATION: 

Background

    The Animal and Plant Health Inspection Service (APHIS) of the U.S. 
Department of Agriculture (USDA or Department) regulates the 
importation of animals and animal products into the United States to 
guard against the introduction of animal diseases. The regulations in 9 
CFR parts 93, 94, 95, and 96 (referred to below as the regulations) 
govern the importation of certain animals, birds, poultry, meat, other 
animal products and byproducts, hay, and straw into the United States 
in order to prevent the introduction of various animal diseases, 
including bovine spongiform encephalopathy (BSE), a chronic 
degenerative disease affecting the central nervous system of cattle.

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 the 
primary route of transmission is through ingestion of feed that has 
been contaminated with a sufficient amount of tissue from an infected 
animal. This route of transmission can be prevented by excluding 
potentially contaminated materials from ruminant feed.

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; 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.

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 
(Wells, et al., 1994; 1996; 1998; 1999; 2005). 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 mice to identify those 
tissues of cattle containing infectivity.
    The 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;

[[Page 54085]]

1998; 1999; 2005). This dose is probably 10-100 times greater than that 
associated with field exposure via feed (DEFRA 2005). 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, change 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, dorsal root ganglia (DRG),\1\ trigeminal ganglia, 
and the distal ileum of the small intestine.
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    \1\ 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, more recent, 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. 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 2005). This method is considered to 
be several hundred-fold more sensitive in detecting BSE infectivity 
than the mouse bioassay (DEFRA 2005). 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).
    In addition to these studies on experimentally infected cattle, 
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 recent 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. This study demonstrated low levels of 
infectivity in the facial and sciatic nerves of the peripheral nervous 
system when injected into these highly sensitive mice. 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 deemed specified risk materials (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 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).
    There are some studies available that report finding the presence 
of the abnormal prion protein in various tissues (Buschmann and 
Groschup, 2005; Masujin et al., 2007). As new methods are developed 
that provide increased sensitivity to detect abnormal PrP, such 
demonstrations of the presence of abnormal PrP in various tissues may 
continue. However, demonstrating the presence of PrP\BSE\ does not 
necessarily indicate the presence of BSE infectivity, especially if no 
infectivity is demonstrated via the

[[Page 54086]]

most direct method available: cattle-to-cattle exposure via 
intracerebral inoculation. Therefore, one cannot automatically assume 
that a finding of PrP\BSE\ in a tissue means the tissue should be 
considered infectious or should be considered an SRM. As noted by the 
World Organization for Animal Health (OIE), the international standard-
setting organization for guidelines related to animal health:

    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 cattle 
to cattle bioassay (OIE TAHSC, 2006).

    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 OIE. International guidelines 
regarding SRM definition and removal have not changed based on the 
results of the studies noted above that report finding the presence of 
the abnormal prion protein in various tissues. U.S. regulations 
regarding SRM removal are consistent with international guidelines.
    Prior to 2005, when the APHIS final rule on BSE minimal-risk 
regions (70 FR 460-553, Docket No. 03-080-3) became effective, APHIS' 
import regulations regarding BSE considered three categories of regions 
with regard to BSE--(1) those in which BSE is known to exist, (2) those 
that present an undue risk of BSE, and (3) all regions not listed in 
either of the other two categories. Imports from BSE-affected regions 
and those considered to present an undue risk are governed by the same 
set of restrictions, including a prohibition on the importation of 
meat, meat products, and edible products other than meat (except for 
milk and milk products and gelatin under certain conditions). All other 
regions were not subject to any import restrictions because of BSE.
    Beginning in 2003, APHIS commenced a rulemaking process to update 
our BSE regulations to reflect the latest scientific data and knowledge 
of the disease. In a document published in the Federal Register on 
November 4, 2003 (68 FR 62386-62405, Docket No. 03-080-1), APHIS 
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. Among the conditions for the importation of meat from BSE 
minimal-risk regions was that the meat be derived from bovines less 
than 30 months of age when slaughtered. This age restriction 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.
    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 FSIS included declaring SRMs to be inedible 
and requiring 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 that the 
entire small intestine be removed and be disposed of as inedible.\2\ 
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).
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    \2\ On September 7, 2005, FSIS published in the Federal Register 
an interim final rule that allowed for use as human food, under 
certain conditions, beef small intestine, excluding the distal 
ileum, derived from cattle slaughtered in official U.S. 
establishments or in certified foreign establishments in countries 
listed by FSIS in 9 CFR 327.2(b) as eligible to export meat products 
to the United States.
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    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 has determined that 
the SRM requirements implemented by Canada in July 2003 are 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, we 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, we 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.\3\
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    \3\ 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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[[Page 54087]]

    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 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 
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 recent 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.
    In January 2005, an APHIS team visited Canada to evaluate the 
epidemiology of the North American BSE cases that had been identified 
at that time. This team concluded that the information available 
suggested a localized exposure, based on the relatively small 
geographical location, the temporal association, and the clustering of 
cases. The team also evaluated the likelihood of higher-risk animal or 
feed exposure to the United States at that time, and concluded that the 
U.S. feed ban and other mitigations had effectively minimized the risk 
of transmission or amplification of the BSE agent (USDA, 2005). In 
addition, also in January 2005, USDA sent a team to Canada to assess 
Canada's feed ban and its feed inspection program to determine whether 
the control measures put in place by the Canadian Government were 
achieving compliance with that country's regulations. APHIS conducted 
an extensive review of the feed ban in Canada and concluded that Canada 
has a robust inspection program, that overall compliance with the feed 
ban in Canada was good, and that the feed ban was reducing the risk of 
transmission of BSE in the Canadian cattle population (USDA, 2005a).
    On January 9, 2007, we published a proposed rule in the Federal 
Register (72 FR 1101-1129, Docket No. APHIS-2006-0041) 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.\4\
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    \4\ 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 standards of the World Organization for Animal Health (OIE) 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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    We conducted an assessment of the risk to U.S. livestock of 
allowing the importation of live bovines according to the provisions of 
the proposed rule from Canada--currently the only region recognized as 
a BSE minimal-risk region by APHIS. That risk assessment incorporated 
and built on information from all of the previous analyses, including 
the 2005 reports of the feed ban team and the epidemiological 
investigation team. In the risk assessment, we evaluated both the 
likelihood of ``release'' of the BSE agent into the United States and 
the likelihood of susceptible animals being exposed, given such 
release. We evaluated the pathways by which infected Canadian cattle, 
if imported, might expose U.S. cattle to BSE, and the likelihood that 
these pathways might lead to the establishment of the disease in the 
U.S. cattle population. We concluded that the likelihood of BSE 
exposure and establishment in the U.S. cattle population as a 
consequence of imports under the proposed rule was negligible.
    In our risk assessment, we explained that several steps must occur 
for BSE to be transmitted to cattle in the United States from a live 
bovine imported from another country. A BSE-infected bovine must be 
imported into the United States; the infected bovine must die or be 
slaughtered; tissues from that animal that contain the infectious agent 
(i.e., the SRMs) must be sent to a rendering facility; the infectivity 
present in these tissues must survive inactivation in the rendering 
process; the resulting meat-and-bone meal containing the abnormal prion 
protein must be incorporated into feed; and this feed must be fed to 
cattle, in contravention of FDA regulations, 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 (Arnold and Wilesmith, 2004)). We 
explained in our risk assessment that some of the steps could occur in 
parallel--i.e., without the occurrence of other steps--while others 
would need to occur in series. Because the impact of any specific step 
would depend on its relationship to other steps, its importance to the 
likelihood of BSE transmission, and, in turn, the impact of disease 
mitigation measures at each step, cannot be understood in isolation 
from the rest of the pathway.
    One component of our risk assessment was an estimate of the 
prevalence of BSE in Canada, which was conducted using the same methods 
as an earlier estimate of the prevalence of BSE in the United States. 
The results of this prevalence estimate were then used to inform the 
subsequent considerations and calculations in the risk assessment. 
Because the prevalence was not zero--i.e., we concluded and 
acknowledged that BSE is still present in Canada at low levels--the 
risk assessment consequently assumed that infected animals could be 
imported into the United States under the provisions of the proposed 
rule. Even with this assumption, our conclusion that the risk of the 
exposure of U.S. cattle and the establishment of BSE in the United 
States was negligible remained unchanged.
    On September 18, 2007, we published in the Federal Register (72 FR 
53314-53379, Docket No. APHIS-2006-0041) a

[[Page 54088]]

final rule 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. 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. As explained previously, the risk of 
transmission of BSE occurs when SRMs from infected cattle enter the 
ruminant feed supply in contravention of current feed regulations. 
Since the risk is tied to those tissues that contain infectivity, if 
those tissues are excluded from import, the risk is mitigated. When 
live cattle are imported, the potential exists that, after their death, 
their SRMs could enter the ruminant feed supply. Even with this 
potential, the conclusion of the risk assessment was that such imports 
present a negligible risk of establishment of BSE in the United States. 
As noted above, one of the requirements for the importation of meat 
from bovines is that the SRMS be removed from the animals from which 
the meat is derived. In other words, the SRMs are excluded from import 
and would not even have the potential to enter the risk pathway in the 
United States. Therefore, the conclusion of negligible risk related to 
the importation of live older bovines 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 than for live bovines.
    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.
    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. In this 
document, we are providing such notice and further opportunity for 
comment. We will consider all comments that we receive by November 17, 
2008.

References

Arnold, M. and J. Wilesmith. (2004). Estimation of the Age-Dependent 
Risk of Infection to BSE of Dairy Cattle in Great Britain. 
Preventive Veterinary Medicine. 66(1): 35-47.
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. The Journal of Infectious Diseases, 192: 934-42. 
September 1.
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. (http://www.food.gov.uk/multimedia/pdfs/otmcomer.pdf)
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)
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). (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)
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) (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--
&

[[Page 54089]]

--Policies/federal--register--publications--&--related--documents/
index.asp)
Masujin, K., D. Matthews, G.A.H. Wells, S. Mohri, and T. Yokoyama. 
(2007). Prions in the peripheral nerves of bovine spongiform 
encephalopathy-affected cattle. J. Gen. Virol. (88): 1850-1858; DOI 
10.1099/vir.0.82779-0.
United States Department of Agriculture (USDA). (2005). U.S. 
Department of Agriculture's Summary of the Epidemiological Finding 
of North American BSE Positive Cattle, April. (http://www.aphis.usda.gov/newsroom/hot_issues/bse/background/documents/bse_epi_report_4-29-05.pdf)
United States Department of Agriculture (USDA). (2005a). Assessment 
of the Canadian Feed Ban, February. (http://www.aphis.usda.gov/newsroom/hot_issues/bse/background)
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: pre-clinical infectivity in tonsil and observations 
on the distribution of lingual tonsil in slaughtered cattle. Vet 
Rec. 156(13): 401-407.
Wells, G.A.H. (2008). Personal communication with APHIS. E-mail. 
January 30. 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)

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

    Done in Washington, DC, this 12th day of September 2008.
Cindy J. Smith,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E8-21786 Filed 9-17-08; 8:45 am]
BILLING CODE 3410-34-P