Federal Register, Volume 69 Issue 7 (Monday, January 12, 2004)

[Federal Register Volume 69, Number 7 (Monday, January 12, 2004)]
[Rules and Regulations]
[Pages 1862-1874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-625]

[[Page 1861]]

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Part V

Department of Agriculture

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Food Safety and Inspection Service

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9 CFR Part 301, 309, et al.

Prohibition of the Use of Specified Risk Materials for Human Food and
Requirements for the Disposition of Non-Ambulatory Disabled Cattle;
Meat Produced by Advanced Meat/Bone Separation Machinery and Meat
Recovery (AMR) Systems; Prohibition of the Use of Certain Stunning
Devices Used To Immobilize Cattle During Slaughter; Bovine Spongiform
Encephalopathy Surveillance Program; Interim Final Rules and Notice

Federal Register / Vol. 69, No. 7 / Monday, January 12, 2004 / Rules
and Regulations

[[Page 1862]]

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 309, 310, 311, 318, and 319

[Docket No. 03-025IF]

Prohibition of the Use of Specified Risk Materials for Human Food
and Requirements for the Disposition of Non-Ambulatory Disabled Cattle

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Interim final rule and request for comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the
Federal meat inspection regulations to designate 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 dorsal root ganglia
(DRG) of cattle 30 months of age and older, and the tonsils and distal
ileum of the small intestine of all cattle, as ``specified risk
materials'' (SRMs). The Agency is declaring that SRMs are inedible and
prohibiting their use for human food. In addition, FSIS is requiring
that all non-ambulatory disabled cattle presented for slaughter be
condemned. The Agency is requiring that federally-inspected
establishments that slaughter cattle and federally-inspected
establishments that process the carcasses or parts of cattle develop,
implement, and maintain written procedures for the removal,
segregation, and disposition of SRMs. Establishments must incorporate
these procedures into their HACCP plans or in their Sanitation SOPs or
other prerequisite program. FSIS is taking this action in response to
the diagnosis on December 23, 2003, by the U.S. Department of
Agriculture of a positive case of bovine spongiform encephalopathy
(BSE) in an adult Holstein cow in the State of Washington. This action
will minimize human exposure to materials that scientific studies have
demonstrated as containing the BSE agent in cattle infected with the
disease. Infectivity has never been demonstrated in the muscle tissue
of cattle experimentally or naturally infected with BSE at any stage of
the disease.

DATES: This interim final rule is effective January 12, 2004. Comments
on this interim final rule must be received by April 12, 2004.

ADDRESSES: Submit written comments to: FSIS Docket Clerk, Docket
03-025IF, Room 102, Cotton Annex, 300 12th and C Street, SW.,
Washington, DC 20250-3700. Reference materials cited in this document
and any comments received will be available for public inspection in
the FSIS Docket Room from 8:30 a.m. to 4:30 p.m., Monday through
Friday. Reference materials that are not copyrighted will also be
available on the FSIS Web site at http://www.fsis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Executive
Associate, Policy Analysis and Formulation, Office of Policy and
Program Development, Food Safety and Inspection Service, U.S.
Department of Agriculture, Washington, DC 20250-3700; (202)205-0495.

SUPPLEMENTARY INFORMATION:

Background

Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et
seq.), FSIS issues regulations governing the production of meat and
meat food products prepared for distribution in commerce. The
regulations, along with FSIS inspection programs, are designed to
ensure that meat and meat food products are safe, wholesome,
unadulterated, and properly marked, labeled, and packaged. The FMIA
prohibits anyone from selling, transporting, offering for sale or
transportation, or receiving for transportation in commerce, any
adulterated or misbranded meat or meat food product (21 U.S.C. 610).
Under the FMIA, a meat food product is adulterated if, among other
circumstances, it bears or contains any poisonous or deleterious
substance that may render it injurious to health (21 U.S.C. 601(m)(1))
or if it is for any reason unsound, unhealthful, unwholesome, or unfit
for human food (21 U.S.C. 601(m)(3)). The FMIA requires that FSIS
inspect the carcasses, parts of carcasses, and meat food products of
all cattle, sheep, swine, goats, horses, mules, or other equines that
are capable for use as human food to ensure that such articles are not
adulterated (21 U.S.C. 604, 606). If the carcasses, parts of carcasses,
and meat food products are found, upon inspection, to be not
adulterated, FSIS marks them as ``Inspected and passed'' (21 U.S.C.
604, 606, 607). The FMIA gives FSIS broad authority to promulgate such
rules and regulations as are necessary to carry out the provisions of
the Act (21 U.S.C. 621).
As discussed in greater detail below, infectivity has been
confirmed in the brain, trigeminal ganglia, tonsils, spinal cord, DRG,
and distal ileum of the small intestine of cattle experimentally
infected with BSE, and in the brain, spinal cord, and eyes of cattle
infected with BSE under field conditions. Data on the age distribution
of clinical cases of BSE in the field reported in the United Kingdom
indicate that clinical BSE disease has rarely been reported in cattle
younger than 30 months of age.
In cattle experimentally infected with BSE, infectivity has been
confirmed in the distal ileum at various stages of the disease process
and as early as 6 months after oral exposure to the BSE agent. The
tonsils of experimentally infected cattle have demonstrated apparently
weak infectivity as early as 10 months after oral exposure to the BSE
agent. The other tissues in which BSE infectivity has been confirmed
have demonstrated infectivity at the end stages of disease, which, in
experimentally infected cattle, was 32 months after exposure to the BSE
agent and later. The brain, trigeminal ganglia, tonsils, DRG, and
distal ileum are materials of experimentally infected cattle in which
infectivity has been confirmed before the onset of clinical disease.
Based on these findings, FSIS has concluded that 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 of cattle 30
months of age and older, and the tonsils and distal ileum of the small
intestine of all cattle are unfit for human food under section 1(m)(3)
of the FMIA (21 U.S.C 601(m)(3)). Therefore, FSIS is designating these
materials as SRMs, declaring that they are inedible and, pursuant to
its authority to promulgate regulations necessary to carry out the
provisions of the FMIA, prohibiting their use for human food.
Because there are currently no restrictions on the incorporation of
spinal cord and DRG into MS(Beef) meat food product, such product may
contain concentrated amounts of these high-risk tissues. Therefore FSIS
has concluded that, like the SRMs described above, MS(Beef) is unfit
for human food under section 1(m)(3) of the FMIA (21 U.S.C. 601(m)(3)).
As discussed in detail below, surveillance data from European
countries in which BSE has been detected indicate that non-ambulatory
cattle are among the animals that have a greater incidence of BSE than
other cattle. Surveillance data also indicate that clinical signs of
BSE cannot always be observed in non-ambulatory cattle. Furthermore,
due to limitations in the testing methods for BSE that are available
today, certain tissues of cattle

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infected with BSE may contain BSE infectivity even though the
diagnostic test does not indicate that the animal has the disease. For
the reasons presented above, FSIS believes that non-ambulatory disabled
cattle present a risk of introducing the BSE agent into the human food
supply. Therefore, FSIS has determined that the carcasses of non-
ambulatory disabled cattle are unfit for human food under section
1(m)(3) of the FMIA and that all non-ambulatory disabled cattle that
are presented for slaughter should be condemned.
By declaring SRMs and MS(Beef) inedible and prohibiting their use
for human food, and by condemning all non-ambulatory disabled cattle,
FSIS will ensure that materials that could present a significant risk
to human health, but whose infectivity status cannot be readily
ascertained, are excluded from the human food supply.
Because BSE was recently confirmed in a cow in the United States,
FSIS has determined that the SRMs identified in this document are unfit
for human food. Thus, the status of most of these materials has changed
from edible to inedible. Such a change is likely to affect the
underlying hazard analysis that must be conducted as prescribed by 9
CFR 417.4(a)(3). Therefore, in response to this change, FSIS expects
that establishments that slaughter cattle and establishments that
process the carcasses or parts of cattle will reassess their HACCP
plans in accordance with 9 CFR 417.4(a)(3) to address SRMs.

BSE and Variant Creutzfeldt-Jakob Disease

BSE is a progressive degenerative disease that affects the central
nervous system (CNS) of adult cattle. BSE belongs to the family of
diseases known as transmissible spongiform encephalopathies (TSEs),
which include, among other diseases, scrapie in sheep and goats,
chronic wasting disease (CWD) in deer and elk, and Cruetzfeldt-Jakob
disease (CJD) in humans. The typical incubation period (the time from
when an animal becomes infected until it first shows disease signs) for
BSE is believed to be from two to eight years. BSE was first documented
in the United Kingdom in 1986 and has since been identified in
approximately 21 other countries in Europe. BSE has also been confirmed
in some non-European countries, including Japan, Israel, and Canada.
On December 23, 2003, USDA announced a presumptive diagnosis of BSE
in an adult Holstein cow from Washington State. Samples were taken from
the cow on December 9 as part of USDA's BSE surveillance program. The
BSE diagnosis was made on December 22 and 23 by histopathology and
immunohistochemical testing at the National Veterinary Services
Laboratory, Ames, Iowa. On December 25, 2003, the International
Reference Laboratory in Weybridge, England confirmed the diagnosis of
BSE.
The agent that causes BSE and other TSEs has yet to be fully
characterized. The theory that is most accepted in the scientific
community is that the agent is a prion, which is an abnormal form of a
normal protein known as cellular prion protein, although other types of
agents have also been implicated. The agent is highly resistant to
heat, ultraviolet light, ionizing radiation, and common disinfectants
that normally inactivate viruses or bacteria.
In 1996, a newly recognized form of the human disease CJD, referred
to as vCJD, was reported in the United Kingdom. Scientific and
epidemiological studies have linked vCJD to exposure to BSE, probably
through human consumption of beef products contaminated with the agent
that causes BSE (Ref. 1-5 available for viewing by the public in the
FSIS Docket Room). To date, approximately 150 probable and confirmed
cases of vCJD have been reported worldwide.
The Centers for Disease Control and Prevention (CDC) leads a
surveillance system for vCJD in the United States, and as of December,
2003, the disease has never been detected in residents of the United
States that have never lived in or traveled to the United Kingdom for
extended periods of time. In 2002, a probable case of vCJD was reported
in a Florida resident who lived in the United Kingdom during the BSE
epidemic. Epidemiological data indicate that the patient was likely
exposed to the BSE agent before moving to the United States. (Ref. 6
available for viewing by the public in the FSIS Docket Room).
The United States government has implemented a number of measures
to prevent BSE from entering the United States and to prevent the
spread of the disease should it be introduced into the United States.
Since 1989, USDA's Animal and Plant Health Inspection Service (APHIS)
has prohibited the importation of live cattle and certain cattle
products, including rendered protein products, from countries where BSE
is known to exist. In 1997, due to concerns about widespread risk
factors and inadequate surveillance for BSE in many European countries,
these importation restrictions were extended to include all of the
countries in Europe. In 1997, FDA prohibited the use of most mammalian
protein in the manufacture of animal feeds given to cattle and other
ruminants. In December 2000, APHIS prohibited all imports of rendered
animal protein products, regardless of species, from BSE-restricted
countries because of concern that feed intended for cattle may have
been cross-contaminated with the BSE agent. In addition, APHIS leads an
ongoing, comprehensive, interagency surveillance system for BSE in the
United States and, in cooperation with FSIS, has drafted an emergency
response plan to be used in the event that BSE is identified in the
United States. This plan was activated when the BSE test for the cow in
Washington State came back presumptive positive on December 23, 2003.
Other Federal agencies also have contingency plans that work in concert
with the USDA plan.

BSE Infectivity

Animal age. The distribution and amount of the BSE agent in cattle
infected with BSE is not known with certainty. It is generally accepted
that in animals with clinical BSE disease, the brain and spinal cord
contain the greatest concentration of the BSE agent, and that the
quantity of the agent increases as the animals progress through the
incubation period to the development of clinical disease. Thus, the
total infective load in cattle in the early stages of the incubation
period is believed to be much lower than in cattle approaching the end
of the incubation period or in those cattle with overt clinical BSE. As
stated above, the typical incubation period for BSE is believed to be
between two to eight years.
Information on the age at which cattle develop clinical BSE under
field conditions, i.e., commercially reared cattle not part of a
specially designed experiment, can be useful in identifying those
cattle that, if infected with the BSE agent, are most likely to contain
the highest levels of infectivity. Age-of-onset was known and recorded
for approximately 135,000 cattle with confirmed clinical BSE in the
United Kingdom between 1988 and August 2003 (Ref. 7, available for
viewing by the public in the FSIS Docket Room). These data demonstrate
that the age at which cattle develop clinical disease varies. The data
from the United Kingdom show a gradual increase in the number of
clinical BSE cases with increasing age, and that the number of
confirmed cases peaks at 5 years of age. The lower ranges of this age
distribution include some cattle younger than 30 months of age.

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The age distribution data show that, of the cattle that developed
clinical BSE in the field, only 0.01% were less than 30 months of age.
Thus, cattle younger than 30 months of age are less likely to be in the
later stages of BSE incubation than older BSE-infected cattle, and
hence, are less likely to contain high levels of BSE infectivity.
Research demonstrates that the incubation period for BSE appears to be
linked to the infectious dose of the BSE agent received, i.e., the
larger the infectious dose received the shorter the incubation period
(Ref. 8, available for viewing by the public in the FSIS docket room).
Thus, given these observations, scientists that have studied the
disease believe that the occurrence of BSE in young cattle is most
likely the result of exposure to a very large dose of the BSE agent at
a very young age.
Detection of BSE in cattle younger than 30 months of age. In
October 2003, Japan reported a BSE case in a 23-month old bull, the 8th
BSE case confirmed in that country. Earlier cases confirmed in Japan
were in cattle over 5 years of age. This recent case apparently did not
have clinical signs of disease and was detected as part of Japan's
regular surveillance for BSE in which all cattle slaughtered for human
consumption are screened for the disease. In reporting on this BSE
case, Japanese officials stated that tests suggested that the form of
the BSE agent found in the affected animal was atypical, and that they
planned to conduct further studies on this form of the disease. A
similar form of the atypical agent detected in the Japanese animal has
been reported in two BSE cases in Italy. However the Italian animals
were 11 and 12 years old. Japan has reported importing feed from Italy.
In early November 2003, shortly after reporting the confirmation of
BSE in a 23-month-old animal, Japan reported that BSE was confirmed in
a 21-month-old animal. The 21-month-old animal is Japan's 9th reported
case of BSE. Like the 23-month-old animal, this animal apparently did
not have clinical signs of disease. However, the abnormal prion protein
detected in this animal does not appear to be the same as the
apparently atypical form detected in the 23-month-old animal. Japanese
officials reported that they will be conducting testing to determine if
the tissues of these relatively young cattle that were recently found
positive for BSE contain BSE infectivity.
The immediate implications of the recent detection of BSE in two
animals younger than 24 months of age in Japan, one of which has an
apparently atypical form of the disease, are not readily apparent at
this time. Although rare, confirmed cases of BSE in animals younger
than 30 months of age have also been reported in the United Kingdom and
in some other European countries. As stated earlier in this document, a
confirmed case of BSE in an animal less than 30 months of age generally
implies that the animal was exposed to a large dose of the infective
agent at a young age. From 1988 to 1996, during the height of the BSE
epidemic in the United Kingdom when large amounts of infective agent
were being circulated among cattle herds, 19 clinical cases of BSE were
confirmed in cattle younger than 30 months of age (Ref. 9, available
for viewing by the public in the FSIS docket room). The youngest
confirmed case of BSE was in the United Kingdom in an animal with
clinical disease at 20 months of age in 1992. However, as of September
30, 2003, no cases of BSE in cattle younger than 30 months of age have
been detected in the United Kingdom since 1996, and only 3 cases have
been found in European animals less than 30 months of age since 2001.
FSIS requests comment on the potential implications, if any, of the
reported 21- and 23-month-old cases of BSE in Japan. The Agency is also
requesting comments on whether, and if so how, it should modify the
measures in this rulemaking to address the fact that, in rare
instances, BSE has been confirmed in cattle younger than 30 months of
age.
Infective tissues. Available data on the development and
distribution of tissue infectivity in BSE-infected cattle are
incomplete. Most of what is known comes from pathogenesis studies
conducted in the United Kingdom (Ref. 10, 11, 12 available for viewing
by the public in the FSIS Docket Room). In these studies, cattle were
deliberately infected with BSE through oral exposure to the brains of
cattle with confirmed BSE. The experimentally infected cattle were
killed at regular intervals as the disease developed, and at each
interval the tissues of the infected cattle were examined for
histopathological changes consistent with BSE and for abnormal prion
proteins. At each interval, tissues of the BSE infected cattle were
also injected into mice to identify those tissues of cattle capable of
transmitting the disease.
The pathogenesis studies involved a small number of cattle (30
animals) that received a large, uniform dose of the BSE agent at a very
young age (4 months). Thus, the findings may not reflect the
development and distribution of infectivity of cattle exposed to the
BSE under field conditions, where the level and age of exposure to the
BSE agent are unpredictable. Furthermore, the pathogenesis studies did
not determine the rate at which the BSE agent increases in the tissues
that have demonstrated infectivity or the tissues that the agent must
pass through to reach its ultimate destination in the animal after it
is ingested. However, the results of these studies are useful in that
they provide experimental evidence of the distribution of the infective
agent in BSE-infected cattle at various stages of the disease.
The pathogenesis 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,
with the highest levels of infectivity detected in the brain and spinal
cord at the end stages of disease. In the studies, some cattle
exhibited clinical signs of BSE as early as 35 months post oral
exposure to the BSE agent. By 37 months post oral exposure, all of the
5 animals that were still alive demonstrated clinical evidence of BSE
(animals had been serially sacrificed at set intervals). In cattle with
clinical BSE, infectivity was demonstrated in the brain, spinal cord,
DRG, trigeminal ganglia, and the distal ileum of the small intestine.
(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.)
In one set of animals, infectivity was demonstrated in the bone
marrow at 38 months post exposure, but these findings were not
conclusive. At this time, bone marrow is not designated as SRM.
However, in today's Federal Register, FSIS is announcing new
requirements to limit the presence of bone marrow in meat produced from
AMR systems, with iron as a marker. This action is not a food safety
measure at this time but is related to misbranding.
In some cattle in the studies, BSE infectivity was demonstrated in
the brain, spinal cord, and DRG as early as 32 months post oral
exposure to the BSE agent. In addition, infectivity was demonstrated in
these tissues three months before animals began to develop clinical
signs of the disease. Infectivity was demonstrated in the distal ileum
of cattle 6 to 18 months post oral exposure to the BSE agent and again
at 38 months and 40 months post oral exposure.
A second phase of the pathogenesis studies that uses a cattle
bioassay is being conducted to ensure that low levels of infectivity
that may not have

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been detected in the first phase using the mouse bioassay are not
missed. The cattle bioassay, in which tissues from cattle deliberately
infected with BSE are injected directly into the brains of BSE-free
cattle, is considered to be several hundred-fold more sensitive in
detecting BSE infectivity than the mouse bioassay. Preliminary results
from the cattle bioassay 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 post oral exposure to the BSE
agent contain infectivity. However, because only one of five animals
injected with infected tonsil material developed clinical BSE at 45
months post-inoculation, the level of infectivity in the tonsils
appears to be very low. The second phase of the study is still underway
and is not expected to be completed for several more years. (Ref. 8 and
13, available for viewing by the public in the FSIS Docket Room).
In cattle infected with BSE under field conditions, BSE infectivity
has been confirmed in the brain, spinal cord, and retina of the eye at
the end stages of the disease (Ref. 8 available for viewing by the
public in the FSIS Docket Room).
BSE infectivity has never been demonstrated in the muscle tissue of
cattle experimentally or naturally infected with the disease at any
stage of the disease.
Proportion of infectivity in certain tissues. In 2001, the European
Commission's Scientific Steering Committee (SSC), a scientific advisory
committee for the European Union, considered the amount and
distribution of BSE infectivity in a typical case of BSE and estimated
that, in an animal with clinical disease, the brain contains 64.1% of
the total infectivity in the animal and the spinal cord contains 25.6%
of the total infectivity (Ref. 14 available for viewing by the public
in the FSIS Docket Room). Thus, the brain and spinal cord of cattle
with clinical BSE are estimated to contain nearly 90% of the total
infectivity in the animal. According to the SSC, the remaining
proportion of infectivity in a typical animal with clinical BSE is
found in the DRG (3.8%), the trigeminal ganglia (2.6%), the distal
ileum (3.3%), the spleen (0.3%), and the eyes (0.04%).\1\ However, as
mentioned above, in experimentally infected cattle BSE infectivity has
been demonstrated in the distal ileum as early as 6 to 18 months post
oral exposure to the BSE agent and in the tonsils as early as 10 months
post exposure. Thus, in younger cattle infected with BSE, these
materials apparently present the greatest risk of exposing humans to
the BSE agent.
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\1\ For this study, low levels of infectivity were assumed for
the spleen and eyes based on scrapie experiments. The spleen has not
demonstrated infectivity in cattle.
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Current Regulatory Requirements for Potentially Infective Materials

Under FSIS' regulations, most of the materials that have
demonstrated BSE infectivity in cattle with clinical disease, i.e.,
brain, eyes, trigeminal ganglia, spinal cord, DRG, and the distal ileum
of the small intestine, may currently be used in some way for human
food. The brains of all livestock species, including the brains of
cattle, are permitted for human food, with the exception of brains from
animals stunned by lead, sponge iron, or frangible bullets (9 CFR
310.18(b)). Unprocessed cattle brains are typically sold chilled,
frozen, or canned, and are consumed as a variety meat. Cattle brains
may also be used as a by-product ingredient in certain processed
products. When used as a by-product ingredient, cattle brains must be
listed in the ingredients statement on the labeling of the product and
declared by species (9 CFR 317.2(f)(1)).
Cattle brains are also permitted to be used as a source material in
edible rendering. Edible rendering involves the processing of materials
inspected and passed for human food into products, such as edible oils,
meals, beef extracts, beef protein, beef broths, beef stocks, and beef
flavorings. Many of these products are regulated by FSIS and FDA.
Given the invariable presence of bone splinters, detached spinal
cords from all livestock species, including cattle, are prohibited for
use in the preparation of edible products (9 CFR 318.6(b)(4)). However,
detached spinal cords may be used as a raw material in edible rendering
(9 CFR 318.6(b)(4)). The labeling of extracts prepared from brains,
spinal cords, or other organs or parts of the carcass other than fresh
meat from all livestock species, including cattle, must include the
true name of the parts from which the product was prepared, e.g.,
``extract from beef brain'' (9 CFR 317.8(b)(15)).
Vertebral columns from cattle contain both spinal cord and DRG.
FSIS' regulations do not require that the spinal cord or DRG of cattle
be removed from the vertebral column at the time of slaughter. Thus,
some bone-in beef products may contain spinal cord, DRG, or both.
Bones from the vertebral column of cattle are permitted to be used
as source materials in the production of processed products
manufactured from edible rendering. When the vertebral columns from
cattle are used in the production of such products, spinal cord and DRG
that remain attached to the vertebral column could potentially become
dislodged and incorporated into the final product. Under the FSIS
regulations, the labeling of the final product is not required to
disclose the fact that the product may contain spinal cord or DRG.
Bones from the vertebral column of cattle are also permitted for
use as a source material in meat recovery systems that use pressure to
separate beef muscle tissue from bones. When the vertebral columns are
used as a source material in these systems, spinal cord and DRG may
become dislodged from the vertebral bones and incorporated into the
final product. The use of vertebral columns in systems that
mechanically separate meat and meat products from bone, and the
labeling requirements for such products, are discussed in greater
detail below.
Casings made from the small intestine, including the distal ileum,
of cattle are permitted to be used as containers for meat food products
(9 CFR 318.6(b)(1)). Cattle intestines, including the distal ileum, are
also permitted for use as ingredients in meat food products that do not
have an FSIS prescribed standard of identity, provided that the
products are properly labeled (9 CFR 318.6(b)(8)).
FSIS' regulations do not prohibit the use of cattle eyes for human
food, although direct consumption of such materials is uncommon in the
United States. The tonsils of all livestock species, including cattle,
are prohibited for use as ingredients of meat food products (9 CFR
318.6(b)(6)). The trigeminal ganglia of cattle are not sold directly as
consumer products. However, the heads of cattle (commonly referred to
as ``market heads'') are permitted for use as human food and are sold
to retail establishments where they are used to produce edible
products. Some retail establishments sell market heads of cattle
directly to consumers. Cattle market heads contain skull, eyes,
trigeminal ganglia, and fragments of brains.
Meat that has been trimmed from the head and cheeks of cattle is
permitted to be used in FSIS-regulated products, although some product
standards place certain restrictions on the use of head and cheek meat
(for examples see 9 CFR 319.81, 9 CFR 319.199, 9 CFR 319.300 9 CFR
319.301, and 9 CFR.303) Head or cheek meat may contain CNS materials if
the meat is not removed before the skull is fragmented or split.
Although rare, the skulls of cattle are sometimes

[[Page 1866]]

intentionally split to remove materials contained within the cranial
cavity, such as the pituitary gland. The skulls of cattle are sometimes
unintentionally fragmented, and the brains of the animals exposed, when
a mechanical device is used to remove horns from cattle. In some
instances, in addition to the fragmentation that occurs during horn
removal, the brain has also been penetrated by the captive bolt of a
stun gun, which results in a hole with weeping material that may
contain CNS tissue. In these cases, when the head and cheek meat are
removed, the heads of the cattle may be manipulated in such a way as to
potentially contaminate the meat. Contamination of head or cheek meat
with trigeminal ganglia is unlikely because the trigeminal ganglia are
embedded within the skull and are not likely to be removed when the
meat is harvested.

Meat Produced Using Advanced Meat Recovery Systems and Mechanically
Separated (Species) Meat Food Product

Advanced Meat Recovery. Advanced Meat Recovery (AMR) is a
technology that enables processors to remove the attached skeletal
muscle tissue from livestock bones without incorporating significant
amounts of bone and bone products into the final meat product. When
produced properly, product from AMR systems is comparable to meat
derived by hand deboning and can be labeled as ``meat'' (9 CFR 301.2).
Under the FSIS regulations, spinal cord is not a component of meat, and
therefore, product from AMR systems identified as ``meat'' that
contains spinal cord is misbranded.
From January through August 2002, FSIS conducted a survey of AMR
products derived from the vertebral column of cattle to establish a
baseline for the prevalence of spinal cord and DRG tissue in beef AMR
products (referred to as the 2002 Beef AMR Survey) (Ref. 15 and 16,
available for viewing by the public in the FSIS docket room and on the
Internet at http://www.fsis.usda.gov/oa/topics/AMRAnalysis.pdf and
http://www.fsis.usda.gov/OA/topics/AMRSurvey.pdf). In the 2002 Beef AMR
Survey, the Agency found that while some establishments were able to
consistently produce beef AMR product that was free of spinal cord and
DRG tissue, a majority of the establishments had difficulty keeping
spinal cord and DRG out of their AMR products. Overall, FSIS found that
that approximately 76% (25 of 34) of the establishments whose AMR
product was tested had positive laboratory results for spinal cord,
DRG, or both in their final beef AMR products. The survey also found
that approximately 35% (89 of 256) of all final AMR product samples
that were tested had positive laboratory results for spinal cord, DRG,
or both.
In March 2003, after completion of the 2002 Beef AMR Survey, FSIS
implemented a routine regulatory sampling program of beef products from
AMR systems as an additional measure to prevent misbranding of beef AMR
products. Prior to the implementation of this regulatory sampling
program, FSIS inspection program personnel collected AMR product
samples for analysis for the presence of spinal cord tissue only if
they believed that the establishment was not completely removing spinal
cord from the vertebral column before the vertebral bones entered the
AMR system (FSIS Directive 7160.2, April 14, 1997). Under the revised
regulatory sampling program, FSIS inspection program personnel take
samples of beef AMR product on a routine basis to verify that spinal
cord tissue is not present in such product (FSIS Directive 7160.03,
Revision 1, August 25, 2003). If spinal cord tissue is detected in beef
AMR product, FSIS inspection program personnel take regulatory control
action against the AMR product and equipment to prevent misbranded
product from entering commerce. If the establishment has distributed
misbranded beef AMR product, FSIS requests a voluntary recall.
Removal of the spinal cord before the vertebral columns enter the
AMR system does not always ensure that spinal cord or DRG will not be
incorporated into the final product. The Harvard study found that, if a
beef carcass is mis-split when the spinal cord is removed, a portion of
the spinal cord may remain encapsulated in the spinal canal of the
vertebral column, and, if it is not removed before the vertebral bones
enter the AMR system, the spinal cord could contaminate the final AMR
product. Even when the spinal cord is completely removed from the
vertebral column, the DRG of cattle are firmly attached to the bones of
the vertebral column and are not removed along with the spinal cord.
Thus, removing the spinal cord from the vertebral column does not
prevent the DRG from entering an AMR system and becoming incorporated
into the final AMR product.
Although FSIS and the regulated industry have recently taken
actions to prevent the incorporation of spinal cord and, in some
instances, DRG, in beef AMR products (Ref. 15 and 16, available for
viewing by the public in the FSIS docket room), FSIS continues to
detect spinal cord and DRG in its routine regulatory sampling of beef
AMR products, although to a lesser extent than it did in the 2002 Beef
AMR Survey. In its routine regulatory sampling conducted from March to
December in 2003, FSIS detected spinal cord in 23 of 340 randomly
scheduled samples, an estimated prevalence of 6.8 percent. In addition,
the prevalence in follow-up samples was 13.6 percent, indicating that
establishments with an initial positive continued to have some problems
controlling for spinal cord in beef AMR systems. While FSIS was testing
samples for spinal cord, FSIS also recorded the results for DRG. The
prevalence for DRG was found in 10.9 percent of the samples in which
DRG was recorded.
Under the current regulations, AMR product that contains DRG is not
misbranded and can be identified as meat. However, given the nature of
DRG, and the fact that BSE has been confirmed in a cow in the United
States, FSIS has reconsidered its approach to this tissue and is
issuing a separate interim final rule on AMR systems in this edition of
the Federal Register that reflects recent developments that have
occurred with regard to BSE. The interim final rule on AMR systems also
establishes non-compliance criteria to discern ``meat'' from non-meat
product.
Mechanically Separated (MS)(Beef). MS(Beef) meat food product is a
finely comminuted product resulting from the mechanical separation and
removal of most of the bone from attached skeletal muscle of cattle
carcasses and parts of carcasses that meets the specifications
contained in 9 CFR 319.5, the regulation that prescribes the standard
of identity for MS(Species). Unlike AMR systems in which bone and bone
products are not purposefully incorporated in the final meat product,
MS(Species) systems are designed to purposefully incorporate
significant amounts of bone and bone components in the resulting meat
food product. The specifications for product identified as MS(Species)
in 9 CFR 319.5 do not establish limits on the incorporation of spinal
cord or DRG into this product. Although beef products produced using
AMR systems that contain spinal cord cannot be identified as meat, if
these products meet the specifications contained in 9 CFR 319.5, they
are permitted to be labeled as MS(Beef).
Under the current regulations, MS(Species) product is permitted for
use as an ingredient in other processed meat and poultry products in
limited amounts (9 CFR 319.6). When MS(Beef) is used as an ingredient
in meat or poultry products, it must be identified in the ingredients
statement as

[[Page 1867]]

MS(Beef). However, the fact that MS(Beef) may contain spinal cord or
DRG is not required to be conveyed on the labeling of MS(Beef) product
or processed products that contain MS(Beef).
The fact that MS(beef) has been permitted to include spinal cord
and DRG makes this product an obvious source of potential human
exposure to the BSE agent. Given that a case of BSE was recently
confirmed in the United States, FSIS believes that it is necessary to
remove this high-risk product from the human food supply. Therefore, in
this interim final rule, the Agency is banning the use of MS(beef) for
human food. Accordingly, no product may bear the label (MS(Beef)).
However, certain products from bones that do not contain CNS tissue,
e.g., long bones, that may contain excess bone solids or bone marrow
may be produced but must be labeled with an appropriate common or usual
name (refer to the interim final rule, ``Meat Produced by Advanced
Meat/Bone Separation Machinery and Meat Recovery Systems,'' docket
number 03-038IF published in this edition of the Federal Register).

The Harvard Risk Assessment

In April 1998, USDA commissioned the Harvard Center for Risk
Analysis to conduct an analysis and evaluation of the current measures
implemented by the United States government to prevent the spread of
BSE in the United States and to reduce the potential exposure of
Americans to the BSE agent. The risk assessment (referred to below as
the Harvard study) reviewed available scientific information related to
BSE and other TSEs, assessed pathways by which BSE could potentially
occur in the United States, and identified measures that could be taken
to protect human and animal health in the United States (Ref. 17,
available for viewing by the public in the FSIS docket room and on the
Internet at http://www.fsis.usda.gov/OA/topics/bse.htm).
The Harvard study concluded that if introduced, due to the
preventive measures currently in place in the United States, BSE is
extremely unlikely to become established in the United States. Should
BSE enter the United States, the Harvard study concluded that only a
small amount of potentially infective tissues would likely reach the
human food supply and be available for human consumption. The Harvard
study expressed the amount of infectivity in terms of cattle oral ID50s
for the purpose of quantifying both animal and human exposure to the
BSE agent. A cattle oral ID50 is the amount of infectious tissue that
would be expected to cause 50% of exposed cattle to develop BSE.
Because the exact quantitative relationship between human exposure
to the BSE agent and the likelihood of human disease is unknown, the
Harvard study did not evaluate the quantitative likelihood that humans
will develop vCJD if BSE were introduced into the United States.
The Harvard study also did not address potential human exposure to
the BSE agent through products containing ingredients of bovine origin,
such as some pharmaceuticals, gelatin, and beef stocks, extracts, and
flavorings. Many of these products are derived through the edible
rendering process. FSIS is working with FDA, the agency that regulates
the use of these products, to address the impact of this issue.
The Harvard study identified three pathways or practices that could
contribute most to either human exposure to the BSE agent or to the
spread of BSE should it be introduced into the United States. The three
pathways are:
[sbull] Noncompliance with FDA regulations prohibiting the use of
certain proteins in feed for cattle and other ruminants;
[sbull] Rendering of animals that die on the farm and use (through
illegal diversion or cross-contamination) of the rendered product in
ruminant feed;
[sbull] Inclusion of high-risk tissue from cattle, such as brain
and spinal cord, in edible products.
FDA and USDA's APHIS are taking action to address the first two
pathways. FDA is enhancing its enforcement of the feed ban and is
evaluating whether further rulemaking is needed (see Advance Notice of
Proposed Rulemaking, ``Substances Prohibited From Use in Animal Food or
Feed; Animal Proteins Prohibited in Ruminant Feed,'' 67 FR 67572,
November 6, 2002). APHIS is developing approaches to control the
potential risk that dead stock and non-ambulatory animals could serve
as potential pathways for the spread of BSE (see Advance Notice of
Proposed Rulemaking, ``Risk Reduction Strategies for Potential BSE
Pathways Involving Downer Cattle and Dead Stock of Cattle and Other
Species,'' 68 FR 2703, January 21, 2003). FSIS is prohibiting the use
of certain materials from cattle for human food to address the third
potential pathway identified in the Harvard study, the inclusion of
high-risk tissues in edible product. In addition, in a separate
rulemaking published in this edition of the Federal Register, FSIS is
prohibiting the use of penetrative stunning devices that inject air
into the cranial cavity of cattle to ensure that portions of the brain
are not dislocated into the tissues of the carcass as a consequence of
humanely stunning cattle during the slaughter process (see
``Prohibition on the Use of Certain Stunning Devices Used to Immobilize
Cattle During Slaughter,'' Docket 01-033IF). Although FSIS is
not aware of any cattle slaughter establishments in the United States
that use air-injection stunning, research has shown that this practice
poses a risk of exposing humans to materials that could contain the BSE
agent. Given that a case of BSE was recently confirmed in the United
States, FSIS believes that this prohibition is a necessary measure to
help strengthen the U.S. Government's actions to prevent human exposure
to the BSE agent.
The Harvard study concluded that, based on conditions as they
existed in 2001, if 10 infected cows were introduced into the United
States, on average, three additional new cases of BSE in cattle would
be expected. In fact, Harvard predicted that there was a 75 to 95%
chance that there would be no new cases at all. The extreme case (95th
percentile of the distribution) predicted 11 new cases. However, in all
cases, the system in 2001 was robust enough so that model predicts that
the disease would be quickly cleared from the United States with
virtually no chance that there would be any infected animals 20 years
following the import of the 10 infected cattle.
The Harvard study concluded the greatest sources of potential human
exposure to the BSE agent would be human consumption of cattle brain
(26% of the total potential exposure on average), cattle spinal cord
(5% of the total potential exposure on average), and beef products
derived from AMR systems (57% of the total potential exposure on
average). The Harvard study also determined that other potential human
exposure routes to the BSE agent include consumption of bone-in beef
(11% of the total potential exposure on average), and intestine (2% of
the total potential exposure on average). However, as stated in the
Harvard study report, these estimates are likely to overstate true
human exposure because they represent the amount of infectivity
presented for human consumption but do not take into account waste or
actual consumption rate. For example, the reported quantity for
potential exposure to infectivity in bone-in beef reflects the presence
of spinal cord and DRG in a fraction of cuts like T-bone steaks,
although the spinal cord and DRG may never be consumed in these cuts of
meat.

[[Page 1868]]

The Harvard study divided potential sources of human exposure to
BSE infectivity into two categories: specific high-risk tissues and
contamination of low risk tissues with high-risk tissues. Specific
high-risk tissues identified by Harvard, in order of infectivity,
include: brain, spinal cord, DRG, distal ileum, and the trigeminal
ganglia and other tissues found in the head (e.g., eyes). Since brain
and spinal cord of cattle infected with BSE contain most of the BSE
infectivity in the animal, the Harvard study concluded that, if BSE
were present in the United States, human consumption of bovine brains
and spinal cords would be an obvious source of exposure to the BSE
agent.
The Harvard study identified the production of meat through the use
of AMR systems as the most important means by which low risk tissue can
become contaminated with high-risk tissues because AMR systems can
leave spinal cord and DRG in the recovered meat. Assuming that there is
no SRM ban in place, the Harvard study estimated that beef AMR product
could account for approximately 57% of the potential human exposure to
the BSE agent.

Specified Risk Materials (SRMs)

Materials designated as SRMs. In determining which materials of
cattle should be removed from the human food supply, FSIS considered
the data on the age distribution of confirmed BSE cases in the United
Kingdom, the findings of the pathogenesis studies conducted in the
United Kingdom, and the findings of the BSE risk analysis conducted by
Harvard.
After considering the factors mentioned above, together with the
fact that a case of BSE was recently confirmed in the United States,
FSIS has decided to designate 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 of cattle 30 months of age and
older, and the tonsils and distal ileum of all cattle as SRMs, declare
them inedible, and prohibit their use for human food. The Agency
believes that removing these materials from the human food supply is a
prudent and appropriate measure for preventing human exposure to the
BSE agent in the United States.
Except for the skull and vertebral column (excluding the vertebrae
of the tail, the transverse processes of the thoracic and lumbar
vertebrae, and the wings of the sacrum) of cattle 30 months of age and
older, the materials listed as SRMs in this interim final rule are all
materials that have demonstrated infectivity in cattle naturally or
experimentally infected with BSE. Thus, in this rule, FSIS is
designating all materials from cattle that have demonstrated BSE
infectivity as SRMs, regardless of the level or proportion of
infectivity contained in each tissue.
Although the skull or 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, FSIS is
including skulls and vertebral columns (excluding the vertebrae of the
tail, the transverse processes of the thoracic and lumbar vertebrae,
and the wings of the sacrum) from cattle 30 months of age and older in
the list of SRMs that the Agency is declaring inedible and prohibiting
for human food. Head meat, cheek meat, and tongue are not part of the
skull. Therefore, under this interim final rule, these materials may
continue to be used for human food, provided they are not contaminated
with SRM. 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 is excluding these parts of the vertebral column
from the materials designated as SRMs. Under this interim final rule,
bone-in beef from cattle 30 months of age and older may be prepared
from these sections of the vertebral column. These sections of the
vertebral column may also be used as a source material for products
produced from edible rendering.
The Harvard study identified the production of meat through the use
of AMR systems as the most important means by which low risk tissue can
become contaminated with high-risk tissues, such as spinal cord and
DRG. Furthermore, as discussed above, although FSIS and the regulated
industry have taken actions to prevent the incorporation of spinal cord
and, in some instances, DRG, in beef AMR products, FSIS continues to
detect spinal cord and DRG in its routine regulatory sampling of this
product. By designating the vertebral column (excluding the vertebrae
of the tail, the transverse processes of the thoracic and lumbar
vertebrae, and the wings of the sacrum) from cattle 30 months of age
and older as SRM and prohibiting its use for human food, FSIS will
ensure that spinal cord and DRG from cattle 30 months of age and older
are not incorporated into beef AMR product.
The Harvard study determined that some potential exposure to BSE
infectivity would result from the presence of spinal cord and DRG in
certain bone-in cuts of beef, such as T-bone steaks. By designating
vertebral column (excluding the vertebrae of the tail, the transverse
processes of the thoracic and lumbar vertebrae, and the wings of the
sacrum) from cattle 30 months of age and older as SRM and prohibiting
its use for human food FSIS will ensure that bone-in cuts of meat from
cattle 30 months of age and older will not contain spinal cord or DRG.
The Harvard study did not address potential human exposure to the
BSE agent through beef stocks, broths, or other products produced from
the edible rendering process. However, it is possible that, when
vertebral column bones are used as a source material for products
produced from edible rendering, spinal cord and DRG could become
dislodged from the vertebral bones and incorporated into the final
product. By designating vertebral column (excluding the vertebrae of
the tail, the transverse processes of the thoracic and lumbar
vertebrae, and the wings of the sacrum) from cattle 30 months of age
and older as SRM and prohibiting its use for human food FSIS will
ensure that spinal cord and DRG from cattle 30 months of age and older
will not be incorporated into beef products produced from the edible
rendering process.
Because of its proximity to the vertebral column, some hand-deboned
meat may contain DRG depending on the technique used to recover the
meat from the bone. Thus, hand-deboned meat from cattle could be a
potential source of human exposure to DRG. FSIS is not aware of any
data on the extent to which DRG are found in hand-deboned meat. FSIS is
examining this issue in a study it is conducting to delineate the
characteristics of hand-deboned meat. FSIS is not, at this time,
prohibiting hand-deboned meat from the vertebral columns of cattle 30
months of age and older for use as human food. The Agency requests
comments on this issue.
The SRMs prohibited for human food in this interim final rule are
the same materials prohibited for use as human food by Canada, thus
establishing a consistent standard in both countries. The Canadian SRMs
include the skull, brain, trigeminal ganglia, eyes, tonsils, spinal
cord, and DRG from cattle 30 months of age and older, and distal ileum
from all cattle. Although the vertebral column (excluding the vertebrae
of the tail, the transverse process of the thoracic and lumbar

[[Page 1869]]

vertebrae, and the wings of the sacrum) from cattle 30 months of age
and older is not identified as SRM in the Canadian regulations, to
ensure complete removal of potentially risky DRG from the human food
supply, the Canadian Food Inspection Agency (CFIA) requires that the
vertebral column of cattle 30 months of age and older, excluding the
vertebrae of the tail, the transverse processes of the thoracic and
lumbar vertebrae, and the wings of the sacrum, be removed and disposed
of as inedible product (Meat Hygiene Directive 2003-18 (Amended), July
24 2003). The CFIA also prohibits the use of vertebral columns from
cattle 30 months of age and older as a raw material in the preparation
of mechanically separated meat or finely textured meat (Meat Hygiene
Directive 2003-18 (Amended), July 24, 2003). The Canadian provisions
for the removal of SRMs from the carcasses of cattle slaughtered in
official Canadian establishments can be accessed on the Internet at
http://www.inspection.gc.ca/english/anima/meavia/mmopmmhv/chap4/annexne.shtml.
The Canadian SRMs include the distal ileum from all cattle.
However, the CFIA presently requires that the small intestine of all
cattle be removed and disposed of as inedible product (Meat Hygiene
Directive 2003-18 (Amended), July 24, 2003). Therefore, FSIS is
designating, consistent with the Canadian rule, the distal ileum of the
small intestine as SRM. To ensure that the distal ileum is completely
removed from the carcass, FSIS is requiring that establishments remove
the entire small intestine and that it be disposed of as inedible.
Processors may be able to effectively remove just the distal ileum,
and, accordingly, the Agency requests comments on this issue.
Rationale. Given the way that infectivity occurs in BSE-infected
cattle, and the fact that a case of BSE has been detected in the United
States, FSIS has determined that certain materials from cattle present
sufficient risk of exposing humans to the BSE agent that it is prudent
and appropriate to find that such materials are unfit for human food
within the meaning of section 1(m)(3) of the FMIA (21 U.S.C.
601(m)(3)). For the reasons presented above, FSIS has concluded that
these materials are 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 of cattle 30 months of age and older, and
the tonsils and distal ileum of all cattle.
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 of cattle 30 months of age and older, and the tonsils and distal
ileum of all cattle, present a persistent risk of exposing humans to
the BSE agent because, in pre-clinical BSE-infected cattle, infectivity
in most of these tissues is not readily ascertainable. Thus, humans
could unknowingly be exposed to the BSE agent through consumption of
these materials.
By designating 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 of cattle 30 months of age and older, and
the tonsils and distal ileum of all cattle as SRMs, declaring that they
are inedible, and prohibiting their use for human food, FSIS will
ensure that materials that could present a significant risk to human
health, but whose infectivity status cannot be readily ascertained, are
excluded from the human food supply.

Procedures for the Removal, Segregation, and Disposition of SRMs

In this interim final rule, FSIS is requiring that establishments
that slaughter cattle and establishments that process the carcasses or
parts of cattle develop, implement, and maintain written procedures for
the removal, segregation, and disposition of SRMs (section
310.22(d)(1)). The Agency is not prescribing specific procedures that
establishments must follow because FSIS believes that establishments
should have the flexibility to implement the most appropriate
procedures that will best achieve the requirements of this rule.
Establishments are responsible for ensuring that SRMs are
completely removed from the carcass, segregated from edible products,
and disposed in an appropriate manner. Establishments must address
their control procedures in their HACCP plans, Sanitation SOPs, or
other prerequisite programs. FSIS will ensure the adequacy and
effectiveness of the establishment's procedures.
This interim final rule also requires (section 310.22(d)(4)) that
establishments that slaughter cattle and establishments that process
the carcasses or parts of cattle maintain daily records that document
the implementation and monitoring of their procedures for the removal,
segregation, and disposition of SRMs, and that the establishments make
these records available to FSIS personnel on request.
FSIS will develop compliance guidelines for use by very small and
small establishments to assist them in the development of validated
methods for meeting the requirements of this interim final rule. FSIS
believes that the use of the Canadian guidance on SRM removal generally
is acceptable. FSIS will assess whether additional guidance is
necessary (see the FSIS docket room and the FSIS Web site for the link
to the Canadian and other compliance guidance information).

Verification of the Age of Cattle

Most of the materials that FSIS is prohibiting for use as human
food in this rulemaking are from cattle 30 months of age and older.
Thus, FSIS is prescribing the method that inspection program personnel
will use to determine the age of cattle slaughtered in official
establishments, to verify that the establishments are effectively
segregating SRMs from edible materials.
The Agency is aware of two methods that can be used to verify the
age of cattle slaughtered in official establishments: (1) Documentation
that identifies the age of the animal, such as a birth certificate,
cattle passport, or some other form of identification, that is
presented with the animal when it arrives for slaughter, and (2)
examination of the dentition of the animal to determine whether at
least one of the second set of permanent incisors has erupted (the
permanent incisors of cattle erupt from 24 through 30 months of age).
The Agency has decided to use a combination of both methods.
If the establishment has records that document the age of the
cattle slaughtered in the facility, FSIS inspection program personnel
will examine the records. If the inspection program personnel conclude
that the records are accurate and reliable, they will accept the
records as verification of the age of the cattle. However, if FSIS
inspection program personnel examine the records and find significant
reasons for questioning their validity, they will verify the age of the
cattle through dental examination. If the establishment does not have
records that document the age of the cattle presented for slaughter, or
the inspection program personnel have any reason to question the age of
the animals, the Agency will verify age through dental examination.
In establishments that only process the carcasses and parts of
carcasses of cattle, the Agency will verify age through establishment
records that document the age of the cattle from

[[Page 1870]]

which the carcasses were derived. If the establishment does not have
records that document the age of the cattle from which the carcasses
were derived, it must handle all carcasses and parts of carcasses as if
they came from cattle 30 months of age and older.
Although there are various methods of cattle identification in the
United States, there is no national cattle identification system. Thus,
there is currently no uniform standard of documentation that FSIS can
rely on to accurately verify the age of cattle slaughtered in official
establishments. On December 30, 2003, the Secretary of Agriculture
announced that the USDA will implement a system of national animal
identification. The development of such a system has been underway for
more than a year and a half to achieve uniformity, consistency, and
efficiency across this national system.
FSIS has developed instructions for use by its inspection personnel
in verifying the age of cattle that is available for viewing by the
public in the FSIS docket room and posted on the FSIS Web site.

Non-Ambulatory Disabled Cattle

Current regulatory requirements. FSIS' regulations prohibit for use
as human food all livestock, including cattle, with clinical signs of a
CNS disorder (9 CFR 309.4) and livestock that are in a dying condition
or that died otherwise than by slaughter (9 CFR 309.3). Under the
current regulation, all seriously crippled livestock and livestock
commonly termed ``downers'' presented for slaughter are automatically
suspected of being affected with a disease or condition that may
require condemnation of the animal, in whole or in part, and are
identified as ``U.S. Suspects'' (9 CFR 309.2(b)). Such animals are
examined at ante-mortem inspection by an FSIS veterinarian, and a
record of the veterinarian's clinical findings accompanies the carcass
to post-mortem inspection if the animal is not condemned on ante-mortem
inspection.
Post-mortem inspections of the carcasses of ``U.S. Suspect''
livestock are performed by veterinarians rather than by food
inspectors, and the results of this inspection are recorded. ``U.S.
Suspects,'' unless otherwise released pursuant to 9 CFR 309.2(p), must
be set apart and slaughtered separately (9 CFR 309.2(n)). If, on post-
mortem inspection, the meat and meat food products from such animals
are found to be not adulterated, such products may be used for human
food (9 CFR 311.1).
Non-ambulatory cattle and BSE. Surveillance data from European
countries in which BSE has been detected, indicate that cattle with
clinical signs of a CNS disorder, dead cattle, and cattle that can not
rise from a recumbent position (in Europe these cattle are
distinguished either as ``fallen stock'' if not for human consumption
or ``emergency slaughter'' cattle if for human consumption) have a
greater incidence of BSE than healthy slaughter cattle. For example, in
2002 the EU reported that for healthy cattle 55-60 months of age, there
were 0.55 positive tests for BSE per 10,000 animals tested compared
with 3.05 positive tests for BSE per 10,000 cattle tested for the high-
risk cattle (i.e., fallen stock, emergency slaughter and animals that
show clinical signs of BSE on ante-mortem inspection) (Ref. 18,
available for viewing by the public in the FSIS docket room). In
addition, an analysis of a targeted screening program for BSE in
Switzerland found that when high-risk cattle were targeted for BSE
testing, the odds of finding a BSE case was 49 times higher in fallen
stock and 58 times higher in emergency-slaughtered cattle than in
cattle tested under passive surveillance, i.e., clinical BSE suspects
reported to the veterinary authorities (Ref. 19, available for viewing
by the public in the FSIS docket room). This study also found that the
BSE cases detected through targeted screening of high risk animals were
on average four months younger than the BSE cases detected through
passive surveillance of clinical suspects.
Surveillance for BSE in Europe has also shown that the typical
clinical signs associated with BSE cannot always be observed in non-
ambulatory cattle infected with BSE because the signs of BSE often
cannot be differentiated from the typical clinical signs of the many
other diseases and conditions affecting non-ambulatory cattle.
Furthermore, as discussed in greater detail below, there are
limitations with the diagnostic tests for BSE that are available today.
Under the current testing methods, which are conducted on sections of
the brain or spinal cord, certain tissues of cattle infected with BSE,
such as the distal ileum and tonsils, may contain BSE infectivity even
though the diagnostic test does not show that the animal has the
disease. Thus, permitting the carcasses of non-ambulatory cattle to be
used for human food if the animal tests negative for BSE will not
provide the same level of protection against human exposure to the BSE
agent that prohibiting these cattle from entering the human food supply
will.
Revised regulatory requirements. Because they present a risk of
introducing the BSE agent into the human food supply, FSIS has
determined that the carcasses of non-ambulatory disabled cattle are
unfit for human food under section 1(m)(3) of the FMIA and that all
non-ambulatory disabled cattle that are presented for slaughter should
be condemned. Therefore, FSIS is amending its ante-mortem inspection
regulations to require the condemnation of non-ambulatory disabled
cattle presented for slaughter.
Specifically, FSIS is amending the regulations that prescribe
requirements for ``U.S. Suspect'' livestock in 9 CFR 309.2 by replacing
the reference to ``animals commonly termed `downers' ' in Sec.
309.2(b) with the term ``non-ambulatory disabled livestock.'' FSIS is
making this modification because there is currently no regulatory
definition of ``downer'' and the Agency believes that the term ``non-
ambulatory disabled'' more accurately describes the cattle that it
believes should be prohibited for human food. ``Non-ambulatory disabled
livestock'' is defined as livestock that cannot rise from a recumbent
position or that cannot walk, including, but not limited to, those with
broken appendages, severed tendons or ligaments, nerve paralysis,
fractured vertebral column, or metabolic conditions. Thus, this
definition includes livestock that are non-ambulatory due to an acute
injury in route to the slaughter facility, such as a broken leg, as
well as livestock that are non-ambulatory due to an underlying
pathological condition.
FSIS is excluding all non-ambulatory disabled cattle from the human
food supply, regardless of the reason for their non-ambulatory status
or the time at which they became non-ambulatory. Thus, if an animal
becomes non-ambulatory in route to the establishment due to an acute
injury, it must be humanely removed from the truck, humanely
euthanized, and the carcass properly disposed of. Likewise, cattle that
become non-ambulatory on the establishment premises, such as an animal
that breaks its leg as it is unloaded from the truck, are also required
to be humanely moved, humanely euthanized, and the carcass properly
disposed of.
FSIS is also amending the regulations that prescribe requirements
for dead, dying, disabled, or diseased and similar livestock in 9 CFR
309.3 to require that non-ambulatory disabled cattle be condemned and
disposed of in accordance with 9 CFR 309.13. Unless another provision
in part 309 applies, under Sec. 309.13, condemned livestock must be
killed by the establishment, if

[[Page 1871]]

not already dead. Such animals cannot be taken into the establishment
to be slaughtered or dressed, or conveyed into any department of the
establishment that is used for edible products. The carcasses of
condemned livestock must be disposed of in the manner provided for in
part 314.
Under part 314, condemned carcasses must be disposed of by
``tanking,'' i.e., inedible rendering (9 CFR 314.1). For those
establishments that do not have facilities for tanking, condemned
carcasses may be disposed of by incineration or denatured by crude
carbolic acid, cresylic disinfectant, a formula consisting of one part
FD&C No. 3 green coloring, 40 parts water, 40 parts liquid detergent,
and 40 parts oil of citronella, or any other proprietary material
approved by the Administrator of FSIS (9 CFR 314.3). The Agency is
aware that many establishments use activated charcoal to denature
inedible materials. Therefore, FSIS recognizes activated charcoal as a
proprietary substance approved by the Administrator.
The regulations in 9 CFR 311.27 permit injured livestock to be
slaughtered for humane reasons at hours when an inspector is not
available to perform ante-mortem inspection, provided that the
carcasses and parts of such animals are kept for inspection. To ensure
that non-ambulatory disabled cattle are not slaughtered under this
provision and their carcasses and parts used for human food, FSIS is
amending 9 CFR 311.27 to prohibit the carcasses and parts of carcasses
from cattle slaughtered on an emergency basis without ante-mortem
inspection from being used for human food. Without performing ante-
mortem inspection on cattle slaughtered on an emergency basis, FSIS
inspection program personnel cannot determine whether the carcasses or
parts from such cattle came from a non-ambulatory disabled animal, and
thus cannot find that the carcasses and parts from these emergency
slaughter cattle are not adulterated.

Testing Cattle for BSE

There is no sensitive and reliable live animal test for BSE, and
the available post-mortem diagnostic tests can only indicate that
cattle have the disease two to three months before the onset of
clinical disease or after the onset of clinical disease. Given the
limitations of the diagnostic tests available today, which are
conducted on sections of the brain or spinal cord, certain tissues of
cattle infected with BSE, such as distal ileum and small intestine, may
contain BSE infectivity even though the diagnostic test will not show
that the animal has the disease. Thus, exempting materials from cattle
that test negative for BSE from the restrictions in this rulemaking
will likely not provide the same level of protection as prohibiting
those materials for use as human food.
Therefore, under this interim final rule, the use of specified risk
materials from cattle is prohibited for human food regardless of
whether the animal has been tested for BSE. FSIS requests comments on
whether further consideration should be given to exempting cattle that
have tested negative for BSE from the requirements contained in this
interim final rule, and if so, what testing methods and protocols the
Agency should accept as providing acceptable and reliable results.

Request for Comments

FSIS requests comments on the measures contained in this interim
final rule, and specifically on whether the Agency has chosen measures
that are most appropriate for preventing human exposure to the BSE
agent in the United States.

Emergency Action

The fact that a cow in Washington State tested as positive for BSE
on December 23, 2003, makes this rulemaking necessary on an emergency
basis. As discussed above, BSE infectivity has been confirmed in the
brain, eyes, trigeminal ganglia, tonsils, spinal cord, DRG and distal
ileum. Furthermore, most of these tissues have demonstrated infectivity
before experimentally infected animals developed clinical signs of
disease. Thus, BSE infectivity in these tissues is not readily
ascertainable. Therefore, FSIS has determined that it must take
immediate action to ensure that materials that could present a
significant risk to human health are excluded from the human food
supply.
Under these circumstances, the FSIS Administrator has determined
that prior notice and opportunity for public comment are contrary to
the public interest, and that there is good cause under 5 U.S.C. 553
for making this rule effective less than 30 days after publication in
the Federal Register. FSIS will consider comments received during the
comment period for this interim rule (see DATES above). After the
comment period closes, the Agency will publish another document in the
Federal Register. The document will include a discussion of any
comments received in response to this interim rule and any amendments
made as a result of those comments.
In an effort to ensure that establishments comply with this interim
final rule upon publication in the Federal Register, FSIS will provide
guidance to inspection program personnel regarding the implementation
strategy. At a minimum, FSIS inspection program personnel will be
directed to meet with management of each affected establishment to
discuss how and when the establishment expects to complete its
reassessment of its HACCP plan and to ensure that SRMs and MS (Beef) do
not adulterate product.

Executive Order 12866 and Regulatory Flexibility Act

This rule has been reviewed under Executive Order 12866. It has
been determined to be economically significant for purposes of
Executive Order 12866 and therefore, has been reviewed by the Office of
Management and Budget (OMB).
The emergency situation surrounding this rulemaking makes timely
compliance with Executive Order 12866 and the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.) impracticable.
FSIS is currently assessing the potential economic effects of this
action. When this work is complete, the Agency will publish a notice of
availability in the Federal Register and will provide an opportunity
for public comment.

Executive Order 12988

This interim final rule has been reviewed under Executive Order
12988, Civil Justice Reform. This rule: (1) Preempts State and local
laws and regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule. However,
the administrative procedures specified in 9 CFR 306.5. must be
exhausted before any judicial challenge of the application of the
provisions of this interim final rule, if the challenge involves any
decision of an FSIS employee relating to inspection services provided
under the FMIA or PPIA.

Paperwork Reduction Act

In accordance with section 3507(j) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection and
recordkeeping requirements included in this interim final rule have
been submitted for emergency approval to the Office of Management and
Budget (OMB).
Title: Prohibition of the Use of Specified Risk Materials for Human
Food and Requirements for the Disposition of Non-Ambulatory Disabled
Cattle.

[[Page 1872]]

Type of collection: New.
Abstract: In this interim final rule, FSIS is requiring that
establishments that slaughter cattle and establishments that process
the carcasses or parts of cattle develop written procedures for the
removal, segregation, and disposition of SRMs. FSIS is also requiring
that these establishments maintain daily records sufficient to document
the implementation and monitoring of their procedures for the removal,
segregation, and disposition of SRMs, and any corrective actions taken.
These records are needed for FSIS to verify the effectiveness of an
establishment's procedures.
Estimate of burden: FSIS estimates that it will take establishments
approximately 8 hours to develop written procedures for the removal,
disposition, and segregation of SRMs. FSIS estimates that an
establishment will spend about five minutes a day developing an average
of nine monitoring records, which includes documentation of any
corrective actions taken, and an additional two minutes a day to file
each record.
Respondents: Official establishments that slaughter cattle and
official establishments that process the carcasses or parts of cattle.
Estimated Number of Respondents: 2,500.
Estimated Number of Responses per Respondent: 2,701.
Estimated Total Annual Burden on Respondents: 807,500 hours.
Copies of this information collection assessment can be obtained
from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety
and Inspection Service, USDA, 112 Annex, 300 12th Street, SW.,
Washington, DC 20250 Comments are invited on: (a) Whether the
collection of information is necessary for the proper performance of
the functions of the Agency, including whether the information will
have practical utility; (b) the accuracy of the Agency's estimate of
the burden of the collection of information, including the validity of
the methodology and assumptions used; (c) ways to enhance the quality,
utility, and clarity of the information to be collected, ways to
minimize the burden of the collection of information on those who are
to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques,
or other forms of information technology. Comments may be sent to both
John O'Connell, Paperwork Reduction Act Coordinator, at the address
provided above, and the Desk Officer for Agriculture, Office of
information and Regulatory Affairs, Office of Management and Budget,
Washington, DC 20253. To be most effective, comments should be sent to
OMB within 30 days of the publication date of this interim final rule.

Government Paperwork Elimination Act (GPEA)

FSIS is committed to achieving the goals of the GPEA, which
requires that Government agencies, in general, provide the public with
the option of submitting information or transacting business
electronically to the maximum extent possible. Under this interim final
rule, records that document the implementation and monitoring of an
establishment's procedures for the removal, segregation, and
disposition of SRMs may be maintained on computers, provided that the
establishment implements appropriate controls to ensure the integrity
of the electronic data. Allowing establishments to comply with the
required recordkeeping requirements will reduce data collection time,
and information processing and handling by the regulated industry and
FSIS.

Additional Public Notification

Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to better ensure
that minorities, women, and persons with disabilities are aware of this
final interim final rule and are informed about the mechanism for
providing their comments, FSIS will announce it and provide copies of
this Federal Register publication in the FSIS Constituent Update. FSIS
provides a weekly FSIS Constituent Update, which is communicated via
fax to over 300 organizations and individuals. In addition, the update
is available on line through the FSIS Web page located at http://www.fsis.usda.gov. The update is used to provide information regarding
FSIS policies, procedures, regulations, Federal Register notices, FSIS
public meetings, recalls, and any other types of information that could
affect or would be of interest to our constituents/stakeholders. The
constituent fax list consists of industry, trade, and farm groups,
consumer interest groups, allied health professionals, scientific
professionals, and other individuals that have requested to be
included. Through these various channels, FSIS is able to provide
information to a much broader, more diverse audience. For more
information and to be added to the constituent fax list, fax your
request to the Congressional and Public Affairs Office, at (202) 720-
5704.

References

The following sources are referred to in this document. All have
been placed on display in the FSIS Docket Room (address above) and may
be seen by interested persons between 8:30 a.m. and 4:30 p.m., Monday
through Friday. Materials that are not copyright protected may also be
accessed on the FSIS Web site as related documents to this interim
final rule.

1. Will, R.G., et al., A new variant of Creutzfeldt-Jakob disease
in the UK. Lancet 347, 921-925 (1996).
2. Collinge, J., et al., Molecular analysis of prion strain
variation and the aetiology of ``new variant'' CJD. Nature 383, 685-690
(1996).
3. Bruce, M.E., et al., Transmission to mice indicates that ``new
variant'' CJD is caused by the BSE agent. Nature 389, 498-501 (1997).
4. Scott, M.R., et al., Compelling transgenentic evidence for
transmission of bovine spongiform encephalopathy prions to humans. Proc
Natl Acad Sci USA 96, 15137-12142 (1997).
5. Belay, E.D., et al., Relationship between transmissible
spongiform encephalopathies in animals and humans. In: Task Force
Report of the Council for Agricultural Science and Technology.
Washington, DC: Council for Agricultrual Science and Technology,
October 2002, No. 136.
6. MMWR, Probable Variant Creutzfeldt-Jakob Disease in a U.S.
Resident--Florida, 2002, 51(41):927-929 (October 18, 2002).
7. Department for Environment Food and Rural Affairs, United
Kingdom, FSIS personal communication.
8. European Union Scientific Steering Committee (EU SSC), 2002.
Update on the Opinion of TSE infectivity distribution in ruminant
tissues (initially adopted by the scientific steering committee at its
meeting of 10-11 January 2002 and amended at its meeting of 7-8
November 2002) following the submission of (1) a risk assessment by the
German Federal Ministry of Consumer Protection Food and Agriculture,
and (2) new scientific evidence regarding BSE infectivity distribution
in tonsils; European Commission, Scientific Steering Committee, Health
and Consumer Protection Directorate General.
9. Department for Environment Food and Rural Affairs, United
Kingdom, DEFRA BSE Information, Youngest and oldest cases by year of
onset-GB (Passive surveillance only), September 30, 2003.

[[Page 1873]]

10. Wells, G.A.H., et al., Infectivity in the ileum of cattle
challenged orally with bovine spongiform encephalopathy. Veterinary
Record 135, 40-41 (1994).
11. Wells, G.A.H., et al., Preliminary observations on the
pathogenesis of experimental bovine spongiform encephalopathy (BSE): an
update. Veterinary Record 142, 103-106 (1998).
12. Wells, G.A.H. Limited detection of sternal bone marrow
infection in the clinical phase of experimental bovine spongiform
encephalopathy. Veterinary Record 144, 292-294 (1999).
13. United Kingdom Food Standards Agency press release, Thursday,
October 17, 2002.
14. European Union Scientific Steering Committee (EU SSC), 2001.
Opinion of 10 December 1999 of the Scientific Steering Committee on the
Human Exposure Risk (HER) via Food with Respect to BSE.
15. Analysis of 2002 FSIS Bovine AMR Products Survey Results,
prepared by the United States Department of Agriculture, Food Safety
and Inspection Service, February 2003. Available on the Internet at
http://www.fsis.usda.gov/oa/topics/AMRAnalysis.pdf.
16. The Follow-up to the Beef AMR Product Survey of 2002: Follow-up
Results and Actions for the Elimination of CNS (Spinal Cord) Tissues
from AMR Products Derived from Beef Vertebrae, prepared by the Food
Safety and Inspection Service, February 2003. Available on the Internet
at http://www.fsis.usda.gov/OA/topics/AMRSurvey.pdf.
17. Harvard Center for Risk Analysis, Harvard School of Public
Health, and Center for Computational Epidemiology, College of
Veterinary Medicine, Tuskegee University, November 26, 2001. Evaluation
of the Potential for Bovine Spongiform Encephalopathy in the United
States.
18. European Commission, 2003. ``Report on the Monitoring and
Testing of Ruminants for the Presence of Transmissible Spongiform
Encephalopathy (TSE) in 2002,'' p. 49.
19. Doherr, M.G., et al., Targeted screening of high-risk cattle
populations for BSE to augment mandatory reporting of clinical
suspects. Preventive Veterinary Medicine 51:1-2, 3-16 (2001).

List of Subjects

9 CFR Part 309

Ante-mortem inspection, Disposition of carcasses.

9 CFR Part 310

Post-mortem inspection, Disposition of carcasses.

9 CFR Part 311

Post-mortem inspection, Disposition of carcasses.

9 CFR Part 318

Entry into official establishments, reinspection and preparation of
products.

9 CFR Part 319

Food grades and standards, Food labeling, Meat inspection.

0
For the reasons discussed in the preamble, FSIS is amending 9 CFR
Chapter III as follows:

PART 309--ANTE-MORTEM INSPECTION

0
1. The authority citation for part 309 continues to read as follows:

Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

0
2. Paragraph (b) of Sec. 309.2 is revised to read as follows:

Sec. 309.2 Livestock suspected of being diseased or affected with
certain conditions; identifying suspects; disposition on post-mortem
inspection or otherwise.

* * * * *
(b) All seriously crippled animals and non-ambulatory disabled
livestock shall be identified as U.S. Suspects and disposed of as
provided in Sec. 311.1 of this subchapter unless they are required to
be classed as condemned under Sec. 309.3. Non-ambulatory disabled
livestock are livestock that cannot rise from a recumbent position or
that cannot walk, including, but not limited to, those with broken
appendages, severed tendons or ligaments, nerve paralysis, fractured
vertebral column, or metabolic conditions.
* * * * *

0
3. Section 309.3 is revised by adding a new paragraph (e) to read as
follows:

Sec. 309.3 Dead, dying, disabled, or diseased and similar livestock.

* * * * *
(e) Non-ambulatory disabled cattle shall be condemned and disposed
of in accordance with Sec. 309.13.

PART 310--POST-MORTEM INSPECTION

0
4. The authority citation for part 310 continues to read as follows:

Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

0
5. A new Sec. 310.22 is added to read as follows:

Sec. 310.22 Specified risk materials from cattle and their handling
and disposition.

(a) The following materials from cattle are specified risk
materials:
(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 dorsal root ganglia of cattle 30 months of age and older;
(2) The tonsils of all cattle; and
(3) The distal ileum of all cattle. To ensure effective removal of
the distal ileum, the establishment shall remove the entire small
intestine, and shall dispose of it in accordance with Sec. Sec. 314.1
or 314.3 of this subchapter.
(b) Specified risk materials are inedible and shall not be used for
human food.
(c) Specified risk materials shall be disposed of in accordance
with Sec. Sec. 314.1 or 314.3 of this subchapter.
(d) Procedures for the removal, segregation, and disposition of
specified risk materials.
(1) Establishments that slaughter cattle and establishments that
process the carcasses or parts of cattle shall develop, implement, and
maintain written procedures for the removal, segregation, and
disposition of specified risk materials. The establishment shall
incorporate such procedures into its HACCP plan or in its Sanitation
SOP or other prerequisite program.
(2) Establishments that slaughter cattle and establishments that
process the carcasses or parts of cattle must take appropriate
corrective action when either the establishment or FSIS determines that
the establishment's procedures for the removal, segregation, and
disposition of specified risk materials, or the implementation or
maintenance of such procedures, have failed to ensure that such
materials are adequately and effectively removed from the carcass of
cattle, segregated from edible materials, and disposed of in accordance
with paragraph (c) of this section.
(3) Establishments that slaughter cattle and establishments that
process the carcasses or parts of cattle shall routinely evaluate the
effectiveness of their procedures for the removal, segregation, and
disposition of specified

[[Page 1874]]

risk materials in preventing the use of these materials for human food
and shall revise the procedures as necessary whenever any changes occur
that could affect the removal, segregation, and disposition of
specified risk materials.
(4) Recordkeeping requirements. (i) Establishments that slaughter
cattle and establishments that process the carcasses or parts of cattle
shall maintain daily records sufficient to document the implementation
and monitoring of the procedures for the removal, segregation, and
disposition of the materials listed in paragraph (a) of this section,
and any corrective actions taken.
(ii) Records required by this section may be maintained on
computers provided that the establishment implements appropriate
controls to ensure the integrity of the electronic data.
(iii) Records required by this section shall be retained for at
least one year and shall be accessible to FSIS. All such records shall
be maintained at the official establishment 48 hours following
completion, after which they may be maintained off-site provided such
records can be made available to FSIS within 24 hours of request.
(e) The materials listed in paragraph (a)(1) of this section will
be deemed to be from cattle 30 months of age and older unless the
establishment can demonstrate that the materials are from an animal
that was younger than 30 months of age at the time of slaughter.

PART 311--DISPOSAL OF DISEASED OR OTHERWISE ADULTERATED CARCASSES
AND PARTS

0
6. The authority citation for part 311 continues to read as follows:

Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

Sec. 311.27 [Amended]

0
7. Section 311.27 is amended as follows:
0
a. By inserting ``of all livestock except for cattle'' in the first
sentence after ``the carcass and all parts'' and before ``shall be kept
for inspection''.
0
b. By adding the following new sentence at the end of the paragraph:
``The parts and carcasses of cattle slaughtered in the absence of an
inspector shall not be used for human food.''

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCTS

0
8. The authority citation for part 318 is revised to read as follows:

Authority: 7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 601-695; 7
CFR 2.18, 2.53.

Sec. 318.6 [Amended]

0
9. Section 318.6 is amended as follows:
0
a. Paragraph (b)(1) is amended by removing the word ``cattle'' and
adding the following new sentence at the end of the paragraph:
``Casings from cattle may be used as containers of products provided
the casings are not derived from the small intestine.''
0
b. Paragraph (b)(4) is amended by adding the following new sentence at
the end of the paragraph: ``Detached spinal cords from cattle 30 months
of age and older shall not be used as raw materials for edible
rendering.''
0
c. Paragraph (b)(8) is amended by adding the following new sentence at
the end of the paragraph: ``The small intestine of cattle shall not be
used in any meat food products or for edible rendering.''

PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION

0
10. The authority citation for part 319 continues to read as follows:

Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.17, 2.55.

0
11. Section 319.5 is amended as follows:
0
a. A new paragraph (b) is added to read as follows:

Sec. 319.5 Mechanically Separated Species.

* * * * *
(b) Mechanically Separated (Beef) is inedible and prohibited for
use as human food.
* * * * *

Done at Washington, DC, on January 7, 2004.
Garry L. McKee,
Administrator.
[FR Doc. 04-625 Filed 1-8-04; 1:43 pm]
BILLING CODE 3410-DM-P