[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

[[Page 1863]]

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