[Federal Register Volume 72, Number 134 (Friday, July 13, 2007)]
[Rules and Regulations]
[Pages 38700-38730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-3350]
[[Page 38699]]
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Part III
Department of Agriculture
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Food Safety and Inspection Service
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9 CFR Parts 309, 310 and 318
Prohibition of the Use of Specified Risk Materials for Human Food and
Requirements for the Disposition of Non-Ambulatory Disabled Cattle;
Prohibition of the Use of Certain Stunning Devices Used To Immobilize
Cattle During Slaughter; Rule
Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules
and Regulations
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 309, 310, and 318
[Docket No. 03-025F]
RIN 0583-AC88
Prohibition of the Use of Specified Risk Materials for Human Food
and Requirements for the Disposition of Non-Ambulatory Disabled Cattle;
Prohibition of the Use of Certain Stunning Devices Used To Immobilize
Cattle During Slaughter
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Affirmation of interim final rules with amendments.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is affirming,
with changes, the interim final rule ``Prohibition of the Use of
Specified Risk Materials for Human Food and Requirements for the
Disposition of Non-Ambulatory Cattle,'' which was published in the
Federal Register on January 12, 2004. The Agency is also affirming the
interim final rule ``Prohibition of the Use of Certain Stunning Devices
Used to Immobilize Cattle During Slaughter,'' also published on January
12, 2004. FSIS issued these interim final rules in response to the
confirmation on December 23, 2003, of bovine spongiform encephalopathy
(BSE) in an imported dairy cow in Washington State. FSIS is taking this
action to make permanent interim measures implemented by the Agency to
minimize human exposure to cattle materials that could potentially
contain the BSE agent.
DATES: This final rule is effective October 1, 2007. Comments on the
information presented under ``Paperwork Reduction Act'' must be
received by September 11, 2007.
FOR FURTHER INFORMATION CONTACT: Dr. Daniel Engeljohn, Deputy Assistant
Administrator, Office of Policy, Program, and Employee Development,
FSIS, U.S. Department of Agriculture, 1400 Independence Avenue, SW.,
Washington, DC 20250-3700, (202) 205-0495.
SUPPLEMENTARY INFORMATION:
Background
On January 12, 2004, FSIS issued a series of three interim final
rules to minimize human exposure to materials that scientific studies
have demonstrated have the potential to contain the BSE agent in cattle
infected with that disease. Scientific and epidemiological studies have
linked the human disease variant Cruetzfelt-Jacob Disease (vCJD) to
exposure to BSE, most likely through human consumption of beef products
contaminated with the BSE agent. FSIS issued the rules in response to
the diagnosis on December 23, 2003, of BSE in an imported dairy cow in
Washington State. The animal had been imported from Canada.
One of the rules, ``Prohibition of the Use of Specified Risk
Materials for Human Food and Requirements for the Disposition of Non-
ambulatory Disabled Cattle'' (69 FR 1862, January 12, 2004) (also
referred to as ``the SRM interim final rule''), designates certain
materials from cattle as specified risk materials (SRMs), declares that
SRMs are inedible, and prohibits the use of these materials for human
food (9 CFR 310.22(a) and 9 CFR 310.22(b)). The SRM interim final rule
also requires 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 and incorporate these procedures
into their HACCP plans or Sanitation Standard Operating Procedures
(SOPs) or other prerequisite programs (9 CFR 310.22(d)).
The materials identified as SRMs in the FSIS SRM interim final rule
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
dorsal root ganglia (DRG) from cattle 30 months of age and older, and
the distal ileum of the small intestine and tonsils from all cattle (9
CFR 310.22(a)). The SRM interim final rule declares that SRMs are
inedible because they present a sufficient risk of exposing humans to
the BSE agent so as to render them ``unfit for human food'' within the
meaning of section 1(m)(3) of the adulteration provisions of the
Federal Meat Inspection Act (FMIA) (21 U.S.C. 601(m)(3)).
The SRM interim final rule designates the distal ileum from all
cattle as an SRM because BSE infectivity has been confirmed in the
distal ileum in the early stages of the disease. To ensure effective
removal of the distal ileum, the SRM interim final rule originally
required that the entire small intestine be removed and disposed of as
inedible. However, in the preamble to the SRM interim final rule, FSIS
noted that beef processors may be able to effectively remove the distal
ileum from the rest of the small intestine and requested comments on
this issue (69 FR 1862, 1869). The Agency again requested comments on
this issue in an advance notice of proposed rulemaking published in
July 2004 (``Federal Measures To Mitigate BSE Risks: Considerations for
Further Action'' (69 FR 42287, 42296)).
In response to these requests, FSIS received several comments that
described detailed procedures on how to remove the distal ileum from
the small intestine. On the basis of these comments, FSIS evaluated
this issue and determined that processors have the technology to
effectively remove the distal ileum from the rest of the small
intestine. Therefore, on September 7, 2005, FSIS issued an amendment to
the SRM interim final rule to permit, under specific conditions, the
use of beef small intestine, excluding the distal ileum, for human food
(70 FR 53043).
In addition to prohibiting SRMs for use as human food, the SRM
interim final rule also prohibits the slaughter for human food of non-
ambulatory disabled cattle that are offered for slaughter. FSIS
prohibited the slaughter of these non-ambulatory disabled cattle
because surveillance data from European countries in which BSE has been
detected indicate that non-ambulatory cattle are among the cattle that
have a greater incidence of BSE than healthy slaughter cattle.
Furthermore, because the typical clinical signs of BSE often cannot be
distinguished from the typical clinical signs of other diseases and
conditions that affect non-ambulatory cattle, FSIS determined that non-
ambulatory disabled cattle present a sufficient risk of introducing the
BSE agent into the human food supply so as to render the carcasses of
these animals unfit for human food under section 1(m)(3) of the FMIA.
The SRM interim final rule requires that all non-ambulatory disabled
cattle that are offered for slaughter be condemned (9 CFR 309.3(e)).
In addition to the SRM interim final rule, FSIS published two other
interim final rules in response to the confirmation of BSE in the cow
in Washington State. One of the rules, Prohibition of the Use of
Certain Stunning Devices Used to Immobilize Cattle During Slaughter (69
FR 1885) (also referred to as ``the air-injection stunning interim
final rule''), prohibits the use of captive bolt stunning devices that
deliberately inject air into the cranial cavity of cattle. The other
rule, ``Meat Produced by Advanced Meat/Bone Separation Machinery and
Meat Recovery (AMR) Systems'' (69 FR 1874) (also referred to as ``the
AMR interim final rule''), establishes requirements for meat produced
using AMR systems. In this document, FSIS is affirming
[[Page 38701]]
without amendment the air-injection stunning interim final rule.
Because the AMR interim final rule contains several non-BSE related
provisions, FSIS intends to affirm and, if necessary, amend that
interim final rule in a separate document that will be published in the
Federal Register at a later date.
Since FSIS issued the SRM, AMR, and air-injection stunning interim
final rules, the Agency has implemented a number of programs to train
its inspection personnel and help plants comply with new requirements.
FSIS has issued several notices to its inspection personnel that detail
specific aspects of the regulations, including BSE surveillance
activities in cooperation with USDA's Animal and Plant Health
Inspection Service (APHIS). In 2004, FSIS held five teaching workshops
around the country to help primarily small and very small plants
understand the regulations and help ensure compliance. As part of a
continuing outreach effort to small and very small plants, FSIS
produced workshop training materials, which remain available on the
FSIS Web site. Additionally, FSIS developed a training CD and
accompanying materials called ``The ABC's of BSE,'' which were released
as part of FSIS' distance learning program.
FSIS is confident it is successfully carrying out its mission to
protect public health by strictly enforcing safeguards designed to
protect Americans from BSE. FSIS will continuously evaluate its
policies and procedures to ensure that they remain based on the most
up-to-date science available.
Since FSIS issued the interim final rules described above, two
native cases of BSE have been confirmed in the United States. In June
2005, the disease was confirmed in a 12 year-old cow born and raised on
a ranch in Texas. In March 2006, a second case was confirmed in a cow
on a farm in Alabama. Experts confirmed through dentition that this
animal was at least 10 years old. Both animals were born before the
Food and Drug Administration (FDA) issued its 1997 prohibition on the
feeding of most mammalian protein to ruminants.
Opportunities To Comment
When it issued the interim final rules described above, FSIS gave
the public until April 12, 2004, to submit comments on the rules. The
comment period was later extended to May 7, 2004 (69 FR 18245, April 7,
2004). In addition, on July 14, 2004, APHIS, FSIS, and FDA issued an
Advance Notice of Proposed Rulemaking (ANPR), ``Federal Measures To
Mitigate BSE Risks: Considerations for Further Action,'' (also referred
to as ``the APHIS/FSIS/FDA ANPR'') that provided another opportunity
for interested parties to comment on certain issues raised in the SRM
interim final rule (69 FR 42287). The comment period for the APHIS/
FSIS/FDA ANPR closed on September 13, 2004. In addition, when FSIS
amended the SRM interim final rule to permit the use of beef small
intestine, excluding the distal ileum, for human food, it gave the
public until November 7, 2005, to comment on the issues raised in that
rulemaking (70 FR 53043).
In developing this final rule to affirm the SRM and air-injection
stunning interim final rules, FSIS considered all comments received in
response to the documents described above. Based on its continued
analysis of the issues, and on information provided by comments, FSIS
has made certain changes to the SRM interim final rule. Those changes
are summarized below and are discussed in detail in the Agency's
responses to comments. As noted above, FSIS is affirming the interim
provisions of the air-injection stunning interim final rule without
amendment.
Summary of Amendments to SRM Interim Final Rule
In this final rule, FSIS is affirming the provisions in the SRM
interim final rule and, in addition, is amending the rule to:
Clarify that non-ambulatory disabled cattle that are
offered for slaughter must be condemned but that FSIS inspection
personnel will determine on a case-by-case basis the disposition of
cattle that become non-ambulatory after they have passed ante-mortem
inspection;
Clarify that veal calves that are unable to rise from a
recumbent position because they are tired or cold may be set apart and
held for treatment;
Exclude from the definition of SRMs materials from cattle
from countries that can demonstrate that their BSE risk status can
reasonably be expected to provide the same level of protection from
human exposure to the BSE agent as prohibiting SRMs for use as human
food does in the United States;
Require that the spinal cord from cattle 30 months of age
and older be removed from the carcass at the establishment where the
animal was slaughtered;
Clarify that an establishment's procedure for the removal,
segregation, and disposition of SRMs must address potential
contamination of edible materials with SRMs before, during, and after
entry into the official establishment;
Codify requirements for the sanitation of equipment used
to cut through SRMs; and
Specify the conditions under which slaughter
establishments may ship carcasses or parts of carcasses that contain
vertebral columns from cattle 30 months of age and older to another
federally-inspected establishment for further processing.
Comments and Responses
FSIS received approximately 23,000 comments in response to the
January 2004 interim final rules, the APHIS/FSIS/FDA ANPR, and the
September 2005 amendment to the SRM interim final rule. Among the
commenters were dairy farmers, cattle producers, meat processors,
importers and exporters of meat products and by-products, members of
Congress, representatives of State governments, representatives of
foreign governments, organizations that represent livestock producers,
organizations that represent meat processors, consumer advocacy
organizations, animal welfare advocacy organizations, members of the
restaurant industry, members of the academic community, private
consultants, and private citizens. Most of the comments were submitted
by animal welfare organizations and citizens concerned about the
welfare of animals. Approximately 150 comments were submitted by
entities other than animal welfare organizations or citizens concerned
about the welfare of animals. The following are the issues raised by
the comments and FSIS' response.
Prohibition on the Slaughter of Non-Ambulatory Disabled Cattle
Comment: Most of the comments received in response to the SRM
interim final rule supported the prohibition on the slaughter of non-
ambulatory disabled cattle for human food. Some of these comments
stated that such a prohibition is needed to prevent human exposure to
the BSE agent. These comments were from members of the restaurant
industry, consumer advocacy organizations, animal welfare
organizations, and a private consultant. Most supported the prohibition
because, as described in the preamble to the SRM interim final rule,
surveillance data from the European Union indicate that cattle that
cannot rise from a recumbent position are among the cattle that have a
greater incidence of BSE than healthy slaughter cattle. One comment
noted that non-ambulatory cattle accounted for over half of the
detected BSE cases
[[Page 38702]]
in both the European Union and Switzerland in 2003. The comment
included references to support this statement.
Many comments also supported the prohibition on the slaughter of
non-ambulatory cattle because the typical clinical signs of BSE may not
always be observed in a non-ambulatory animal. According to the
comments, determining the reason that an animal is non-ambulatory is
often extremely difficult, if not impossible, without a full diagnostic
work-up. One comment noted that neurological, metabolic, or other
diseases that affect coordination and other aspects of gait often
predispose an animal to injuries, such as broken limbs or soft tissue
damage. The comment stated that if an animal is non-ambulatory because
of a broken leg or torn ligament, the injury may be the prominent or
sole presenting sign. The comment asserted that, without a complete
diagnostic work-up and history of disease progression, the true
underlying cause of the non-ambulatory condition may be impossible to
ascertain.
This same comment also included a list of clinical signs of BSE
from the United Kingdom's Department for Environment, Food, and Rural
Affairs (DEFRA) Web site. The comment observed that the vast majority
of signs (apprehensiveness; nervousness; reluctance to cross concrete,
turn corners, enter yards, go through doorways, or permit milking;
occasional kicking when milked; head shyness; high stepping gait,
particularly hind legs; difficulties in rising; tremors; loss of
condition, weight, or milk yield) would be difficult, if not
impossible, to observe in a non-ambulatory animal.
Some comments argued that the previous system of clinical
examination of non-ambulatory disabled cattle is not adequate to
determine the disposition of cattle with regard to BSE. The comments
asserted that when the SRM interim rule was issued, both cases of BSE
that had been detected in North America at that point were non-
ambulatory cattle that had been observed by veterinarians prior to
slaughter, and neither had been identified as a BSE clinical suspect.
One comment stated that although the objective of the prohibition
on the slaughter of non-ambulatory disabled cattle for human food is to
minimize human exposure to the BSE agent, such a measure may also
safeguard against other foodborne diseases, drug residues, and
bioterrorism.
Most comments that opposed the prohibition on the slaughter of non-
ambulatory disabled cattle asserted that prohibiting the slaughter of
all non-ambulatory cattle for human food is overly broad and not
necessary to protect the public. These comments were submitted by
individual farmers, cattle producers, custom slaughter operations,
small meat processors, trade associations that represent cattle
producers, trade associations that represent meat processors, and State
Departments of Agriculture.
One comment argued that the provisions in the SRM interim final
rule associated with non-ambulatory disabled cattle do not take into
consideration the basis for the animal's non-ambulatory status or the
risk mitigation measures implemented by the U.S. government to prevent
the spread of the BSE agent in the U.S. human and cattle populations.
Several comments stated that the fact that an animal cannot rise from a
recumbent position or walk does not necessarily render its carcass
unfit for human food. Some of the comments argued that otherwise
healthy cattle that are non-ambulatory solely due to an acute injury,
such as a broken leg or torn ligament, are no more likely to test
positive for BSE than healthy slaughter cattle. These comments asserted
that the carcasses of these cattle pose little risk of exposing humans
to the BSE agent.
Some comments stated that Federal and state veterinarians are able
to readily discern through ante-mortem or post-mortem inspection
whether an animal has suffered an acute injury or is affected with a
pathological condition. One comment submitted detailed guidance on
establishing the clinical signs consistent with cattle suspected of
having BSE. According to the comment, the guidance was developed by
veterinarians that have extensive experience dealing with cattle with
confirmed BSE. The comment stated that while these veterinarians noted
that the clinical signs of BSE are subtle, the document establishes
clear and objective guidelines for determining clinical risk factors.
One comment noted that, although the SRM interim final rule cited
epidemiological data from the European Union that suggests that animals
that generally fit the description of ``non-ambulatory'' are among the
animals most likely to test positive for BSE, there remain significant
differences among countries concerning the definition of this class of
cattle. As an example, the comment provided BSE surveillance data from
Switzerland that indicates that there was no difference between the BSE
prevalence rate of cattle in the ``sick slaughter'' category and those
from the general ``healthy population'' within the Swiss cattle herd in
2002. The comment also noted that the Swiss study cited in the SRM
interim final rule that demonstrates an increased likelihood of
detecting BSE in targeted testing of fallen stock and emergency-
slaughtered animals compared to the general population of healthy
animals only looked at cattle over 24 months of age.
Some comments recommended that FSIS limit the prohibition on the
slaughter of non-ambulatory disabled cattle to the specific subgroup of
cattle that are most likely to present a higher risk of testing
positive for BSE. According to the comments, these would be cattle that
are 30 months of age and older whose non-ambulatory status cannot be
attributed to an acute injury. Many of these comments suggested that
FSIS allow non-ambulatory disabled cattle younger than 30 months that
are unable to rise or walk due to an acute injury to be used for human
food if the animal passes ante-mortem inspection and the carcass passes
post-mortem inspection.
In addition to the comments described above, on July 7, 2005, the
Humane Society of the United States, Farm Sanctuary, and a private
citizen petitioned FSIS to take action to issue a final rule to
prohibit the slaughter of non-ambulatory disabled cattle for human
food. According to the petition, the confirmation on June 24, 2005, of
a second case of BSE in a non-ambulatory animal in the United States
demonstrates that the issuance of a final rule to prohibit the
slaughter of these animals cannot be delayed any further. The petition
asserted that FSIS should promptly issue a permanent ban on the
slaughter of non-ambulatory disabled cattle to ensure that the U.S food
supply is safe, export markets for beef remain open, and animals are
treated in a humane and compassionate manner.
Response: After careful consideration of this issue and the
comments received in response to the SRM interim final rule, FSIS has
decided to affirm the prohibition on the slaughter of non-ambulatory
disabled cattle offered for slaughter for human food. As discussed in
the preamble to the SRM interim final rule, surveillance data from the
European Union indicate that cattle that cannot rise from a recumbent
position are among the cattle that have a greater prevalence of BSE
than healthy slaughter cattle and the typical clinical signs of BSE may
not always be observed when cattle are non-ambulatory.
As noted by some of the comments, the clinical signs of BSE are
often subtle, and many typical signs, such as
[[Page 38703]]
gait disturbances, can only be observed in an animal that is able to
rise from a recumbent position and walk. FSIS agrees that if an animal
with clinical BSE is non-ambulatory due to an acute injury, such as a
broken leg or torn ligament, the injury may be the prominent or sole
presenting sign. Furthermore, the fact that there have been confirmed
cases of BSE in North America in non-ambulatory cattle that had been
observed by veterinarians prior to slaughter that had not been
identified as BSE clinical suspects provides evidence that the
underlying reason for an animal's non-ambulatory condition cannot
always be accurately ascertained when these animals are presented for
slaughter.
As noted by one comment, the non-ambulatory disabled cattle that
are more likely to test positive for BSE may differ depending on how a
particular country defines this class of animals. However, to minimize
the risk that clinical signs of BSE may not be observed in non-
ambulatory cattle, FSIS is affirming the SRM interim final rule's
definition of non-ambulatory disabled livestock 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.
This final rule affirms the requirement that non-ambulatory
disabled cattle offered for slaughter be condemned but also clarifies
that FSIS inspection personnel will determine on a case-by-case basis
the disposition of cattle that become non-ambulatory after they have
passed ante-mortem inspection. This amendment reflects current Agency
practice as described in FSIS Notice 5-04, ``Interim Guidance for Non-
Ambulatory Disabled Cattle and Age Determination'' (originally issued
January 12, 2004, extension of effective date January 17, 2006) and
FSIS Notice 05-06, ``Re-Examination of Bovine that become Non-
Ambulatory after Passing Ante-Mortem Inspection'' (January 18, 2006)).
FSIS Notices 5-04 and 05-06 instruct FSIS PHVs on the actions they
are to take when cattle become non-ambulatory after they have passed
ante-mortem inspection. These notices provide that FSIS PHVs are to
permit cattle that have passed ante-mortem inspection but that become
non-ambulatory prior to slaughter from an acute injury to proceed to
slaughter and post-mortem inspection if the PHV can verify that the
animal suffered an acute injury. Under FSIS Notice 05-06, PHVs are to
tag these cattle as ``U.S. suspects.'' If PHVs cannot verify that an
animal that has passed ante-mortem inspection but that becomes non-
ambulatory prior to slaughter suffered an acute injury, FSIS Notice 05-
06 instructs the PHV to tag the animal as ``U.S. condemned.''
While FSIS agrees that non-ambulatory cattle younger than 30 months
are less likely to present a risk of introducing the BSE agent into the
human food supply than non-ambulatory disabled cattle that are 30
months of age and older, as explained in the preamble to the SRM
interim final rule, although rare, there have been instances in which
BSE has been confirmed in cattle younger than 30 months. Thus, FSIS has
determined that it is prudent to continue to require the condemnation
of cattle that exhibit some type of clinical abnormality that could be
consistent with the end stages of BSE, regardless of the age of the
animal.
As explained in the final regulatory impact analysis (FRIA) of this
final rule, FSIS considered information presented in a recently updated
version of the Harvard Risk Assessment (the 2005 model) in making its
decision as to which measures are prudent for preventing potential
human exposure to the BSE agent. Estimates generated using the 2005
model indicate that removal of SRMs is the most effective measure for
preventing human exposure to the BSE agent and that such a measure
would reduce, over a 20-year period, human exposure to the BSE agent by
99% from the baseline. The 2005 model also estimates that excluding
non-ambulatory cattle from the human food supply would reduce, over a
twenty-year period, human exposure to the BSE agent by approximately 3%
from the baseline level.
Accordingly, FSIS has decided to affirm the prohibition on the
slaughter of non-ambulatory disabled cattle because, as explained
above, the typical clinical signs of BSE cannot always be observed in
an animal that cannot rise from a recumbent position or walk, and BSE
surveillance data from the European Union indicate that non-ambulatory
disabled cattle are among the cattle sub-populations that have
demonstrated the highest prevalence of BSE in countries where BSE has
been identified. As discussed in the preamble to the SRM interim final
rule, certain materials from cattle infected with BSE have demonstrated
BSE infectivity a few months before the onset of clinical disease.
Thus, it is not always possible to identify on ante-mortem inspection
those cattle that are approaching the end stages of disease, which is
when levels of the BSE agent are the highest. However, the Agency has
determined that continuing to require the condemnation of cattle that
exhibit some type of clinical abnormality that could be consistent with
the end stages of BSE will reduce the potential for materials with
infectious levels of the BSE agent to be introduced into the human food
supply through the inadvertent contamination of edible tissue with
SRMS.
Thus, after considering the available data on BSE and non-
ambulatory disabled cattle, FSIS has determined that requiring the
condemnation of these animals when they are offered for slaughter
continues to be a prudent measure to prevent potential human exposure
to the BSE agent.
Comment: Many comments argued that the prohibition on the slaughter
of non-ambulatory disabled cattle for human food should not apply to
non-ambulatory disabled cattle slaughtered or processed in custom
operations for the owner's exclusive use if the animal is non-
ambulatory as the result of an acute injury. Most of these comments
were from farmers and owners of custom slaughter operations. Some of
the comments suggested that FSIS allow the owner of the animal to
present documentation at the time of slaughter to verify that the
animal is non-ambulatory because of an acute injury. The comments
suggested that this documentation could include an affidavit from a
witness to the injury or from a state or local veterinarian that
examined the animal shortly after the injury occurred. One comment
suggested that the attending veterinarian for the farm where the animal
was injured fill out an ante-mortem inspection form to document the
reason for the animal's non-ambulatory condition. To ensure that non-
ambulatory disabled cattle are non-ambulatory as the result of a recent
injury, some comments suggested that FSIS limit the time that is
permitted to elapse between the injury and the slaughter of the animal.
One comment suggested that this time be limited to 12 hours.
Some comments stated that prohibiting the owners of non-ambulatory
disabled cattle from having these animals slaughtered or processed in
custom operations for their personal use will result in the slaughter
and processing of non-ambulatory disabled cattle on the farm under
insanitary conditions and without proper refrigeration, which will
create a greater risk to public health than allowing these animals to
be slaughtered or their products prepared in custom operations.
[[Page 38704]]
Other comments questioned FSIS' ability to enforce the prohibition on
the slaughter of non-ambulatory disabled cattle in custom facilities,
given that products produced in these facilities are exempt from the
inspection requirements of the FMIA.
Some comments questioned FSIS' legal authority to prohibit the
slaughter or processing of non-ambulatory disabled cattle in custom
facilities for the personal use of the owner of the animal. Most of
these comments were submitted by representatives of State Departments
of Agriculture. These comments argued that: (1) The term
``adulterated'' as used in the FMIA only applies to carcasses, parts
thereof, meat, and meat food products, and not to live animals that
have not received ante-mortem inspection by a government veterinarian;
(2) the FMIA exempts the slaughter of livestock and the processing of
their carcasses and parts for the personal use of the owner from the
inspection requirements of the FMIA; and therefore, (3) animals
slaughtered in custom operations cannot be condemned by FSIS because
they are not inspected. Some of these comments also asserted that a
government prohibition on the slaughter or processing of any animal
raised by an individual for his or her own personal use amounts to a
seizure of property without just compensation.
Response: FSIS has determined that it cannot permit the custom
slaughter or preparation of products of non-ambulatory disabled cattle
for human food even if it is for the owner's exclusive use because the
Agency considers the carcasses of these animals to be adulterated.
As explained in the background section of this document, when it
issued the SRM interim final rule, FSIS determined that non-ambulatory
disabled cattle present a sufficient risk of introducing the BSE agent
into the human food supply so as to render the carcasses of these
animals ``unfit for human food'' under section 1(m)(3) of the
adulteration provisions of the FMIA. To prevent the use of adulterated
carcasses for human food, the SRM interim final rule requires that all
non-ambulatory disabled cattle offered for slaughter be condemned on
ante-mortem inspection (9 CFR 309.3(e)).
Although the custom slaughter and preparation of products of cattle
and other livestock are exempt from inspection under section 23(a) of
the FMIA, meat and meat food products prepared in custom operations are
still subject to the FMIA's adulteration and misbranding provisions (21
U.S.C. 623(a), 21 U.S.C. 623(d)). Thus, while FSIS inspectors are not
present in custom facilities to condemn non-ambulatory disabled cattle
that are offered for slaughter, custom operators are effectively
prohibited from slaughtering or preparing products of non-ambulatory
disabled cattle, because the carcasses of these animals are considered
unfit for human food.
Therefore, FSIS not only disagrees with the comments that assert
that it lacks the legal authority to prohibit the custom slaughter or
preparation of products of non-ambulatory disabled cattle, the Agency
has concluded that the FMIA requires that the carcasses of these
animals be prohibited for human food regardless of whether the animal
is slaughtered in a custom operation for the owner's exclusive use or
in an official establishment for distribution in commerce.
As discussed above, while this final rule requires that all non-
ambulatory disabled cattle that are offered for slaughter be condemned,
it also clarifies that FSIS inspection personnel will determine the
disposition of cattle that become non-ambulatory after they have passed
ante-mortem inspection on a case-by-case basis (9 CFR 309.3(e)). Thus,
as explained above, FSIS PHVs may permit cattle that have passed ante-
mortem inspection but that become non-ambulatory because of an acute
injury prior to slaughter to proceed to slaughter and post-mortem
inspection if the PHV can verify that the animal suffered an acute
injury.
As noted above, FSIS inspectors are not present in custom
operations to examine cattle that become non-ambulatory after they have
been offered for slaughter. However, if an animal becomes non-
ambulatory from an acute injury after its owner has delivered it to a
custom operation for slaughter, the custom operator may slaughter the
animal for human food if both the operator and the owner of the animal
did not observe any other clinical abnormalities that could be
consistent with BSE before the animal sustained the acute injury.
Comment: Some comments suggested that, instead of prohibiting the
slaughter of all non-ambulatory disabled cattle, FSIS should require
that all non-ambulatory disabled cattle be tested for BSE, and if the
test result is negative, the Agency should allow the carcass to be used
for human food. The comments noted that FSIS' ``test and hold'' policy,
which requires that the carcasses of cattle tested for BSE be retained
until the test results are known, would apply. Some comments stated
that FSIS should facilitate the testing of non-ambulatory disabled
cattle on the farm and use the results to determine the disposition or
marketing of the animal.
Other comments agreed with FSIS' conclusion in the SRM interim
final rule that, because of limitations in the available testing
methods, testing non-ambulatory cattle for BSE would not provide the
same level of protection from human exposure to BSE as excluding non-
ambulatory disabled cattle from the human food supply.
Response: FSIS disagrees with the comments that suggested that it
should permit non-ambulatory disabled cattle that test negative for BSE
to be slaughtered for human food. As was explained in the preamble to
the SRM interim final rule, under the BSE tests that are available
today, certain tissues of cattle infected with BSE may contain the BSE
agent even though the diagnostic test does not indicate that the animal
has the disease. Thus, FSIS has determined that the BSE tests that are
available today are not appropriate for use as a food safety measure.
Comment: Some comments argued that since SRMs are the only
materials in which BSE infectivity has been confirmed, rather than
prohibiting the slaughter of non-ambulatory disabled cattle, FSIS
should require that all materials that have been designated as SRMs be
removed from non-ambulatory disabled cattle regardless of the age of
the animal. As stated by the comments, removal of SRMs is the action
that has the greatest impact on ensuring that materials that may
contain the BSE agent do not enter the human food supply.
Response: Although the BSE agent has only been confirmed in certain
materials of cattle infected with BSE, unintentional contamination of
edible materials with SRMs could potentially occur during slaughter and
processing. As noted above, non-ambulatory disabled cattle are among
the cattle that are more likely to test positive for the BSE agent than
healthy slaughter cattle. Thus, these animals are more likely to be in
the end stages of the disease, which is when infective tissues are
known to contain the highest levels of the BSE agent. Therefore, FSIS
has determined that requiring the condemnation of cattle that exhibit
some type of clinical abnormality that could be consistent with BSE
will reduce the potential for materials with infectious levels of the
BSE agent to be introduced into the human food supply through the
inadvertent contamination of edible tissue with SRMs.
Comment: Some comments stated that the prohibition on the slaughter
of non-ambulatory disabled cattle will hamper USDA's surveillance
testing for BSE by
[[Page 38705]]
removing access to these animals at slaughter establishments.
Response: Experience with APHIS' testing for BSE has demonstrated
that this has not been the case. Surveillance for BSE in the United
States has always targeted those cattle populations where the disease
is most likely to be found. The goal of APHIS' enhanced BSE
surveillance program, which began on June 1, 2004, was a one-time
effort designed to give a snapshot of the cattle population in the
United States and to help define whether BSE is present in the cattle
population and, if so, at what level. The program tested as many
animals in the targeted population as possible over a 12- to 18-month
period. Although there have been fewer non-ambulatory disabled cattle
available for testing at official slaughter establishments since FSIS
issued the SRM interim final rule, APHIS has increased the number of
samples collected from non-ambulatory and other high-risk cattle at
farms, slaughter facilities, rendering facilities, livestock auctions,
veterinary clinics, and public health laboratories.
As discussed in more detail below, based on the information
obtained through both the enhanced surveillance program and the BSE
surveillance conducted by the United States in the 5 years before the
enhanced surveillance program was implemented, USDA has concluded that
the prevalence of BSE in the United States is extremely low. Therefore,
in July 2006, USDA's APHIS announced that it would begin transitioning
its enhanced BSE surveillance program to an ongoing surveillance
program (http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/BSE_ongoing_surv_plan_final_71406%20.pdf). APHIS' ongoing BSE
surveillance program, which samples approximately 40,000 animals each
year, continues to sample the cattle populations where the disease is
most likely to be found. The targeted population for APHIS' ongoing
surveillance includes cattle exhibiting signs of CNS disorders or any
other signs that may be associated with BSE, including emaciation or
injury, and dead cattle, as well as non-ambulatory cattle. Samples from
the targeted population are being taken from the same locations as
those used during the enhanced surveillance program.
Comment: A few comments requested that FSIS clarify that the
prohibition on the slaughter of non-ambulatory disabled cattle does not
apply to veal calves that are unable to stand on arrival at the
slaughter establishment because they are tired or cold. The comments
stated that FSIS should allow the establishment to rest these animals
or warm them up prior to ante-mortem inspection. Other comments stated
that cattle that have become non-ambulatory for reasons related to
stress or fatigue, and have no other clinical signs associated with
BSE, should be given the opportunity to recover from the fatigue to
determine if they can become ambulatory.
Response: The prohibition on the slaughter of non-ambulatory
disabled cattle applies to all cattle that are offered for slaughter,
including veal calves. However, the regulations that prescribe
requirements for the disposition of condemned livestock permit
livestock condemned on account of certain conditions to be set apart
and held for treatment (9 CFR 309.13 (b)). These animals are permitted
to proceed through normal slaughter procedures if, following treatment,
FSIS inspection personnel find that the condition that required
condemnation has resolved.
Since it issued the SRM interim final rule, FSIS has permitted veal
calves that cannot stand because they are tired or cold to be set aside
for treatment. In this final rule, FSIS is revising 9 CFR 309.13 to
clarify that this is an accepted practice. The regulations that
prescribe requirements for the disposition of condemned livestock also
permit condemned livestock to be released for a purpose other than
slaughter if permission is obtained by the local, State, or Federal
official that has jurisdiction over the movement of the animal (9 CFR
309.13). Thus, cattle and calves that are unable to stand when they
arrive at slaughter may, if permission is obtained, be released from
the establishment for treatment.
Comment: Several comments from cattle farmers and ranchers asserted
that the prohibition on the slaughter of non-ambulatory disabled cattle
has placed a serious economic burden on livestock owners. Many of these
comments, particularly those from dairy farmers, stated that prior to
the implementation of the new regulations, when a healthy cow suffered
an acute injury, farmers were able to send the animal to slaughter and
receive compensation for it. According to the comments, as a result of
the rule, livestock owners must not only incur a loss when a healthy
animal becomes non-ambulatory, but also incur costs associated with
destroying the animal and disposing of its carcass.
Several comments from small meat processors and custom operations
said that the prohibition on the slaughter of non-ambulatory disabled
cattle places a serious economic burden on them. These comments stated
that because they do not slaughter or process a large number of
animals, they stand to lose a significant source of revenue, and some
stated that a prohibition on the slaughter of non-ambulatory disabled
cattle will cause them to go out of business.
Response: FSIS acknowledges that prohibiting the slaughter of all
non-ambulatory disabled cattle offered for slaughter has certain
economic effects on farmers, small meat processors, and custom
operators. However, as discussed above, the carcasses of non-ambulatory
disabled cattle offered for slaughter are adulterated and as such
cannot be used for human food. The final regulatory impact analysis
section of this document contains a more complete description of the
economic impact of prohibiting the slaughter of non-ambulatory disabled
cattle for human food.
Materials Designated as SRMs
Comment: Several comments concurred with the list of materials that
FSIS designated as SRMs. Some comments indicated that removal of these
materials is supported by the Harvard Risk Assessment.
One comment stated that the 30-month cut-off for exclusion of SRMs
provides very strong protection of human health, given that fewer than
0.01% of BSE cases have been recorded in cattle under 30 months of age.
The comment also said that in regions such as North America, where BSE
is very rare, and where measures to prevent its spread have been in
place for a number of years, it is improbable that cattle will be
exposed to high doses of the BSE agent. Therefore, the commenter
postulates that short incubation periods are unlikely in the United
States, which makes a 30-month age cut-off for SRMs adequate and
reasonable.
Response: FSIS agrees that the current scientific understanding
supports these comments. As explained in more detail below, FSIS is
affirming the 30-month age and older classification for certain SRMS.
Comment: Some comments stated that the materials designated as SRMs
if they are from cattle 30 months of age and older should be considered
SRMs if they are from cattle 12 months of age and older. The comments
asserted that the pathogenesis of BSE is not clearly understood, and
that there is still scientific uncertainty regarding when during the
incubation period infectivity occurs. The comments noted that cattle as
young as 21 months have tested positive for BSE in both Japan and the
United Kingdom.
[[Page 38706]]
Some of the comments also noted that the post-mortem tests that are
available today are only capable of identifying the presence of the BSE
agent near the end of the incubation period. As stated by the comments,
cattle younger than 30 months of age in the early stages of BSE that do
not test positive for the disease may still be harboring the BSE agent.
Some comments argued that permitting the brain or spinal cord from
cattle of any age for human food carries an unjustifiable risk of
exposing humans to the BSE agent. These comments suggested that FSIS
prohibit brain and spinal cord from all cattle for human food.
Response: In the SRM interim final rule, FSIS designated all
materials that have demonstrated BSE infectivity as SRMs, regardless of
the level or proportion of infectivity contained in each tissue.
However, because BSE infectivity has only been confirmed in certain
tissues when cattle are approaching the end of the disease incubation
period, or after cattle have developed overt clinical disease, FSIS
designated some tissues as SRMs only if they are from cattle 30 months
of age and older. As discussed in detail in the preamble to the SRM
interim final rule and in the APHIS/FSIS/FDA ANPR, the Agency has
determined that a 30-month-and-older age classification for certain
SRMs is reasonable because BSE surveillance data from European
countries demonstrate that cattle younger than 30 months are unlikely
to be in the later stages of BSE and, thus, are unlikely to contain
high levels of BSE infectivity. Materials that have demonstrated
infectivity in the early stages of disease are SRMs regardless of the
age of the animal. In addition, prevalence estimates from USDA's APHIS
enhanced BSE surveillance program also support the 30 month-and-older
age classification for certain SRMs. BSE surveillance data from the
European Union and the United States are discussed below.
FSIS is aware of the cases of BSE in animals 21 and 23 months of
age reported by Japan mentioned by the comments. FSIS took comment on
the significance of these cases. The response to those comments is
provided later in the preamble to this final rule. In short, a report
issued by the European Food Safety Authority (EFSA), Scientific Panel
on Biological Hazards, states that ``it is unclear whether the very
young cases [reported in Japan] were adequately identified and formally
confirmed.'' \1\
---------------------------------------------------------------------------
\1\ The EFSA Journal 2005 220, 1-21, Annex to the Opinion,
Report of the Working Group on the assessment of the age limit in
cattle for the removal of certain specified risk materials (SRM)
(see 1.2.3. Age distribution of young BSE cases outside the EU, p.
11). Available on the Internet at: http://www.efsa.eu.int/science/biohaz/biohaz_opinions/opinion_annexes/933/biohaz_report_ej220_srmremove_en1.pdf.
---------------------------------------------------------------------------
BSE surveillance in the European Union. As discussed in the
preamble to the SRM interim final rule and the APHIS/FSIS/FDA ANPR,
although rare, BSE has been confirmed in cattle younger than 30 months.
As explained in those documents, the occurrence of BSE in young animals
is most likely the result of exposure to a high infective dose of the
BSE agent at a young age.
BSE surveillance data from the European Union indicate that most
cases of BSE detected in animals younger than 30 months involve cattle
that were most likely exposed to the BSE agent at a time when their
countries-of-origin had significant levels of circulating BSE
infectivity. As the level of BSE disease in the European Union has
decreased, so has the number of confirmed cases in cattle younger than
30 months.\2\ This most likely reflects a reduction in the amount of
circulating BSE infectivity that occurred after full implementation by
most E.U. countries of measures to prevent the spread of BSE.
---------------------------------------------------------------------------
\2\ European Commission (EC), 2005; Report on the monitoring and
testing of ruminants for the presence of transmissible spongiform
encephalopathy (TSE) in 2004, European Commission Health and
Consumer Protection Directorate-General; European Commission (EC),
2004; Report on the monitoring and testing of ruminants for the
presence of transmissible spongiform encephalopathy (TSE) in 2003,
European Commission Health and Consumer Protection Directorate-
General; European Commission (EC), 2003; Report on the monitoring
and testing of ruminants for the presence of transmissible
spongiform encephalopathy (TSE) in 2002, European Commission Health
and Consumer Protection Directorate-General (http://europa.eu.int/comm/food/food/biosafety/bse/mthly_reps_en.htm).
---------------------------------------------------------------------------
These analyses of BSE surveillance data from the European Union
indicate that when disease prevalence is low, and effective measures
for preventing the spread of BSE are in place, it is unlikely that
there will be a sufficient amount of circulating BSE infectivity to
result in clinical cases in young animals.
BSE surveillance in the United States. As discussed below, analysis
of USDA's APHIS BSE surveillance testing program has led FSIS to
conclude that the BSE prevalence in the United States is extremely low.
Based on the low estimated prevalence of BSE in the United States, FSIS
has determined that U.S. cattle younger than 30 months are unlikely to
contain high levels of the BSE agent and that a 30-month-and-older age
classification for certain SRMs remains appropriate for the United
States.
USDA's APHIS has conducted surveillance for BSE disease since 1990.
Surveillance has always targeted those cattle populations where the
disease is most likely to be found. The level of surveillance in the
United States has increased steadily from 1990 and jumped significantly
in 2004 when USDA implemented enhanced surveillance following the
detection of BSE in an imported cow in December 2003.
As stated above, the goal of USDA's enhanced BSE surveillance
program, which began on June 1, 2004, was to test as many animals in
the targeted population as possible over a 12- to 18-month period. This
program was designed to provide a snapshot of the domestic cattle
population to help define whether BSE is present in the United States
and, if so, at what level.
Based on the information gained during both the enhanced
surveillance program and the BSE surveillance conducted in the United
States in the five years before the enhanced surveillance program was
implemented, APHIS recently concluded that the prevalence of the
disease in this country is extremely low, less than one case per
million adult cattle. Two models were used to estimate the prevalence,
and the most likely values calculated by these models estimate that the
number of cases is between 4 and 7 infected animals out of 42 million
adult cattle.\3\ APHIS' analysis was submitted to the scrutiny of a
peer review process, and the expert panel agreed with the
appropriateness of APHIS' assumptions and the factors it considered, as
well as with the estimate of BSE prevalence. APHIS has transitioned
into an ongoing BSE surveillance program designed to test a targeted
sample of approximately 40,000 targeted animals each year, a level
consistent with international animal health standards.\4\
---------------------------------------------------------------------------
\3\ ``An Estimate of the Prevalence of BSE in the United
States,'' Animal and Plant Health Inspection Service, USDA, July 20,
2006. Available on the Internet at: http://www.aphis.usda.gov/peer_review/content/printable_version/BSE_Prevalance_scientific_doc_after.pdf.
\4\ OIE Terrestrial Animal Health Code 2006, Appendix 3.8.4,
Surveillance for Bovine Spongiform Encephalopathy.
---------------------------------------------------------------------------
Comment: Some commenters indicated that expanding the list of SRMs
to include materials from cattle 12 months of age and older is
consistent with recommendations made in a report by an international
expert BSE panel (the International Review Team or IRT) that was
convened at the request of the
[[Page 38707]]
Secretary of Agriculture to review actions taken by the United States
in response to a single finding of BSE. The commenters noted that the
IRT report recommended that the brain, skull, spinal cord, and
vertebral column of all cattle over 12 months be excluded from both the
human food and animal food chains unless aggressive surveillance proves
the BSE risk in the USA to be minimal according to [former] standards
of the World Organization for Animal Health (the OIE). \5\
---------------------------------------------------------------------------
\5\ The OIE guidelines no longer provide for a minimal BSE risk
category. Since the IRT issued its report, the OIE has revised its
BSE risk categories. OIE now has three BSE risk categories instead
of five: negligible risk, controlled risk, and undetermined risk.
---------------------------------------------------------------------------
Response: As noted by the commenters, the IRT report did recommend
that the brain, skull, spinal cord, and vertebral column of all cattle
over 12 months be excluded from both the human food and animal food
chains unless aggressive surveillance indicates otherwise. However, as
discussed above, USDA's APHIS has conducted the aggressive surveillance
recommended by the IRT, and the extremely low prevalence estimates, in
conjunction with the E.U. experience, provide evidence that a 30-month-
and-older age classification for certain SRMs is a prudent measure for
preventing human exposure to the BSE agent in the United States. The
30-month-and-older age classification for SRMs that have demonstrated
BSE infectivity in the end stages of the disease incubation is accepted
internationally in BSE standards set by various countries and is
consistent with OIE recommendations.
In addition, FSIS' regulations contain measures that reduce the
potential for cattle younger than 30 months to introduce the BSE agent
into the human food supply. Under 9 CFR 309.4 of the ante-mortem
inspection regulations, all livestock with signs of a neurological
disease must be condemned. Thus, the regulations prohibit the slaughter
of those cattle younger than 30 months having any characteristics
consistent with the end stages of BSE, i.e., those with clinical signs
consistent with the disease. Furthermore, the prohibition on the
slaughter of non-ambulatory disabled cattle, which FSIS is affirming in
this document, ensures that non-ambulatory cattle younger than 30
months that may have clinical signs consistent with BSE that are
difficult to observe do not enter the human food supply. Thus, the
regulations require the condemnation of all cattle that exhibit some
type of clinical abnormality that could be consistent with the end
stages of BSE, regardless of the age of the animal.
Comment: One comment noted that a recently published study suggests
that there may be another form of transmissible spongiform
encephalopathy in cattle, referred to as bovine amyloidotic spongiform
encephalopathy (BASE). According to the comment, given the possibility
of an additional strain of BSE, together with the continued lack of
scientific understanding concerning the pathogenesis of the disease,
FSIS must minimize human exposure to all animal materials that could
potentially harbor the BSE agent. The comment argued that as long as
there is uncertainty, SRMs from cattle over 12 months of age should be
excluded from both the human and animal food chain.
Response: There is very little data on the BASE strain of BSE
described by the comment. The data that are available do not indicate
that cattle with this form of BSE are more likely to contain high
levels of the infective agent early in the incubation period than
cattle with the ``typical'' BSE strain. Further study on the BASE form
of BSE is needed to determine its significance.
Comment: One comment stated that a ban on SRMs regardless of the
age of the animal would significantly improve enforcement of the
regulations and would eliminate the need to determine the age of each
animal offered for slaughter. Another comment said that the only
plausible explanation for not prohibiting SRMs from cattle of all ages
is an implicit cost/benefit analysis. According to the comment, the
FMIA does not allow the Agency to rely on a cost/benefit analysis. It
requires that the Agency remove all adulterated materials from the
market.
Response: FSIS disagrees with these comments. With regard to the
comment that stated that the FMIA requires that the Agency remove all
adulterated materials from the market without consideration of costs or
benefits, the SRM interim final rule does require that all adulterated
materials be excluded from the human food supply. Under the SRM interim
final rule, certain materials are only considered adulterated if they
are from cattle 30 months of age and older.
FSIS disagrees that prohibiting materials designated as SRMs for
human food regardless of the age of the animal is needed to improve
enforcement of the regulations, as was suggested by one of the
comments. Under the regulations, establishments must develop,
implement, and maintain written procedures to ensure that SRMs are
completely removed from the carcass, segregated from edible materials,
and disposed of as inedible. FSIS is responsible for ensuring that the
establishment's procedures are adequate and effective, and is
responsible for taking appropriate action if they are not. As discussed
in more detail later in this document, the Agency has developed
effective procedures for verifying the age of cattle offered for
slaughter.
Comment: One comment noted that in its 2002 ``Current Thinking
Paper'' on BSE, FSIS identified prohibiting the brain and spinal cords
from cattle 24 months of age and older for human food, and prohibiting
the vertebral column from cattle 24 months of age and older as a source
material in mechanical meat recovery systems, as measures that the
Agency was considering implementing to minimize potential human
exposure to the BSE agent. The comment stated that FSIS must offer some
justification as to why the Agency determined that a 30-month age cut-
off for SRMs is appropriate in preventing potential human exposure to
the BSE agent when it had previously stated that a 24-month age cut-off
was necessary to protect public health.
Another comment stated that Germany, Italy, and France test all
cattle older than 24 month of age that are slaughtered for human food
for BSE. According to the comment, this suggests that these countries
have concluded that there is a significant risk that cattle between 24
and 30 months of age may transmit the BSE agent to humans.
Response: FSIS made its ``current thinking paper'' on BSE available
to the public January 17, 2002. The 24-month age cut-off for SRMs as
described in that document was based on the best information available
at the time and was intended to address the fact that, in rare
instances, BSE had been confirmed in cattle younger than 30 months in
the European Union.\6\
---------------------------------------------------------------------------
\6\ Food Safety and Inspection Service (FSIS): Current Thinking
On Measures That Could Be Implemented To Minimize Human Exposure To
Materials That Could Potentially Contain the Bovine Spongiform
Encephalopathy Agent, January 15, 2002 (see page 8). Available on
the Internet at http://www.fsis.usda.gov/oa/topics/bse_thinking.htm.
---------------------------------------------------------------------------
However, the E.U. BSE surveillance data that were available at the
time that FSIS issued the paper were limited because they generally
reflected cases detected by means of traditional passive
surveillance.\7\ In January 2001, the European Union implemented more
systematic testing for BSE, which has increased the number of BSE cases
detected. Thus, more complete
[[Page 38708]]
information on the age distribution of confirmed BSE cases has become
available since FSIS issued its current thinking paper.
---------------------------------------------------------------------------
\7\ Frequently asked questions about BSE. 6 April 2001. Europa
Web site: http://europa.eu.int/comm/food/fs/bse/bse20_en.html.
---------------------------------------------------------------------------
The E.U. BSE surveillance data that are available today indicate
that BSE is unlikely to be confirmed in animals younger than 30 months
in the European Union, which, as explained above, most likely reflects
a reduction in the amount of circulating BSE infectivity that occurred
after full implementation by most E.U. countries of measures to prevent
the spread of BSE. For example, in E.U. BSE surveillance testing
conducted in 2002, 2003, and 2004, none of the 4,355 animals that
tested positive for BSE were younger than 30 months.\8\ A total of
31,514,999 BSE tests were conducted in those years. In addition, as
discussed above, the extremely low BSE prevalence estimates obtained
from APHIS' analysis of its BSE surveillance data reinforce the
conclusion that a 30-month-and-older age classification for certain
SRMs is a prudent measure for preventing human exposure to the BSE
agent as opposed to the 24-month age cut-off that the Agency was
contemplating when it issued its current thinking paper.
---------------------------------------------------------------------------
\8\ European Commission (EC), 2005; Report on the monitoring and
testing of ruminants for the presence of transmissible spongiform
encephalopathy (TSE) in 2004, European Commission Health and
Consumer Protection Directorate-General; European Commission (EC),
2004; Report on the monitoring and testing of ruminants for the
presence of transmissible spongiform encephalopathy (TSE) in 2003,
European Commission Health and Consumer Protection Directorate-
General; European Commission (EC), 2003; Report on the monitoring
and testing of ruminants for the presence of transmissible
spongiform encephalopathy (TSE) in 2002, European Commission Health
and Consumer Protection Directorate-General (http://europa.eu.int/comm/food/food/biosafety/bse/mthly_reps_en.htm).
---------------------------------------------------------------------------
As noted by one comment, Germany, Italy, and France require that
cattle older than 24 months be tested for BSE if they are slaughtered
for human food. However, testing for BSE conducted in these countries
from 2001 through 2004 has detected only two animals younger than 30
months of age, and both were detected in 2001.\9\ Of note is that these
animals were 28 and 29 months of age. Furthermore, measures implemented
by other European countries appear to recognize that cattle older than
30 months present the greatest risk of introducing the BSE agent into
the human food supply. Under the E.U. regulations, cattle over 30
months of age must be tested for BSE if they are slaughtered for human
food.\10\ In addition, since 1996, the United Kingdom has prohibited
the slaughter of cattle over 30 months of age for human food. This
prohibition was recently replaced with a program that permits cattle
over 30 months to be used for human food if these animals test negative
for BSE (except for cattle born before August 1, 1996).\11\ In the
United Kingdom and the rest of the European Union, SRMs must still be
removed from animals that test negative for BSE.
---------------------------------------------------------------------------
\9\ European Commission (EC), 2002; Report on the monitoring and
testing of ruminants for the presence of transmissible spongiform
encephalopathy (TSE) in 2001, European Commission Health and
Consumer Protection Directorate-General (http://europa.eu.int/comm/food/food/biosafety/bse/mthly_reps_bse2001_en.htm).
\10\ Commission Regulation (EC) No 1248/2001 of 22 June 2001
amending Regulation (EC) No 999/2001 of the European Parliament and
of the Council as regards epidemio-surveillance and testing of
transmissible spongiform encephalopathies.
\11\ United Kingdom, Department for Environment Food and
Regulatory Affairs (DEFRA) Web site at http://www.defra.gov.uk/animalh/bse/otm/index.html (accessed November 2005).
---------------------------------------------------------------------------
Comment: A few comments stated that FSIS should designate bone
marrow as an SRM even though pathogenesis studies have not conclusively
demonstrated that bone marrow contains BSE infectivity. The comments
stated that FSIS should not wait for a ``conclusive'' study to take
action to prevent human exposure to a potential source of BSE
infectivity. One comment stated that the FMIA mandates a precautionary
approach that does not require conclusive demonstration that a meat
food product will cause adverse health effects.
Response: FSIS has reviewed the available research with regard to
BSE infectivity in bone marrow and has determined that it does not
support designating bone marrow as an SRM.
As noted in the preamble to the SRM interim final rule, in
pathogenesis studies conducted in the United Kingdom, bone marrow from
one set of cattle demonstrated BSE infectivity 38 months post oral
exposure to the BSE agent.\12\ However, because bone marrow from cattle
sacrificed at earlier (32 and 36 months) and later (40 months)
intervals post exposure to the BSE agent did not demonstrate
infectivity, these findings are considered inconclusive. The
infectivity at 38 months was detected through use of a mouse bioassay
and occurred after the cattle had developed clinical signs of disease.
---------------------------------------------------------------------------
\12 \ Wells GA, Hawkins DA, Green RB, Spencer YI, Dexter I,
Dawson M. 1999, Limited detection of sternal bone marrow infectivity
in the clinical phase of experimental Bovine Spongiform
Encephalopathy (BSE). Vet Rec. Mar 13: 144 (11): 292-4.
---------------------------------------------------------------------------
BSE infectivity in bone marrow has also been tested using a more
sensitive cattle bioassay. In November 2003, the U.K. Spongiform
Encephalopathy Advisory Committee (SEAC) reported that in the cattle
bioassay, no infectivity had been reported in bone marrow of cattle up
to 55-56 months post exposure to the BSE agent.\13\ SEAC concluded that
research from the cattle bioassay indicate that the level of
infectivity in the bone marrow is at most very low, and that the single
positive finding from the mouse bioassay may be an experimental
artifact but cannot be discounted.
---------------------------------------------------------------------------
\13 \ Eightieth Meeting of the Spongiform Encephalopathy
Advisory Committee Meeting, November 2003. Available on the Internet
at: www.seac.gov.uk/minutes/final80.pdf.
---------------------------------------------------------------------------
On the basis of the information on BSE infectivity in bone marrow
that is described above, FSIS has concluded that there is insufficient
evidence to indicate that bone marrow should be designated as an SRM.
FSIS will continue to follow the research with regard to BSE
infectivity in bone marrow. However, even if there is weak infectivity
in the bone marrow of cattle, it likely presents little risk of
exposing humans to the BSE agent because FSIS requires condemnation of
the cattle most likely to contain infectivity, i.e., those with
clinical signs of disease and non-ambulatory animals.
Comment: Some comments suggested that FSIS prohibit organs in close
proximity to SRMs, such as the dura mater, hypophysis, pineal gland,
and cerebrospinal fluid, for human food. One comment noted that the
dura was harvested but not tested in pathogenesis studies conducted in
the United Kingdom. According to the comment, the dura's close
association with the brain and spinal cord, along with the documented
evidence of its role in the human-to-human transmission of CJD, has
prompted scientists to designate bovine dura as a high-risk tissue. The
comment also noted that if the dura is not removed and disposed of as
inedible prior to processing, it may come loose and be incorporated
into ground product or contaminate surfaces where de-boning occurs.
Response: FSIS agrees that, because of their close association to
the CNS, the dura mater and CSF from cattle 30 months of age and older
could potentially come in contact with SRMs; contamination could result
from such contact if the animal had BSE. While the dura and CSF are not
designated as SRMs, establishments are required to address the
potential for edible products to become contaminated with SRMs in their
procedures for the removal, segregation, and disposition of SRMS.
[[Page 38709]]
Anatomically, the hypophysis and pineal gland are part of the brain
and thus must be removed from the carcass when the brain is removed.
Comment: A few comments suggested that FSIS designate bovine spleen
and pancreas as SRMs.
Response: Neither the spleen nor pancreas from cattle has
demonstrated BSE infectivity, nor are they closely associated with any
materials that have been designated as SRMs. Therefore, the spleen and
pancreas from cattle are not SRMs.
Comment: One comment stated that FSIS should designate the entire
head from cattle 30 months of age and older as SRM and require that the
cheek and head meat of cattle 12 months of age and older be removed
before the skull is fragmented or split.
Response: The SRM interim final rule designates potentially
infective materials, as well as certain materials that are closely
associated with potentially infective materials, from cattle 30 months
of age and older as SRMs. Furthermore, under the SRM interim final
rule, establishments are required to address contamination of all
edible materials, which would include head meat, with SRMs in their
procedures for the removal, segregation, and disposition of SRMs.
Therefore, FSIS has concluded that it is not necessary to designate the
entire head from cattle 30 months of age and older as an SRM.
None of the materials located in the head of cattle younger than 30
months of age are considered SRMs. Therefore, FSIS does not believe
that it is necessary to prescribe procedures for the removal of head
meat from cattle younger than 30 months in order to minimize potential
human exposure to the BSE agent.
Comment: One comment stated that FSIS must better articulate its
rationale for excluding other areas of the carcass from the list of
SRMs. According to the comment, there is scientific evidence to
indicate that the BSE agent is not confined to the brain and spinal
cords of cattle, and that it can be found in several other compartments
and extra-CNS spinal nerve centers. The comment criticized FSIS for not
including a discussion on whether peripheral nerves coursing throughout
the carcass may potentially contain BSE infectivity.
Response: As discussed in the preamble to the SRM interim final
rule, available data on the development and distribution of tissue
infectivity in BSE-infected cattle are incomplete, and most of what is
known comes from the pathogenesis studies conducted in the United
Kingdom (69 FR 1862, 1864, January 12, 2004). When it issued the SRM
interim final rule, FSIS noted that while the results of the
pathogenesis 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, these studies did not
determine the rate at which the BSE agent increases in the tissues that
have demonstrated infectivity or identify the tissues that the BSE
agent must pass through to reach its ultimate destination. Of the
peripheral nervous tissues tested in the pathogenesis studies, only the
DRG and trigeminal ganglia demonstrated infectivity, which occurred
late in the disease incubation and in cattle with clinical disease.
After FSIS issued the SRM interim final rule, a study in which
highly BSE-susceptible transgenic mice challenged with a variety of
tissue samples from a clinically diseased cow was published.\14\ Of the
tissues sampled in this study, infectivity was confirmed in the CNS, as
well as in the optic nerve and the retina. In addition, samples of the
facial and sciatic nerve of the peripheral nervous system (PNS) also
demonstrated infectivity, although at lower levels than the CNS
tissues. The study also tested tissue samples from the radial nerve of
the PNS and reported no demonstrated infectivity at the time of
publication.
---------------------------------------------------------------------------
\14\ Buschmann, A, Groschup, MH. Highly Bovine Spongiform
Encephalopahty-Sensitive Transgenic Mice Confirm the Essential
Restriction of Infectivity to the Nervous System in Clinically
Diseased Cattle. Journal of Infectious Disease, 2005; 192:934-42.
---------------------------------------------------------------------------
While both the U.K. pathogenesis study and the study involving the
highly BSE-susceptible transgenic mouse bioassay described above
demonstrate that BSE infectivity may occur in certain PNS tissues of
cattle in the end stages of BSE disease, FSIS has determined that these
studies do not provide conclusive evidence that peripheral nerves
coursing throughout the carcass contain BSE infectivity. In both
studies, the PNS tissues that demonstrated BSE infectivity were closely
associated with the CNS, and infectivity was only detected in these
tissues late in the disease incubation, or when cattle had overt
clinical disease. While FSIS acknowledges that these findings do not
exclude the possibility that other parts of the PNS may contain
infectivity at some point in the course of BSE disease, the Agency
believes that the fact that infectivity has only been confirmed in PNS
tissues that are closely associated with the CNS indicates that if BSE
infectivity does occur in other parts of the PNS, it is most likely at
low or undetectable levels.
Thus, based on the available research, FSIS believes that the
primary tissues of concern for spreading the BSE agent have been
identified. FSIS will continue to follow the results of future studies
on BSE to further refine this determination and inform its policies
with regard to BSE.
Comment: Several comments requested that FSIS continue to designate
the spinal cord and DRG from cattle 30 months of age and older as SRMs
but remove the vertebral column from the list of materials designated
as SRMs. The comments stated that designation of vertebral column as
SRM because of its proximity to the DRG is not scientifically
justifiable. The comments asserted that technologies can be developed
to effectively remove DRG without requiring removal of the vertebral
column. One comment stated that the regulatory intent of designating
the vertebral column as SRM can be achieved by designating spinal cord
and DRG as SRMs and adding the following sentence: ``Unless the
establishment can demonstrate through scientific methods that the
spinal cord and DRG have been completely removed, the entire vertebral
column (excluding the vertebrae of the tail, the transverse processes
of the thoracic and lumbar vertebrae, and the wings of the sacrum)
shall be removed.''
Response: While the comments submitted on this issue suggested that
technologies can be developed to remove the DRG without requiring
removal of certain parts of the vertebral column, they did not provide
any evidence to demonstrate that such technologies exist or how
establishments would accomplish removal of DRG without removing
sections of the vertebral column. Therefore, under this final rule, 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 is among the materials
designated as SRM. The Agency will reconsider this issue if this
technology becomes available.
Comment: Some comments stated that vertebral bones should not be
SRMs if they are part of a bone-in cut of meat. According to one
comment, establishments should already have or, if they do not, could
easily implement procedures for the thorough removal of the spinal cord
and sheath from the vertebral column. The comment stated that the
remaining DRG are contained within the vertebral bones and as such are
not likely to be consumed by
[[Page 38710]]
humans unless they are processed using AMR technology. As noted by the
comment, another regulation issued by FSIS, i.e., the AMR interim final
rule, prohibits the use of vertebral columns from cattle 30 months of
age and older in the production of AMR product. The comment stated that
allowing vertebral bones from cattle 30 months of age and older to
remain in traditional cuts, like T-bone steaks, will not result in any
increased risk of consumer exposure to the BSE agent.
Some comments stated that requiring the removal of the vertebral
column from cattle 30 months of age and older imposes costs on farmers
and small processors and has raised consumer satisfaction issues. One
comment noted that the United Kingdom lifted its ban on bone-in beef
because scientists concluded that the potential risk of human exposure
to the BSE agent from bone-in beef was insignificant.
Response: FSIS disagrees that vertebral bones should not be SRMs if
they are part of a bone-in cut of meat. As noted by the comments, most
establishments have the technology to completely remove the spinal cord
from the vertebral column, but FSIS is not aware of any that have the
technology to remove the DRG without removing parts of the vertebral
column.
Although the DRG are located within the vertebral bones, FSIS has
determined that because they could potentially become dislodged during
consumption of bone-in beef products, the DRG from cattle 30 months of
age and older are still a potential source of human exposure to the BSE
agent. An updated risk assessment conducted for USDA by the Harvard
Center for Risk Analysis (the 2005 Harvard model) determined that
consumption of bone-in-beef could account for 23% of the total
potential human exposure to the BSE agent on average (based on the
conditions as they existed in 2003 and assuming the introduction of 10
infected cows).\15\ The 2005 Harvard BSE Update assumes that the total
infectivity in bone-in-beef is the sum of the contribution of spinal
cord contained in these cuts of meat and the DRG attached to the bones.
---------------------------------------------------------------------------
\15\ Harvard Center for Risk Analysis, `` Harvard Risk
Assessment of Bovine Spongiform Encephalopathy Phase IA.,'' 2005.
Available for viewing by the public in the FSIS docket room and on
the FSIS Web site at: http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp#bse.
---------------------------------------------------------------------------
With regard to the comment that the United Kingdom has lifted its
bone-in-beef ban, the United Kingdom does not permit for use as human
food bone-in-beef derived from parts of the vertebral column that have
been designated as SRMs. The vertebral column (excluding the vertebrae
of the tail, the spinous and transverse processes of the cervical,
thoracic and lumbar vertebrae and the median sacral crest, the wings of
the sacrum, but including the DRG) from cattle over 24 months is
considered an SRM in the United Kingdom.\16\
---------------------------------------------------------------------------
\16\ United Kingdom Food Standards Agency (FSA) 2005, Web site
http://www.food.gov.uk/bse/what/beef/controls.
---------------------------------------------------------------------------
Comment: Comments submitted on whether FSIS should require that the
entire small intestine be removed to ensure effective removal of the
distal ileum were addressed in the amendment to the SRM interim final
rule issued on September 7, 2005 (70 FR 53043). FSIS received seven
comments in response to the amended interim final rule. Most were
supportive of the Agency's decision to permit the use of beef small
intestine, excluding the distal ileum, for human food. Some asserted
that FSIS only considered comments submitted by the casing and meat
processing industry.
Response: FSIS in fact carefully considered all comments on removal
of the distal ileum that were submitted in response to the SRM interim
final rule and the APHIS/FSIS/FDA ANPR and addressed the issues raised
by the comments in the September 7, 2005 amendment to the SRM interim
final rule (see 70 FR 53043).
Comment: Since FSIS issued the amendment to the SRM interim final
rule that permits, under certain conditions, beef small intestine,
excluding the distal ileum, for use as human food, establishments
interested in harvesting the small intestine for human food have
requested that the Agency clarify whether procedures that involve
removal of the small intestine without uncoiling it comply with the
requirements of the rule if the establishment can verify that, when it
is uncoiled, the part of the small intestine that is not harvested for
human food measures at least 80 inches from where the distal ileum
attaches to the cecum.
Response: 9 CFR 310.22(a)(3)(ii) of the amended SRM interim final
rule provides that the small intestine may be used for human food if
the distal ileum is removed by a procedure that removes at least 80
inches of the uncoiled and trimmed small intestine as measured from the
ceco-colic junction and progressing proximally towards the jejunum or
by a procedure that the establishment demonstrates is effective in
ensuring complete removal of the distal ileum. Procedures in which the
small intestine is harvested without uncoiling it are likely to comply
with 9 CFR 310.22(a)(3)(ii) if the establishment can verify that when
it is uncoiled, the portion of the intestine that was not harvested for
human food measures at least 80 inches from the ceco-colic junction
progressing proximally towards the jejunum.
Requirements for the Removal, Segregation, and Disposition of SRMs
Comment: Some comments stated that FSIS should prescribe specific
procedures for the removal, segregation, and disposition of SRMs rather
than rely on private industry to implement appropriate procedures that
will best achieve the requirements of the interim final rule. One
comment stated that in the interim final rule, FSIS did not specify who
would approve the procedures for the removal, segregation, and
disposition of SRMs in the establishment's HACCP plan or Sanitation
SOP.
Response: As noted in the preamble to the SRM interim final rule,
FSIS did not prescribe specific procedures for the removal,
segregation, and disposition of SRMs because the Agency believes that
establishments should have the flexibility to implement the most
appropriate procedures that will best achieve the requirements of the
rule. The regulations recognize that procedures that are appropriate
for some establishments to ensure that SRMs are completely removed from
the carcass, segregated from edible materials, and disposed of as
inedible may not be effective when used in other establishments.
Therefore, FSIS disagrees that it should prescribe specific procedures
for the removal, segregation, and disposition of SRMs.
While FSIS does not approve an establishment's procedures for the
removal, segregation, and disposition of SRMs, the Agency is
responsible for ensuring that these procedures are adequate and
effective. If FSIS inspection personnel determine that an
establishment's procedures are not effective in excluding SRMs from the
human food supply, the Agency will take appropriate action.
Comment: One comment suggested that FSIS require that
establishments address SRMs in their HACCP plans, and that the Agency
create a regulatory sampling program to verify that edible portions of
carcasses are not contaminated with SRMs. The comment stated that the
program could be similar to the testing program required for
establishments that use AMR technology.
Response: The regulations require that establishments address SRMs
as part of their food safety systems, i.e., in their
[[Page 38711]]
HACCP plans or Sanitation SOPs or other prerequisite programs. To
ensure that SRMs are not present in meat products, FSIS inspection
personnel verify that establishments are removing SRMs in a manner that
does not result in contamination of edible tissues. Unlike AMR
products, gross contamination of beef carcasses and solid cuts of meat
with SRMs can often be detected visually. Therefore, FSIS has
determined that it is not necessary to establish a verification
sampling program for SRM removal at this time.
Comment: One comment requested that FSIS exclude references to
HACCP in 9 CFR 310.22(d)(1) because there is no scientific basis for
determining that abnormal prions are a hazard reasonably likely to
occur when conducting a hazard analysis. The comment stated that
removal of SRMs would be better covered in an establishment's
Sanitation SOPs or other prerequisite program.
Response: When conducting a hazard analysis, some establishments
may determine that SRMs are a hazard that is reasonably likely to occur
and that should be addressed in the HACCP plan. Other establishments
may determine that it is more appropriate to address the removal and
disposition of SRMs in their Sanitation SOPs or other prerequisite
programs. Thus, because FSIS believes that establishments should have
the flexibility to implement the most appropriate procedures that will
best achieve the requirements of this rule, the Agency is not removing
references to HACCP in this final rule.
Comment: Some comments suggested that FSIS prescribe and supervise
the methods of destruction for SRMs rather than leave those choices to
the producers, slaughterers, or processors. One comment stated that
because the rule does not specify how SRM disposal must be
accomplished, FSIS cannot assure that once removed, SRMs are
consistently disposed of in a manner that will not introduce the BSE
agent into the environment. One comment noted that alkaline hydrolysis
at elevated temperatures is the most effective and environmentally
responsible method of destroying materials that could potentially
contain the BSE agent. Another comment stated that FSIS did not
evaluate alternative methods of disposition for SRMs or the
consequences of each alternative.
Response: The SRM interim final rule requires that SRMs be handled
and disposed of in accordance with 9 CFR part 314.1 or 9 CFR 314.3 of
FSIS' regulations for the handling and disposition of condemned or
other inedible products at official establishments (see 9 CFR part
314). For establishments that have the appropriate facilities,
condemned or other inedible carcasses or parts must be disposed of by
inedible rendering (also referred to as ``tanking'') in accordance with
the procedure prescribed by 9 CFR 314.1. Under 9 CFR 314.3, those
establishments that do not have tanking facilities may dispose of
condemned or other inedible carcasses or parts by incineration or by
denaturing using crude carbolic acid, cresylic disinfectant a formula
consisting of one part DF&C No. 3 green coloring, 40 parts water, 40
parts liquid detergent, and 40 parts oil of citronella, or any other
proprietary substance approved by the Administrator.
The purpose of the prescribed methods of disposal of condemned or
other inedible carcasses and parts in FSIS' regulations is to ensure
that condemned and other inedible materials are rendered incapable of
use as human food. After these materials have been subjected to an
inedible rendering process, incinerated, or denatured, further
disposition is conducted in accordance with applicable Federal, state,
and local laws and regulations. FSIS works with other governmental
entities to ensure that the disposition of SRMs and other inedible
materials complies with environmental requirements.
Comment: Some comments requested that FSIS develop compliance
guidelines on the removal, segregation, and disposition of SRMs
specifically for the U.S. meat packing industry.
Response: FSIS has posted compliance guidance materials for its
BSE-related rules on the FSIS Technical Services Center Web page at:
http://www.fsis.usda.gov/About_FSIS/Technical_Service_Center/index.asp.
In addition, after it issued the SRM interim final rule, FSIS held
a series of teaching workshops from January through March 2004 to
discuss the actions that the Agency had taken to prevent human exposure
to the BSE agent. These workshops were designed to assist small and
very small plants to understand the requirements of the measures
implemented by FSIS to prevent human exposure to the BSE agent.
Materials provided at these workshops are available on the FSIS Web
site at: http://www.fsis.usda.gov/Science/Workshop_SmallPlants_BSE/index.asp.
Shipment of Carcasses and Parts That Contain Vertebral Columns
9 CFR 310.22(e) of the SRM interim final rule (which has been re-
designated as 9 CFR 310.22(h) in this final rule) provides that
materials designated as SRMs 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 at the
time of slaughter. In the preamble to the SRM interim final rule, FSIS
explained that for 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 which
the carcasses or parts were derived (60 FR 1861, 1869-1870, January 12,
2004). The preamble also states that if an establishment that processes
the carcasses or parts of cattle does not have records that document
the age of the cattle from which the carcasses were derived, it must
handle all carcasses and parts as if they were from cattle 30 months of
age and older.
FSIS permits federally-inspected establishments that slaughter
cattle to ship carcasses and parts that contain vertebral columns from
cattle that were 30 months of age and older at the time of slaughter to
another federally-inspected establishment for processing if both
establishments have controls in place to ensure that the SRM portions
of the vertebral column are removed and properly disposed of. When beef
carcasses or parts that contain SRM vertebral columns are transported
from one official establishment to another, both the transporting
establishment and the receiving establishment must develop and maintain
documentation and on-going verification to ensure that the SRMs are
removed, segregated from edible materials, and disposed of as inedible.
If establishments have implemented appropriate controls, FSIS
inspection personnel at the shipping establishment will apply the mark
of inspection to carcasses or parts that contain SRM vertebral bones as
an accommodation to facilitate their transport to a processing facility
where the SRMs can be removed and properly disposed of.
To assist with implementation of the SRM interim final rule, FSIS
issued an FSIS notice that instructs its inspection program personnel
on how to verify the effectiveness of controls adopted by
establishments that transport or receive cattle carcasses or parts that
contain vertebral columns from cattle 30 months of age and older (see
FSIS Notice 68-05, ``Verification Activities at Establishments that
Transport or Receive Cattle Carcasses or Parts with Vertebral Columns
that Contain Specified Risk Materials (SRMs),'' October 6, 2005). FSIS
Notice 68-05 instructs inspection program personnel at establishments
that transport for
[[Page 38712]]
further processing carcasses or parts of carcasses that contain
vertebral columns from cattle that were 30 months of age and older at
the time of slaughter to verify that the establishment: (1) Maintains
control of the carcasses or parts while they are in transit (through
companies seals or under FSIS control); (2) ensures that the carcasses
or parts are accompanied by documentation that clearly identifies that
the carcasses or parts are from cattle that were 30 months of age and
older at the time of slaughter or that clearly states that the
vertebral column must be removed and disposed of as an SRM; (3)
maintains records that identify the official establishment that
received the carcasses or parts; (4) incorporates its procedures into
its HACCP System. FSIS Notice 68-05 also provides that inspectors at
establishments that process cattle carcasses and parts are to verify
that the establishment (1) has implemented controls to identify
carcasses or parts that contain vertebral columns with SRM portions;
(2) has implemented controls to ensure that the SRM portions of the
vertebral column are properly handled and disposed of; (3) has
incorporated its controls into its HACCP System; and (4) maintains
records that verify that the SRM portions of the vertebral column were
removed and disposed of as inedible.
In January 2006, the USDA Office of the Inspector General (OIG)
issued an audit report that found that establishments transporting
carcasses and parts from cattle 30 months and older often did not have
appropriate controls and procedures in place to ensure that SRMs were
removed and properly disposed of by downstream processors.\17\ The
report provided an example of a receiving establishment that received a
bill of lading from the transporting establishment that identified four
carcasses as being from cattle that were 30 months or older at the time
of slaughter when there were actually 11 such carcasses.
---------------------------------------------------------------------------
\17\ Animal and Plant Health Inspection Service Bovine
Spongiform Encephalopathy (BSE) Surveillance Program--Phase II and
Food Safety and Inspection Service Controls over BSE Sampling,
Specified Risk Materials, and Advanced Meat Recovery Product--Phase
III (Report no. 50601-10-KC, January 2006). Available on the
Internet at: http://www.usda.gov/oig/webdocs/50601-10-KC.pdf.
---------------------------------------------------------------------------
Following are the comments submitted on this issue and FSIS'
response. As discussed in detail below, after considering the comments
submitted on this issue, and the findings in the OIG report, FSIS has
decided to codify and strengthens the requirements that must be
satisfied for a federally-inspected establishment to ship beef
carcasses that contain vertebral columns from cattle that were 30
months of age and older at the time of slaughter to another federally-
inspected establishments for further processing.
Comments: Some comments argued that it is not necessary to require
that processors provide documentation from their suppliers to
demonstrate that beef carcasses or parts that contain vertebral bones
are from cattle that were younger than 30 months of age at the time of
slaughter. According to these comments, the fact that carcasses or
parts bear the USDA mark of inspection is sufficient to verify that
they are from cattle that were younger than 30 months at the time of
slaughter because FSIS only applies the mark of inspection to carcasses
or parts if they do not contain SRMs or, for carcasses or parts that do
contain SRMs, if the establishment has controls in place to ensure that
the SRMs will be removed at the processing establishment.
Response: As indicated in the OIG report described above, carcasses
or parts transported to a processing facility may not always be
accompanied by documentation that properly identifies which carcasses
or parts are from cattle that were 30 months and older at the time of
slaughter. Thus, to ensure that SRM vertebral columns do not
inadvertently enter the human food supply, FSIS has determined that
processors must either obtain documentation from their suppliers to
demonstrate that carcasses or parts are from cattle that were younger
than 30 months at the time of slaughter or handle all carcasses and
parts as if they were from cattle 30 months and older.
Under this final rule, it is the establishment's responsibility to
demonstrate that beef carcasses or parts are from cattle that were
younger than 30 months of age at the time of slaughter. An
establishment that merely indicates that carcasses or parts bear the
USDA mark of inspection has not met this responsibility. If the
establishment cannot demonstrate, through documentation from the
supplier, that beef carcasses or parts are from cattle that were
younger than 30 months at the time of slaughter, it must handle all
carcasses and parts for which this documentation is not provided as if
they were from cattle 30 months of age and older.
Comment: Some comments argued that FSIS should not allow the
shipment of beef carcasses that contain SRMs to bear the mark of
inspection even if the establishment has a program in place to ensure
that SRMs will be removed by the receiving establishment. According to
the comments, the only way to ensure that vertebral columns from cattle
30 months of age and older do not inadvertently enter the food supply
is to require that these materials be removed at the time of slaughter.
The comments noted that identifying marks on carcasses could be
obliterated or altered, and identification and tracking information
could be lost as the carcasses pass from slaughterhouse to the
processor. One comment said that allowing beef carcasses and parts that
contain SRMs to bear the mark of inspection could erode public
confidence in the mark of inspection as a symbol of meat safety.
One comment suggested that if FSIS were to reject the suggestion to
require that the vertebral column be removed at the time of slaughter,
the Agency should make it clear that carcasses with SRMs must not be
shipped to uninspected establishments, such as retail stores or
restaurants. The comment stated that such a prohibition should be in
the final rule, not in an FSIS internal document, such as an FSIS
notice or directive.
Response: As stated above, after considering this issue, and the
findings of the OIG audit report, FSIS has decided to continue to
permit, and to codify and strengthen the requirements that must be
satisfied for federally-inspected establishments to ship beef carcasses
that contain vertebral columns from cattle that were 30 months of age
and older at the time of slaughter to other federally-inspected
establishments for further processing. As discussed above, FSIS
currently permits this practice if both establishments have implemented
controls to ensure that the vertebral column (excluding the vertebrae
of the tail, the transverse processes of the thoracic and lumbar
vertebrae, and the wings of the sacrum), is removed from the carcass
and disposed of as inedible at the receiving establishment. To ensure
that SRMs are removed to the greatest extent possible at slaughter, the
Agency is amending the SRM interim final rule to clarify that the
spinal cord from cattle 30 months of age and older must be removed at
the establishment where the animals were slaughtered. Thus, under this
final rule, the only SRMs that are permitted to be transported from one
federally-inspected facility to another are vertebral columns and the
DRG contained in the vertebral columns.
In addition, to ensure that beef carcasses or parts that contain
vertebral bones from cattle that were 30 months of age and older at the
time of slaughter do not inadvertently enter the human food supply,
this final rule strengthens
[[Page 38713]]
and codifies the conditions under which establishments will be
permitted to ship these carcasses or parts for further processing.
Under this final rule, FSIS will permit slaughter establishments to
ship beef carcasses or parts that contain vertebral columns from cattle
30 months of age and older for further processing if the slaughter
establishment: (1) Maintains control of the carcasses or parts while
they are in transit (e.g., through company seals) or ensures that the
carcasses or parts move under FSIS control (e.g., under USDA seal or
accompanied by FSIS Form 7350-1); (2) ensures that the carcasses or
parts are accompanied by documentation that clearly states that the
carcasses or parts contain vertebral columns from cattle that were 30
months of age or older at the time of slaughter; (3) maintains records
that identify the official establishment that received the carcasses or
parts; and (4) maintains records that verify that the official
establishment that received the carcasses or parts removed the SRM
portions of the vertebral column and disposed of them as inedible.
The first three requirements described above codify the conditions
that FSIS inspection personnel at establishments that transport
carcasses or parts that contain SRM vertebral columns are instructed to
verify under FSIS Notice 68-05. Thus, these requirements reflect
current practices. However, the fourth condition, which requires that
shipping establishments maintain records that verify that the official
establishment that received carcasses or parts from cattle 30 months
and older removed and properly disposed of the SRMs, is a new
requirement designed to strengthen existing controls. Because this new
provision establishes a new recordkeeping requirement, it has been
submitted to OMB for approval. This provision will not become effective
until OMB approves the information and recordkeeping requirements. More
detailed information on the information and recordkeeping requirements
associated with this final rule, including instructions for submitting
comments on these requirements, are described in the Paperwork
Reduction Act Section of this document.
FSIS is adopting this additional control on the transportation of
carcasses and parts that contain SRM vertebral columns, in part, in
response to the OIG audit report described above. As noted above, the
OIG report found that establishments transporting carcasses and parts
from cattle 30 months and older often did not have appropriate controls
and procedures in place to ensure that SRMs were removed and properly
disposed of by downstream processors. This new provision addresses this
finding by establishing an addition control that transporting
establishments must implement to ensure that receiving establishments
are removing and properly disposing of SRMs.
In addition, requiring that transporting establishments maintain
records that verify that the receiving establishment removed and
properly disposed of SRMs is consistent with other Agency policies that
address situations in which products are transported from an official
establishment to another facility for processing or disposition. For
example, establishments that transport non-intact beef products that
test positive or presumptive positive for E. coli O157:H7 to another
official establishment, or a landfill or rendering operation, for
further processing or disposal must obtain documentation from the
receiving operation that indicates that the product was properly
processed or disposed of.
As requested by the comment, for clarification, federally-inspected
establishments are not permitted to ship for further processing beef
carcasses or parts that contain vertebral columns from cattle 30 months
of age and older to establishments that are not under Federal
inspection, such as retail stores, restaurants, or state-inspected
processing establishments. The SRMs must be removed in the Federal
system.\18\ Establishments that receive beef carcasses or parts for
further processing are required to address removal of the vertebral
column from cattle 30 months of age and older in their procedures for
the removal, segregation, and disposition of SRMs.
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\18\ State-inspected establishments are permitted to transport
for further processing carcasses or parts that contain vertebral
columns from cattle 30 months of age and older to other State-
inspected establishments in the same State if the State enforces
requirements that are at least equal to those imposed under the
FMIA.
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Sanitation and Cross-Contamination
To assist with implementation of the SRM interim final rule, FSIS
developed procedures to verify that cross-contamination of edible
tissue with SRMs was reduced to the maximum extent practical in
facilities that slaughter cattle, and in facilities that process the
carcasses or parts of cattle, that are both younger than 30 months of
age and that are 30 months of age and older (see FSIS Notice 10-04,
``Questions and Answers Regarding the Age Determination of Cattle and
Sanitation,'' January 29, 2004, reissued January 2005). Under these
procedures, if an establishment uses dedicated equipment to cut through
SRMs, or if it segregates cattle 30 months of age and older from cattle
younger than 30 months of age, then the establishment may use routine
operational sanitation procedures (i.e., no special sanitation
procedures are required). If the establishment does not segregate
cattle 30 months of age and older from younger cattle, equipment used
to cut through SRMs must be cleaned and sanitized before it is used on
carcasses or parts from cattle younger than 30 months of age.
When it issued FSIS Notice 10-04, FSIS determined that, because of
the multiple risk mitigation measures implemented in the United States
to prevent the spread of BSE, these procedures reduce to the maximum
extent practical cross-contamination of carcasses with high-risk
tissues. However, to assist in determining whether it should strengthen
these measures, FSIS requested further comment on this issue in the
joint ANPR issued by APHIS, FSIS, and FDA on July 14, 2004, (see
``Federal Measures To Mitigate BSE Risks: Considerations for Further
Action,'' 69 FR 42287, 42290). The Agency also issued a press release
during the comment period for the SRM interim final rule that
specifically requested public comment on methods to prevent cross-
contamination of carcasses with SRMs.
Comment: Most of the comments received on this issue agreed that
establishments must have a system in place to prevent cross-
contamination between edible materials and SRMs. Some of the comments
agreed with the current FSIS procedures that permit sanitation of
equipment by establishments between the processing of carcasses or
parts of carcasses from cattle 30 months of age and older and those
from cattle younger than this age. According to the comments, while the
cleaning and sanitizing procedures that are available will not
inactivate the BSE agent, these procedures are adequate to prevent
cross-contamination due to the multiple risk mitigation measures
implemented by the U.S. government to prevent the spread of BSE. One
comment stated that separate or dedicated equipment is not necessary if
proper cleaning and sanitizing procedures are in place and documented.
Other comments argued that, until effective decontamination
procedures are developed, FSIS should require that establishments use
dedicated and visually coded equipment for the severing and removal of
SRMs. Some
[[Page 38714]]
comments indicated that if dedicated equipment is not used, FSIS should
require separate slaughter and processing lines for cattle 30 months
and older and cattle younger than 30 months.
One comment included a CD-ROM with suggestions and practices to
reduce cross-contamination during slaughter. Among the suggested
practices were capping the stun hole, using separate equipment for the
severing and removal of SRMs, keeping saws clean to prevent build-up of
SRMs, using both high and low stations for removal of the spinal cord,
removing both the spinal cord and dura on the kill floor, and taking
care of mis-split carcasses on the kill floor.
One comment suggested that FSIS require that the spinal cord be
removed on the slaughter floor using dedicated equipment. The comment
argued that once spinal cord or other CNS tissue enters the boning room
and contaminates the tables and equipment, the potential risk from BSE
is already there and removal at this point is not completely
sufficient.
Response: After considering the comments submitted on this issue,
FSIS has decided to continue its current practices for verifying the
effectiveness of establishments' procedures for preventing cross-
contamination of edible tissue with SRMs. The Agency has concluded
that, within the context of the probability that SRMs from slaughtered
cattle would carry infectivity (i.e., removal of cattle most likely to
have BSE and the extremely low prevalence of BSE in the United States),
the current procedures appropriately reduce the potential for cross-
contamination of carcasses with SRMs. To ensure that establishments
conduct what the Agency has determined are appropriate sanitation
procedures for equipment used to sever SRMs, the Agency is also
codifying the sanitation procedures described in FSIS Notice 10-04.
Therefore, under this final rule, if an establishment does not
segregate the carcasses and parts from cattle 30 months of age and
older from the carcasses and parts from cattle younger than 30 months
during processing operations it must either use dedicated equipment to
cut through SRMs or clean and sanitize equipment used to cut through
SRMs before the equipment is used on carcasses or parts from cattle
younger than 30 months of age. Establishments that use dedicated
equipment to cut through SRMs may continue to conduct routine
operational sanitation procedures between carcasses. Establishments
that segregate the carcasses and parts of cattle 30 months of age and
older from cattle younger than 30 months, and that process the
carcasses and parts from the younger animals first, may conduct routine
operational sanitation procedures on equipment used to cut through
SRMs.
Furthermore, establishments must address potential contamination of
edible products with SRMs, including tonsils and the distal ileum from
all cattle, as well as CNS and CNS-type tissues from cattle 30 months
of age and older, in their procedures for the removal, segregation, and
disposition of SRMs.
As discussed in detail above, the estimated prevalence of BSE in
the United States is extremely low, and FSIS prohibits the slaughter of
cattle that, if infected with BSE, are most likely to contain high
levels of the BSE agent, i.e., cattle with CNS signs and non-ambulatory
cattle. Thus, because cattle slaughtered in U.S. establishments are
highly unlikely to be in the end stages of BSE, equipment used to
slaughter or process U.S. cattle is highly unlikely to become
contaminated with the BSE agent. Therefore, given the extremely low
estimated U.S. BSE prevalence, FSIS has determined that the sanitation
procedures prescribed in this rule are appropriate for preventing
potential contamination of carcasses with the BSE agent. The Agency
agrees with the comment that stated that separate or dedicated
equipment is not necessary if proper cleaning and sanitizing procedures
are in place and documented.
Comment: One comment stated that new technologies must be developed
to detect both SRMs and the BSE agent on equipment and finished
products to permit establishments to conduct testing to verify that no
contamination with SRMs or prion proteins has occurred. The Agency
supports the development of new technologies to detect SRMs and the BSE
agent on equipment and finished products and agrees that this type of
technology would be useful in verifying that no contamination with SRMs
or prion proteins has occurred. While FSIS is not aware of any accurate
or practical technologies that could be used to determine whether
equipment or carcasses have been contaminated with SRMs or prion
proteins, the Agency will continue to follow research on the
development of these kinds of technologies.
Comment: One comment suggested that, to prevent edible products
from coming into contact with SRMs during transport, FSIS should
prohibit SRMs from being transported in the same vehicle as cattle
parts destined for human food.
Response: FSIS is amending the SRM interim final rule to clarify
that establishments must address contamination of edible materials with
SRMs before, during, and after entry into the establishment in their
procedures for the removal, segregation, and disposition of SRMs. This
provision ensures that procedures for the removal, segregation, and
disposition of SRMs are consistent with 9 CFR 417.3(a) of the HACCP
regulations, which require that an establishment's hazard analysis
include food safety hazards that can occur before, during, and after
entry into the establishment.
Age Verification
In the preamble to the SRM interim final rule, FSIS stated that if
the establishment has accurate records that document the age of the
cattle slaughtered in the facility, FSIS inspection program personnel
would accept these records as verification of the age of the cattle. If
the establishment does not have records that document the age of the
cattle presented for slaughter, the Agency verifies age through dental
examination. Under its age verification procedures, FSIS deems cattle
to be 30 months of age and older if 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).
Comment: Several comments concurred with FSIS' procedures for
verifying the age of cattle through dental examination. The comments
noted that determining age based on eruption of one of the 2nd set of
permanent incisors is a conservative and appropriate approach. One
commenter, a trade association that represents cattle producers,
conducted research to determine whether FSIS' standard for verifying
the age of cattle is the appropriate standard for today's cattle and
concluded that, given the lack of a standard method for documenting
age, the FSIS dentition guidelines are the best alternative. The
commenter stated that it will be adding to this research, and if the
data show that a new standard is appropriate, it will share the results
with FSIS and propose a change in policy. The commenter also noted that
it is working with the industry to develop a standard document that can
be used by producers to verify the age of cattle that will be accepted
by slaughter establishments and FSIS.
Response: FSIS agrees with these comments and supports the need for
further research on methods for estimating the age of cattle when
[[Page 38715]]
reliable documentation is not available. The Agency also supports the
development of a standard document that can be used to verify the age
of cattle at slaughter.
Comment: Some comments disagreed with FSIS' method for verifying
the age of cattle through dentition. Most of the comments asserted that
the method is inaccurate because many cattle have all four permanent
incisors by the time they are 24 months old. According to the comments,
under FSIS' method for aging cattle, many cattle are deemed to be 30
months of age and older when they are probably 24 months or less. One
comment noted that dentition varies from herd-to-herd and animal-to-
animal due to genetics, diets, and the varied geographic locations in
which animals are raised. Another comment indicated that the dentition
standards used by FSIS were established more than 50 years ago and do
not reflect the advancements in animal genetics that may account for
early maturity, nor do they reflect the development of new hybrid
breeds over the past 50 years.
One comment questioned the amount of research that FSIS completed
when developing its guidelines for verifying age through dentition. The
comment said that, according to a leading veterinary medicine anatomy
textbook, the permanent incisors of cattle erupt from 18 to 48 months
rather than 24 months to 30 months of age. The comment went on to note
that another veterinary text states that the second pair of permanent
incisors is fully developed, and the gingiva at the base of the third
deciduous incisors is receding from the gum line, when the animal is
approximately 29\1/2\ months of age. The comment asserted that these
guidelines would provide a more accurate method to verify the age of
cattle than the method adopted by FSIS.
Another comment stated that good veterinary practice recognizes
that cattle develop their first set of permanent incisors at 18 to 24
months, their second set at 24 to 30 months, and their third set at 30
to 42 months. The comment asserted that it would be more accurate for
FSIS to verify the age of cattle based on the eruption of the fifth
permanent incisor rather then the eruption of the third permanent
incisor. Another comment also suggested that FSIS deem cattle to be 30
months of age and older based on the eruption of the fourth set of
permanent incisors.
Response: FSIS acknowledges that under the Agency's age
verification procedures some cattle younger than 30 months will be
deemed to be 30 months of age and older. As noted by the comments,
dentition may vary from herd-to-herd and animal-to-animal depending on
genetics, diet, and the geographic locations. However, despite its
limitations, the Agency has determined that the dentition evaluation
adopted in these rules is the best and most practical means of
estimating the age of cattle at slaughter in the absence of reliable
records. Thus, FSIS will continue to use current dentition evaluation
procedures to verify the age of cattle when records are not available.
The procedures adopted by FSIS to verify the age of cattle offered
for slaughter are based on data from veterinary anatomy texts and
academic articles.\19\ These sources indicate that the second set of
permanent incisors erupt when cattle are between 24 to 30 months of
age. Based on this information, FSIS adopted a conservative approach
and considers cattle in which at least one of the second set of
permanent incisors has erupted to be 30 months of age or older. This
approach is accepted internationally and is consistent with the
dentition standards used in Canada.\20\
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\19\ See references to the FSIS Technical Services Center
document ``Using Dentition to Age Cattle, '' which is available on
the FSIS Web site at: http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OFO/TSC/bse_information.htm.
\20\ Canadian Food Inspection Agency, Meat Hygiene Directive,
Chapter 4, Annex IV. Available on the Internet at http://www.inspection.gc.ca/english/anima/meavia/mmopmmhv/chap4/annexne.shtml.
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Comment: Some comments strongly suggested that FSIS inspection
personnel rely more heavily on producer documentation to verify the age
of cattle. Some comments requested that FSIS restate the pre-eminence
of documented birth records over approximating age through dentition.
The comments stated that FSIS should not use dentition to verify
supportable documentation, such as breeding or birth records.
Response: If establishments use accurate and reliable documentation
to determine the age of cattle at slaughter, FSIS will not use
dentition to verify the accuracy of the records. After it issued the
SRM interim final rule, FSIS issued FSIS Notice 10-04 ``Questions and
Answers Regarding the Age Determination of Cattle and Sanitation''
(January 29, 2004) to clarify that documentation will be the primary
means to determine the age of cattle at slaughter. The notice makes
clear that if reliable documentation is provided at slaughter, FSIS
inspectors should not use dentition to verify the age of cattle.
Comment: Some comments requested that FSIS clarify the type of
records that the Agency considers acceptable for determining age. The
comments suggested that herd calving record books be included as
acceptable evidence of age.
Response: The FSIS Notice described above (FSIS Notice 10-04)
describes the type of documents that can be used to provide an accurate
and reliable basis for determining the age of cattle. Included among
the acceptable forms of documentation are records that certify that an
entire herd was born on a farm during a specific time ( e.g.,
certification that a group of Angus cattle were born during the calving
season of Spring 200X or Fall 200X), together with information from the
feedlot that identifies each animal individually (e.g., eartags). As
provided in the notice, when calving birthing ranges are provided, the
oldest possible age based on the ranges should be assigned to the group
of cattle.
Comment: Some comments asserted that FSIS' method for verifying the
age of cattle frequently overestimates the age of cattle that are
younger than 30 months, resulting in an economic loss to cattle
producers. One comment stated that certain meatpackers have indicated
that they intend to deduct 15 cents per pound per head for any animal
that is determined to be over 30 months of age by dentition. According
to the comment, the implementation of the rule is devaluing a group of
cattle (heiferettes) that previously returned a premium over their
current class (cull cows). The comment also noted that after Canada
implemented similar procedures for determining the age of cattle
offered for slaughter, cattle in Canada with more than two permanent
incisors are now being sold for a total prices of 8 to 20 cents
(Canadian) per pound live weight.
This same comment stated that cattle feeders are losing nearly
$200.00 per head for any animal found to have more than two permanent
incisors, which is a per head loss of nearly 20%. The comment also
claimed that ranchers are losing up to $360.00 per head for any animal
found to have more than two permanent incisors, which amounts to a per
head loss of nearly 50%. The comment estimated that the costs
associated with FSIS' method for verifying the age of cattle using
dentition will cost the cattle producing industry in excess of
$1,035,936,000.00. One comment submitted by a rancher indicated that he
takes a discount of $60.00 to $100.00 per head on cattle deemed to be
30 months of age and older, which could force him to discontinue his
business unless he is able to purchase cattle that have documentation
of age.
[[Page 38716]]
Response: FSIS discusses in detail the economic impacts of age
verification in the final regulatory impact analysis (FRIA) of this
final rule. The FRIA explains that generally, in any group of steers
and heifers, some cattle will appear to be 30 months of age and older
based on dentition even if all of the animals in the group are younger
than 30 months of age. The FRIA states that estimates of the proportion
of steers and heifers that will appear to be 30 months of age and older
based on dentition range from 1 to 5 percent (Hodges and Seward, 2004).
The FRIA notes that after FSIS implemented the SRM interim final
rule, the USDA Market News Service (of the Agricultural Marketing
Service (AMS)) began to report discounts for cattle 30 months of age
and older (including those determined by dentition). Weekly values have
ranged from $35 to $50 per cwt (carcass weight), which translates to an
approximate discount of $175 to $250 per head for a 500-pound cow or
bull carcass ( e.g., on the lower end, $35 per cwt times 5 cwt equates
to $175).
The comments on this issue and the analysis in the FRIA demonstrate
the advantage of using accurate records rather than dentition to
determine the age of cattle. Nonetheless, while FSIS' dentition
standards are conservative, the Agency has determined that they are the
most appropriate way to estimate the age of cattle in the absence of
accurate documentation. As mentioned above, the dentition standards
adopted by the Agency are internationally accepted and based on data
from veterinary anatomy texts and academic articles. These standards
are also objective and practical to implement. Furthermore, according
to one study, determining physiological maturity by the number of
permanent incisors may be a more accurate technique of sorting beef
carcasses into less variable age groups than the USDA bone
ossification-based maturity system used for beef grading.\21\
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\21\ Lawrence, TE, 2001. A comparison of the USDA ossification-
based maturity system to a system based on dentition, J. Anim. Sci.,
79:1683-1690.
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If cattle producers are interested in preventing potential
financial losses associated with the use of dentition to estimate the
age of their cattle, they may prefer to maintain records that can be
used to accurately document the age of their animals. As stated above,
if reliable documentation is available at slaughter, FSIS inspectors
will rely on documentation, not dentition, to verify the age of cattle.
Comment: One comment stated that dentition should only be used to
verify the age of cattle imported into the United States from countries
that are not classified as ``BSE-free,'' such as Canada. The comment
asserted that because the United States has never had a native case of
BSE,\22\ the use of dentition to age U.S. cattle unnecessarily
penalizes American producers and feeders without offering any
substantial public health benefits to the public or long term benefits
to cattle producers.
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\22\ This statement reflects the situation at the time that FSIS
issued the SRM interim final rule.
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Response: As discussed earlier in this document, two native cases
of BSE have been confirmed in the United States since FSIS issued the
SRM interim final rule. Therefore, the statement that the United States
has never had a native case of BSE is no longer accurate. Furthermore,
FSIS disagrees that its dentition evaluation procedures unnecessarily
penalize American producers and feeders. As discussed in detail above,
although the dentition standards adopted by FSIS may be conservative,
the Agency has determined that these standards are the most appropriate
means to estimate the age of cattle at slaughter in the absence of
accurate documentation.
Comment: One comment was submitted by a company that has developed
a new technology that it claims will permit the creation of secure and
auditable records of the dentition of cattle when they arrive at the
feedlot. According to the company, these records would allow slaughter
establishments to determine the age of cattle offered for slaughter on
the basis of dental exam at the feedlot.
According to the comment, literature shows that the standard error
of the association of age with dentition is smaller with animals at
younger ages. The comment asserted that because cattle usually enter
feedlots between 10 and 16 months of age, dentition exam could be used
more accurately at those ages to assign a maximum possible age. Since
the dentition exam on these cattle would typically show no permanent
incisor eruption, the comment suggested that cattle with no permanent
incisors upon arrival to the feedlot be assigned a maximum age of 24
months. Then, said the commenter, cattle with an auditable record of
their dentition examination at the feedlot could be deemed as being
under 30 months of age at slaughter if their dentition examination upon
arrival to the feedlot showed no permanent incisors and if they are
sent to slaughter within six months of their arrival at the feedlot.
The comment noted that it has already submitted a notification to
the FSIS New Technology Staff (NTS) of its new technology. The
commenter submitted a copy of a letter from the FSIS NTS stating that
the NTS has no objection to the use of the new technology. However, as
stated in the letter, the regulations and implementing notice do not
include documentation of dentition examination prior to slaughter as a
method for verifying the age of cattle presented for slaughter.
Therefore, the comment requested that FSIS allow the use of its new
technology as a method to verify the age of cattle presented for
slaughter.
Response: FSIS considers auditable records of the dentition
examination of cattle at the feedlot as a form of documentation that
can be used to estimate the age of cattle at slaughter. Thus, the
Agency does not object to the use of the technology described above to
verify the age of cattle offered for slaughter. To assist with
implementation of this final rule, FSIS intends update the guidance
provided in FSIS Notice 10-04 to issue to clarify that auditable
records of dentition examination on the feedlot are an acceptable form
of documentation for verifying the age of cattle.
Importation of Products From Countries With a ``Negligible BSE Risk''
Comment: FSIS received a number of comments from countries that
export meat food products to the United States, as well as from
importers of meat food products, requesting that FSIS exempt countries
that present a ``negligible BSE risk'' from the requirements of the SRM
interim final rule.\23\ According to the comments, a country's
negligible BSE risk status provides the same level of protection from
human exposure to the BSE agent as does exclusion of SRMs and non-
ambulatory disabled cattle from the human food supply in the United
States.
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\23\ The comments requested that FSIS exempt countries with a
``BSE-free'' or ``provisionally free'' risk status. However, the OIE
BSE risk categories have been revised since FSIS issued the SRM
interim final rule. To reflect these revisions, instead of referring
to countries as having a ``BSE-free'' or ``provisionally free,''
risk status, FSIS will use the term ``negligible BSE risk.''
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The comments asserted that application of the SRM interim final
rule to all establishments that export meat food products to the United
States regardless of a country's BSE risk status is without scientific
justification and requires that certain countries implement costly and
unnecessary
[[Page 38717]]
measures. According to the comments, application of the U.S. BSE
measures to countries that can demonstrate that they present a
negligible BSE risk violates the World Trade Organization Agreement on
the Application of Sanitary and Phytosanitary Measures (the SPS
Agreement) because it is more trade restrictive than necessary to
achieve the appropriate level of sanitary protection required by the
United States.
Many comments noted that providing an exemption for countries with
a negligible BSE risk would be consistent with guidelines established
by the OIE, which recommend that countries restrict the importation of
potentially infective materials on the basis of the BSE risk
classification of the region of origin. Some comments stated that
providing an exemption for countries with a negligible BSE risk would
be consistent with the position already adopted by Canada. The comments
also stated that exempting countries with a negligible BSE risk would
be consistent with U.S. efforts to achieve uniformity and consistency
in international standards. As noted by the comments, E.U. regulations
exclude from the definition of SRMs materials from animals from
countries that fall within the European Union's lowest risk range of
BSE risk categories.
Many of the comments also submitted information on standards that
FSIS could use to determine a foreign country's BSE risk status. Some
comments suggested that FSIS apply guidelines for determining the BSE
risk status of a country or zone established by the OIE. The comments
stated that FSIS could rely on evaluations conducted by the OIE Ad-hoc
Group for BSE to determine whether a country meets the OIE criteria for
negligible BSE risk status, or the Agency could conduct its own
evaluations using the OIE criteria. Some comments suggested that FSIS
adopt criteria similar to the criteria used by Canada for determining
whether a country qualifies for an exemption from that country's BSE-
related requirements. Other comments recommended that FSIS consider
countries to have a negligible BSE risk if they are not listed by APHIS
in 9 CFR 94.18(a) as regions that present a risk of introducing BSE
into the United States. One comment suggested that, if a country's BSE
risk is to be evaluated by U.S. authorities, one U.S. agency should be
responsible for conducting the assessment. According to the comment,
USDA's APHIS would be the most appropriate agency because of it has
experience in conducting this type of evaluation.
Response: FSIS has been persuaded by these comments. The Agency
agrees that it is possible for a country's BSE risk status to provide
the same level of protection from human exposure to the BSE agent as
excluding SRMs from the human food supply does in the United States.
The Agency also agrees that restricting the importation of potentially
infective materials on the basis of the BSE risk of the region of
origin is more consistent with international guidelines than an
approach that does not consider a country's BSE risk.
Therefore, after careful consideration of this issue and the
comments received in response to the SRM interim final rule and the
APHIS/FSIS/FDA ANPR, FSIS has decided to amend the SRM interim final
rule to exclude from the definition of SRMs materials from cattle from
foreign countries that can demonstrate that their BSE risk status can
reasonably be expected to provide the same level of protection from
human exposure to the BSE agent as prohibiting SRMs for use as human
food does in the United States.\24\
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\24\ Materials may be derived from any animal from the country's
cattle population if the animal has been inspected and passed for
human food.
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Section 20 of the FMIA prohibits the importation of carcasses,
parts, meat, and meat food products that are adulterated or misbranded,
and that do not comply with all other requirements of the FMIA and its
implementing regulations (21 U.S.C. 620(a)). Under the FMIA, the
Secretary of Agriculture (and FSIS by delegation) is authorized to
treat as equivalent to a U.S. requirement, an alternative measure
proposed by an exporting country if the country provides scientific
evidence or other information, in accordance with risk assessment
methodologies agreed to by the Secretary and the exporting country, to
demonstrate that the alternative measure achieves the level of
protection that the Secretary considers appropriate (21 U.S.C.
620(e)(1)(B)).
FSIS' import regulations specify that a country's eligibility to
export meat and meat products to the United States must be based on an
equivalence evaluation (9 CFR 327.2(a)). To determine equivalence, FSIS
conducts two types of evaluations. The Agency conducts an initial
evaluation to determine whether a foreign meat inspection system is
equivalent in the case of a country that is not presently eligible to
export meat products to the United States. FSIS also conducts
evaluations to determine whether an individual sanitary measure is
equivalent in the case of a country that has already established its
equivalence and is requesting that FSIS recognize an alternative method
of eliminating or abating a particular food safety hazard.\25\
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\25\ FSIS may also consider an alternative sanitary measure as
part of an initial equivalence evaluation if the applicant country
were to propose alternative sanitary measures as part of its initial
equivalence submission.
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The initial equivalence evaluations of foreign meat inspection
systems are a prerequisite for trade. Countries that have completed
this initial equivalence process and that are eligible to export meat
and meat products to the United States are listed under 9 CFR 327.2(b)
of FSIS' import regulations. After a country is listed in 9 CFR
327.2(b) as eligible to export meat and meat products to the United
States, the country may request that FSIS conduct an evaluation to
determine whether an alternative sanitary measure proposed by the
country is equivalent to a U.S. requirement. FSIS will allow a country
to adopt an alternative sanitary measure if the country provides
sufficient scientific evidence to demonstrate that the alternative
measure achieves the same level of protection that is provided by the
U.S. requirement.
FSIS adopted regulations that prescribe requirements for the
removal, segregation, and disposition of SRMs as a measure to prevent
potential human exposure to the BSE agent. When it issued the SRM
interim final rule, FSIS explained that because of the way that BSE
infectivity occurs in BSE-infected cattle, and the fact that a case of
BSE has been detected in an imported animal in the United States, the
Agency has determined that certain materials from cattle present a
sufficient risk of exposing humans to the BSE agent that is prudent and
appropriate to find that these materials are unfit for human food
within the meaning of section 1(m)(3) of the adulteration provisions of
FMIA. As discussed earlier in this document, since FSIS issued the SRM
interim final rule, BSE has been confirmed in two native U.S. animals.
Thus, given these additional cases, FSIS has concluded that the
materials designated as SRMs in this final rule continue to present a
sufficient risk of exposing humans to the BSE agent so as to render
them ``unfit for human food'' under the FMIA.
However, not all countries have the same situation with regard to
BSE as the United States. Based on past import histories, import
controls, animal health risk mitigations, animal surveillance, and
other factors, some countries may be able to demonstrate that their BSE
risk status is such that materials from their cattle population that
would be designated as SRMs in the United States do not present a
sufficient risk of
[[Page 38718]]
exposing humans to the BSE agent to render these materials ``unfit for
human food'' as defined under the adulteration provisions of the FMIA.
Thus, the BSE risk status of these countries would accomplish the same
objective as the U.S. requirement for the removal, segregation, and
disposition of SRMs, which is to prevent human exposure to the BSE
agent.
Therefore, because the BSE risk status of certain countries may be
equivalent to U.S. requirements with regard to SRMs, FSIS has decided
to exclude from the definition of SRMs, materials from cattle from a
country that can demonstrate that its BSE risk status can reasonably be
expected to provide the same level of protection from human exposure to
the BSE agent as excluding SRMs from the human food supply does in the
United States. Because a country's BSE risk status would be considered
as an individual alternative sanitary measure to the U.S. requirement
for the removal, segregation, and disposition of SRMs, only those
countries that are listed in 9 CFR 327.2(b) as eligible to export meat
and meat products to the United States are eligible to request this
exemption.
When FSIS implements a measure to eliminate or abate a food safety
hazard, an exporting country must either adopt the same measure or
notify the Agency that it proposes to apply a different measure that
provides the same level of protection. Thus, countries that believe
that they are eligible to have materials from their cattle excluded
from FSIS' definition of SRMs should notify FSIS' Office of
International Affairs (OIA) and provide that office with sufficient
scientific evidence to support its claimed BSE risk status. FSIS will
then develop criteria to evaluate the equivalence request.
In developing equivalence criteria, FSIS will consider evidence
that the country proposes to submit in support of its BSE risk status,
including a BSE risk status evaluation, if one was conducted, or any
other supporting documentation. An exporting country may submit an
evaluation of its BSE risk status conducted by the OIE, another
country, or any other appropriate entity. Countries may also conduct
their own evaluations. However, any evaluation and supporting
documentation submitted by a country must contain sufficient scientific
evidence to demonstrate that the country's BSE risk status can
reasonably be expected to achieve the same level of protection from
human exposure to the BSE agent as excluding SRMs from human food does
in the United States.
An evaluation of a country's BSE risk status would consider whether
appropriate measures are in place to manage identified risks. This
would include consideration of import policies and import history to
determine the likelihood of the introduction of BSE into the country.
It could also include (among other things) consideration of any of the
following: effective surveillance efforts; measures to identify and
effectively control pathways for the amplification of BSE; appropriate
awareness programs; effective epidemiological investigations as
necessary, with appropriate tracing, control and destruction of risk
animals; continuing risk considerations with corresponding revisions of
existing mitigations; appropriate public health control measures
commensurate with risk; and the infrastructure sufficient to define and
implement any of the above.
As part of the equivalence process, FSIS officials with technical
program expertise and, where appropriate, technical experts from other
agencies, such as APHIS and FDA, consider the evidence provided by an
exporting country to demonstrate that its alternative sanitary measure
provides the same level of protection as the U.S. measure. During the
process, FSIS may request more information from the country to
facilitate the evaluation. Upon completion of the review process, FSIS
makes an equivalence determination and notifies the exporting country
of its decision. The Agency also provides the basis for the decision,
whether positive or negative. FSIS documents the equivalence process.
In addition to equivalence requirements, FSIS' import regulations
also provide that compliance with the conditions for importation of
products under FSIS' regulations does not excuse the need for
compliance with applicable requirements under other laws, including the
provisions in APHIS' regulations that prohibit or restrict the
importation of certain animals and animal products for animal health
purposes (9 CFR 327.2(b)). Thus, foreign countries that comply with all
of FSIS' requirements with regard to BSE must also comply with any
requirements related to BSE imposed by APHIS and FDA. Therefore, to
ensure, to the greatest extent possible, that FSIS' import policies
with regard to BSE are consistent with policies implemented by USDA's
APHIS and HHS' FDA, FSIS intends to consult with these agencies
whenever a country requests to have materials from its cattle
population excluded from FSIS' definition of SRMs.
As part of this consultation process, FSIS may request that
technical experts from APHIS and FDA review the BSE risk evaluation and
other evidence of equivalence submitted by the exporting country. FSIS
will consider APHIS' and FDA's conclusions as to whether information
submitted by the exporting country provides sufficient scientific
evidence to support the country's claimed BSE risk status. FSIS will
also consider whether APHIS or FDA impose any BSE-related restrictions
on imports from the country and, if so, the basis for those
restrictions.
After FSIS is finished considering the evidence submitted by a
country in support of its BSE risk status, the Agency will: (1)
Recognize that the country's BSE risk status is equivalent to excluding
SRMs from the human food supply in the United States or (2) request
more information to facilitate consideration of the submission or (3)
reject equivalence of the country's BSE risk status and provide
appropriate reasons for that decision. FSIS will notify the exporting
country of its judgment within a reasonable period of time, although
the time that it takes FSIS to complete its equivalence determination
may vary depending on the evidence submitted by the country and its
specific situation with regard to BSE. FSIS will also provide the
country with basis for its decision should the judgment be that the
country's BSE risk status is not equivalent.
FSIS retains a sovereign right to decide whether the exporting
country's sanitary measure is equivalent to its own provided that the
process is fair and transparent and the decision is based on sufficient
scientific evidence. Exporting countries must receive an equivalence
determination from FSIS before any alternative sanitary measure is
implemented in the country. Following a judgment of alternative
sanitary measure equivalence based upon document analysis, FSIS will
verify on-site during the next regularly scheduled audit that the
alternative sanitary measure has been appropriately implemented.
Thereafter, FSIS and the exporting country should advise each other of
any changes in their programs or infrastructure that may affect the
original determination of equivalence.
In addition, after FSIS completes its initial equivalence
determination, the Agency uses a three-part process to verify that an
exporting country's meat inspection system and proposed alternative
sanitary measures continue to be equivalent. The first part of this
process is a recurring document analysis, which is used to gradually
repeat and update initial equivalence determinations. The second is on-
site meat inspection system audits
[[Page 38719]]
conducted at least annually in every country that exports meat and
poultry products to the United States. The third is port-of-entry re-
inspections in which FSIS randomly samples meat product as they enter
the United States. These re-inspections provide evidence of how the
foreign inspection system is functioning.
Because FSIS, APHIS, and FDA have different regulatory
responsibilities, it is not practical for one U.S. Government agency to
be responsible for conducting all aspects of every evaluation of a
foreign country's BSE risk. However, FSIS' approach for considering
evidence of an exporting country's claimed BSE risk status is
consistent with the approach used by USDA's APHIS to determine a
foreign country's animal health risk status related to BSE. When it
considers a country's BSE risk, APHIS evaluates an individual country's
specific situation and analyzes risk based on the overall effectiveness
of actions taken by the country to prevent the introduction and spread
of BSE. APHIS also takes into consideration the OIE guidelines, as well
as evaluations conducted by other countries.
FSIS has determined that the type of comprehensive approach used by
APHIS to consider a country's animal health risk status is also an
appropriate approach for FSIS to use to determine whether materials
from cattle from countries considered to be of negligible risk will
present no greater risk of exposing humans to the BSE agent than do
beef products permitted for human food in the United States, including
those materials that would be designated as SRMs if they were from
cattle from the United States.
Comment: One comment suggested that the prohibition on the
slaughter of non-ambulatory disabled cattle may have been motivated to
some degree by animal welfare objectives in that automatic condemnation
of these animals will deter attempts to ship non-ambulatory cattle and
perhaps persuade truckers to do more to prevent injury during
transport. The comment stated that if this is the case, some countries
have implemented alternative measures that address the animal welfare
implications associated with the transportation of non-ambulatory
animals. According to the comment, when making equivalence
determinations, FSIS should give due consideration to countries, such
as Canada, that prohibit non-ambulatory animals from leaving the farm.
Response: As discussed below, above, FSIS is affirming the
prohibition on the slaughter of non-ambulatory disabled cattle because
the Agency has determined that it is a prudent measure to prevent
potential human exposure to the BSE agent. Thus, under this final rule,
if a foreign country can demonstrate that its BSE risk status can
reasonably be expected to achieve the same level of protection from
potential human exposure to the BSE agent as requiring the condemnation
of non-ambulatory disabled cattle that are offered for slaughter does
in the United States, the country will not be required to prohibit the
slaughter of all non-ambulatory disabled cattle for human food in order
to be eligible to export beef products to the United States.
Comment: One comment asked how FSIS will provide assurance that
products imported into the United States were produced in compliance
with the requirements in the SRM interim final rule.
Response: FSIS ensures that imported meat in the U.S. marketplace
is safe, wholesome, unadulterated, and properly labeled by (1)
determining whether foreign countries and their establishments have
implemented a food safety system and inspection requirements equivalent
to those in the United States and (2) re-inspecting imported meat and
poultry products from those countries through random sampling of
shipments. The FSIS regulations in 9 CFR 327.2 provide that countries
eligible to export meat to the United States must have a meat
inspection system that has been determined by FSIS to be equivalent to
the U.S. meat inspection system. The FSIS equivalence determination is
based on a review of the foreign country's relevant laws and
regulations and on an on-site audit of the foreign country's inspection
system.
Once a country is listed as eligible to export meat and meat
products to the United States, it is responsible for certifying
individual exporting establishments to FSIS and for providing annual
recertification documentation. FSIS regularly conducts on-site audits
of the eligible foreign inspection systems to ensure they remain
equivalent to the U.S. system.
Air-Injection Stunning
Comment: Most of the comments received in response to the air-
injection stunning interim final rule were supportive and encouraged
FSIS to make the interim provisions permanent. Some comments indicated
that even though the U.S. beef slaughter industry no longer uses air-
injection stunning devices, the regulation is still important to
prohibit any future use of these devices and to ensure the safety of
imported beef products into the United States.
One comment concurred with FSIS' decision to reject the option of a
performance standard for CNS emboli that may occur after stunning. As
noted by the comment, a performance standard and testing for CNS emboli
would be costly and unwieldy to both industry and government
enforcement officials.
Response: FSIS agrees with these comments. Accordingly, in this
final rule, FSIS is adopting, without changes, the provisions of the
air injection stunning interim final rule.
Comment: One comment noted that the Canadian Food Inspection Agency
(CFIA) has prohibited the use of air-injection stunning equipment for
any red meat species processed in federally-registered Canadian
establishments since May 2000. The comment also indicated that CFIA
prohibits the destruction of brain matter using a rod (referred to as
``pithing'') because this procedure can cause dislocation of portions
of brain and release emboli into the circulatory system of stunned
cattle.
Response: U.S. requirements for stunning cattle are consistent with
the Canadian requirements. The pithing method of stunning is not
permitted in the United States and it is not listed as an approved
humane method of slaughter in 9 CFR part 313.
Comment: One comment criticized FSIS for not including a discussion
of CNS micro-emboli in the preamble to the rule. According to the
comment, trauma sufficient to cause unconsciousness will cause damage
that ranges from contusions and ultra structural changes, including the
disruption of the blood-brain barrier to frank tissue destruction and
accompanying hemorrhage. The comment asserted that other types of
stunning devices, such as penetrating captive bolt stunners that do not
inject air and non-penetrating captive bolt stunners, may result in CNS
micro-emboli.
Response: In the preamble to the air-injection stunning interim
final rule, FSIS addressed the potential for captive bolt stunning
devices that do not use air-injection to result in CNS micro-emboli in
its discussion of the Harvard Risk Assessment study. In that
discussion, the Agency noted that the original Harvard study (2001/
2003) (also referred to as the Harvard-Tuskegee study) estimated that
for each BSE-infected animal stunned with a standard captive bolt
stunner (without air injection), there is a 50 percent probability that
a very small fraction of the BSE agent will be transferred to the
[[Page 38720]]
blood (see 69 FR 1885, 1888). The Harvard-Tuskegee study assumes that
this small fraction is what would be contained within micro-emboli that
might occur. As noted in the discussion, the Harvard-Tuskegee study
concluded that the stunning method used on cattle is not a major
potential source of human exposure to the BSE agent, but that potential
human exposure to the BSE agent would increase with greater use of air-
injection stunning.
Since FSIS issued the air-injection stunning rule, information has
become available to the Agency that indicates that the use of both
penetrating and non-penetrating captive bolt stunning on cattle may
result in CNS tissue emboli. A report of the EFSA Working Group on BSE
risk from dissemination of brain particles in blood and carcass
reported that recent studies have shown that brain damage caused by
both penetrating and non-penetrating captive bolt stunning in cattle
can result in occurrence of CNS tissue emboli in venous blood draining
the head.\26\ The EFSA report also concludes that while experimental
studies have indicated that widespread distribution of CNS emboli via
systemic arterial circulation may occur, this has not been confirmed
under commercial conditions. The report recommends that further
validation studies on the occurrence of stunning-associated CNS emboli
be conducted under commercial conditions and that these studies should
focus on the involvement of systemic arterial circulation in the
distribution of CNS emboli.
---------------------------------------------------------------------------
\26\ Annex to the EFSA Journal (2004). Report of the EFSA
Working Group on BSE risk from dissemination of brain particles in
blood and carcasses, adopted on 21 October 2004. (pp. 16-17) (http://www.efsa.eu.int).
---------------------------------------------------------------------------
Thus, further research is needed to assess how various methods used
to stun cattle at slaughter in the United States affect the risk of
potential human exposure to the BSE agent. The Agency supports the need
for additional research on stunning methods and CNS emboli. FSIS will
use the results of future studies to evaluate the stunning methods
permitted for use on cattle in the United States and, if necessary,
will take appropriate action to ensure that stunning devices are not a
significant potential source of human exposure to the BSE agent.
Comment: One comment stated that if FSIS is not aware of any U.S.
slaughter establishments that use air-injection stunning, why did the
Agency issue a rule to prohibit this practice? The comment asserted
that the rule appears to be unnecessary and may negatively affect
consumer confidence in the safety of the U.S. beef production system.
Response: As indicated by one of the comments above, even though
the U.S. beef slaughter industry no longer uses air-injection stunning
devices on cattle, prohibiting the use of these devices is still
important to ensure that they are not used in the future and to ensure
the safety of imported beef products into the United States.
Comment: One comment asked how FSIS will ensure that certified
foreign establishments in countries that permit the use of air-
injection stunning are not using air injection stunning devices on
cattle whose products are exported to the United States.
Response: Foreign countries that import meat food products into the
United States must employ sanitary measures that can reasonably be
expected to provide the same level of protection from human exposure to
BSE that is achieved domestically. Therefore, foreign establishments
that use air-injection stunning on cattle are prohibited from exporting
meat food products to the United States. FSIS regularly conducts on-
site audits of eligible foreign inspection systems to ensure they
remain equivalent to the U.S. system.
MS(Beef)
Comment: Most comments submitted in response to the SRM interim
final rule's prohibition on the use of MS(beef) for human food
expressed support for this provision. Some comments suggested that
instead of banning MS(beef), FSIS should consider prohibiting the use
of cattle skulls and vertebral columns in the production of this
product. One comment stated FSIS could revise the specifications for
MS(beef) to prohibit the incorporation of CNS-type tissues and apply
controls similar to those for beef produced using AMR systems.
Response: Because they are SRMs, 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 are prohibited for use as source materials
in AMR systems. However, skulls and vertebral columns from cattle
younger than 30 months are permitted to be used as a source material in
AMR systems if they do not contain any CNS-type tissues. Under the AMR
interim final rule, beef AMR product that does not qualify to be
labeled or used as ``meat,'' but that meets the requirements of 9 CFR
319.5 (the requirements for MS(species)), may be used for human food if
skulls or vertebral column bones that contain CNS-type tissues from
cattle younger than 30 months of age were not used as a source material
in the production of the product and the product does not contain
spinal cord or DRG from bones of cattle younger than 30 months (9 CRF
318.24(c)(2)(iii)). While this product, which has the characteristics
of MS(beef) without CNS-type tissues, cannot bear the name MS(beef), it
may bear a common or usual name that is not false or misleading.
Hand De-Boned Meat
In the SRM interim final rule, FSIS noted that because of its
proximity to the vertebral column, some hand de-boned meat may contain
DRG depending on the technique used to remove the meat from the bone.
The Agency requested comments on whether it should prohibit hand de-
boned meat from the vertebral columns of cattle 30 months of age and
older for use as human food (69 FR 1862, 1868).
Comment: Some comments stated that as long as standard boning
procedures are followed, hand de-boned meat from the vertebral columns
of cattle 30 months of age and older is safe and should not be
prohibited for human food. One comment suggested that FSIS allow
companies to determine whether hand de-boned meat from the vertebral
bones of cattle 30 months of age and older is acceptable based on the
individual design of the plant's HACCP plan. Another comment argued
that FSIS should prohibit hand de-boned meat from the vertebral column
of cattle 30 months of age and older for human food until data on
whether it may contain DRG is more conclusive.
A comment submitted by the Canadian Food Inspection Agency (CFIA)
noted that hand de-boning of parts of the vertebral column can result
in DRG tissue being excised, particularly in the lumbar region. The
comment stated that CFIA and Health Canada would welcome the
opportunity to compare data with FSIS and to collaborate in an
assessment of the risk associated with this practice and identification
of appropriate risk management measures.
Response: After considering this issue, FSIS has determined that
there are insufficient data to demonstrate that hand de-boned meat
presents a risk of exposing humans to the BSE agent. Therefore, in this
final rule, FSIS will continue to permit hand de-boned meat from the
vertebral column of cattle 30 months of age and older for human food.
However, because of the DRG's close association to the vertebral bones,
the Agency requires that establishments
[[Page 38721]]
that produce hand de-boned beef from the vertebral column of cattle 30
months of age and older address the potential for contamination of
edible materials with SRMs, including the DRG, in their procedures for
the removal, segregation, and disposition of SRMs.
FSIS appreciates and accepts the CFIA's offer to compare data on
the potential for DRG to become dislodged when meat is hand de-boned.
The Agency intends to work with CFIA to further assess the risk
associated with DRG in hand de-boned meat and to identify appropriate
risk mitigation measures.
BSE in Japanese Cattle Younger Than 30 Months
Comment: In the preamble to the SRM interim final rule, FSIS
requested comments on the implications, if any, of the reported 21- and
23-month-old cases of BSE in Japan (69 FR 1862, 1864). One comment
submitted on this issue stated that it endorsed recommendations made by
an OIE Expert Group convened in Paris on December 2, 2003. According to
the comment, the OIE group concluded that the so-called atypical BSE
cases reported in Japan were no cause for changes in the international
standards for trade in cattle and cattle products.
Another comment suggested that FSIS investigate the findings of the
21- and 23-month old Japanese cattle that were reported as testing
positive for BSE and publicly clarify that these results were reached
using inadequate methodology. The comment asserted that the tissue
samples from these animals were later confirmed as negative by the
International Reference Laboratory in Weybridge, England.
Response: The two Japanese cases of BSE in animals 21- and 23-
months old were reported in 2003 and were detected as part of Japan's
program to test all cattle slaughtered for human food for BSE. While
FSIS is not aware of any data to indicate that these animals were later
confirmed as negative by the U.K. International Reference Laboratory, a
report issued by the European Food Safety Authority (EFSA), Scientific
Panel on Biological Hazards, states that ``it is unclear whether the
very young cases [reported in Japan] were adequately identified and
formally confirmed.'' \27\ This same report concluded that these cases
``seem to be epidemiologically peculiar as their cohort would have been
expected to yield further cases.'' FSIS has concluded that the
available evidence surrounding the two very young cases of BSE reported
in Japan is insufficient to support any changes in the measures
implemented by FSIS to prevent human exposure to the BSE agent.
---------------------------------------------------------------------------
\27\ The EFSA Journal 2005 220, 1-21, Annex to the Opinion,
Report of the Working Group on the assessment of the age limit in
cattle for the removal of certain specified risk materials (SRM)
(see 1.2.3. Age distribution of young BSE cases outside the EU, p.
11). Available on the Internet at: http://www.efsa.eu.int/science/biohaz/biohaz_opinions/opinion_annexes/933/biohaz_report_ej220_srmremove_en1.pdf.
---------------------------------------------------------------------------
Testing Cattle for BSE
Comment: Some comments stated that all cattle offered for slaughter
should be tested for BSE and their carcasses should be permitted for
use as human food only if the test result is negative. The comments
noted that the carcasses would be held pending the test result in
accordance with FSIS' ``test and hold'' policy. Some comments suggested
that cattle over 20 months of age be tested for BSE. Others suggested
that testing be limited to cattle over 30 months. One comment stated
that establishments should not be required to remove SRMs if an animal
tests negative for BSE.
Other comments agreed with statements made by FSIS in the preamble
to the SRM interim final rule on the limitations of available test
methods for BSE. The comments agreed that removal of SRMs provides more
protection from human exposure to the BSE agent than testing cattle for
BSE at slaughter.
Response: As discussed in the SRM interim final rule, the BSE tests
that are available today are not appropriate for use as a food safety
measure. Thus, the Agency believes that cattle should only be tested
for BSE at slaughter as part of USDA's surveillance for BSE. FSIS
agrees with the comments that assert that removal of SRMs at slaughter
provides more protection from human exposure to the BSE agent than
testing cattle for BSE.
The earliest point at which current testing methods can detect a
positive case of BSE is 2 to 3 months before the animal begins to
demonstrate clinical signs. The incubation period for BSE--the time
between initial infection and the manifestation of clinical signs--is
generally very long, on average about 5 years. Therefore, there is a
long period in the life of an infected animal when tests with the
current methodology would not detect the disease. Thus, testing all
slaughter cattle for BSE might offer misleading assurances to the
public and to U.S. trading partners.
In contrast, the current test technology provides highly meaningful
and reliable results when used for surveillance purposes on animals
within USDA's targeted populations--specifically, adult animals
exhibiting some type of clinical abnormality that could be consistent
with BSE. This targeted approach is based on the assumption that if the
disease is rare in the most likely population, it will be even more
unlikely to be found in the non-targeted population. Thus, USDA's APHIS
is able to calculate the estimated prevalence of BSE in the U.S. cattle
population as a whole from fewer samples when those samples are drawn
from the target population. The current testing technology enables
APHIS to assess the prevalence within the context of surveillance and
therefore the effectiveness of various risk mitigation measures that
have been implemented.
Comment: A few comments stated that there is a need to develop
improved tests for BSE. The comments stated that a live animal test
must be developed so that cattle can be tested for BSE at slaughter.
Another comment said that enhanced diagnostics for BSE must be
developed to minimize the possibility of false negatives. The comment
provided the example of the use of sodium phosphotungstic acid to
preferentially precipitate prions. Another comment said that the
discovery of a normal-appearing animal in Italy with an apparently new
strain of BSE that may elude tests used in the United States
underscores the need for more sensitive and rapid tests that are in
widespread use in Europe.
Response: FSIS agrees and supports the development of improved BSE
tests and agrees that there is a need for an accurate and reliable live
animal test.
Comment: Some comments stated that USDA should permit private
companies to test cattle for BSE at slaughter.
Response: USDA's APHIS is responsible for approving the use and
distribution of approved BSE test kits. However, as stated above, FSIS
believes that the BSE tests that are available today are not
appropriate for use as a food safety measure.
Reassess Measures as Needed
Comment: Several comments suggested that FSIS make appropriate
adjustments to the SRM interim final rule if new scientific findings or
the results of the increased surveillance indicate that the regulations
should be modified. The comments stated that if no additional cases of
BSE are confirmed under APHIS' enhanced surveillance, FSIS should
evaluate whether the removal of SRMs from cattle older than 30 months
of age is warranted given the near-zero risk posed to the public and
the high costs imposed on producers. One comment said that FSIS should
rescind the SRM interim final rule if no additional BSE cases are
confirmed in the United
[[Page 38722]]
States. Another stated that FSIS should permit the use of some, if not
all, SRMs and permit vertebral bones from cattle 30 months of age and
older in the production of beef AMR product if no additional cases are
confirmed.
One comment said that any action to prevent human exposure to the
BSE agent should be evaluated based on its public health outcome.
According to the comment, a human health risk assessment should be
conducted to determine the extent of public health protection that the
SRM interim final rule provides before FSIS issues a final rule.
Another comment stated that FSIS should leave the current measures in
place regardless of the outcome of APHIS' enhanced BSE surveillance.
A few comments suggested that FSIS work with Canada and Mexico to
harmonize BSE regulations in North America. One comment stated that
FSIS should harmonize its requirements for SRM removal with the OIE
standards to the maximum extent possible.
Response: FSIS will continue to evaluate the science, international
standards for, and the risk of BSE in the United States on an ongoing
basis to ensure that the measures implemented by the U.S. government to
minimize potential human exposure to the BSE agent continue to provide
the appropriate level of protection. The Agency, in coordination with
APHIS and FDA, will make appropriate adjustments to this final rule if
new scientific findings or information on the risk of BSE in the United
States indicate that prescribed measures should be modified, added, or
eliminated.
Humane Handling of Livestock
Comment: Most of the comments received in response to the SRM
interim final rule were from animal welfare advocacy organizations and
private citizens concerned about the welfare of animals. These comments
expressed support for the interim prohibition on the slaughter of non-
ambulatory disabled cattle for human food and requested that FSIS make
it permanent. The comments also requested that FSIS extend the
prohibition to cover all livestock species under FSIS'' jurisdiction,
i.e., sheep, swine, goats, and horses and other equines, and to require
that all non-ambulatory animals be immediately and humanely euthanized
on arrival at a slaughter facility. According to the comments, a
permanent prohibition on the slaughter of non-ambulatory disabled
cattle and other non-ambulatory livestock is necessary to ensure that
these animals are handled in a humane manner.
Response: FSIS has carefully considered the humane handling
implications of the interim prohibition on the slaughter of non-
ambulatory disabled cattle and has concluded that the comments have
merit. Thus, the Agency has determined requiring the condemnation of
non-ambulatory disabled cattle that are offered for slaughter may be
necessary ensure that these animals are humanely handled in connection
with slaughter as required under the Humane Methods of Slaughter Act
(HMSA) of 1978 (7 U.S.C. 1901 et seq.).
However, because FSIS did not discuss issues related to the humane
handling of non-ambulatory disabled cattle or other non-ambulatory
disabled livestock that are offered for slaughter in the SRM interim
final rule or in the July 14, 2004, FSIS/APHIS/FDA ANPR, this final
rule affirms the prohibition on the slaughter of non-ambulatory
disabled cattle that are offered for slaughter as a measure to prevent
potential human exposure to the BSE agent. FSIS intends to initiate a
separate action in which it will discuss measures that may be necessary
to ensure that non-ambulatory disabled cattle and other non-ambulatory
disabled livestock are humanely handling in connection with slaughter.
Comment: Some comments suggested that FSIS amend the regulations in
9 CFR 309.13 that permit condemned livestock to be set apart and
treated, or to be released from the establishment premises if
permission is granted, to exclude all non-ambulatory disabled
livestock.
Response: FSIS disagrees with these comments. Some non-ambulatory
livestock that have been condemned may be affected with reversible
conditions. The Agency believes that livestock that are condemned on
the account of conditions such as ketosis, swine erysipelas,
leptospirosis, inflammatory conditions, or the other conditions
identified under 9 CFR 309.13, should continue to be permitted to be
set apart and held for treatment under supervision of an FSIS program
employee or an official designated by the area supervisor.
Comment: Some comments noted that prohibiting the slaughter of non-
ambulatory disabled cattle for human food provides an incentive for
cattle producers and transporters to engage in responsible husbandry
and management practices to prevent cattle from becoming non-ambulatory
before they are slaughtered. One comment stated that USDA should
prohibit the transport of non-ambulatory disabled cattle from the farm.
Response: Although the purpose of requiring the condemnation of
non-ambulatory disabled cattle that are offered for slaughter is to
prevent potential human exposure to the BSE agent, FSIS agrees with the
comments that stated that prohibiting the slaughter of non-ambulatory
disabled cattle may provide incentives for cattle producers to adopt
animal husbandry practices that prevent cattle from becoming non-
ambulatory. The Agency also agrees that it may provide incentives for
transporters to handle cattle in a manner that prevents them from
becoming non-ambulatory.
Comments Concerning Livestock Other Than Cattle
Comment: One comment asked that the slaughter of all non-ambulatory
disabled livestock be prohibited to prevent potential human exposure to
the BSE agent. The comment argued that, in addition to the BSE variant
discovered in the cow in Washington State, there are likely other
variants of BSE that afflict cattle, as well as other poorly understood
or unidentified TSE variants that affect other livestock species.
According to the comment, variants of BSE or other TSEs may be linked
to cases of the classical or the ``sporadic'' form of CJD in the United
States and elsewhere.
The comment also stated that researchers in the United Kingdom have
recently discovered a type of scrapie that resembles BSE. The comment
argued that scientists cannot rule out the possibility that this is a
new form of BSE that has adapted to sheep. As stated by the comment,
prion diseases in sheep can be transmitted from animal to animal and,
as a result, a form of BSE acquired prior to the feed ban may be
circulating in the United States. The comment also noted that TSE
agents are more widely distributed in the tissues of sheep than they
are in cattle.
The comment also argued that the fact that requirements in the
interim final rule on AMR systems also apply to pork demonstrates that
FSIS acknowledges that materials from livestock other than cattle may
pose a BSE risk.
Response: When FSIS issued the SRM interim final rule, the
prohibition on the slaughter of non-ambulatory disabled cattle for
human food was limited to cattle because the Agency was not aware of
any data to indicate that livestock other than cattle could contract
BSE under natural conditions. Thus, the Agency did not believe that
extending the prohibition on the slaughter of non-ambulatory disabled
cattle to other livestock would be appropriate in this rulemaking.
[[Page 38723]]
On January 28, 2005, a suspected case of BSE in a goat slaughtered
in France in 2002 was confirmed by a panel of European scientists.\28\
In response to this finding, the European Commission proposed to
increase testing for BSE among goats for at least six months to
determine if this one positive case was an isolated incident. As of the
date of the publication of this document, no additional cases of BSE
have been confirmed under natural conditions in livestock species other
than cattle. Therefore, the Agency has concluded that there are
insufficient data to indicate that a prohibition on the slaughter of
non-ambulatory disabled livestock other than cattle is needed to
minimize human exposure to the BSE agent. The Agency will continue to
follow the research with regard to BSE in livestock species other than
cattle and will use the findings of future research to inform its
policies with regard to BSE.
---------------------------------------------------------------------------
\28\ Case of BSE in goat confirmed: Commission extends testing
programme, Europa Web site, January 28. 2005. http://europa.eu.int/rapid/pressReleasesAction.do?reference=IP/05/
105&format=HTML&aged=0&language=EN&guiLanguage=fr.
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FSIS disagrees that requirements in the interim final rule on AMR
systems indicate that the Agency acknowledges that materials from
livestock other than cattle may pose a BSE risk. One of the objectives
of the AMR interim final rule is to define the criteria that products
produced using AMR systems must comply with to be represented as
``meat.'' The preamble to the AMR rule makes clear that the presence of
``CNS-type tissues,'' i.e., CNS tissue, DRG, and trigeminal ganglia,
from livestock other than cattle 30 months of age and older in AMR
product renders the product misbranded (69 FR 1874, 1881).
Comment: A few comments stated that the change in the regulation
that replaces ``seriously crippled animals commonly termed ``downers''
in Sec. 309.2(b) with ``non-ambulatory disabled livestock''
unnecessarily and inappropriately broadens the rule's scope. The
comments noted that the SRM interim final rule, as written, applies the
definition of non-ambulatory disabled livestock to swine even though
there is no scientific link between swine and BSE. The comment
suggested that FSIS consider species-specific language that recognizes
that swine or other amenable species can be ``temporarily disabled''
and still be suitable for slaughter for human food. The comment
requested that FSIS amend the definition of non-ambulatory disabled
livestock to recognize the differences in species and the conditions
that may warrant the condemnation of those animals on a species and
case-by-case basis.
Response: The definition of non-ambulatory disabled livestock does
not broaden the scope of the rule to require the immediate condemnation
of non-ambulatory disabled livestock other than cattle. The regulations
at 9 CFR 309.2(b) provide that all seriously crippled animals and non-
ambulatory disabled livestock shall be identified as U.S. Suspects
unless they are required to be classed as condemned under 9 CFR 309.3.
The regulations in 9 CFR 309.3 require that all non-ambulatory disabled
cattle be condemned. However, non-ambulatory disabled livestock other
than cattle may be identified as U.S. Suspects, set apart, and
slaughtered separately from livestock that have passed ante-mortem
inspection (9 CFR 309.2(n)). If an FSIS veterinarian finds that the
meat and meat food products from a U.S. Suspect are not adulterated,
these products may be used for human food (9 CFR 311.1).
Animal Feed
Comment: Several comments requested that FSIS prohibit the use of
SRMs and non-ambulatory disabled cattle in animal feed and pet food.
Other comments suggested that FSIS work with FDA to completely remove
all SRMs, as well as non-ambulatory and dead stock from the animal feed
chains. One comment stated that the U.S. government should ban the
feeding of any mammalian protein to all mammals and prohibit the use of
poultry litter in animal feed.
Response: The FDA is responsible for regulating animal food and
feed in the United States. On October 6, 2005, FDA published a proposed
rule to amend its animal feed regulations to prohibit from use in the
food or feed of all animals certain high risk cattle materials that can
potentially carry the BSE agent (``Substances Prohibited From Use in
Animal Food or Feed,'' 70 FR 58570). The issues raised by these
comments are addressed in that rulemaking. FSIS with APHIS will
continue to work closely with FDA on its rulemaking.
Surveillance, Disposal of Dead Cattle, and Cattle Identification
Comment: Some comments noted that surveillance for BSE is essential
for establishing the prevalence of the disease and for evaluating the
effectiveness of control measures. One comment said that FSIS should
test all high-risk cattle 30 months of age and older for BSE and
randomly sample healthy cattle over 30 months of age to determine the
true prevalence of the disease and to evaluate risk management measures
in this country. One comment said that testing all non-ambulatory
disabled cattle for BSE regardless of the reason for their non-
ambulatory status may bias the representative population of potentially
infected cattle. As stated by the comment, young injured cattle are
unlikely to have BSE. Another comment suggested that USDA test all non-
ambulatory disabled cattle.
One comment stated that USDA should require licensing of all
entities, including farms and ranches, that dispose of cattle. As
stated by the comment, FSIS has some authority over registration and
recordkeeping of handlers of 4-D livestock and should explore extending
this to disposal of these livestock to aid surveillance.
A few comments asserted that APHIS' BSE surveillance testing on the
farm provides no incentive for farmers or ranchers to voluntarily
subject their non-ambulatory cattle to testing. According to the
comments, the program offers only risk and no compensation. The
comments suggested that USDA establish a program for producers to
submit animals that die on the farm for testing for BSE.
Response: USDA's APHIS has primary responsibility for BSE
surveillance activities in the United States and is responsible for
developing the BSE sampling protocols. We forwarded these comments to
APHIS for consideration as they designed their current BSE surveillance
program. As discussed above, APHIS has now transitioned to an ongoing
BSE surveillance program, which samples approximately 40,000 animals
each year, and continues to sample the cattle populations where the
disease is most likely to be found. The targeted population for APHIS'
ongoing surveillance includes cattle exhibiting signs of CNS disorders
or any other signs that may be associated with BSE, including
emaciation or injury, and dead cattle, as well as non-ambulatory
cattle. Samples from the targeted population are taken from the same
locations as those used during the enhanced surveillance program.
FSIS has and continues to assist APHIS in implementing its BSE
surveillance program by, among other activities, collecting brain
samples of all cattle condemned on ante-mortem inspection, including
non-ambulatory disabled cattle and cattle that show signs of CNS
disease, and verifying that ante-mortem condemned cattle that are to be
tested by APHIS at an off-site sample collection location arrive at the
location.
[[Page 38724]]
As noted by the comments, FSIS has some authority over registration
and recordkeeping of handlers of 4-D livestock. FSIS does not believe
further regulatory action is required as suggested by the comment.
Comment: One comment stated that USDA should develop, implement,
and enforce safe and effective methods for destroying animals that are
found to have a TSE. Another comment suggested that all dead cattle on
farms be transported to a federally regulated facility for disposal.
Response: USDA's APHIS is the agency primarily responsible for
ensuring the proper disposition of animals that have confirmed TSEs. At
the same time, APHIS, FSIS, FDA, and the Environmental Protection
Agency (EPA), coordinate efforts to ensure that the carcasses of
animals with TSEs and other diseases are properly disposed of.
Comment: Several comments expressed support for a national cattle
identification system. Some comments stated that USDA should implement
an identification system for all livestock, not just cattle, and that
is should be mandatory. One comment stated that animals at slaughter
should be required to have identification records and that the records
should be retained for 7 years.
Response: Since April 2004, USDA has been in the process of
implementing the National Animal Identification System (NAIS), a
voluntary animal identification and tracking system that will be used
in all States and that will operate under national standards. When
fully operational, the system will be capable of tracing a sick animal
or group of animals back to the herd or premises that is the most
likely source of infection. It will also be able to trace potentially
exposed animals that were removed from that herd or premises.
Information regarding the NAIS can be found on the Internet at: http://animalid.aphis.usda.gov/nais/index.shtml.
Other Comments
Comment: One comment suggested that FSIS require that the packaging
of beef products bear labeling to warn the American public about the
potential risk of BSE. Another comment stated that the labeling of
products that contain brain or spinal cord from cattle younger than 30
months of age should include a warning about the potential BSE risk.
Another comment said that country-of-origin labeling for meat products
would be invaluable for tracking individual animals or herds implicated
in disease transmission.
Response: As discussed in detail above, the estimated BSE
prevalence in the United States is extremely low, less than one case
per million cattle. On the basis of these prevalence estimates, in
conjunction with effective implementation of the risk mitigation
measures discussed here, FSIS has determined that beef and beef
products produced in the United States are, and will remain, highly
unlikely to be contaminated with the BSE agent. Therefore, the Agency
disagrees that beef products or products that contain brain or spinal
cord from cattle less than 30 months should bear warning labels about
the potential BSE risk.
Under the Farm and Security and Rural Investment Act of 2002 and
the 2002 Supplemental Appropriations Act, USDA is required to implement
a mandatory country of origin labeling program (COOL).\29\ USDA's
Agricultural Marketing Service (AMS) published a proposed rule on the
COOL program on October 30, 2003 (68 FR 61944-61985, Docket No. LS-03-
04). Under the proposal, retailers would be required to notify their
customers of the country of origin of all beef (including veal), lamb,
pork, fish, and selected other perishable commodities being marketed in
their stores. In addition, the AMS proposal identifies criteria that
these commodities must meet to be considered of U.S. origin. In January
2004, President Bush signed Public Law 108-199, which included a
provision to delay until September 2006 the implementation of mandatory
COOL for all covered commodities except wild and farm-raised fish and
shellfish. On November 10, 2005, President Bush signed Public Law 109-
97, which delayed implementation of mandatory COOL for all covered
commodities except wild and farm-raised fish and shellfish until
September 30, 2008.
---------------------------------------------------------------------------
\29\ AMS USDA, ``Country of Origin Labeling--Current Status of
Country of Origin Labeling,'' available at http://www.ams.usda.gov/cool/status.htm.
---------------------------------------------------------------------------
Comment: One comment stated that the U.S. government must trace CJD
in humans.
Response: The U.S. Centers for Disease Control and Prevention (CDC)
conducts surveillance and does tracing for CJD and other human TSEs in
the United States. Information on surveillance for CJD in the United
States is available on the CDC Web site at: http://www.cdc.gov/ncidod/dvrd/vcjd/index.htm.
Comment: One comment suggested that USDA encourage farmers to feed
cattle natural, organic feed. Another comment stated that USDA should
phase out all growing and raising of animals for human consumption.
Response: These comments are outside the scope of this rulemaking
and outside the scope of FSIS' regulatory authority.
Comment: One comment requested that USDA eliminate the requirement
that beef imported from Canada be processed on dedicated equipment if
establishments slaughter cattle 30 months of age and older and cattle
younger than 30 months in the same facility.
Response: This comment was addressed by APHIS in its final rule,
``Bovine Spongiform Encephalopathy; Minimal-Risk Regions and
Importation of Commodities'' (70 FR 459-553, January 4, 2005). In that
rulemaking, APHIS removed the proposed requirement that meat derived
from bovines in a BSE minimal-risk region that are slaughtered in that
region come from animals slaughtered at a facility that either
slaughters only bovines less than 30 months of age or complies with an
approved segregation process.
2005 Risk Assessment
Background. In the Final Regulatory Impact Analysis (FRIA) of this
final rule, FSIS used an updated version of the 2001 and 2003 Harvard
Risk Assessment models developed by the Harvard Center for Risk
Analysis (HCRA) of the Harvard School of Public Health and the Center
for Computational Epidemiology at Tuskegee University to develop
baseline and mitigation estimates of potential human exposure to the
BSE agent. The update is referred to here as ``the 2005 model.'' The
Agency used estimates generated by the 2005 model to assess the
benefits associated with the measures adopted in this final rule.
In the 2005 model, the HCRA developed a new baseline, analyzed the
effects of the measures implemented by USDA and FDA in response to the
confirmation of the BSE case in Washington State, and analyzed
recommendations made by an international expert BSE panel that was
convened at the request of the Secretary of Agriculture to review the
actions taken by the United States in response to the confirmation of
the BSE case in Washington State.
The authors submitted the 2005 model to FSIS in June 2005, and a
peer review of the 2005 model and resulting assessment was completed in
September 2005. The final products were submitted to FSIS following the
peer review.
On July 12, 2006, FSIS published a notice in the Federal Register
announcing that the Agency was making
[[Page 38725]]
the 2005 Harvard BSE Update (i.e., the 2005 model) available to the
public (71 FR 39282). In the notice, FSIS gave the public until August
11, 2006, to submit comments on the updated risk assessment. The notice
also announced that the Agency would be holding a technical meeting to
provide information on the 2005 model and resulting assessment. This
meeting was held on July 25, 2006.
In response to a comment submitted on August 1, 2006, FSIS extended
the comment period on the 2005 model to October 27, 2006, which is 45
days from the date on which the Agency made the transcript of the July
25, 2006, technical meeting publicly available. The transcripts of the
public meeting were posted on the FSIS Web site on September 12, 2006
(http://www.fsis.usda.gov/PDF/BSE_Transcript_072506.pdf).
FSIS received six comments on the 2005 model. The commenters
included a consumer advocacy organization, two animal welfare
organizations, a cattle producer trade association, a consultant, and a
private citizen. In response to some of these comments, revisions were
made to the 2005 model.
This document refers to the analyses conducted before the 2005
model was revised in response to public comments as ``the pre-public
comment runs of the 2005 model'' and the analyses that were conducted
after the 2005 model was revised as ``the post-public comment runs of
the 2005 model.'' Both the pre-public comment and post-public comment
runs of the 2005 model are discussed below.
Pre-public comment runs of the 2005 model. The pre-public comment
runs of the 2005 model use the base case provided by Harvard (i.e.,
prior to the revisions made in response to public comments). The pre-
public comment runs yielded an estimated mean total potential human
exposure of 3,800 cattle oral ID50s to the BSE agent over 20
years following the hypothetical introduction of 500 BSE-infected
cattle into the U.S. This base case yielded an average of 180 new BSE
cases in the U.S. over 20 years.
The pre-public comment runs found that the food safety measures
enacted by USDA all reduce potential human exposure to BSE infectivity
but have little effect on spread of BSE in the cattle population.
Removing non-ambulatory disabled cattle from the human food supply
reduces predicted potential human exposure by about 3% (leaving a mean
of 3,700 cattle oral ID50s). The pre-public comment runs
found that removing SRMs from cattle 30 months of age and older almost
completely eliminates potential human exposure, reducing it to 11
cattle oral ID50s. Prohibiting the use of skulls and
vertebral columns from cattle 30 months of age and older in advanced
meat recovery (AMR) systems reduces potential human exposure by
approximately two-fifths to 2,200 ID50s. It is worth noting
that these are relative reductions to what is already a small risk in
absolute terms, especially in light of the fact that these simulations
reflect the assumed introduction of 500 infected cattle into the U.S.
None of the combined measures yielded substantial improvements over
their components.
The 2005 model evaluates two measures under consideration by FDA,
including a prohibition on the use of ruminant blood in ruminant feed,
and the requirement that plants producing both prohibited material
(i.e., ruminant-derived material) and non-prohibited material use
dedicated production lines. The pre-public comment runs indicate that
neither of these actions would have much impact on the spread of BSE.
The 2003 Harvard report concluded that blood contributes relatively
little to the spread of BSE. Similarly, earlier work done by the HCRA
suggests that cross-contamination is a relatively minor factor.
As discussed earlier in this document, the IRT (the International
Review Subcommittee convened by the Secretary of Agriculture) suggested
the possibility of a ban on SRMs from animals 12 months and older for
both human food and animal feed. The 2005 model evaluates the impact of
this ban assuming perfect compliance. The pre-public comment runs of
the 2005 model suggest that this measure would reduce potential human
exposure to the BSE agent by more than 99% relative to the base case.
Because the model assumed that the ban also removes SRMs from dead
stock prior to their rendering, the measure achieves a substantial
reduction in the spread of BSE among cattle, decreasing the number of
new infected BSE cases in the U.S. to 35 from 180. The pre-public
comment runs found that the removal of all animal-derived protein from
cattle feed, as suggested by the IRT, would decrease the number of new
BSE cases from 180 to 170 over 20 years. The remaining cases result
primarily from mis-feeding of rations containing ruminant proteins
(feed intended for other species) to cattle. This measure has a small-
predicted impact on potential human exposure.
Post-public comment runs of the 2005 model. For the post-public
comment runs, the 2005 model was revised to incorporate poultry litter
as a potential pathway for the spread of BSE in the United States. The
model's revised base case assumes that 40% of prohibited meat and bone
meal produced by either mixed or prohibited-only renderers is used in
poultry feed. It also assumes that 1% of chicken litter is recycled
back to cattle feed.
The poultry litter assumption is based on information provided by
stakeholders to FDA. FDA shared this information with an interagency
(APHIS, FDA, and FSIS) group that reviewed the data and incorporated
them into the post-comment revisions of the 2005 model.
In addition, for the post-public comment runs, the 2005 model base
case was revised to lower the rate that animals with clinical signs of
BSE are detected on ante-mortem inspection. The 2005 post-public
comment model's revised base case assumes that ante-mortem inspection
detects 50% of ambulatory animals with clinical BSE signs, and 25% of
non-ambulatory animals with clinical BSE signs. A revised sensitivity
analysis investigates the impact of assuming ante-mortem inspection
fails to detect any animals with clinical signs of BSE.
FSIS used the post-public comment revised base case and new
mitigation measures to estimate of potential human exposure to the BSE
agent. Like the base case used for the pre-public comment runs, the
revised base case for the post-public comment runs does not reflect the
measures to minimize human exposure to the BSE agent implemented by
FSIS in the SRM interim final rule.
The post-public comment runs of the 2005 model lead to an increase
in the estimated number of infected cattle and an increase in potential
human exposure. Specifically, when the two modifications discussed
above (i.e., inclusion of the poultry litter pathway and inclusion of
the less optimistic assumptions regarding ante-mortem inspection) were
added to the model, the base case from the post-public comment runs
yielded an increase in the estimated mean total potential human
exposure to the BSE agent over 20 years following the hypothetical
introduction of 500 BSE-infected cattle into the U.S. from 3,800 to
6,600 cattle oral ID50s. These modifications also resulted
in an increase from 180 to 200 in the average number of new BSE cases
in the U.S. over 20 years.
However, although both the number of BSE cases and the level of
human exposure increased in the post-public comment runs, conclusions
with regard to prohibiting the use of SRMs for human food remain the
same. More specifically, even with the revised base
[[Page 38726]]
case, the post-public comment runs show that excluding the materials
designated as SRMs in this final rule almost completely eliminates
potential human exposure to the BSE agent if compliance is perfect.
Similarly, the post-public comment runs found that neither lowering the
age classification for SRMs from cattle 30 month of age and older to 12
months of age and older, nor from 30 months of age and older to 24
months of age and older, provides additional benefits in reducing the
level of potential human exposure to the BSE agent. Thus, the results
of the 2005 model, regardless of the base case used, have not led the
Agency to change its conclusion that the measures adopted in this final
rule are prudent for preventing potential human exposure to the BSE
agent.
The 2005 pre-public comment and 2005 post-public comment models are
available for viewing by the public on the FSIS Web site at: http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp. Also available
on the Web site are the comments received on the 2005 model, and FSIS'
response to these comments.
Summary of the Final Rule
In this final rule, FSIS is affirming, with amendments, the SRM
interim final rule. The Agency is also affirming the air-injection
stunning interim final rule. As discussed earlier in this document, the
Agency intends to affirm and, if necessary, amend the AMR interim final
rule in a separate document that will be published in the Federal
Register at a later date. In addition, FSIS also intends to address the
humane handing implications of the slaughter of non-ambulatory disabled
cattle and other non-ambulatory disabled livestock in a separate
action.
In this final rule, FSIS is affirming, without amendment, the
provisions in 9 CFR 309.2(b) of the SRM interim final rule which
replace the term ``downer'' with ``non-ambulatory disabled livestock''
and which define ``non-ambulatory disabled livestock'' 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. The Agency is revising paragraph 9 CFR 309.3(e)
to clarify that non-ambulatory disabled cattle that are offered for
slaughter must be condemned but that FSIS inspection personnel will
determine the disposition of cattle that become non-ambulatory after
they have passed ante-mortem inspection on a case-by-case basis. As
discussed earlier in this document, this amendment reflects the current
Agency practice.
In addition, FSIS is amending 9 CFR 309.13(b) of the regulations
that prescribe requirements for the disposition of condemned livestock
to add veal calves that cannot rise from a recumbent position or that
cannot walk because they are tired or cold to the list of conditions
for which condemned livestock may be set aside and treated.
FSIS is affirming, with amendments, the provisions of the SRM
interim final rule that define SRMs and prescribe requirements for the
handling and disposition of SRMS. The Agency is amending 9 CFR
310.22(a) to exclude from the definition of SRMs materials from cattle
from foreign countries that can demonstrate that their BSE risk status
can reasonably be expected to provide the same level of protection from
human exposure to the BSE agent as prohibiting SRMs for use as human
food does in the United States. As discussed earlier in this document,
countries that believe that they have the appropriate BSE risk status
to qualify for this exemption should submit evidence to support their
claimed BSE risk to FSIS' Office of International Affairs.
FSIS is affirming without changes the list of materials designated
as SRMs in 9 CFR 310.22(a)(1). 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 dorsal root ganglia
of cattle 30 months of age and older. 9 CFR 310.22(a)(2) designates the
distal ileum of the small intestine and the tonsils of all cattle as
SRMs. The Agency is removing 9 CFR 310.22(a)(3) and re-designating the
provisions in that paragraph that prescribe the conditions under which
the small intestine, excluding the distal ileum, from cattle may be
used for human food as 9 CFR 310.22(d).
The Agency is affirming, with minor grammatical changes, 9 CFR
310.22(b), which declares that SRMs are inedible and prohibits their
use for human food. FSIS is also affirming the provisions in 9 CFR
310.22(c) that specify that SRMs must be removed and disposed of as
inedible in accordance with 9 CFR 314.1 or 9 CFR 314.3. In addition,
the Agency is amending 9 CFR 310.22(c) to require that the spinal cord
from cattle 30 months of age and older be removed from the carcass at
the establishment where the animal was slaughtered.
FSIS is re-designating 9 CFR 310.22(d) of the SRM interim final
rule, the requirements for the removal, segregation, and disposition of
SRMs, as 9 CFR 310.22(e) and moving the conditions under which the
small intestine, excluding the distal ileum, may be used for human
food, formerly found in 9 CFR 310.22(a)(3), to 9 CFR 310.22(d).
Specifically, 9 CFR 310.22(d)(1) provides that the small intestine
from cattle may be used for human food if it is derived from cattle
that were inspected and passed in an official establishment in the
United States, or in a certified foreign establishment, and it is
otherwise eligible for importation into the United States under 9 CFR
327.1(b) of FSIS' import regulations (9 CFR 310.22(d)(1)(i)) and the
distal ileum has been removed by a procedure that removes at least 80
inches of the uncoiled and trimmed small intestine as measured from the
ceco-colic junction and progressing towards the jejunum or by a
procedure that the establishment demonstrates is effective in ensuring
complete removal of the distal ileum (9 CFR 310.22(d)(1)(ii)). FSIS is
also amending 9 CFR 310.22(d)(1) to add a paragraph (d)(1)(iii), which
clarifies that if the conditions described above are not met, the small
intestine must be removed and disposed of as inedible.
9 CFR 310.22(d)(2) provides that requirements for the removal of
the small intestine prescribed in 9 CFR 310.22(d)(1) do not apply to
materials from cattle from countries that can demonstrate that their
BSE risk status provides the same level of protection from human
exposure to the BSE agent as prohibiting SRMs for use as human food
does in the United States.
FSIS is re-designating paragraph 9 CFR 310.22(e) of the SRM interim
final rule, which specifies that materials that are SRMs will be deemed
to be from cattle 30 months of age and older unless the establishment
can demonstrate through documentation that the materials are from an
animal that was younger than 30 months of age at the time of slaughter,
as 9 CFR 310.22(h). FSIS is affirming with minor grammatical changes,
most of the requirements for the removal, segregation, and disposition
of SRMs in 9 CFR 310.22(d) of the SRM interim final rule and re-
designating them as 9 CFR 310.22(e). In 9 CFR 310.22(e)(1), the Agency
is adding a provision to clarify that an establishment's procedures for
the removal, segregation, and disposition of SRMs must address
potential contamination of edible materials with SRMs before, during,
and after entry into the establishment.
FSIS is adding a new paragraph, 9 CFR 310.22(f), that prescribes
requirements for the sanitation of
[[Page 38727]]
equipment used to cut through SRMs. 9 CFR 310.22(f)(1) prescribes
requirements for establishments that do not segregate the carcasses or
parts from cattle 30 months of age and older from the carcasses or
parts from cattle younger than 30 months. 9 CFR 310.22(f)(1) requires
that such establishments either (1) use dedicated equipment to cut
through SRMs (9 CFR 310.22(f)(1)(i)) or (2) clean and sanitize
equipment used to cut through SRMs before the equipment is used on
carcasses or parts from cattle younger than 30 months (9 CFR
310.22(f)(1)(ii)). Under 9 CFR 310.22(f)(2), establishments that
segregate the carcasses or parts from cattle 30 months of age and older
from the carcasses or parts from cattle younger than 30 months, and
that process the carcasses of the younger cattle first, may use routine
operational sanitation procedures on equipment used to cut through
SRMs.
FSIS is also adding a new paragraph 310.22(g) that specifies the
conditions under which slaughter establishments may ship beef carcasses
or parts that contain vertebral columns from cattle 30 months of age
and older to another federally-inspected facility for further
processing. FSIS is adding these provisions to ensure that
establishments that ship carcasses or parts that contain vertebral
columns from cattle that were 30 months of age and older at the time of
slaughter implement the appropriate controls to prevent the inadvertent
introduction of SRMs into the human food supply.
Under 9 CFR 310.22(g), establishments may ship carcasses or parts
of carcasses that contain vertebral columns from cattle 30 months of
age and older to another federally-inspected establishment for further
processing if the establishment: (1) Maintains control of the carcasses
or parts while these materials are in transit or ensures that the
carcasses or parts move under FSIS control (310.22(g)(1)); (2) ensures
that the carcasses or parts are accompanied by documentation that
clearly states that they contain vertebral columns from cattle that
were 30 months of age or older at the time of slaughter (9 CFR
310.22(g)(2)); (3) maintains records that identify the official
establishment that received the carcasses or parts (9 CFR
310.22(g)(3)); and (4) maintains records that verify that the receiving
establishment removed and properly disposed of the SRM portions of the
vertebral column (9 CFR 310.22(g)(4)). Establishments that do not meet
these conditions must remove the SRM portions of the vertebral column
from cattle 30 months of age and older prior to shipping the carcass.
Establishments that receive beef carcasses or parts must address
removal of the vertebral column from cattle 30 months of age and older
in their procedures for the removal, segregation, and disposition of
SRMs.
FSIS is affirming without amendment the provisions in 9 CFR 311.27
of the SRM interim final rule that prohibit for use as human food the
parts and carcasses of cattle slaughtered for humane reasons in the
absence of an inspector. FSIS is affirming without amendment the
interim provisions in 9 CFR 313.15(b)(2) and 9 CFR 310.13(a)(2)(iv)(C)
that prohibit the use of stunning devices that deliberately inject
compressed air into the cranial cavity of cattle.
FSIS is amending 9 CFR 318.6(b)(1) and 9 CFR 318.6(b)(8) to reflect
the re-designation of the requirements on the use of the small
intestine for human food from 9 CFR 310.2(a)(3) to 9 CFR 310.22(d). 9
CFR 318.6(b)(1) prescribes requirements for the use of animal casings
as containers of meat food products and 9 CFR 318.6(b)(8) prescribes
requirements for the use of intestines in meat food products and edible
rendering. Finally, FSIS is affirming the prohibition on the use of MS
(beef) for human food in 9 CFR 319.5(b).
Executive Order 12866 and Regulatory Flexibility Act
This final rule has been determined to be economically significant
and, therefore, it has been reviewed by the Office of Management and
Budget. This final rule affirms the air-injection stunning interim
final rule and affirms, with changes, the SRM interim final rule. As
discussed above, because the AMR interim final rule contains several
non-BSE related provisions, FSIS intends to affirm and, if necessary,
amend that interim final rule at a later date. The Agency will include
a regulatory impact analysis of the final AMR rule at that time. The
complete regulatory impact analysis for this final rule is available
through the FSIS Web site at http://www.fsis.usda.gov/ regulations/
2007--Interim--&--Final--Rules--Index/.
Summary of the Final Regulatory Impact Analysis
In developing this Final Regulatory Impact Analysis (FRIA), FSIS
reviewed the public comments received on the Preliminary Regulatory
Impact Analysis (PRIA) and the interim final rules. In addition, FSIS
developed and analyzed a set of regulatory alternatives for the FRIA.
The FRIA shows that the actions of this final rule require about
3,512 establishments that slaughter cattle or process bone-in beef
products to take measures to minimize human exposure to cattle
materials that could potentially contain the BSE agent. The FRIA
estimates that the total annual average cost of the measure adopted in
this final rule is $171.2 million annualized over 5 years at an
interest rate of 7 percent.\30\ The primary impacts of this final rule
are the exclusion of SRMs from use in the human food supply; the
prohibition of the slaughter of non-ambulatory disabled cattle that are
offered for slaughter; and modifications of HACCP plans or Sanitation
SOPs or other prerequisite programs and recordkeeping requirements. The
FRIA found that there is no cost associated with the air-injection
stunning final rule because air injection stunning devices are no
longer in use in the United States.
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\30\ The estimated costs are higher compared with those
estimated for the PRIA of the interim final rule because more
establishments needed to take measures than what the PRIA
anticipated. However, the PRIA accounted for the removal of the
entire small intestine instead of just the distal ileum portion of
the small intestine. The savings of only removing the distal ileum
offset partially the extra costs of more establishments (state-
inspected and custom-exempt) needing to take the measures contained
in the final rule. FSIS changed the small intestine provision in
September 2005.
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The FRIA assesses the benefits of the measures adopted in this
final rule. The measures adopted in this final rule are reasonable and
necessary measures to ensure food safety. In doing so, they help to
assure domestic and foreign consumers that the U.S. food supply is
safe.
FSIS used the 2005 Harvard BSE Risk Assessment model, which is
described above, to develop baseline and mitigation estimates of
potential human exposure to the BSE agent for this rule. As discussed
in detail above, the 2005 model was modified in response to comments.
Both the pre-public comment and post-public comment runs of the
2005 model estimated that the measures adopted in this final rule will
result in a greater than 99 percent (at the mean) relative reduction in
potential human exposure to the BSE agent when compliance is 100%.
Because the amount of the BSE agent necessary to cause disease in
humans is unknown, FSIS has not estimated monetary values for
reductions in human morbidity and mortality associated with this final
rule. No known cases of vCJD have been associated with consuming beef
products in the United States.
[[Page 38728]]
The FRIA does estimate a benefit for the restoration of beef export
markets (gross sales), which may, in part, have been affected by the
measures implemented in this final rule. However, because of the many
other factors that are also relevant to regained market access, the
affects on the restoration of beef export markets that may be
attributed to the measures implemented in this final rule are difficult
to determine. In pre-BSE 2003, beef export markets totaled $3,861.9
million annually for veal, beef, and beef variety meats. Then, in post-
BSE 2004, these beef export market sales dropped about 79 percent or
$3,053.8 million to $808.1 million. However, in 2005, the U.S. had
restored its beef export market sales to a total of $1,365.3 million.
Compared to 2004, this is an increase of about 69 percent or $557.2
million in beef export market sales.
In addition, the FRIA shows that this final rule is cost-effective
when compared to considered regulatory alternatives. Further, the FRIA
addresses how this final rule affects about 3,278 very small, 197
small, and 37 large establishments of a total of about 3,512
establishments affected.\31\
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\31\ FSIS defined small and very small establishments by its
HACCP (Hazard Analysis and Critical Control Points) size definition.
Establishments that have fewer than 10 employees or generate less
than $2.5 million in annual sales are ``very small'' establishments;
establishments that have between 10 and 499 employees or generate
more than $2.5 million in annual sales are ``small'' establishments;
and establishments that have 500 or more employees are ``large''
establishments. The size definition classification is different from
the Small Business Administration's categorization of small and
large business due to the unique nature of the meat and poultry
slaughter and processing industry.
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FSIS expects that the aggregate beef price impacts of the measures
contained in the final rule are not significant. FSIS estimates that
the affected establishments have a relatively insignificant increase in
operating costs, given that this increase is typically a relatively
small share of the total operating costs affected. In addition, the
removal of SRMs from the supply of variety meats is not expected to
have a significant impact on prices, given the availability of
substitutes (e.g., brains from cattle younger than 30 months of age,
and the remaining small intestine excluding the distal ileum).
Furthermore, FSIS estimates that only a relatively small share of the
beef variety meat supply is affected. In addition, the removal of non-
ambulatory disabled cattle from the food supply is not expected to have
a significant impact on beef prices given the relatively small share of
beef supply affected (less than 0.15 percent).
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. In this final rule: (1) All state and local laws
and regulations that are inconsistent with this rule will be pre-
empted; (2) no retroactive effect will be given to this rule; and (3)
administrative proceedings will not be required before parties may file
suit in court challenging this rule.
Paperwork Requirements
In accordance with section 3507(j) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), FSIS has reviewed the information and
recordkeeping requirements in this final rule and has determined that
the paperwork requirements associated with the regulations that require
that establishments develop written procedures for the removal,
segregation, and disposition of SRMs, have already been accounted for
in the Specified Risk Materials information collection approved by the
Office of Management and Budget (OMB). FSIS has also determined that
the paperwork requirements for the regulations that require that
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,
have also been accounted for in the Specified Risk Materials
information collection approved by OMB. The OMB approval number for the
Specified Risk Materials information collection is 0583-0129.
In this final rule, FSIS is adding a new regulation that requires
that federally-inspected slaughter establishments that transport
carcasses or parts that contain vertebral columns from cattle 30 months
of age and older to another federally-inspected establishment for
further processing maintain records that verify that the official
establishment that received the carcasses or parts removed and properly
disposed of the portions of the vertebral column designated as SRMs.
This is a new recordkeeping requirement that FSIS has submitted to OMB
for approval.
Title: ``Specified Risk Materials Transport Documentation''.
Type of Collection: New.
Abstract: In this final rule, FSIS is requiring that slaughter
establishments that transport carcasses or parts that contain vertebral
columns from cattle that were 30 months of age and older at the time of
slaughter to another federally-inspected establishment for further
processing maintain documentation that verifies that the receiving
establishment removed and properly disposed of the SRM portions of the
vertebral column. This is a new information and recordkeeping
requirement.
Under the current regulations, establishments that slaughter
cattle, and establishments that process the carcasses and parts of
cattle, are required to maintain daily records sufficient to document
the implementation and monitoring of their procedures for the removal,
segregation, and disposition of SRMs. Under this final rule,
establishments that transport carcasses or parts from cattle 30 months
of age and older for further processing will have to obtain these
records from the receiving establishment in order to verify that the
receiving establishment removed and properly disposed of the SRMs.
Estimate of burden: FSIS estimates that it will take establishments
that receive for further processing carcasses or parts that contain
vertebral columns from cattle 30 months of age and older approximately
2 minutes a day to submit to the transporting establishment records
that document the implementation and monitoring of the receiving
establishment's procedures for the removal, segregation, and
disposition of SRMs. FSIS estimates that it will take the transporting
establishments approximately 2 minutes a day to file this documentation
once it is received.
Respondents: Official establishments that transport vertebral
columns from cattle that were 30 months of age and older to another
official establishment for further processing, and official
establishments that receive for further processing carcasses or parts
that contain vertebral columns from cattle that were 30 months of age
at the time of slaughter.
Estimated Number of Respondents: 70.
Estimated Number of Responses per Respondent: 300 annually.
Estimated Total Annual Burden on Respondents: 700 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 proposed collection of
information is necessary for the proper performance of FSIS' functions,
including whether the information will have practical utility; (b) the
accuracy of FSIS' estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used;
[[Page 38729]]
(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 60 days
of the publication date of this 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 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 record-keeping 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 ensure that
minorities, women, and persons with disabilities are aware of this
rule, FSIS will announce it on-line through the FSIS Web page located
at http://www.fsis.usda.gov/regulations_&_policies/2007_Interim_&_Final_Rules_Index/index.asp.
The Regulations.gov Web site is the central online rulemaking
portal of the United States government. It is being offered as a public
service to increase participation in the Federal government's
regulatory activities. FSIS participates in Regulations.gov and will
accept comments on documents published on the site. The site allows
visitors to search by keyword or Department or Agency for rulemakings
that allow for public comment. Each entry provides a quick link to a
comment form so that visitors can type in their comments and submit
them to FSIS. The Web site is located at http://www.regulations.gov/.
FSIS also will make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, public meetings, recalls, and other types of
information that could affect or would be of interest to our
constituents and stakeholders. The update is communicated via Listserv,
a free e-mail subscription service consisting of industry, trade, and
farm groups, consumer interest groups, allied health professionals,
scientific professionals, and other individuals who have requested to
be included. The update also is available on the FSIS Web page. Through
Listserv and the Web page, FSIS is able to provide information to a
much broader, more diverse audience.
In addition, FSIS offers an e-mail subscription service that
provides an automatic and customized notification when popular pages
are updated, including Federal Register publications and related
documents. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/ and allows FSIS customers to sign up
for subscription options across eight categories. Options range from
recalls to export information to regulations, directives and notices.
Customers can add or delete subscriptions themselves and have the
option to password protect their account.
List of Subjects
9 CFR Part 309
Meat inspection.
9 CFR Part 310
Meat inspection, Meat and meat products, Reporting and
recordkeeping requirements.
9 CFR Part 318
Meat inspection, Meat and meat products, recordkeeping
requirements.
0
Accordingly, the interim final rules amending 9 CFR Chapter III, which
were published on January 12, 2004, at 69 FR 1862 and 69 FR 1885, and
amended on September 7, 2005, at 70 FR 53043, are adopted as a final
rule with the following changes:
PART 309--ANTE-MORTEM INSPECTION
0
1. The authority citation for part 309 is revised to read as follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
0
2. Section 309.3 is amended by revising paragraph (e) to read as
follows:
Sec. 309.3 Dead, dying, disabled, or diseased and similar livestock.
* * * * *
(e) Non-ambulatory disabled cattle that are offered for slaughter
must be condemned and disposed of in accordance with Sec. 309.13. FSIS
inspection personnel will determine the disposition of cattle that
become non-ambulatory after they have passed ante-mortem inspection on
a case-by-case basis.
0
3. Paragraph (b) of Sec. 309.13 is amended by adding a new second
sentence to read as follows:
Sec. 309.13 Disposition of condemned livestock.
* * * * *
(b) * * * Veal calves that are unable to rise from a recumbent
position and walk because they are tired or cold may also be set apart
and held as provided in this paragraph. * * *
* * * * *
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. Section 310.22 is revised 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, except when they are from cattle from a country that can
demonstrate that its bovine spongiform encephalopathy (BSE) risk status
can reasonable be expected to provide the same level of protection from
human exposure to the BSE agent as prohibiting specified risk materials
for use as human food does in the United States:
(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 from cattle 30 months of age and older
and
(2) The distal ileum of the small intestine and the tonsils from
all cattle.
(b) Specified risk materials are inedible and prohibited for use as
human food.
(c) Specified risk materials must be removed from the carcasses of
cattle, segregated from edible materials, and
[[Page 38730]]
disposed of in accordance with Sec. 314.1 or Sec. 314.3 of this
subchapter. The spinal cord from cattle 30 months of age and older must
be removed from the carcass at the establishment where the animal was
slaughtered.
(d) Requirements for use of the small intestine for human food. (1)
The small intestine from all cattle may be used for human food if:
(i) It is derived from cattle that were inspected and passed in an
official establishment in the United States or in a certified foreign
establishment in a country listed in 9 CFR 327.2(b) as eligible to
export meat and meat products to the United States and it is otherwise
eligible for importation under 9 CFR 327.1(b), and
(ii) The distal ileum is removed by a procedure that removes at
least 80 inches of the uncoiled and trimmed small intestine as measured
from the ceco-colic junction and progressing proximally towards the
jejunum or by a procedure that the establishment demonstrates is
effective in ensuring complete removal of the distal ileum.
(iii) If the conditions in paragraphs (d)(1)(i) or (ii) of this
section are not met, the entire small intestine must be removed from
the carcass, segregated from edible materials, and disposed of in
accordance with Sec. Sec. 314.1 or 314.3 of this subchapter.
(2) The requirements in paragraph (d)(1) of this section do not
apply to materials from cattle from countries that can demonstrate that
their BSE risk status can reasonably be expected to provide the same
level of protection from human exposure to the BSE agent as prohibiting
specified risk materials for use as human food does in the United
States.
(e) 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 must
develop, implement, and maintain written procedures for the removal,
segregation, and disposition of specified risk materials. These
procedures must address potential contamination of edible materials
with specified risk materials before, during, and after entry into the
establishment. Establishments must incorporate their procedures for the
removal, segregation, and disposition of specified risk materials into
their HACCP plans or Sanitation SOPs or other prerequisite programs.
(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 these procedures, have failed to ensure that specified
risk materials are adequately and effectively removed from the
carcasses 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 must routinely evaluate the
effectiveness of their procedures for the removal, segregation, and
disposition of specified risk materials in preventing the use of these
materials for human food and must 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
must 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 must be retained for at
least one year and must be accessible to FSIS. All such records must be
maintained at the official establishment for 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.
(f) Sanitation of equipment used to cut through specified risk
materials. (1) If an establishment that slaughters cattle, or that
processes the carcasses or parts from cattle, does not segregate the
carcasses and parts from cattle 30 months of age and older from the
carcasses and parts from cattle younger than 30 months during
processing operations it must:
(i) Use dedicated equipment to cut through specified risk
materials; or
(ii) Clean and sanitize equipment used to cut through specified
risk materials before the equipment is used on carcasses or parts from
cattle younger than 30 months of age.
(2) If an establishments that slaughters cattle, or that process
the carcasses or parts from cattle, segregates the carcasses and parts
of cattle 30 months of age and older from cattle younger than 30 months
of age during processing operations, and processes the carcasses or
parts from the cattle younger than 30 months first, it may use routine
operational sanitation procedures on equipment used to cut through
specified risk materials.
(g) Slaughter establishments may ship beef carcasses or parts that
contain vertebral columns from cattle 30 months of age and older to
another federally-inspected establishment for further processing if the
establishment shipping these materials:
(1) Maintains control of the carcasses or parts while they are in
transit or ensures that the carcasses or parts move under FSIS control;
(2) Ensures that the carcasses or parts are accompanied by
documentation that clearly states that the carcasses or parts contain
vertebral columns from cattle that were 30 months of age and older at
the time of slaughter;
(3) Maintains records that identify the official establishment that
received the carcasses or parts;
(4) Maintains records that verify that the official establishment
that received the carcasses or parts removed the portions of the
vertebral column designated as specified risk materials in paragraph
(a)(1) of this section and disposed of them in accordance with Sec.
314.1 or Sec. 314.3 of this subchapter.
(h) 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 through documentation that the materials
are from an animal that was younger than 30 months of age at the time
of slaughter.
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCTS
0
6. The authority citation for part 318 continues to read as follows:
Authority: 7 U.S.C. 38f, 450, 1901-1906; 21 U.S.C. 601-695; 7
CFR 2.18, 2.53.
Sec. 318.6 [Amended]
0
7. Section 318.6 is amended as follows:
0
a. In the third and fourth sentences of paragraph (b)(1) remove ``9 CFR
310.22(a)(3)'' and add ``9 CFR 310.22(d)'' in its place.
0
b. In the second sentence in paragraph (b)(8) remove ``9 CFR
310.22(a)(3)'' and add ``9 CFR 310.22(d)'' in its place.
Done at Washington, DC, on July 5, 2007.
David P. Goldman,
Acting Administrator.
[FR Doc. 07-3350 Filed 7-12-07; 8:45 am]
BILLING CODE 3410-DM-P