[Federal Register: July 13, 2007 (Volume 72, Number 134)]
[Rules and Regulations]
[Page 38699-38730]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jy07-19]
[[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
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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: http://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_http://www.fsis.usda.gov/OFO/TSC/bse_
o=http://www.fsis.usda.gov/OFO/TSC/bse_
">http://www.fsis.usda.gov/OFO/TSC/bse_e_">http://www.fsis.usda.gov/OFO/TSC/bse_
">http://www.fsis.usda.gov/OFO/TSC/bse_
/bse_">http://www.fsis.usda.gov/OFO/TSC/bse_SC/bse_
Chapter 4, Annex IV. Available on the Internet at http://
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 anim