38700 Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules and Regulations 

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. 

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 nonambulatory 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 nonambulatory 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 nonambulatory 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 


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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 nonambulatory after they have passed antemortem 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 NonAmbulatory 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 


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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 nonambulatory 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 nonambulatory 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 nonambulatory disabled cattle asserted that 

prohibiting the slaughter of all nonambulatory 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 nonambulatory 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 ‘‘nonambulatory’’ 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 nonambulatory 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 nonambulatory 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 nonambulatory. 

As noted by some of the comments, 

the clinical signs of BSE are often 

subtle, and many typical signs, such as 


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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 nonambulatory 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 nonambulatory 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-bycase 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 NonAmbulatory 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 nonambulatory after they have passed antemortem inspection. These notices 

provide that FSIS PHVs are to permit 

cattle that have passed ante-mortem 

inspection but that become nonambulatory 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 nonambulatory cattle younger than 30 

months are less likely to present a risk 

of introducing the BSE agent into the 

human food supply than nonambulatory 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 nonambulatory 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 nonambulatory 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 nonambulatory 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 nonambulatory disabled cattle are nonambulatory 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 nonambulatory 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. 


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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 antemortem 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 nonambulatory 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 nonambulatory disabled cattle offered for 

slaughter be condemned on antemortem 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 nonambulatory 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 antemortem inspection but that become nonambulatory 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 nonambulatory 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 nonambulatory 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 nonambulatory 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 nonambulatory disabled cattle will hamper 

USDA’s surveillance testing for BSE by 


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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 nonambulatory 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 nonambulatory 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 nonambulatory disabled cattle offered for 

slaughter has certain economic effects 

on farmers, small meat processors, and 

custom operators. However, as 

discussed above, the carcasses of nonambulatory 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. 


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1The 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. 

2European 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). 

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. 

4OIE Terrestrial Animal Health Code 2006, 

Appendix 3.8.4, Surveillance for Bovine 

Spongiform Encephalopathy. 

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-andolder 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

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. 

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-andolder 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

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 


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Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules and Regulations 38707 

5The 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. 

6Food 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. 

7Frequently asked questions about BSE. 6 April 

2001. Europa Web site: http://europa.eu.int/comm/ 

food/fs/bse/bse20_en.html. 

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

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 nonambulatory 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

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 


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38708 Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules and Regulations 

8European 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). 

9European 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). 

10Commission 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. 

11United 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). 

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. 

13 Eightieth Meeting of the Spongiform 

Encephalopathy Advisory Committee Meeting, 

November 2003. Available on the Internet at: 

www.seac.gov.uk/minutes/final80.pdf. 

information on the age distribution of 

confirmed BSE cases has become 

available since FSIS issued its current 

thinking paper. 

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. 

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. 

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. 

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. 

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. 


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Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules and Regulations 38709 

14Buschmann, 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. 

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 extraCNS 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 BSEinfected 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 BSEsusceptible 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. 

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 


rwilkins on PROD1PC63 with RULES3
38710 Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules and Regulations 

15Harvard 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. 

16United Kingdom Food Standards Agency (FSA) 

2005, Web site http://www.food.gov.uk/bse/what/ 

beef/controls. 

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 bonein-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. 

With regard to the comment that the 

United Kingdom has lifted its bone-inbeef ban, the United Kingdom does not 

permit for use as human food bone-inbeef 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

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 


rwilkins on PROD1PC63 with RULES3
Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules and Regulations 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 federallyinspected 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 


rwilkins on PROD1PC63 with RULES3
38712 Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules and Regulations 

17Animal 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. 

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. 

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 federallyinspected 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 federallyinspected 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 federallyinspected 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 


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18State-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. 

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. 

Sanitation and Cross-Contamination 

To assist with implementation of the 

SRM interim final rule, FSIS developed 

procedures to verify that crosscontamination 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 crosscontamination 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 


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38714 Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules and Regulations 

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 


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19See references to the FSIS Technical Services 

Center document ‘‘Using Dentition to Age Cattle, ’’

which is available on the FSIS Web site at: 

http://www.fsis.usda.gov/Frame/ 

FrameRedirect.asp?main=http://www.fsis.usda.gov/ 

OFO/TSC/bse_information.htm. 

20Canadian Food Inspection Agency, Meat 

Hygiene Directive, Chapter 4, Annex IV. Available 

on the Internet at http://www.inspection.gc.ca/ 

english/anima/meavia/mmopmmhv/chap4/ 

annexne.shtml. 

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-toanimal 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 291⁄2 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

Comment: Some comments strongly 

suggested that FSIS inspection 

personnel rely more heavily on 

producer documentation to verify the 

age of cattle. Some comments requested 

that FSIS restate the pre-eminence of 

documented birth records over 

approximating age through dentition. 

The comments stated that FSIS should 

not use dentition to verify supportable 

documentation, such as breeding or 

birth records. 

Response: If establishments use 

accurate and reliable documentation to 

determine the age of cattle at slaughter, 

FSIS will not use dentition to verify the 

accuracy of the records. After it issued 

the SRM interim final rule, FSIS issued 

FSIS Notice 10–04 ‘‘Questions and 

Answers Regarding the Age 

Determination of Cattle and Sanitation’’ 

(January 29, 2004) to clarify that 

documentation will be the primary 

means to determine the age of cattle at 

slaughter. The notice makes clear that if 

reliable documentation is provided at 

slaughter, FSIS inspectors should not 

use dentition to verify the age of cattle. 

Comment: Some comments requested 

that FSIS clarify the type of records that 

the Agency considers acceptable for 

determining age. The comments 

suggested that herd calving record books 

be included as acceptable evidence of 

age. 

Response: The FSIS Notice described 

above (FSIS Notice 10–04) describes the 

type of documents that can be used to 

provide an accurate and reliable basis 

for determining the age of cattle. 

Included among the acceptable forms of 

documentation are records that certify 

that an entire herd was born on a farm 

during a specific time ( e.g., certification 

that a group of Angus cattle were born 

during the calving season of Spring 

200X or Fall 200X), together with 

information from the feedlot that 

identifies each animal individually (e.g., 

eartags). As provided in the notice, 

when calving birthing ranges are 

provided, the oldest possible age based 

on the ranges should be assigned to the 

group of cattle. 

Comment: Some comments asserted 

that FSIS’ method for verifying the age 

of cattle frequently overestimates the 

age of cattle that are younger than 30 

months, resulting in an economic loss to 

cattle producers. One comment stated 

that certain meatpackers have indicated 

that they intend to deduct 15 cents per 

pound per head for any animal that is 

determined to be over 30 months of age 

by dentition. According to the comment, 

the implementation of the rule is 

devaluing a group of cattle (heiferettes) 

that previously returned a premium 

over their current class (cull cows). The 

comment also noted that after Canada 

implemented similar procedures for 

determining the age of cattle offered for 

slaughter, cattle in Canada with more 

than two permanent incisors are now 

being sold for a total prices of 8 to 20 

cents (Canadian) per pound live weight. 

This same comment stated that cattle 

feeders are losing nearly $200.00 per 

head for any animal found to have more 

than two permanent incisors, which is 

a per head loss of nearly 20%. The 

comment also claimed that ranchers are 

losing up to $360.00 per head for any 

animal found to have more than two 

permanent incisors, which amounts to a 

per head loss of nearly 50%. The 

comment estimated that the costs 

associated with FSIS’ method for 

verifying the age of cattle using 

dentition will cost the cattle producing 

industry in excess of $1,035,936,000.00. 

One comment submitted by a rancher 

indicated that he takes a discount of 

$60.00 to $100.00 per head on cattle 

deemed to be 30 months of age and 

older, which could force him to 

discontinue his business unless he is 

able to purchase cattle that have 

documentation of age. 


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21Lawrence, TE, 2001. A comparison of the 

USDA ossification-based maturity system to a 

system based on dentition, J. Anim. Sci., 79:1683–

1690. 

22This statement reflects the situation at the time 

that FSIS issued the SRM interim final rule. 

23The comments requested that FSIS exempt 

countries with a ‘‘BSE-free’’ or ‘‘provisionally free’’

risk status. However, the OIE BSE risk categories 

have been revised since FSIS issued the SRM 

interim final rule. To reflect these revisions, instead 

of referring to countries as having a ‘‘BSE-free’’ or 

‘‘provisionally free,’’ risk status, FSIS will use the 

term ‘‘negligible BSE risk.’’

Response: FSIS discusses in detail the 

economic impacts of age verification in 

the final regulatory impact analysis 

(FRIA) of this final rule. The FRIA 

explains that generally, in any group of 

steers and heifers, some cattle will 

appear to be 30 months of age and older 

based on dentition even if all of the 

animals in the group are younger than 

30 months of age. The FRIA states that 

estimates of the proportion of steers and 

heifers that will appear to be 30 months 

of age and older based on dentition 

range from 1 to 5 percent (Hodges and 

Seward, 2004). 

The FRIA notes that after FSIS 

implemented the SRM interim final 

rule, the USDA Market News Service (of 

the Agricultural Marketing Service 

(AMS)) began to report discounts for 

cattle 30 months of age and older 

(including those determined by 

dentition). Weekly values have ranged 

from $35 to $50 per cwt (carcass 

weight), which translates to an 

approximate discount of $175 to $250 

per head for a 500-pound cow or bull 

carcass ( e.g., on the lower end, $35 per 

cwt times 5 cwt equates to $175). 

The comments on this issue and the 

analysis in the FRIA demonstrate the 

advantage of using accurate records 

rather than dentition to determine the 

age of cattle. Nonetheless, while FSIS’

dentition standards are conservative, the 

Agency has determined that they are the 

most appropriate way to estimate the 

age of cattle in the absence of accurate 

documentation. As mentioned above, 

the dentition standards adopted by the 

Agency are internationally accepted and 

based on data from veterinary anatomy 

texts and academic articles. These 

standards are also objective and 

practical to implement. Furthermore, 

according to one study, determining 

physiological maturity by the number of 

permanent incisors may be a more 

accurate technique of sorting beef 

carcasses into less variable age groups 

than the USDA bone ossification-based 

maturity system used for beef grading.21

If cattle producers are interested in 

preventing potential financial losses 

associated with the use of dentition to 

estimate the age of their cattle, they may 

prefer to maintain records that can be 

used to accurately document the age of 

their animals. As stated above, if 

reliable documentation is available at 

slaughter, FSIS inspectors will rely on 

documentation, not dentition, to verify 

the age of cattle. 

Comment: One comment stated that 

dentition should only be used to verify 

the age of cattle imported into the 

United States from countries that are not 

classified as ‘‘BSE-free,’’ such as 

Canada. The comment asserted that 

because the United States has never had 

a native case of BSE,22 the use of 

dentition to age U.S. cattle 

unnecessarily penalizes American 

producers and feeders without offering 

any substantial public health benefits to 

the public or long term benefits to cattle 

producers. 

Response: As discussed earlier in this 

document, two native cases of BSE have 

been confirmed in the United States 

since FSIS issued the SRM interim final 

rule. Therefore, the statement that the 

United States has never had a native 

case of BSE is no longer accurate. 

Furthermore, FSIS disagrees that its 

dentition evaluation procedures 

unnecessarily penalize American 

producers and feeders. As discussed in 

detail above, although the dentition 

standards adopted by FSIS may be 

conservative, the Agency has 

determined that these standards are the 

most appropriate means to estimate the 

age of cattle at slaughter in the absence 

of accurate documentation. 

Comment: One comment was 

submitted by a company that has 

developed a new technology that it 

claims will permit the creation of secure 

and auditable records of the dentition of 

cattle when they arrive at the feedlot. 

According to the company, these 

records would allow slaughter 

establishments to determine the age of 

cattle offered for slaughter on the basis 

of dental exam at the feedlot. 

According to the comment, literature 

shows that the standard error of the 

association of age with dentition is 

smaller with animals at younger ages. 

The comment asserted that because 

cattle usually enter feedlots between 10 

and 16 months of age, dentition exam 

could be used more accurately at those 

ages to assign a maximum possible age. 

Since the dentition exam on these cattle 

would typically show no permanent 

incisor eruption, the comment suggested 

that cattle with no permanent incisors 

upon arrival to the feedlot be assigned 

a maximum age of 24 months. Then, 

said the commenter, cattle with an 

auditable record of their dentition 

examination at the feedlot could be 

deemed as being under 30 months of age 

at slaughter if their dentition 

examination upon arrival to the feedlot 

showed no permanent incisors and if 

they are sent to slaughter within six 

months of their arrival at the feedlot. 

The comment noted that it has 

already submitted a notification to the 

FSIS New Technology Staff (NTS) of its 

new technology. The commenter 

submitted a copy of a letter from the 

FSIS NTS stating that the NTS has no 

objection to the use of the new 

technology. However, as stated in the 

letter, the regulations and implementing 

notice do not include documentation of 

dentition examination prior to slaughter 

as a method for verifying the age of 

cattle presented for slaughter. Therefore, 

the comment requested that FSIS allow 

the use of its new technology as a 

method to verify the age of cattle 

presented for slaughter. 

Response: FSIS considers auditable 

records of the dentition examination of 

cattle at the feedlot as a form of 

documentation that can be used to 

estimate the age of cattle at slaughter. 

Thus, the Agency does not object to the 

use of the technology described above to 

verify the age of cattle offered for 

slaughter. To assist with 

implementation of this final rule, FSIS 

intends update the guidance provided 

in FSIS Notice 10–04 to issue to clarify 

that auditable records of dentition 

examination on the feedlot are an 

acceptable form of documentation for 

verifying the age of cattle. 

Importation of Products From 

Countries With a ‘‘Negligible BSE Risk’’ 

Comment: FSIS received a number of 

comments from countries that export 

meat food products to the United States, 

as well as from importers of meat food 

products, requesting that FSIS exempt 

countries that present a ‘‘negligible BSE 

risk’’ from the requirements of the SRM 

interim final rule.23 According to the 

comments, a country’s negligible BSE 

risk status provides the same level of 

protection from human exposure to the 

BSE agent as does exclusion of SRMs 

and non-ambulatory disabled cattle 

from the human food supply in the 

United States. 

The comments asserted that 

application of the SRM interim final 

rule to all establishments that export 

meat food products to the United States 

regardless of a country’s BSE risk status 

is without scientific justification and 

requires that certain countries 

implement costly and unnecessary 


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24Materials may be derived from any animal from 

the country’s cattle population if the animal has 

been inspected and passed for human food. 

25FSIS may also consider an alternative sanitary 

measure as part of an initial equivalence evaluation 

if the applicant country were to propose alternative 

sanitary measures as part of its initial equivalence 

submission. 

measures. According to the comments, 

application of the U.S. BSE measures to 

countries that can demonstrate that they 

present a negligible BSE risk violates the 

World Trade Organization Agreement 

on the Application of Sanitary and 

Phytosanitary Measures (the SPS 

Agreement) because it is more trade 

restrictive than necessary to achieve the 

appropriate level of sanitary protection 

required by the United States. 

Many comments noted that providing 

an exemption for countries with a 

negligible BSE risk would be consistent 

with guidelines established by the OIE, 

which recommend that countries 

restrict the importation of potentially 

infective materials on the basis of the 

BSE risk classification of the region of 

origin. Some comments stated that 

providing an exemption for countries 

with a negligible BSE risk would be 

consistent with the position already 

adopted by Canada. The comments also 

stated that exempting countries with a 

negligible BSE risk would be consistent 

with U.S. efforts to achieve uniformity 

and consistency in international 

standards. As noted by the comments, 

E.U. regulations exclude from the 

definition of SRMs materials from 

animals from countries that fall within 

the European Union’s lowest risk range 

of BSE risk categories. 

Many of the comments also submitted 

information on standards that FSIS 

could use to determine a foreign 

country’s BSE risk status. Some 

comments suggested that FSIS apply 

guidelines for determining the BSE risk 

status of a country or zone established 

by the OIE. The comments stated that 

FSIS could rely on evaluations 

conducted by the OIE Ad-hoc Group for 

BSE to determine whether a country 

meets the OIE criteria for negligible BSE 

risk status, or the Agency could conduct 

its own evaluations using the OIE 

criteria. Some comments suggested that 

FSIS adopt criteria similar to the criteria 

used by Canada for determining 

whether a country qualifies for an 

exemption from that country’s BSErelated requirements. Other comments 

recommended that FSIS consider 

countries to have a negligible BSE risk 

if they are not listed by APHIS in 9 CFR 

94.18(a) as regions that present a risk of 

introducing BSE into the United States. 

One comment suggested that, if a 

country’s BSE risk is to be evaluated by 

U.S. authorities, one U.S. agency should 

be responsible for conducting the 

assessment. According to the comment, 

USDA’s APHIS would be the most 

appropriate agency because of it has 

experience in conducting this type of 

evaluation. 

Response: FSIS has been persuaded 

by these comments. The Agency agrees 

that it is possible for a country’s BSE 

risk status to provide the same level of 

protection from human exposure to the 

BSE agent as excluding SRMs from the 

human food supply does in the United 

States. The Agency also agrees that 

restricting the importation of potentially 

infective materials on the basis of the 

BSE risk of the region of origin is more 

consistent with international guidelines 

than an approach that does not consider 

a country’s BSE risk. 

Therefore, after careful consideration 

of this issue and the comments received 

in response to the SRM interim final 

rule and the APHIS/FSIS/FDA ANPR, 

FSIS has decided to amend the SRM 

interim final rule to exclude from the 

definition of SRMs materials from cattle 

from foreign countries that can 

demonstrate that their BSE risk status 

can reasonably be expected to provide 

the same level of protection from human 

exposure to the BSE agent as prohibiting 

SRMs for use as human food does in the 

United States.24

Section 20 of the FMIA prohibits the 

importation of carcasses, parts, meat, 

and meat food products that are 

adulterated or misbranded, and that do 

not comply with all other requirements 

of the FMIA and its implementing 

regulations (21 U.S.C. 620(a)). Under the 

FMIA, the Secretary of Agriculture (and 

FSIS by delegation) is authorized to 

treat as equivalent to a U.S. 

requirement, an alternative measure 

proposed by an exporting country if the 

country provides scientific evidence or 

other information, in accordance with 

risk assessment methodologies agreed to 

by the Secretary and the exporting 

country, to demonstrate that the 

alternative measure achieves the level of 

protection that the Secretary considers 

appropriate (21 U.S.C. 620(e)(1)(B)). 

FSIS’ import regulations specify that 

a country’s eligibility to export meat and 

meat products to the United States must 

be based on an equivalence evaluation 

(9 CFR 327.2(a)). To determine 

equivalence, FSIS conducts two types of 

evaluations. The Agency conducts an 

initial evaluation to determine whether 

a foreign meat inspection system is 

equivalent in the case of a country that 

is not presently eligible to export meat 

products to the United States. FSIS also 

conducts evaluations to determine 

whether an individual sanitary measure 

is equivalent in the case of a country 

that has already established its 

equivalence and is requesting that FSIS 

recognize an alternative method of 

eliminating or abating a particular food 

safety hazard.25

The initial equivalence evaluations of 

foreign meat inspection systems are a 

prerequisite for trade. Countries that 

have completed this initial equivalence 

process and that are eligible to export 

meat and meat products to the United 

States are listed under 9 CFR 327.2(b) of 

FSIS’ import regulations. After a 

country is listed in 9 CFR 327.2(b) as 

eligible to export meat and meat 

products to the United States, the 

country may request that FSIS conduct 

an evaluation to determine whether an 

alternative sanitary measure proposed 

by the country is equivalent to a U.S. 

requirement. FSIS will allow a country 

to adopt an alternative sanitary measure 

if the country provides sufficient 

scientific evidence to demonstrate that 

the alternative measure achieves the 

same level of protection that is provided 

by the U.S. requirement. 

FSIS adopted regulations that 

prescribe requirements for the removal, 

segregation, and disposition of SRMs as 

a measure to prevent potential human 

exposure to the BSE agent. When it 

issued the SRM interim final rule, FSIS 

explained that because of the way that 

BSE infectivity occurs in BSE-infected 

cattle, and the fact that a case of BSE has 

been detected in an imported animal in 

the United States, the Agency has 

determined that certain materials from 

cattle present a sufficient risk of 

exposing humans to the BSE agent that 

is prudent and appropriate to find that 

these materials are unfit for human food 

within the meaning of section 1(m)(3) of 

the adulteration provisions of FMIA. As 

discussed earlier in this document, 

since FSIS issued the SRM interim final 

rule, BSE has been confirmed in two 

native U.S. animals. Thus, given these 

additional cases, FSIS has concluded 

that the materials designated as SRMs in 

this final rule continue to present a 

sufficient risk of exposing humans to 

the BSE agent so as to render them 

‘‘unfit for human food’’ under the FMIA. 

However, not all countries have the 

same situation with regard to BSE as the 

United States. Based on past import 

histories, import controls, animal health 

risk mitigations, animal surveillance, 

and other factors, some countries may 

be able to demonstrate that their BSE 

risk status is such that materials from 

their cattle population that would be 

designated as SRMs in the United States 

do not present a sufficient risk of 


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38718 Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules and Regulations 

exposing humans to the BSE agent to 

render these materials ‘‘unfit for human 

food’’ as defined under the adulteration 

provisions of the FMIA. Thus, the BSE 

risk status of these countries would 

accomplish the same objective as the 

U.S. requirement for the removal, 

segregation, and disposition of SRMs, 

which is to prevent human exposure to 

the BSE agent. 

Therefore, because the BSE risk status 

of certain countries may be equivalent 

to U.S. requirements with regard to 

SRMs, FSIS has decided to exclude from 

the definition of SRMs, materials from 

cattle from a country that can 

demonstrate that its BSE risk status can 

reasonably be expected to provide the 

same level of protection from human 

exposure to the BSE agent as excluding 

SRMs from the human food supply does 

in the United States. Because a 

country’s BSE risk status would be 

considered as an individual alternative 

sanitary measure to the U.S. 

requirement for the removal, 

segregation, and disposition of SRMs, 

only those countries that are listed in 9 

CFR 327.2(b) as eligible to export meat 

and meat products to the United States 

are eligible to request this exemption. 

When FSIS implements a measure to 

eliminate or abate a food safety hazard, 

an exporting country must either adopt 

the same measure or notify the Agency 

that it proposes to apply a different 

measure that provides the same level of 

protection. Thus, countries that believe 

that they are eligible to have materials 

from their cattle excluded from FSIS’

definition of SRMs should notify FSIS’

Office of International Affairs (OIA) and 

provide that office with sufficient 

scientific evidence to support its 

claimed BSE risk status. FSIS will then 

develop criteria to evaluate the 

equivalence request. 

In developing equivalence criteria, 

FSIS will consider evidence that the 

country proposes to submit in support 

of its BSE risk status, including a BSE 

risk status evaluation, if one was 

conducted, or any other supporting 

documentation. An exporting country 

may submit an evaluation of its BSE risk 

status conducted by the OIE, another 

country, or any other appropriate entity. 

Countries may also conduct their own 

evaluations. However, any evaluation 

and supporting documentation 

submitted by a country must contain 

sufficient scientific evidence to 

demonstrate that the country’s BSE risk 

status can reasonably be expected to 

achieve the same level of protection 

from human exposure to the BSE agent 

as excluding SRMs from human food 

does in the United States. 

An evaluation of a country’s BSE risk 

status would consider whether 

appropriate measures are in place to 

manage identified risks. This would 

include consideration of import policies 

and import history to determine the 

likelihood of the introduction of BSE 

into the country. It could also include 

(among other things) consideration of 

any of the following: effective 

surveillance efforts; measures to identify 

and effectively control pathways for the 

amplification of BSE; appropriate 

awareness programs; effective 

epidemiological investigations as 

necessary, with appropriate tracing, 

control and destruction of risk animals; 

continuing risk considerations with 

corresponding revisions of existing 

mitigations; appropriate public health 

control measures commensurate with 

risk; and the infrastructure sufficient to 

define and implement any of the above. 

As part of the equivalence process, 

FSIS officials with technical program 

expertise and, where appropriate, 

technical experts from other agencies, 

such as APHIS and FDA, consider the 

evidence provided by an exporting 

country to demonstrate that its 

alternative sanitary measure provides 

the same level of protection as the U.S. 

measure. During the process, FSIS may 

request more information from the 

country to facilitate the evaluation. 

Upon completion of the review process, 

FSIS makes an equivalence 

determination and notifies the exporting 

country of its decision. The Agency also 

provides the basis for the decision, 

whether positive or negative. FSIS 

documents the equivalence process. 

In addition to equivalence 

requirements, FSIS’ import regulations 

also provide that compliance with the 

conditions for importation of products 

under FSIS’ regulations does not excuse 

the need for compliance with applicable 

requirements under other laws, 

including the provisions in APHIS’

regulations that prohibit or restrict the 

importation of certain animals and 

animal products for animal health 

purposes (9 CFR 327.2(b)). Thus, foreign 

countries that comply with all of FSIS’

requirements with regard to BSE must 

also comply with any requirements 

related to BSE imposed by APHIS and 

FDA. Therefore, to ensure, to the 

greatest extent possible, that FSIS’

import policies with regard to BSE are 

consistent with policies implemented 

by USDA’s APHIS and HHS’ FDA, FSIS 

intends to consult with these agencies 

whenever a country requests to have 

materials from its cattle population 

excluded from FSIS’ definition of SRMs. 

As part of this consultation process, 

FSIS may request that technical experts 

from APHIS and FDA review the BSE 

risk evaluation and other evidence of 

equivalence submitted by the exporting 

country. FSIS will consider APHIS’ and 

FDA’s conclusions as to whether 

information submitted by the exporting 

country provides sufficient scientific 

evidence to support the country’s 

claimed BSE risk status. FSIS will also 

consider whether APHIS or FDA impose 

any BSE-related restrictions on imports 

from the country and, if so, the basis for 

those restrictions. 

After FSIS is finished considering the 

evidence submitted by a country in 

support of its BSE risk status, the 

Agency will: (1) Recognize that the 

country’s BSE risk status is equivalent 

to excluding SRMs from the human food 

supply in the United States or (2) 

request more information to facilitate 

consideration of the submission or (3) 

reject equivalence of the country’s BSE 

risk status and provide appropriate 

reasons for that decision. FSIS will 

notify the exporting country of its 

judgment within a reasonable period of 

time, although the time that it takes 

FSIS to complete its equivalence 

determination may vary depending on 

the evidence submitted by the country 

and its specific situation with regard to 

BSE. FSIS will also provide the country 

with basis for its decision should the 

judgment be that the country’s BSE risk 

status is not equivalent. 

FSIS retains a sovereign right to 

decide whether the exporting country’s 

sanitary measure is equivalent to its 

own provided that the process is fair 

and transparent and the decision is 

based on sufficient scientific evidence. 

Exporting countries must receive an 

equivalence determination from FSIS 

before any alternative sanitary measure 

is implemented in the country. 

Following a judgment of alternative 

sanitary measure equivalence based 

upon document analysis, FSIS will 

verify on-site during the next regularly 

scheduled audit that the alternative 

sanitary measure has been appropriately 

implemented. Thereafter, FSIS and the 

exporting country should advise each 

other of any changes in their programs 

or infrastructure that may affect the 

original determination of equivalence. 

In addition, after FSIS completes its 

initial equivalence determination, the 

Agency uses a three-part process to 

verify that an exporting country’s meat 

inspection system and proposed 

alternative sanitary measures continue 

to be equivalent. The first part of this 

process is a recurring document 

analysis, which is used to gradually 

repeat and update initial equivalence 

determinations. The second is on-site 

meat inspection system audits 


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Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules and Regulations 38719 

conducted at least annually in every 

country that exports meat and poultry 

products to the United States. The third 

is port-of-entry re-inspections in which 

FSIS randomly samples meat product as 

they enter the United States. These reinspections provide evidence of how the 

foreign inspection system is 

functioning. 

Because FSIS, APHIS, and FDA have 

different regulatory responsibilities, it is 

not practical for one U.S. Government 

agency to be responsible for conducting 

all aspects of every evaluation of a 

foreign country’s BSE risk. However, 

FSIS’ approach for considering evidence 

of an exporting country’s claimed BSE 

risk status is consistent with the 

approach used by USDA’s APHIS to 

determine a foreign country’s animal 

health risk status related to BSE. When 

it considers a country’s BSE risk, APHIS 

evaluates an individual country’s 

specific situation and analyzes risk 

based on the overall effectiveness of 

actions taken by the country to prevent 

the introduction and spread of BSE. 

APHIS also takes into consideration the 

OIE guidelines, as well as evaluations 

conducted by other countries. 

FSIS has determined that the type of 

comprehensive approach used by 

APHIS to consider a country’s animal 

health risk status is also an appropriate 

approach for FSIS to use to determine 

whether materials from cattle from 

countries considered to be of negligible 

risk will present no greater risk of 

exposing humans to the BSE agent than 

do beef products permitted for human 

food in the United States, including 

those materials that would be 

designated as SRMs if they were from 

cattle from the United States. 

Comment: One comment suggested 

that the prohibition on the slaughter of 

non-ambulatory disabled cattle may 

have been motivated to some degree by 

animal welfare objectives in that 

automatic condemnation of these 

animals will deter attempts to ship nonambulatory cattle and perhaps persuade 

truckers to do more to prevent injury 

during transport. The comment stated 

that if this is the case, some countries 

have implemented alternative measures 

that address the animal welfare 

implications associated with the 

transportation of non-ambulatory 

animals. According to the comment, 

when making equivalence 

determinations, FSIS should give due 

consideration to countries, such as 

Canada, that prohibit non-ambulatory 

animals from leaving the farm. 

Response: As discussed below, above, 

FSIS is affirming the prohibition on the 

slaughter of non-ambulatory disabled 

cattle because the Agency has 

determined that it is a prudent measure 

to prevent potential human exposure to 

the BSE agent. Thus, under this final 

rule, if a foreign country can 

demonstrate that its BSE risk status can 

reasonably be expected to achieve the 

same level of protection from potential 

human exposure to the BSE agent as 

requiring the condemnation of nonambulatory disabled cattle that are 

offered for slaughter does in the United 

States, the country will not be required 

to prohibit the slaughter of all nonambulatory disabled cattle for human 

food in order to be eligible to export 

beef products to the United States. 

Comment: One comment asked how 

FSIS will provide assurance that 

products imported into the United 

States were produced in compliance 

with the requirements in the SRM 

interim final rule. 

Response: FSIS ensures that imported 

meat in the U.S. marketplace is safe, 

wholesome, unadulterated, and 

properly labeled by (1) determining 

whether foreign countries and their 

establishments have implemented a 

food safety system and inspection 

requirements equivalent to those in the 

United States and (2) re-inspecting 

imported meat and poultry products 

from those countries through random 

sampling of shipments. The FSIS 

regulations in 9 CFR 327.2 provide that 

countries eligible to export meat to the 

United States must have a meat 

inspection system that has been 

determined by FSIS to be equivalent to 

the U.S. meat inspection system. The 

FSIS equivalence determination is based 

on a review of the foreign country’s 

relevant laws and regulations and on an 

on-site audit of the foreign country’s 

inspection system. 

Once a country is listed as eligible to 

export meat and meat products to the 

United States, it is responsible for 

certifying individual exporting 

establishments to FSIS and for 

providing annual recertification 

documentation. FSIS regularly conducts 

on-site audits of the eligible foreign 

inspection systems to ensure they 

remain equivalent to the U.S. system. 

Air-Injection Stunning 

Comment: Most of the comments 

received in response to the air-injection 

stunning interim final rule were 

supportive and encouraged FSIS to 

make the interim provisions permanent. 

Some comments indicated that even 

though the U.S. beef slaughter industry 

no longer uses air-injection stunning 

devices, the regulation is still important 

to prohibit any future use of these 

devices and to ensure the safety of 

imported beef products into the United 

States. 

One comment concurred with FSIS’

decision to reject the option of a 

performance standard for CNS emboli 

that may occur after stunning. As noted 

by the comment, a performance 

standard and testing for CNS emboli 

would be costly and unwieldy to both 

industry and government enforcement 

officials. 

Response: FSIS agrees with these 

comments. Accordingly, in this final 

rule, FSIS is adopting, without changes, 

the provisions of the air injection 

stunning interim final rule. 

Comment: One comment noted that 

the Canadian Food Inspection Agency 

(CFIA) has prohibited the use of airinjection stunning equipment for any 

red meat species processed in federallyregistered Canadian establishments 

since May 2000. The comment also 

indicated that CFIA prohibits the 

destruction of brain matter using a rod 

(referred to as ‘‘pithing’’) because this 

procedure can cause dislocation of 

portions of brain and release emboli into 

the circulatory system of stunned cattle. 

Response: U.S. requirements for 

stunning cattle are consistent with the 

Canadian requirements. The pithing 

method of stunning is not permitted in 

the United States and it is not listed as 

an approved humane method of 

slaughter in 9 CFR part 313. 

Comment: One comment criticized 

FSIS for not including a discussion of 

CNS micro-emboli in the preamble to 

the rule. According to the comment, 

trauma sufficient to cause 

unconsciousness will cause damage that 

ranges from contusions and ultra 

structural changes, including the 

disruption of the blood-brain barrier to 

frank tissue destruction and 

accompanying hemorrhage. The 

comment asserted that other types of 

stunning devices, such as penetrating 

captive bolt stunners that do not inject 

air and non-penetrating captive bolt 

stunners, may result in CNS microemboli. 

Response: In the preamble to the airinjection stunning interim final rule, 

FSIS addressed the potential for captive 

bolt stunning devices that do not use 

air-injection to result in CNS microemboli in its discussion of the Harvard 

Risk Assessment study. In that 

discussion, the Agency noted that the 

original Harvard study (2001/2003) (also 

referred to as the Harvard-Tuskegee 

study) estimated that for each BSEinfected animal stunned with a standard 

captive bolt stunner (without air 

injection), there is a 50 percent 

probability that a very small fraction of 

the BSE agent will be transferred to the 


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38720 Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules and Regulations 

26Annex to the EFSA Journal (2004). Report of 

the EFSA Working Group on BSE risk from 

dissemination of brain particles in blood and 

carcasses, adopted on 21 October 2004. (pp. 16–17) 

(http://www.efsa.eu.int). 

blood (see 69 FR 1885, 1888). The 

Harvard-Tuskegee study assumes that 

this small fraction is what would be 

contained within micro-emboli that 

might occur. As noted in the discussion, 

the Harvard-Tuskegee study concluded 

that the stunning method used on cattle 

is not a major potential source of human 

exposure to the BSE agent, but that 

potential human exposure to the BSE 

agent would increase with greater use of 

air-injection stunning. 

Since FSIS issued the air-injection 

stunning rule, information has become 

available to the Agency that indicates 

that the use of both penetrating and 

non-penetrating captive bolt stunning 

on cattle may result in CNS tissue 

emboli. A report of the EFSA Working 

Group on BSE risk from dissemination 

of brain particles in blood and carcass 

reported that recent studies have shown 

that brain damage caused by both 

penetrating and non-penetrating captive 

bolt stunning in cattle can result in 

occurrence of CNS tissue emboli in 

venous blood draining the head.26 The 

EFSA report also concludes that while 

experimental studies have indicated 

that widespread distribution of CNS 

emboli via systemic arterial circulation 

may occur, this has not been confirmed 

under commercial conditions. The 

report recommends that further 

validation studies on the occurrence of 

stunning-associated CNS emboli be 

conducted under commercial conditions 

and that these studies should focus on 

the involvement of systemic arterial 

circulation in the distribution of CNS 

emboli. 

Thus, further research is needed to 

assess how various methods used to 

stun cattle at slaughter in the United 

States affect the risk of potential human 

exposure to the BSE agent. The Agency 

supports the need for additional 

research on stunning methods and CNS 

emboli. FSIS will use the results of 

future studies to evaluate the stunning 

methods permitted for use on cattle in 

the United States and, if necessary, will 

take appropriate action to ensure that 

stunning devices are not a significant 

potential source of human exposure to 

the BSE agent. 

Comment: One comment stated that if 

FSIS is not aware of any U.S. slaughter 

establishments that use air-injection 

stunning, why did the Agency issue a 

rule to prohibit this practice? The 

comment asserted that the rule appears 

to be unnecessary and may negatively 

affect consumer confidence in the safety 

of the U.S. beef production system. 

Response: As indicated by one of the 

comments above, even though the U.S. 

beef slaughter industry no longer uses 

air-injection stunning devices on cattle, 

prohibiting the use of these devices is 

still important to ensure that they are 

not used in the future and to ensure the 

safety of imported beef products into the 

United States. 

Comment: One comment asked how 

FSIS will ensure that certified foreign 

establishments in countries that permit 

the use of air-injection stunning are not 

using air injection stunning devices on 

cattle whose products are exported to 

the United States. 

Response: Foreign countries that 

import meat food products into the 

United States must employ sanitary 

measures that can reasonably be 

expected to provide the same level of 

protection from human exposure to BSE 

that is achieved domestically. Therefore, 

foreign establishments that use airinjection stunning on cattle are 

prohibited from exporting meat food 

products to the United States. FSIS 

regularly conducts on-site audits of 

eligible foreign inspection systems to 

ensure they remain equivalent to the 

U.S. system. 

MS(Beef) 

Comment: Most comments submitted 

in response to the SRM interim final 

rule’s prohibition on the use of MS(beef) 

for human food expressed support for 

this provision. Some comments 

suggested that instead of banning 

MS(beef), FSIS should consider 

prohibiting the use of cattle skulls and 

vertebral columns in the production of 

this product. One comment stated FSIS 

could revise the specifications for 

MS(beef) to prohibit the incorporation 

of CNS-type tissues and apply controls 

similar to those for beef produced using 

AMR systems. 

Response: Because they are SRMs, 

skulls and vertebral columns (excluding 

the vertebrae of the tail, the transverse 

processes of the thoracic and lumbar 

vertebrae, and the wings of the sacrum) 

from cattle 30 months of age and older 

are prohibited for use as source 

materials in AMR systems. However, 

skulls and vertebral columns from cattle 

younger than 30 months are permitted 

to be used as a source material in AMR 

systems if they do not contain any CNStype tissues. Under the AMR interim 

final rule, beef AMR product that does 

not qualify to be labeled or used as 

‘‘meat,’’ but that meets the requirements 

of 9 CFR 319.5 (the requirements for 

MS(species)), may be used for human 

food if skulls or vertebral column bones 

that contain CNS-type tissues from 

cattle younger than 30 months of age 

were not used as a source material in 

the production of the product and the 

product does not contain spinal cord or 

DRG from bones of cattle younger than 

30 months (9 CRF 318.24(c)(2)(iii)). 

While this product, which has the 

characteristics of MS(beef) without 

CNS-type tissues, cannot bear the name 

MS(beef), it may bear a common or 

usual name that is not false or 

misleading. 

Hand De-Boned Meat 

In the SRM interim final rule, FSIS 

noted that because of its proximity to 

the vertebral column, some hand deboned meat may contain DRG 

depending on the technique used to 

remove the meat from the bone. The 

Agency requested comments on whether 

it should prohibit hand de-boned meat 

from the vertebral columns of cattle 30 

months of age and older for use as 

human food (69 FR 1862, 1868). 

Comment: Some comments stated that 

as long as standard boning procedures 

are followed, hand de-boned meat from 

the vertebral columns of cattle 30 

months of age and older is safe and 

should not be prohibited for human 

food. One comment suggested that FSIS 

allow companies to determine whether 

hand de-boned meat from the vertebral 

bones of cattle 30 months of age and 

older is acceptable based on the 

individual design of the plant’s HACCP 

plan. Another comment argued that 

FSIS should prohibit hand de-boned 

meat from the vertebral column of cattle 

30 months of age and older for human 

food until data on whether it may 

contain DRG is more conclusive. 

A comment submitted by the 

Canadian Food Inspection Agency 

(CFIA) noted that hand de-boning of 

parts of the vertebral column can result 

in DRG tissue being excised, 

particularly in the lumbar region. The 

comment stated that CFIA and Health 

Canada would welcome the opportunity 

to compare data with FSIS and to 

collaborate in an assessment of the risk 

associated with this practice and 

identification of appropriate risk 

management measures. 

Response: After considering this 

issue, FSIS has determined that there 

are insufficient data to demonstrate that 

hand de-boned meat presents a risk of 

exposing humans to the BSE agent. 

Therefore, in this final rule, FSIS will 

continue to permit hand de-boned meat 

from the vertebral column of cattle 30 

months of age and older for human 

food. However, because of the DRG’s 

close association to the vertebral bones, 

the Agency requires that establishments 


rwilkins on PROD1PC63 with RULES3
Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules and Regulations 38721 

27The 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. 

that produce hand de-boned beef from 

the vertebral column of cattle 30 months 

of age and older address the potential 

for contamination of edible materials 

with SRMs, including the DRG, in their 

procedures for the removal, segregation, 

and disposition of SRMs. 

FSIS appreciates and accepts the 

CFIA’s offer to compare data on the 

potential for DRG to become dislodged 

when meat is hand de-boned. The 

Agency intends to work with CFIA to 

further assess the risk associated with 

DRG in hand de-boned meat and to 

identify appropriate risk mitigation 

measures. 

BSE in Japanese Cattle Younger Than 

30 Months 

Comment: In the preamble to the SRM 

interim final rule, FSIS requested 

comments on the implications, if any, of 

the reported 21- and 23-month-old cases 

of BSE in Japan (69 FR 1862, 1864). One 

comment submitted on this issue stated 

that it endorsed recommendations made 

by an OIE Expert Group convened in 

Paris on December 2, 2003. According to 

the comment, the OIE group concluded 

that the so-called atypical BSE cases 

reported in Japan were no cause for 

changes in the international standards 

for trade in cattle and cattle products. 

Another comment suggested that FSIS 

investigate the findings of the 21- and 

23-month old Japanese cattle that were 

reported as testing positive for BSE and 

publicly clarify that these results were 

reached using inadequate methodology. 

The comment asserted that the tissue 

samples from these animals were later 

confirmed as negative by the 

International Reference Laboratory in 

Weybridge, England. 

Response: The two Japanese cases of 

BSE in animals 21- and 23-months old 

were reported in 2003 and were 

detected as part of Japan’s program to 

test all cattle slaughtered for human 

food for BSE. While FSIS is not aware 

of any data to indicate that these 

animals were later confirmed as 

negative by the U.K. International 

Reference Laboratory, a report issued by 

the European Food Safety Authority 

(EFSA), Scientific Panel on Biological 

Hazards, states that ‘‘it is unclear 

whether the very young cases [reported 

in Japan] were adequately identified and 

formally confirmed.’’ 27 This same 

report concluded that these cases ‘‘seem 

to be epidemiologically peculiar as their 

cohort would have been expected to 

yield further cases.’’ FSIS has concluded 

that the available evidence surrounding 

the two very young cases of BSE 

reported in Japan is insufficient to 

support any changes in the measures 

implemented by FSIS to prevent human 

exposure to the BSE agent. 

Testing Cattle for BSE 

Comment: Some comments stated that 

all cattle offered for slaughter should be 

tested for BSE and their carcasses 

should be permitted for use as human 

food only if the test result is negative. 

The comments noted that the carcasses 

would be held pending the test result in 

accordance with FSIS’ ‘‘test and hold’’

policy. Some comments suggested that 

cattle over 20 months of age be tested 

for BSE. Others suggested that testing be 

limited to cattle over 30 months. One 

comment stated that establishments 

should not be required to remove SRMs 

if an animal tests negative for BSE. 

Other comments agreed with 

statements made by FSIS in the 

preamble to the SRM interim final rule 

on the limitations of available test 

methods for BSE. The comments agreed 

that removal of SRMs provides more 

protection from human exposure to the 

BSE agent than testing cattle for BSE at 

slaughter. 

Response: As discussed in the SRM 

interim final rule, the BSE tests that are 

available today are not appropriate for 

use as a food safety measure. Thus, the 

Agency believes that cattle should only 

be tested for BSE at slaughter as part of 

USDA’s surveillance for BSE. FSIS 

agrees with the comments that assert 

that removal of SRMs at slaughter 

provides more protection from human 

exposure to the BSE agent than testing 

cattle for BSE. 

The earliest point at which current 

testing methods can detect a positive 

case of BSE is 2 to 3 months before the 

animal begins to demonstrate clinical 

signs. The incubation period for BSE—

the time between initial infection and 

the manifestation of clinical signs—is 

generally very long, on average about 5 

years. Therefore, there is a long period 

in the life of an infected animal when 

tests with the current methodology 

would not detect the disease. Thus, 

testing all slaughter cattle for BSE might 

offer misleading assurances to the 

public and to U.S. trading partners. 

In contrast, the current test 

technology provides highly meaningful 

and reliable results when used for 

surveillance purposes on animals 

within USDA’s targeted populations—

specifically, adult animals exhibiting 

some type of clinical abnormality that 

could be consistent with BSE. This 

targeted approach is based on the 

assumption that if the disease is rare in 

the most likely population, it will be 

even more unlikely to be found in the 

non-targeted population. Thus, USDA’s 

APHIS is able to calculate the estimated 

prevalence of BSE in the U.S. cattle 

population as a whole from fewer 

samples when those samples are drawn 

from the target population. The current 

testing technology enables APHIS to 

assess the prevalence within the context 

of surveillance and therefore the 

effectiveness of various risk mitigation 

measures that have been implemented. 

Comment: A few comments stated 

that there is a need to develop improved 

tests for BSE. The comments stated that 

a live animal test must be developed so 

that cattle can be tested for BSE at 

slaughter. Another comment said that 

enhanced diagnostics for BSE must be 

developed to minimize the possibility of 

false negatives. The comment provided 

the example of the use of sodium 

phosphotungstic acid to preferentially 

precipitate prions. Another comment 

said that the discovery of a normalappearing animal in Italy with an 

apparently new strain of BSE that may 

elude tests used in the United States 

underscores the need for more sensitive 

and rapid tests that are in widespread 

use in Europe. 

Response: FSIS agrees and supports 

the development of improved BSE tests 

and agrees that there is a need for an 

accurate and reliable live animal test. 

Comment: Some comments stated that 

USDA should permit private companies 

to test cattle for BSE at slaughter. 

Response: USDA’s APHIS is 

responsible for approving the use and 

distribution of approved BSE test kits. 

However, as stated above, FSIS believes 

that the BSE tests that are available 

today are not appropriate for use as a 

food safety measure. 

Reassess Measures as Needed 

Comment: Several comments 

suggested that FSIS make appropriate 

adjustments to the SRM interim final 

rule if new scientific findings or the 

results of the increased surveillance 

indicate that the regulations should be 

modified. The comments stated that if 

no additional cases of BSE are 

confirmed under APHIS’ enhanced 

surveillance, FSIS should evaluate 

whether the removal of SRMs from 

cattle older than 30 months of age is 

warranted given the near-zero risk 

posed to the public and the high costs 

imposed on producers. One comment 

said that FSIS should rescind the SRM 

interim final rule if no additional BSE 

cases are confirmed in the United 


rwilkins on PROD1PC63 with RULES3
38722 Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules and Regulations 

States. Another stated that FSIS should 

permit the use of some, if not all, SRMs 

and permit vertebral bones from cattle 

30 months of age and older in the 

production of beef AMR product if no 

additional cases are confirmed. 

One comment said that any action to 

prevent human exposure to the BSE 

agent should be evaluated based on its 

public health outcome. According to the 

comment, a human health risk 

assessment should be conducted to 

determine the extent of public health 

protection that the SRM interim final 

rule provides before FSIS issues a final 

rule. Another comment stated that FSIS 

should leave the current measures in 

place regardless of the outcome of 

APHIS’ enhanced BSE surveillance. 

A few comments suggested that FSIS 

work with Canada and Mexico to 

harmonize BSE regulations in North 

America. One comment stated that FSIS 

should harmonize its requirements for 

SRM removal with the OIE standards to 

the maximum extent possible. 

Response: FSIS will continue to 

evaluate the science, international 

standards for, and the risk of BSE in the 

United States on an ongoing basis to 

ensure that the measures implemented 

by the U.S. government to minimize 

potential human exposure to the BSE 

agent continue to provide the 

appropriate level of protection. The 

Agency, in coordination with APHIS 

and FDA, will make appropriate 

adjustments to this final rule if new 

scientific findings or information on the 

risk of BSE in the United States indicate 

that prescribed measures should be 

modified, added, or eliminated. 

Humane Handling of Livestock 

Comment: Most of the comments 

received in response to the SRM interim 

final rule were from animal welfare 

advocacy organizations and private 

citizens concerned about the welfare of 

animals. These comments expressed 

support for the interim prohibition on 

the slaughter of non-ambulatory 

disabled cattle for human food and 

requested that FSIS make it permanent. 

The comments also requested that FSIS 

extend the prohibition to cover all 

livestock species under FSIS’’

jurisdiction, i.e., sheep, swine, goats, 

and horses and other equines, and to 

require that all non-ambulatory animals 

be immediately and humanely 

euthanized on arrival at a slaughter 

facility. According to the comments, a 

permanent prohibition on the slaughter 

of non-ambulatory disabled cattle and 

other non-ambulatory livestock is 

necessary to ensure that these animals 

are handled in a humane manner. 

Response: FSIS has carefully 

considered the humane handling 

implications of the interim prohibition 

on the slaughter of non-ambulatory 

disabled cattle and has concluded that 

the comments have merit. Thus, the 

Agency has determined requiring the 

condemnation of non-ambulatory 

disabled cattle that are offered for 

slaughter may be necessary ensure that 

these animals are humanely handled in 

connection with slaughter as required 

under the Humane Methods of 

Slaughter Act (HMSA) of 1978 (7 U.S.C. 

1901 et seq.). 

However, because FSIS did not 

discuss issues related to the humane 

handling of non-ambulatory disabled 

cattle or other non-ambulatory disabled 

livestock that are offered for slaughter in 

the SRM interim final rule or in the July 

14, 2004, FSIS/APHIS/FDA ANPR, this 

final rule affirms the prohibition on the 

slaughter of non-ambulatory disabled 

cattle that are offered for slaughter as a 

measure to prevent potential human 

exposure to the BSE agent. FSIS intends 

to initiate a separate action in which it 

will discuss measures that may be 

necessary to ensure that non-ambulatory 

disabled cattle and other nonambulatory disabled livestock are 

humanely handling in connection with 

slaughter. 

Comment: Some comments suggested 

that FSIS amend the regulations in 9 

CFR 309.13 that permit condemned 

livestock to be set apart and treated, or 

to be released from the establishment 

premises if permission is granted, to 

exclude all non-ambulatory disabled 

livestock. 

Response: FSIS disagrees with these 

comments. Some non-ambulatory 

livestock that have been condemned 

may be affected with reversible 

conditions. The Agency believes that 

livestock that are condemned on the 

account of conditions such as ketosis, 

swine erysipelas, leptospirosis, 

inflammatory conditions, or the other 

conditions identified under 9 CFR 

309.13, should continue to be permitted 

to be set apart and held for treatment 

under supervision of an FSIS program 

employee or an official designated by 

the area supervisor. 

Comment: Some comments noted that 

prohibiting the slaughter of nonambulatory disabled cattle for human 

food provides an incentive for cattle 

producers and transporters to engage in 

responsible husbandry and management 

practices to prevent cattle from 

becoming non-ambulatory before they 

are slaughtered. One comment stated 

that USDA should prohibit the transport 

of non-ambulatory disabled cattle from 

the farm. 

Response: Although the purpose of 

requiring the condemnation of nonambulatory disabled cattle that are 

offered for slaughter is to prevent 

potential human exposure to the BSE 

agent, FSIS agrees with the comments 

that stated that prohibiting the slaughter 

of non-ambulatory disabled cattle may 

provide incentives for cattle producers 

to adopt animal husbandry practices 

that prevent cattle from becoming nonambulatory. The Agency also agrees that 

it may provide incentives for 

transporters to handle cattle in a manner 

that prevents them from becoming nonambulatory. 

Comments Concerning Livestock Other 

Than Cattle 

Comment: One comment asked that 

the slaughter of all non-ambulatory 

disabled livestock be prohibited to 

prevent potential human exposure to 

the BSE agent. The comment argued 

that, in addition to the BSE variant 

discovered in the cow in Washington 

State, there are likely other variants of 

BSE that afflict cattle, as well as other 

poorly understood or unidentified TSE 

variants that affect other livestock 

species. According to the comment, 

variants of BSE or other TSEs may be 

linked to cases of the classical or the 

‘‘sporadic’’ form of CJD in the United 

States and elsewhere. 

The comment also stated that 

researchers in the United Kingdom have 

recently discovered a type of scrapie 

that resembles BSE. The comment 

argued that scientists cannot rule out 

the possibility that this is a new form of 

BSE that has adapted to sheep. As stated 

by the comment, prion diseases in sheep 

can be transmitted from animal to 

animal and, as a result, a form of BSE 

acquired prior to the feed ban may be 

circulating in the United States. The 

comment also noted that TSE agents are 

more widely distributed in the tissues of 

sheep than they are in cattle. 

The comment also argued that the fact 

that requirements in the interim final 

rule on AMR systems also apply to pork 

demonstrates that FSIS acknowledges 

that materials from livestock other than 

cattle may pose a BSE risk. 

Response: When FSIS issued the SRM 

interim final rule, the prohibition on the 

slaughter of non-ambulatory disabled 

cattle for human food was limited to 

cattle because the Agency was not aware 

of any data to indicate that livestock 

other than cattle could contract BSE 

under natural conditions. Thus, the 

Agency did not believe that extending 

the prohibition on the slaughter of nonambulatory disabled cattle to other 

livestock would be appropriate in this 

rulemaking. 


rwilkins on PROD1PC63 with RULES3
Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules and Regulations 38723 

28Case of BSE in goat confirmed: Commission 

extends testing programme, Europa Web site, 

January 28. 2005. http://europa.eu.int/rapid/

pressReleasesAction.do?reference=IP/05/

105&format=HTML&aged=0&

language=EN&guiLanguage=fr. 

On January 28, 2005, a suspected case 

of BSE in a goat slaughtered in France 

in 2002 was confirmed by a panel of 

European scientists.28 In response to 

this finding, the European Commission 

proposed to increase testing for BSE 

among goats for at least six months to 

determine if this one positive case was 

an isolated incident. As of the date of 

the publication of this document, no 

additional cases of BSE have been 

confirmed under natural conditions in 

livestock species other than cattle. 

Therefore, the Agency has concluded 

that there are insufficient data to 

indicate that a prohibition on the 

slaughter of non-ambulatory disabled 

livestock other than cattle is needed to 

minimize human exposure to the BSE 

agent. The Agency will continue to 

follow the research with regard to BSE 

in livestock species other than cattle 

and will use the findings of future 

research to inform its policies with 

regard to BSE. 

FSIS disagrees that requirements in 

the interim final rule on AMR systems 

indicate that the Agency acknowledges 

that materials from livestock other than 

cattle may pose a BSE risk. One of the 

objectives of the AMR interim final rule 

is to define the criteria that products 

produced using AMR systems must 

comply with to be represented as 

‘‘meat.’’ The preamble to the AMR rule 

makes clear that the presence of ‘‘CNStype tissues,’’ i.e., CNS tissue, DRG, and 

trigeminal ganglia, from livestock other 

than cattle 30 months of age and older 

in AMR product renders the product 

misbranded (69 FR 1874, 1881). 

Comment: A few comments stated 

that the change in the regulation that 

replaces ‘‘seriously crippled animals 

commonly termed ‘‘downers’’ in 

§ 309.2(b) with ‘‘non-ambulatory 

disabled livestock’’ unnecessarily and 

inappropriately broadens the rule’s 

scope. The comments noted that the 

SRM interim final rule, as written, 

applies the definition of non-ambulatory 

disabled livestock to swine even though 

there is no scientific link between swine 

and BSE. The comment suggested that 

FSIS consider species-specific language 

that recognizes that swine or other 

amenable species can be ‘‘temporarily 

disabled’’ and still be suitable for 

slaughter for human food. The comment 

requested that FSIS amend the 

definition of non-ambulatory disabled 

livestock to recognize the differences in 

species and the conditions that may 

warrant the condemnation of those 

animals on a species and case-by-case 

basis. 

Response: The definition of nonambulatory disabled livestock does not 

broaden the scope of the rule to require 

the immediate condemnation of nonambulatory disabled livestock other 

than cattle. The regulations at 9 CFR 

309.2(b) provide that all seriously 

crippled animals and non-ambulatory 

disabled livestock shall be identified as 

U.S. Suspects unless they are required 

to be classed as condemned under 9 

CFR 309.3. The regulations in 9 CFR 

309.3 require that all non-ambulatory 

disabled cattle be condemned. However, 

non-ambulatory disabled livestock other 

than cattle may be identified as U.S. 

Suspects, set apart, and slaughtered 

separately from livestock that have 

passed ante-mortem inspection (9 CFR 

309.2(n)). If an FSIS veterinarian finds 

that the meat and meat food products 

from a U.S. Suspect are not adulterated, 

these products may be used for human 

food (9 CFR 311.1). 

Animal Feed 

Comment: Several comments 

requested that FSIS prohibit the use of 

SRMs and non-ambulatory disabled 

cattle in animal feed and pet food. Other 

comments suggested that FSIS work 

with FDA to completely remove all 

SRMs, as well as non-ambulatory and 

dead stock from the animal feed chains. 

One comment stated that the U.S. 

government should ban the feeding of 

any mammalian protein to all mammals 

and prohibit the use of poultry litter in 

animal feed. 

Response: The FDA is responsible for 

regulating animal food and feed in the 

United States. On October 6, 2005, FDA 

published a proposed rule to amend its 

animal feed regulations to prohibit from 

use in the food or feed of all animals 

certain high risk cattle materials that 

can potentially carry the BSE agent 

(‘‘Substances Prohibited From Use in 

Animal Food or Feed,’’ 70 FR 58570). 

The issues raised by these comments are 

addressed in that rulemaking. FSIS with 

APHIS will continue to work closely 

with FDA on its rulemaking. 

Surveillance, Disposal of Dead Cattle, 

and Cattle Identification 

Comment: Some comments noted that 

surveillance for BSE is essential for 

establishing the prevalence of the 

disease and for evaluating the 

effectiveness of control measures. One 

comment said that FSIS should test all 

high-risk cattle 30 months of age and 

older for BSE and randomly sample 

healthy cattle over 30 months of age to 

determine the true prevalence of the 

disease and to evaluate risk 

management measures in this country. 

One comment said that testing all nonambulatory disabled cattle for BSE 

regardless of the reason for their nonambulatory status may bias the 

representative population of potentially 

infected cattle. As stated by the 

comment, young injured cattle are 

unlikely to have BSE. Another comment 

suggested that USDA test all nonambulatory disabled cattle. 

One comment stated that USDA 

should require licensing of all entities, 

including farms and ranches, that 

dispose of cattle. As stated by the 

comment, FSIS has some authority over 

registration and recordkeeping of 

handlers of 4–D livestock and should 

explore extending this to disposal of 

these livestock to aid surveillance. 

A few comments asserted that APHIS’

BSE surveillance testing on the farm 

provides no incentive for farmers or 

ranchers to voluntarily subject their 

non-ambulatory cattle to testing. 

According to the comments, the 

program offers only risk and no 

compensation. The comments suggested 

that USDA establish a program for 

producers to submit animals that die on 

the farm for testing for BSE. 

Response: USDA’s APHIS has primary 

responsibility for BSE surveillance 

activities in the United States and is 

responsible for developing the BSE 

sampling protocols. We forwarded these 

comments to APHIS for consideration as 

they designed their current BSE 

surveillance program. As discussed 

above, APHIS has now transitioned to 

an ongoing BSE surveillance program, 

which samples approximately 40,000 

animals each year, and continues to 

sample the cattle populations where the 

disease is most likely to be found. The 

targeted population for APHIS’ ongoing 

surveillance includes cattle exhibiting 

signs of CNS disorders or any other 

signs that may be associated with BSE, 

including emaciation or injury, and 

dead cattle, as well as non-ambulatory 

cattle. Samples from the targeted 

population are taken from the same 

locations as those used during the 

enhanced surveillance program. 

FSIS has and continues to assist 

APHIS in implementing its BSE 

surveillance program by, among other 

activities, collecting brain samples of all 

cattle condemned on ante-mortem 

inspection, including non-ambulatory 

disabled cattle and cattle that show 

signs of CNS disease, and verifying that 

ante-mortem condemned cattle that are 

to be tested by APHIS at an off-site 

sample collection location arrive at the 

location. 


rwilkins on PROD1PC63 with RULES3
38724 Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules and Regulations 

29AMS USDA, ‘‘Country of Origin Labeling—

Current Status of Country of Origin Labeling,’’

available at http://www.ams.usda.gov/cool/ 

status.htm. 

As noted by the comments, FSIS has 

some authority over registration and 

recordkeeping of handlers of 4–D 

livestock. FSIS does not believe further 

regulatory action is required as 

suggested by the comment. 

Comment: One comment stated that 

USDA should develop, implement, and 

enforce safe and effective methods for 

destroying animals that are found to 

have a TSE. Another comment 

suggested that all dead cattle on farms 

be transported to a federally regulated 

facility for disposal. 

Response: USDA’s APHIS is the 

agency primarily responsible for 

ensuring the proper disposition of 

animals that have confirmed TSEs. At 

the same time, APHIS, FSIS, FDA, and 

the Environmental Protection Agency 

(EPA), coordinate efforts to ensure that 

the carcasses of animals with TSEs and 

other diseases are properly disposed of. 

Comment: Several comments 

expressed support for a national cattle 

identification system. Some comments 

stated that USDA should implement an 

identification system for all livestock, 

not just cattle, and that is should be 

mandatory. One comment stated that 

animals at slaughter should be required 

to have identification records and that 

the records should be retained for 7 

years. 

Response: Since April 2004, USDA 

has been in the process of implementing 

the National Animal Identification 

System (NAIS), a voluntary animal 

identification and tracking system that 

will be used in all States and that will 

operate under national standards. When 

fully operational, the system will be 

capable of tracing a sick animal or group 

of animals back to the herd or premises 

that is the most likely source of 

infection. It will also be able to trace 

potentially exposed animals that were 

removed from that herd or premises. 

Information regarding the NAIS can be 

found on the Internet at: http:// 

animalid.aphis.usda.gov/nais/ 

index.shtml. 

Other Comments 

Comment: One comment suggested 

that FSIS require that the packaging of 

beef products bear labeling to warn the 

American public about the potential risk 

of BSE. Another comment stated that 

the labeling of products that contain 

brain or spinal cord from cattle younger 

than 30 months of age should include a 

warning about the potential BSE risk. 

Another comment said that country-oforigin labeling for meat products would 

be invaluable for tracking individual 

animals or herds implicated in disease 

transmission. 

Response: As discussed in detail 

above, the estimated BSE prevalence in 

the United States is extremely low, less 

than one case per million cattle. On the 

basis of these prevalence estimates, in 

conjunction with effective 

implementation of the risk mitigation 

measures discussed here, FSIS has 

determined that beef and beef products 

produced in the United States are, and 

will remain, highly unlikely to be 

contaminated with the BSE agent. 

Therefore, the Agency disagrees that 

beef products or products that contain 

brain or spinal cord from cattle less than 

30 months should bear warning labels 

about the potential BSE risk. 

Under the Farm and Security and 

Rural Investment Act of 2002 and the 

2002 Supplemental Appropriations Act, 

USDA is required to implement a 

mandatory country of origin labeling 

program (COOL).29 USDA’s Agricultural 

Marketing Service (AMS) published a 

proposed rule on the COOL program on 

October 30, 2003 (68 FR 61944–61985, 

Docket No. LS–03–04). Under the 

proposal, retailers would be required to 

notify their customers of the country of 

origin of all beef (including veal), lamb, 

pork, fish, and selected other perishable 

commodities being marketed in their 

stores. In addition, the AMS proposal 

identifies criteria that these 

commodities must meet to be 

considered of U.S. origin. In January 

2004, President Bush signed Public Law 

108–199, which included a provision to 

delay until September 2006 the 

implementation of mandatory COOL for 

all covered commodities except wild 

and farm-raised fish and shellfish. On 

November 10, 2005, President Bush 

signed Public Law 109–97, which 

delayed implementation of mandatory 

COOL for all covered commodities 

except wild and farm-raised fish and 

shellfish until September 30, 2008. 

Comment: One comment stated that 

the U.S. government must trace CJD in 

humans. 

Response: The U.S. Centers for 

Disease Control and Prevention (CDC) 

conducts surveillance and does tracing 

for CJD and other human TSEs in the 

United States. Information on 

surveillance for CJD in the United States 

is available on the CDC Web site at: 

http://www.cdc.gov/ncidod/dvrd/vcjd/ 

index.htm. 

Comment: One comment suggested 

that USDA encourage farmers to feed 

cattle natural, organic feed. Another 

comment stated that USDA should 

phase out all growing and raising of 

animals for human consumption. 

Response: These comments are 

outside the scope of this rulemaking and 

outside the scope of FSIS’ regulatory 

authority. 

Comment: One comment requested 

that USDA eliminate the requirement 

that beef imported from Canada be 

processed on dedicated equipment if 

establishments slaughter cattle 30 

months of age and older and cattle 

younger than 30 months in the same 

facility. 

Response: This comment was 

addressed by APHIS in its final rule, 

‘‘Bovine Spongiform Encephalopathy; 

Minimal-Risk Regions and Importation 

of Commodities’’ (70 FR 459–553, 

January 4, 2005). In that rulemaking, 

APHIS removed the proposed 

requirement that meat derived from 

bovines in a BSE minimal-risk region 

that are slaughtered in that region come 

from animals slaughtered at a facility 

that either slaughters only bovines less 

than 30 months of age or complies with 

an approved segregation process. 

2005 Risk Assessment 

Background. In the Final Regulatory 

Impact Analysis (FRIA) of this final 

rule, FSIS used an updated version of 

the 2001 and 2003 Harvard Risk 

Assessment models developed by the 

Harvard Center for Risk Analysis 

(HCRA) of the Harvard School of Public 

Health and the Center for 

Computational Epidemiology at 

Tuskegee University to develop baseline 

and mitigation estimates of potential 

human exposure to the BSE agent. The 

update is referred to here as ‘‘the 2005 

model.’’ The Agency used estimates 

generated by the 2005 model to assess 

the benefits associated with the 

measures adopted in this final rule. 

In the 2005 model, the HCRA 

developed a new baseline, analyzed the 

effects of the measures implemented by 

USDA and FDA in response to the 

confirmation of the BSE case in 

Washington State, and analyzed 

recommendations made by an 

international expert BSE panel that was 

convened at the request of the Secretary 

of Agriculture to review the actions 

taken by the United States in response 

to the confirmation of the BSE case in 

Washington State. 

The authors submitted the 2005 

model to FSIS in June 2005, and a peer 

review of the 2005 model and resulting 

assessment was completed in September 

2005. The final products were submitted 

to FSIS following the peer review. 

On July 12, 2006, FSIS published a 

notice in the Federal Register 

announcing that the Agency was making 


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the 2005 Harvard BSE Update (i.e., the 

2005 model) available to the public (71 

FR 39282). In the notice, FSIS gave the 

public until August 11, 2006, to submit 

comments on the updated risk 

assessment. The notice also announced 

that the Agency would be holding a 

technical meeting to provide 

information on the 2005 model and 

resulting assessment. This meeting was 

held on July 25, 2006. 

In response to a comment submitted 

on August 1, 2006, FSIS extended the 

comment period on the 2005 model to 

October 27, 2006, which is 45 days from 

the date on which the Agency made the 

transcript of the July 25, 2006, technical 

meeting publicly available. The 

transcripts of the public meeting were 

posted on the FSIS Web site on 

September 12, 2006 (http:// 

www.fsis.usda.gov/PDF/ 

BSE_Transcript_072506.pdf). 

FSIS received six comments on the 

2005 model. The commenters included 

a consumer advocacy organization, two 

animal welfare organizations, a cattle 

producer trade association, a consultant, 

and a private citizen. In response to 

some of these comments, revisions were 

made to the 2005 model. 

This document refers to the analyses 

conducted before the 2005 model was 

revised in response to public comments 

as ‘‘the pre-public comment runs of the 

2005 model’’ and the analyses that were 

conducted after the 2005 model was 

revised as ‘‘the post-public comment 

runs of the 2005 model.’’ Both the prepublic comment and post-public 

comment runs of the 2005 model are 

discussed below. 

Pre-public comment runs of the 2005 

model. The pre-public comment runs of 

the 2005 model use the base case 

provided by Harvard (i.e., prior to the 

revisions made in response to public 

comments). The pre-public comment 

runs yielded an estimated mean total 

potential human exposure of 3,800 

cattle oral ID50s to the BSE agent over 

20 years following the hypothetical 

introduction of 500 BSE-infected cattle 

into the U.S. This base case yielded an 

average of 180 new BSE cases in the 

U.S. over 20 years. 

The pre-public comment runs found 

that the food safety measures enacted by 

USDA all reduce potential human 

exposure to BSE infectivity but have 

little effect on spread of BSE in the 

cattle population. Removing nonambulatory disabled cattle from the 

human food supply reduces predicted 

potential human exposure by about 3% 

(leaving a mean of 3,700 cattle oral 

ID50s). The pre-public comment runs 

found that removing SRMs from cattle 

30 months of age and older almost 

completely eliminates potential human 

exposure, reducing it to 11 cattle oral 

ID50s. Prohibiting the use of skulls and 

vertebral columns from cattle 30 months 

of age and older in advanced meat 

recovery (AMR) systems reduces 

potential human exposure by 

approximately two-fifths to 2,200 ID50s. 

It is worth noting that these are relative 

reductions to what is already a small 

risk in absolute terms, especially in light 

of the fact that these simulations reflect 

the assumed introduction of 500 

infected cattle into the U.S. None of the 

combined measures yielded substantial 

improvements over their components. 

The 2005 model evaluates two 

measures under consideration by FDA, 

including a prohibition on the use of 

ruminant blood in ruminant feed, and 

the requirement that plants producing 

both prohibited material (i.e., ruminantderived material) and non-prohibited 

material use dedicated production lines. 

The pre-public comment runs indicate 

that neither of these actions would have 

much impact on the spread of BSE. The 

2003 Harvard report concluded that 

blood contributes relatively little to the 

spread of BSE. Similarly, earlier work 

done by the HCRA suggests that crosscontamination is a relatively minor 

factor. 

As discussed earlier in this document, 

the IRT (the International Review 

Subcommittee convened by the 

Secretary of Agriculture) suggested the 

possibility of a ban on SRMs from 

animals 12 months and older for both 

human food and animal feed. The 2005 

model evaluates the impact of this ban 

assuming perfect compliance. The prepublic comment runs of the 2005 model 

suggest that this measure would reduce 

potential human exposure to the BSE 

agent by more than 99% relative to the 

base case. Because the model assumed 

that the ban also removes SRMs from 

dead stock prior to their rendering, the 

measure achieves a substantial 

reduction in the spread of BSE among 

cattle, decreasing the number of new 

infected BSE cases in the U.S. to 35 

from 180. The pre-public comment runs 

found that the removal of all animalderived protein from cattle feed, as 

suggested by the IRT, would decrease 

the number of new BSE cases from 180 

to 170 over 20 years. The remaining 

cases result primarily from mis-feeding 

of rations containing ruminant proteins 

(feed intended for other species) to 

cattle. This measure has a smallpredicted impact on potential human 

exposure. 

Post-public comment runs of the 2005 

model. For the post-public comment 

runs, the 2005 model was revised to 

incorporate poultry litter as a potential 

pathway for the spread of BSE in the 

United States. The model’s revised base 

case assumes that 40% of prohibited 

meat and bone meal produced by either 

mixed or prohibited-only renderers is 

used in poultry feed. It also assumes 

that 1% of chicken litter is recycled 

back to cattle feed. 

The poultry litter assumption is based 

on information provided by 

stakeholders to FDA. FDA shared this 

information with an interagency 

(APHIS, FDA, and FSIS) group that 

reviewed the data and incorporated 

them into the post-comment revisions of 

the 2005 model. 

In addition, for the post-public 

comment runs, the 2005 model base 

case was revised to lower the rate that 

animals with clinical signs of BSE are 

detected on ante-mortem inspection. 

The 2005 post-public comment model’s 

revised base case assumes that antemortem inspection detects 50% of 

ambulatory animals with clinical BSE 

signs, and 25% of non-ambulatory 

animals with clinical BSE signs. A 

revised sensitivity analysis investigates 

the impact of assuming ante-mortem 

inspection fails to detect any animals 

with clinical signs of BSE. 

FSIS used the post-public comment 

revised base case and new mitigation 

measures to estimate of potential human 

exposure to the BSE agent. Like the base 

case used for the pre-public comment 

runs, the revised base case for the postpublic comment runs does not reflect 

the measures to minimize human 

exposure to the BSE agent implemented 

by FSIS in the SRM interim final rule. 

The post-public comment runs of the 

2005 model lead to an increase in the 

estimated number of infected cattle and 

an increase in potential human 

exposure. Specifically, when the two 

modifications discussed above (i.e., 

inclusion of the poultry litter pathway 

and inclusion of the less optimistic 

assumptions regarding ante-mortem 

inspection) were added to the model, 

the base case from the post-public 

comment runs yielded an increase in 

the estimated mean total potential 

human exposure to the BSE agent over 

20 years following the hypothetical 

introduction of 500 BSE-infected cattle 

into the U.S. from 3,800 to 6,600 cattle 

oral ID50s. These modifications also 

resulted in an increase from 180 to 200 

in the average number of new BSE cases 

in the U.S. over 20 years. 

However, although both the number 

of BSE cases and the level of human 

exposure increased in the post-public 

comment runs, conclusions with regard 

to prohibiting the use of SRMs for 

human food remain the same. More 

specifically, even with the revised base 


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case, the post-public comment runs 

show that excluding the materials 

designated as SRMs in this final rule 

almost completely eliminates potential 

human exposure to the BSE agent if 

compliance is perfect. Similarly, the 

post-public comment runs found that 

neither lowering the age classification 

for SRMs from cattle 30 month of age 

and older to 12 months of age and older, 

nor from 30 months of age and older to 

24 months of age and older, provides 

additional benefits in reducing the level 

of potential human exposure to the BSE 

agent. Thus, the results of the 2005 

model, regardless of the base case used, 

have not led the Agency to change its 

conclusion that the measures adopted in 

this final rule are prudent for preventing 

potential human exposure to the BSE 

agent. 

The 2005 pre-public comment and 

2005 post-public comment models are 

available for viewing by the public on 

the FSIS Web site at: http:// 

www.fsis.usda.gov/Science/ 

Risk_Assessments/index.asp. Also 

available on the Web site are the 

comments received on the 2005 model, 

and FSIS’ response to these comments. 

Summary of the Final Rule 

In this final rule, FSIS is affirming, 

with amendments, the SRM interim 

final rule. The Agency is also affirming 

the air-injection stunning interim final 

rule. As discussed earlier in this 

document, the Agency intends to affirm 

and, if necessary, amend the AMR 

interim final rule in a separate 

document that will be published in the 

Federal Register at a later date. In 

addition, FSIS also intends to address 

the humane handing implications of the 

slaughter of non-ambulatory disabled 

cattle and other non-ambulatory 

disabled livestock in a separate action. 

In this final rule, FSIS is affirming, 

without amendment, the provisions in 9 

CFR 309.2(b) of the SRM interim final 

rule which replace the term ‘‘downer’’

with ‘‘non-ambulatory disabled 

livestock’’ and which define ‘‘nonambulatory disabled livestock’’ as 

livestock that cannot rise from a 

recumbent position or that cannot walk, 

including, but not limited to, those with 

broken appendages, severed tendons or 

ligaments, nerve paralysis, fractured 

vertebral column, or metabolic 

conditions. The Agency is revising 

paragraph 9 CFR 309.3(e) to clarify that 

non-ambulatory disabled cattle that are 

offered for slaughter must be 

condemned but that FSIS inspection 

personnel will determine the 

disposition of cattle that become nonambulatory after they have passed antemortem inspection on a case-by-case 

basis. As discussed earlier in this 

document, this amendment reflects the 

current Agency practice. 

In addition, FSIS is amending 9 CFR 

309.13(b) of the regulations that 

prescribe requirements for the 

disposition of condemned livestock to 

add veal calves that cannot rise from a 

recumbent position or that cannot walk 

because they are tired or cold to the list 

of conditions for which condemned 

livestock may be set aside and treated. 

FSIS is affirming, with amendments, 

the provisions of the SRM interim final 

rule that define SRMs and prescribe 

requirements for the handling and 

disposition of SRMS. The Agency is 

amending 9 CFR 310.22(a) to exclude 

from the definition of SRMs materials 

from cattle from foreign countries that 

can demonstrate that their BSE risk 

status can reasonably be expected to 

provide the same level of protection 

from human exposure to the BSE agent 

as prohibiting SRMs for use as human 

food does in the United States. As 

discussed earlier in this document, 

countries that believe that they have the 

appropriate BSE risk status to qualify for 

this exemption should submit evidence 

to support their claimed BSE risk to 

FSIS’ Office of International Affairs. 

FSIS is affirming without changes the 

list of materials designated as SRMs in 

9 CFR 310.22(a)(1). These materials are 

the brain, skull, eyes, trigeminal ganglia, 

spinal cord, vertebral column 

(excluding the vertebrae of the tail, the 

transverse processes of the thoracic and 

lumbar vertebrae, and the wings of the 

sacrum), and dorsal root ganglia of cattle 

30 months of age and older. 9 CFR 

310.22(a)(2) designates the distal ileum 

of the small intestine and the tonsils of 

all cattle as SRMs. The Agency is 

removing 9 CFR 310.22(a)(3) and redesignating the provisions in that 

paragraph that prescribe the conditions 

under which the small intestine, 

excluding the distal ileum, from cattle 

may be used for human food as 9 CFR 

310.22(d). 

The Agency is affirming, with minor 

grammatical changes, 9 CFR 310.22(b), 

which declares that SRMs are inedible 

and prohibits their use for human food. 

FSIS is also affirming the provisions in 

9 CFR 310.22(c) that specify that SRMs 

must be removed and disposed of as 

inedible in accordance with 9 CFR 314.1 

or 9 CFR 314.3. In addition, the Agency 

is amending 9 CFR 310.22(c) to require 

that the spinal cord from cattle 30 

months of age and older be removed 

from the carcass at the establishment 

where the animal was slaughtered. 

FSIS is re-designating 9 CFR 310.22(d) 

of the SRM interim final rule, the 

requirements for the removal, 

segregation, and disposition of SRMs, as 

9 CFR 310.22(e) and moving the 

conditions under which the small 

intestine, excluding the distal ileum, 

may be used for human food, formerly 

found in 9 CFR 310.22(a)(3), to 9 CFR 

310.22(d). 

Specifically, 9 CFR 310.22(d)(1) 

provides that the small intestine from 

cattle may be used for human food if it 

is derived from cattle that were 

inspected and passed in an official 

establishment in the United States, or in 

a certified foreign establishment, and it 

is otherwise eligible for importation into 

the United States under 9 CFR 327.1(b) 

of FSIS’ import regulations (9 CFR 

310.22(d)(1)(i)) and the distal ileum has 

been removed by a procedure that 

removes at least 80 inches of the 

uncoiled and trimmed small intestine as 

measured from the ceco-colic junction 

and progressing towards the jejunum or 

by a procedure that the establishment 

demonstrates is effective in ensuring 

complete removal of the distal ileum (9 

CFR 310.22(d)(1)(ii)). FSIS is also 

amending 9 CFR 310.22(d)(1) to add a 

paragraph (d)(1)(iii), which clarifies that 

if the conditions described above are not 

met, the small intestine must be 

removed and disposed of as inedible. 

9 CFR 310.22(d)(2) provides that 

requirements for the removal of the 

small intestine prescribed in 9 CFR 

310.22(d)(1) do not apply to materials 

from cattle from countries that can 

demonstrate that their BSE risk status 

provides the same level of protection 

from human exposure to the BSE agent 

as prohibiting SRMs for use as human 

food does in the United States. 

FSIS is re-designating paragraph 9 

CFR 310.22(e) of the SRM interim final 

rule, which specifies that materials that 

are SRMs will be deemed to be from 

cattle 30 months of age and older unless 

the establishment can demonstrate 

through documentation that the 

materials are from an animal that was 

younger than 30 months of age at the 

time of slaughter, as 9 CFR 310.22(h). 

FSIS is affirming with minor 

grammatical changes, most of the 

requirements for the removal, 

segregation, and disposition of SRMs in 

9 CFR 310.22(d) of the SRM interim 

final rule and re-designating them as 9 

CFR 310.22(e). In 9 CFR 310.22(e)(1), 

the Agency is adding a provision to 

clarify that an establishment’s 

procedures for the removal, segregation, 

and disposition of SRMs must address 

potential contamination of edible 

materials with SRMs before, during, and 

after entry into the establishment. 

FSIS is adding a new paragraph, 9 

CFR 310.22(f), that prescribes 

requirements for the sanitation of 


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30The estimated costs are higher compared with 

those estimated for the PRIA of the interim final 

rule because more establishments needed to take 

measures than what the PRIA anticipated. However, 

the PRIA accounted for the removal of the entire 

small intestine instead of just the distal ileum 

portion of the small intestine. The savings of only 

removing the distal ileum offset partially the extra 

costs of more establishments (state-inspected and 

custom-exempt) needing to take the measures 

contained in the final rule. FSIS changed the small 

intestine provision in September 2005. 

equipment used to cut through SRMs. 9 

CFR 310.22(f)(1) prescribes 

requirements for establishments that do 

not segregate the carcasses or parts from 

cattle 30 months of age and older from 

the carcasses or parts from cattle 

younger than 30 months. 9 CFR 

310.22(f)(1) requires that such 

establishments either (1) use dedicated 

equipment to cut through SRMs (9 CFR 

310.22(f)(1)(i)) or (2) clean and sanitize 

equipment used to cut through SRMs 

before the equipment is used on 

carcasses or parts from cattle younger 

than 30 months (9 CFR 310.22(f)(1)(ii)). 

Under 9 CFR 310.22(f)(2), 

establishments that segregate the 

carcasses or parts from cattle 30 months 

of age and older from the carcasses or 

parts from cattle younger than 30 

months, and that process the carcasses 

of the younger cattle first, may use 

routine operational sanitation 

procedures on equipment used to cut 

through SRMs. 

FSIS is also adding a new paragraph 

310.22(g) that specifies the conditions 

under which slaughter establishments 

may ship beef carcasses or parts that 

contain vertebral columns from cattle 30 

months of age and older to another 

federally-inspected facility for further 

processing. FSIS is adding these 

provisions to ensure that establishments 

that ship carcasses or parts that contain 

vertebral columns from cattle that were 

30 months of age and older at the time 

of slaughter implement the appropriate 

controls to prevent the inadvertent 

introduction of SRMs into the human 

food supply. 

Under 9 CFR 310.22(g), 

establishments may ship carcasses or 

parts of carcasses that contain vertebral 

columns from cattle 30 months of age 

and older to another federally-inspected 

establishment for further processing if 

the establishment: (1) Maintains control 

of the carcasses or parts while these 

materials are in transit or ensures that 

the carcasses or parts move under FSIS 

control (310.22(g)(1)); (2) ensures that 

the carcasses or parts are accompanied 

by documentation that clearly states that 

they contain vertebral columns from 

cattle that were 30 months of age or 

older at the time of slaughter (9 CFR 

310.22(g)(2)); (3) maintains records that 

identify the official establishment that 

received the carcasses or parts (9 CFR 

310.22(g)(3)); and (4) maintains records 

that verify that the receiving 

establishment removed and properly 

disposed of the SRM portions of the 

vertebral column (9 CFR 310.22(g)(4)). 

Establishments that do not meet these 

conditions must remove the SRM 

portions of the vertebral column from 

cattle 30 months of age and older prior 

to shipping the carcass. Establishments 

that receive beef carcasses or parts must 

address removal of the vertebral column 

from cattle 30 months of age and older 

in their procedures for the removal, 

segregation, and disposition of SRMs. 

FSIS is affirming without amendment 

the provisions in 9 CFR 311.27 of the 

SRM interim final rule that prohibit for 

use as human food the parts and 

carcasses of cattle slaughtered for 

humane reasons in the absence of an 

inspector. FSIS is affirming without 

amendment the interim provisions in 9 

CFR 313.15(b)(2) and 9 CFR 

310.13(a)(2)(iv)(C) that prohibit the use 

of stunning devices that deliberately 

inject compressed air into the cranial 

cavity of cattle. 

FSIS is amending 9 CFR 318.6(b)(1) 

and 9 CFR 318.6(b)(8) to reflect the redesignation of the requirements on the 

use of the small intestine for human 

food from 9 CFR 310.2(a)(3) to 9 CFR 

310.22(d). 9 CFR 318.6(b)(1) prescribes 

requirements for the use of animal 

casings as containers of meat food 

products and 9 CFR 318.6(b)(8) 

prescribes requirements for the use of 

intestines in meat food products and 

edible rendering. Finally, FSIS is 

affirming the prohibition on the use of 

MS (beef) for human food in 9 CFR 

319.5(b). 

Executive Order 12866 and Regulatory 

Flexibility Act 

This final rule has been determined to 

be economically significant and, 

therefore, it has been reviewed by the 

Office of Management and Budget. This 

final rule affirms the air-injection 

stunning interim final rule and affirms, 

with changes, the SRM interim final 

rule. As discussed above, because the 

AMR interim final rule contains several 

non-BSE related provisions, FSIS 

intends to affirm and, if necessary, 

amend that interim final rule at a later 

date. The Agency will include a 

regulatory impact analysis of the final 

AMR rule at that time. The complete 

regulatory impact analysis for this final 

rule is available through the FSIS Web 

site at http://www.fsis.usda.gov/

regulations/ 

2007_Interim_&_Final_Rules_Index/. 

Summary of the Final Regulatory 

Impact Analysis 

In developing this Final Regulatory 

Impact Analysis (FRIA), FSIS reviewed 

the public comments received on the 

Preliminary Regulatory Impact Analysis 

(PRIA) and the interim final rules. In 

addition, FSIS developed and analyzed 

a set of regulatory alternatives for the 

FRIA. 

The FRIA shows that the actions of 

this final rule require about 3,512 

establishments that slaughter cattle or 

process bone-in beef products to take 

measures to minimize human exposure 

to cattle materials that could potentially 

contain the BSE agent. The FRIA 

estimates that the total annual average 

cost of the measure adopted in this final 

rule is $171.2 million annualized over 5 

years at an interest rate of 7 percent.30

The primary impacts of this final rule 

are the exclusion of SRMs from use in 

the human food supply; the prohibition 

of the slaughter of non-ambulatory 

disabled cattle that are offered for 

slaughter; and modifications of HACCP 

plans or Sanitation SOPs or other 

prerequisite programs and 

recordkeeping requirements. The FRIA 

found that there is no cost associated 

with the air-injection stunning final rule 

because air injection stunning devices 

are no longer in use in the United 

States. 

The FRIA assesses the benefits of the 

measures adopted in this final rule. The 

measures adopted in this final rule are 

reasonable and necessary measures to 

ensure food safety. In doing so, they 

help to assure domestic and foreign 

consumers that the U.S. food supply is 

safe. 

FSIS used the 2005 Harvard BSE Risk 

Assessment model, which is described 

above, to develop baseline and 

mitigation estimates of potential human 

exposure to the BSE agent for this rule. 

As discussed in detail above, the 2005 

model was modified in response to 

comments. 

Both the pre-public comment and 

post-public comment runs of the 2005 

model estimated that the measures 

adopted in this final rule will result in 

a greater than 99 percent (at the mean) 

relative reduction in potential human 

exposure to the BSE agent when 

compliance is 100%. Because the 

amount of the BSE agent necessary to 

cause disease in humans is unknown, 

FSIS has not estimated monetary values 

for reductions in human morbidity and 

mortality associated with this final rule. 

No known cases of vCJD have been 

associated with consuming beef 

products in the United States. 


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38728 Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules and Regulations 

31FSIS defined small and very small 

establishments by its HACCP (Hazard Analysis and 

Critical Control Points) size definition. 

Establishments that have fewer than 10 employees 

or generate less than $2.5 million in annual sales 

are ‘‘very small’’ establishments; establishments 

that have between 10 and 499 employees or 

generate more than $2.5 million in annual sales are 

‘‘small’’ establishments; and establishments that 

have 500 or more employees are ‘‘large’’

establishments. The size definition classification is 

different from the Small Business Administration’s 

categorization of small and large business due to the 

unique nature of the meat and poultry slaughter and 

processing industry. 

The FRIA does estimate a benefit for 

the restoration of beef export markets 

(gross sales), which may, in part, have 

been affected by the measures 

implemented in this final rule. 

However, because of the many other 

factors that are also relevant to regained 

market access, the affects on the 

restoration of beef export markets that 

may be attributed to the measures 

implemented in this final rule are 

difficult to determine. In pre-BSE 2003, 

beef export markets totaled $3,861.9 

million annually for veal, beef, and beef 

variety meats. Then, in post-BSE 2004, 

these beef export market sales dropped 

about 79 percent or $3,053.8 million to 

$808.1 million. However, in 2005, the 

U.S. had restored its beef export market 

sales to a total of $1,365.3 million. 

Compared to 2004, this is an increase of 

about 69 percent or $557.2 million in 

beef export market sales. 

In addition, the FRIA shows that this 

final rule is cost-effective when 

compared to considered regulatory 

alternatives. Further, the FRIA 

addresses how this final rule affects 

about 3,278 very small, 197 small, and 

37 large establishments of a total of 

about 3,512 establishments affected.31

FSIS expects that the aggregate beef 

price impacts of the measures contained 

in the final rule are not significant. FSIS 

estimates that the affected 

establishments have a relatively 

insignificant increase in operating costs, 

given that this increase is typically a 

relatively small share of the total 

operating costs affected. In addition, the 

removal of SRMs from the supply of 

variety meats is not expected to have a 

significant impact on prices, given the 

availability of substitutes (e.g., brains 

from cattle younger than 30 months of 

age, and the remaining small intestine 

excluding the distal ileum). 

Furthermore, FSIS estimates that only a 

relatively small share of the beef variety 

meat supply is affected. In addition, the 

removal of non-ambulatory disabled 

cattle from the food supply is not 

expected to have a significant impact on 

beef prices given the relatively small 

share of beef supply affected (less than 

0.15 percent). 

Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. In this final rule: (1) All 

state and local laws and regulations that 

are inconsistent with this rule will be 

pre-empted; (2) no retroactive effect will 

be given to this rule; and (3) 

administrative proceedings will not be 

required before parties may file suit in 

court challenging this rule. 

Paperwork Requirements 

In accordance with section 3507(j) of 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.), FSIS has 

reviewed the information and 

recordkeeping requirements in this final 

rule and has determined that the 

paperwork requirements associated with 

the regulations that require that 

establishments develop written 

procedures for the removal, segregation, 

and disposition of SRMs, have already 

been accounted for in the Specified Risk 

Materials information collection 

approved by the Office of Management 

and Budget (OMB). FSIS has also 

determined that the paperwork 

requirements for the regulations that 

require that establishments maintain 

daily records sufficient to document the 

implementation and monitoring of their 

procedures for the removal, segregation, 

and disposition of SRMs, and any 

corrective actions taken, have also been 

accounted for in the Specified Risk 

Materials information collection 

approved by OMB. The OMB approval 

number for the Specified Risk Materials 

information collection is 0583–0129. 

In this final rule, FSIS is adding a new 

regulation that requires that federallyinspected slaughter establishments that 

transport carcasses or parts that contain 

vertebral columns from cattle 30 months 

of age and older to another federallyinspected establishment for further 

processing maintain records that verify 

that the official establishment that 

received the carcasses or parts removed 

and properly disposed of the portions of 

the vertebral column designated as 

SRMs. This is a new recordkeeping 

requirement that FSIS has submitted to 

OMB for approval. 

Title: ‘‘Specified Risk Materials 

Transport Documentation’’. 

Type of Collection: New. 

Abstract: In this final rule, FSIS is 

requiring that slaughter establishments 

that transport carcasses or parts that 

contain vertebral columns from cattle 

that were 30 months of age and older at 

the time of slaughter to another 

federally-inspected establishment for 

further processing maintain 

documentation that verifies that the 

receiving establishment removed and 

properly disposed of the SRM portions 

of the vertebral column. This is a new 

information and recordkeeping 

requirement. 

Under the current regulations, 

establishments that slaughter cattle, and 

establishments that process the 

carcasses and parts of cattle, are 

required to maintain daily records 

sufficient to document the 

implementation and monitoring of their 

procedures for the removal, segregation, 

and disposition of SRMs. Under this 

final rule, establishments that transport 

carcasses or parts from cattle 30 months 

of age and older for further processing 

will have to obtain these records from 

the receiving establishment in order to 

verify that the receiving establishment 

removed and properly disposed of the 

SRMs. 

Estimate of burden: FSIS estimates 

that it will take establishments that 

receive for further processing carcasses 

or parts that contain vertebral columns 

from cattle 30 months of age and older 

approximately 2 minutes a day to 

submit to the transporting establishment 

records that document the 

implementation and monitoring of the 

receiving establishment’s procedures for 

the removal, segregation, and 

disposition of SRMs. FSIS estimates that 

it will take the transporting 

establishments approximately 2 minutes 

a day to file this documentation once it 

is received. 

Respondents: Official establishments 

that transport vertebral columns from 

cattle that were 30 months of age and 

older to another official establishment 

for further processing, and official 

establishments that receive for further 

processing carcasses or parts that 

contain vertebral columns from cattle 

that were 30 months of age at the time 

of slaughter. 

Estimated Number of Respondents: 

70. 

Estimated Number of Responses per 

Respondent: 300 annually. 

Estimated Total Annual Burden on 

Respondents: 700 hours. 

Copies of this information collection 

assessment can be obtained from John 

O’Connell, Paperwork Reduction Act 

Coordinator, Food Safety and Inspection 

Service, USDA, 112 Annex, 300 12th 

Street, SW., Washington, DC 20250. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FSIS’ functions, including whether 

the information will have practical 

utility; (b) the accuracy of FSIS’ estimate 

of the burden of the proposed collection 

of information, including the validity of 

the methodology and assumptions used; 


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Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Rules and Regulations 38729 

(c) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; ways to minimize the burden 

of the collection of information on those 

who are to respond, including through 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques, or 

other forms of information technology. 

Comments may be sent to both John 

O’Connell, Paperwork Reduction Act 

Coordinator, at the address provided 

above, and the Desk Officer for 

Agriculture, Office of Information and 

Regulatory Affairs, Office of 

Management and Budget, Washington, 

DC 20253. 

To be most effective, comments 

should be sent to OMB within 60 days 

of the publication date of this final rule. 

Government Paperwork Elimination 

Act (GPEA) 

FSIS is committed to achieving the 

goals of the GPEA, which requires that 

Government agencies, in general, 

provide the public with the option of 

submitting information or transacting 

business electronically to the maximum 

extent possible. Under this final rule, 

records that document the 

implementation and monitoring of an 

establishment’s procedures for the 

removal, segregation, and disposition of 

SRMs may be maintained on computers, 

provided that the establishment 

implements appropriate controls to 

ensure the integrity of the electronic 

data. Allowing establishments to 

comply with the required recordkeeping requirements will reduce data 

collection time and information 

processing and handling by the 

regulated industry and FSIS. 

Additional Public Notification 

Public awareness of all segments of 

rulemaking and policy development is 

important. Consequently, in an effort to 

ensure that minorities, women, and 

persons with disabilities are aware of 

this rule, FSIS will announce it on-line 

through the FSIS Web page located at 

http://www.fsis.usda.gov/ 

regulations_&_policies/ 

2007_Interim_&_Final_Rules_Index/ 

index.asp. 

The Regulations.gov Web site is the 

central online rulemaking portal of the 

United States government. It is being 

offered as a public service to increase 

participation in the Federal 

government’s regulatory activities. FSIS 

participates in Regulations.gov and will 

accept comments on documents 

published on the site. The site allows 

visitors to search by keyword or 

Department or Agency for rulemakings 

that allow for public comment. Each 

entry provides a quick link to a 

comment form so that visitors can type 

in their comments and submit them to 

FSIS. The Web site is located at http:// 

www.regulations.gov/. 

FSIS also will make copies of this 

Federal Register publication available 

through the FSIS Constituent Update, 

which is used to provide information 

regarding FSIS policies, procedures, 

regulations, Federal Register notices, 

public meetings, recalls, and other types 

of information that could affect or 

would be of interest to our constituents 

and stakeholders. The update is 

communicated via Listserv, a free e-mail 

subscription service consisting of 

industry, trade, and farm groups, 

consumer interest groups, allied health 

professionals, scientific professionals, 

and other individuals who have 

requested to be included. The update 

also is available on the FSIS Web page. 

Through Listserv and the Web page, 

FSIS is able to provide information to a 

much broader, more diverse audience. 

In addition, FSIS offers an e-mail 

subscription service that provides an 

automatic and customized notification 

when popular pages are updated, 

including Federal Register publications 

and related documents. This service is 

available at http://www.fsis.usda.gov/ 

news_and_events/email_subscription/ 

and allows FSIS customers to sign up 

for subscription options across eight 

categories. Options range from recalls to 

export information to regulations, 

directives and notices. Customers can 

add or delete subscriptions themselves 

and have the option to password protect 

their account. 

List of Subjects 

9 CFR Part 309 

Meat inspection. 

9 CFR Part 310 

Meat inspection, Meat and meat 

products, Reporting and recordkeeping 

requirements. 

9 CFR Part 318 

Meat inspection, Meat and meat 

products, recordkeeping requirements. 

■ Accordingly, the interim final rules 

amending 9 CFR Chapter III, which 

were published on January 12, 2004, at 

69 FR 1862 and 69 FR 1885, and 

amended on September 7, 2005, at 70 

FR 53043, are adopted as a final rule 

with the following changes: 

PART 309—ANTE-MORTEM 

INSPECTION 

■ 1. The authority citation for part 309 

is revised to read as follows: 

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

2.53. 

■ 2. Section 309.3 is amended by 

revising paragraph (e) to read as follows: 

§ 309.3 Dead, dying, disabled, or diseased 

and similar livestock. 

* * * * * 

(e) Non-ambulatory disabled cattle 

that are offered for slaughter must be 

condemned and disposed of in 

accordance with § 309.13. FSIS 

inspection personnel will determine the 

disposition of cattle that become nonambulatory after they have passed antemortem inspection on a case-by-case 

basis. 

■ 3. Paragraph (b) of § 309.13 is 

amended by adding a new second 

sentence to read as follows: 

§ 309.13 Disposition of condemned 

livestock. 

* * * * * 

(b) * * * Veal calves that are unable 

to rise from a recumbent position and 

walk because they are tired or cold may 

also be set apart and held as provided 

in this paragraph. * * * 

* * * * * 

PART 310—POST-MORTEM 

INSPECTION 

■ 4. The authority citation for part 310 

continues to read as follows: 

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

2.53. 

■ 5. Section 310.22 is revised to read as 

follows: 

§ 310.22 Specified risk materials from 

cattle and their handling and disposition. 

(a) The following materials from cattle 

are specified risk materials, except 

when they are from cattle from a 

country that can demonstrate that its 

bovine spongiform encephalopathy 

(BSE) risk status can reasonable be 

expected to provide the same level of 

protection from human exposure to the 

BSE agent as prohibiting specified risk 

materials for use as human food does in 

the United States: 

(1) The brain, skull, eyes, trigeminal 

ganglia, spinal cord, vertebral column 

(excluding the vertebrae of the tail, the 

transverse processes of the thoracic and 

lumbar vertebrae, and the wings of the 

sacrum), and dorsal root ganglia from 

cattle 30 months of age and older and 

(2) The distal ileum of the small 

intestine and the tonsils from all cattle. 

(b) Specified risk materials are 

inedible and prohibited for use as 

human food. 

(c) Specified risk materials must be 

removed from the carcasses of cattle, 

segregated from edible materials, and 


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disposed of in accordance with § 314.1 

or § 314.3 of this subchapter. The spinal 

cord from cattle 30 months of age and 

older must be removed from the carcass 

at the establishment where the animal 

was slaughtered. 

(d) Requirements for use of the small 

intestine for human food. (1) The small 

intestine from all cattle may be used for 

human food if: 

(i) It is derived from cattle that were 

inspected and passed in an official 

establishment in the United States or in 

a certified foreign establishment in a 

country listed in 9 CFR 327.2(b) as 

eligible to export meat and meat 

products to the United States and it is 

otherwise eligible for importation under 

9 CFR 327.1(b), and 

(ii) The distal ileum is removed by a 

procedure that removes at least 80 

inches of the uncoiled and trimmed 

small intestine as measured from the 

ceco-colic junction and progressing 

proximally towards the jejunum or by a 

procedure that the establishment 

demonstrates is effective in ensuring 

complete removal of the distal ileum. 

(iii) If the conditions in paragraphs 

(d)(1)(i) or (ii) of this section are not 

met, the entire small intestine must be 

removed from the carcass, segregated 

from edible materials, and disposed of 

in accordance with §§ 314.1 or 314.3 of 

this subchapter. 

(2) The requirements in paragraph 

(d)(1) of this section do not apply to 

materials from cattle from countries that 

can demonstrate that their BSE risk 

status can reasonably be expected to 

provide the same level of protection 

from human exposure to the BSE agent 

as prohibiting specified risk materials 

for use as human food does in the 

United States. 

(e) Procedures for the removal, 

segregation, and disposition of specified 

risk materials. (1) Establishments that 

slaughter cattle and establishments that 

process the carcasses or parts of cattle 

must develop, implement, and maintain 

written procedures for the removal, 

segregation, and disposition of specified 

risk materials. These procedures must 

address potential contamination of 

edible materials with specified risk 

materials before, during, and after entry 

into the establishment. Establishments 

must incorporate their procedures for 

the removal, segregation, and 

disposition of specified risk materials 

into their HACCP plans or Sanitation 

SOPs or other prerequisite programs. 

(2) Establishments that slaughter 

cattle and establishments that process 

the carcasses or parts of cattle must take 

appropriate corrective action when 

either the establishment or FSIS 

determines that the establishment’s 

procedures for the removal, segregation, 

and disposition of specified risk 

materials, or the implementation or 

maintenance of these procedures, have 

failed to ensure that specified risk 

materials are adequately and effectively 

removed from the carcasses of cattle, 

segregated from edible materials, and 

disposed of in accordance with 

paragraph (c) of this section. 

(3) Establishments that slaughter 

cattle and establishments that process 

the carcasses or parts of cattle must 

routinely evaluate the effectiveness of 

their procedures for the removal, 

segregation, and disposition of specified 

risk materials in preventing the use of 

these materials for human food and 

must revise the procedures as necessary 

whenever any changes occur that could 

affect the removal, segregation, and 

disposition of specified risk materials. 

(4) Recordkeeping requirements. (i) 

Establishments that slaughter cattle and 

establishments that process the 

carcasses or parts of cattle must 

maintain daily records sufficient to 

document the implementation and 

monitoring of the procedures for the 

removal, segregation, and disposition of 

the materials listed in paragraph (a) of 

this section, and any corrective actions 

taken. 

(ii) Records required by this section 

may be maintained on computers 

provided that the establishment 

implements appropriate controls to 

ensure the integrity of the electronic 

data. 

(iii) Records required by this section 

must be retained for at least one year 

and must be accessible to FSIS. All such 

records must be maintained at the 

official establishment for 48 hours 

following completion, after which they 

may be maintained off-site provided 

such records can be made available to 

FSIS within 24 hours of request. 

(f) Sanitation of equipment used to 

cut through specified risk materials. (1) 

If an establishment that slaughters 

cattle, or that processes the carcasses or 

parts from cattle, does not segregate the 

carcasses and parts from cattle 30 

months of age and older from the 

carcasses and parts from cattle younger 

than 30 months during processing 

operations it must: 

(i) Use dedicated equipment to cut 

through specified risk materials; or 

(ii) Clean and sanitize equipment 

used to cut through specified risk 

materials before the equipment is used 

on carcasses or parts from cattle younger 

than 30 months of age. 

(2) If an establishments that slaughters 

cattle, or that process the carcasses or 

parts from cattle, segregates the 

carcasses and parts of cattle 30 months 

of age and older from cattle younger 

than 30 months of age during processing 

operations, and processes the carcasses 

or parts from the cattle younger than 30 

months first, it may use routine 

operational sanitation procedures on 

equipment used to cut through specified 

risk materials. 

(g) Slaughter establishments may ship 

beef carcasses or parts that contain 

vertebral columns from cattle 30 months 

of age and older to another federallyinspected establishment for further 

processing if the establishment shipping 

these materials: 

(1) Maintains control of the carcasses 

or parts while they are in transit or 

ensures that the carcasses or parts move 

under FSIS control; 

(2) Ensures that the carcasses or parts 

are accompanied by documentation that 

clearly states that the carcasses or parts 

contain vertebral columns from cattle 

that were 30 months of age and older at 

the time of slaughter; 

(3) Maintains records that identify the 

official establishment that received the 

carcasses or parts; 

(4) Maintains records that verify that 

the official establishment that received 

the carcasses or parts removed the 

portions of the vertebral column 

designated as specified risk materials in 

paragraph (a)(1) of this section and 

disposed of them in accordance with 

§ 314.1 or § 314.3 of this subchapter. 

(h) The materials listed in paragraph 

(a)(1) of this section will be deemed to 

be from cattle 30 months of age and 

older unless the establishment can 

demonstrate through documentation 

that the materials are from an animal 

that was younger than 30 months of age 

at the time of slaughter. 

PART 318—ENTRY INTO OFFICIAL 

ESTABLISHMENTS; REINSPECTION 

AND PREPARATION OF PRODUCTS 

■ 6. The authority citation for part 318 

continues to read as follows: 

Authority: 7 U.S.C. 38f, 450, 1901–1906; 21 

U.S.C. 601–695; 7 CFR 2.18, 2.53. 

§ 318.6 [Amended] 

■ 7. Section 318.6 is amended as 

follows: 

■ a. In the third and fourth sentences of 

paragraph (b)(1) remove ‘‘9 CFR 

310.22(a)(3)’’ and add ‘‘9 CFR 

310.22(d)’’ in its place. 

■ b. In the second sentence in paragraph 

(b)(8) remove ‘‘9 CFR 310.22(a)(3)’’ and 

add ‘‘9 CFR 310.22(d)’’ in its place. 

Done at Washington, DC, on July 5, 2007. 

David P. Goldman, 

Acting Administrator. 

[FR Doc. 07–3350 Filed 7–12–07; 8:45 am] 

BILLING CODE 3410–DM–P 


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