[Federal Register Volume 74, Number 51 (Wednesday, March 18, 2009)]
[Rules and Regulations]
[Pages 11463-11466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-5987]



 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 Prices of new books are listed in the first FEDERAL REGISTER issue of each 
 week.
 
 ========================================================================
 

  Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / 
Rules and Regulations  

[[Page 11463]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 309

[Docket No. FSIS-2008-0022]
RIN 0583-AD35


Requirements for the Disposition of Cattle that Become Non-
Ambulatory Disabled Following Ante-Mortem Inspection

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the 
Federal meat inspection regulations to require that all cattle that are 
non-ambulatory disabled at an official establishment, including those 
that become non-ambulatory disabled after passing ante-mortem 
inspection, be condemned and disposed of properly. In addition, this 
rule requires that establishments notify FSIS inspection personnel when 
cattle become non-ambulatory disabled after passing ante-mortem 
inspection. FSIS is taking this action to better ensure effective 
implementation of inspection and humane handling requirements at 
official establishments.

DATES: Effective Date: This regulation is effective April 17, 2009.

FOR FURTHER INFORMATION CONTACT: Dr. Daniel Engeljohn, Deputy Assistant 
Administrator, Office of Policy and Program Development, FSIS, U.S. 
Department of Agriculture, 1400 Independence Avenue, SW., Washington, 
DC 20250-3700, (202) 205-0495.

SUPPLEMENTARY INFORMATION: 

Background

    On August 29, 2008, FSIS published a proposed rule to amend the 
regulations in 9 CFR 309.3(e) to remove the provision that allows FSIS 
inspection personnel to determine, on a case-by-case basis, the 
disposition of cattle that become non-ambulatory disabled after they 
have passed ante-mortem inspection (``Requirements for the Disposition 
of Cattle That Become Non-Ambulatory Disabled Following Ante-Mortem 
Inspection'' (73 FR 50889)). In that proposed rule, FSIS also proposed 
to require that establishments notify FSIS inspection personnel when 
cattle become non-ambulatory disabled after passing ante-mortem 
inspection.
    The Agency issued the proposed rule in response to a January 2008 
investigation into events at the Hallmark/Westland Meat Packing Company 
that highlighted a vulnerability in our inspection system and that 
disclosed instances where cattle had been inhumanely handled. Based on 
these findings, FSIS determined that the proposed amendments to 9 CFR 
309.3 were necessary to ensure that animals that may be unfit for human 
food do not proceed to slaughter, and to improve the effectiveness and 
efficiency of our inspection program. The Agency concluded that the 
revision proposed would reduce uncertainty in determining the proper 
disposition of non-ambulatory disabled cattle and would eliminate the 
time FSIS public health veterinarians (PHVs) spend determining whether 
or not an animal can be tagged as ``U.S. Suspect'', proceed to 
slaughter, and then re-inspected after slaughter, thereby increasing 
the time inspection program personnel can focus on other inspection 
activities (73 FR at 50890-50891). FSIS also concluded that the 
proposal would improve humane handling practices and preclude 
establishments from attempting to force non-ambulatory disabled cattle 
to rise.
    FSIS also proposed to clarify in 9 CFR 309.3(e) that establishments 
are required to specifically notify FSIS inspection personnel when 
cattle become non-ambulatory disabled after passing ante-mortem 
inspection. The Agency proposed to make clear that establishments have 
an affirmative obligation to make FSIS personnel aware when an animal 
goes down.
    This final rule adopts the proposed amendments to 9 CFR 309.3(e) 
without changes. These amendments will ensure more effective and 
efficient inspection procedures under the Federal Meat Inspection Act 
(FMIA), 21 U.S.C. 603, and improved compliance with the humane handling 
requirements established pursuant to 21 U.S.C. 603(b).
    In the preamble to the proposed rule, FSIS stated that it would 
expect custom operators not to slaughter cattle that become non-
ambulatory disabled after they are delivered to the custom operation 
(73 FR at 50890-50891). Based on comments received and after further 
consideration of the issue, FSIS has decided to continue to permit 
custom operators to slaughter for human food cattle that become non-
ambulatory disabled after they are delivered to a custom operation if 
the custom operator does not observe any other condition that would 
render the animal unfit for human food.

Comments and Responses

    FSIS received approximately 58,000 comments in response to the 
proposed rule. Among the commenters were private citizens, animal 
welfare advocacy organizations, meat and dairy trade associations, 
consumer advocacy organizations, organizations that represent meat 
processors, cattlemen and cattle feeders associations, a stockgrowers 
association, a state department of agriculture, a veterinary medical 
association, a physician's committee, and a national restaurant chain. 
The majority of comments were form letters submitted by private 
citizens and animal welfare organizations concerned about the humane 
treatment of animals.
    Comment: The majority of private citizen, animal welfare advocacy 
organization, and consumer advocacy organization comments supported the 
adoption of the proposed rule requiring the condemnation of all non-
ambulatory disabled cattle, including those that become non-ambulatory 
disabled after passing ante-mortem inspection. The commenters asserted 
that the rule is necessary to improve food safety and to ensure the 
humane handling of non-ambulatory disabled cattle at slaughter.
    The commenters asserted that the current regulatory provision for a 
case-by-case determination concerning the disposition of certain non-
ambulatory disabled cattle created the unintended effect of encouraging 
establishments to present weakened cattle for ante-

[[Page 11464]]

mortem inspection. The commenters argued that this unintended 
circumstance encourages the abusive treatment of cattle.
    Response: FSIS agrees with the commenters that this rule will 
foster more efficient and effective ante-mortem inspection procedures 
and better ensure compliance with humane handling requirements. FSIS 
also agrees with commenters that the rule is necessary to preclude 
establishments from attempting to force non-ambulatory disabled animals 
to rise for FSIS re-inspection. The Agency also believes that it is 
important to clarify whether establishments must specifically notify 
FSIS when cattle become non-ambulatory disabled after passing ante-
mortem inspection to ensure that animals not eligible for slaughter do 
not enter the slaughter operation, and that they are properly and 
humanely handled and disposed of in accordance with regulatory 
requirements.
    Comment: Several meat processor and cattlemen associations 
requested that the Agency reevaluate the decision regarding the custom 
slaughter exemption for personal use.
    Response: After carefully considering this issue, the Agency has 
decided to continue to allow custom operators to slaughter for human 
food cattle that become non-ambulatory disabled after they are 
delivered to a custom slaughter facility if the operator does not 
observe any other condition that would render the animal unfit for 
human food. Cattle slaughtered under a custom exemption and the 
associated beef products are not sold in commerce to the public. Custom 
exempt product is required to be delivered to the owner of the 
livestock and only for the owner's personal use.
    In addition, based upon the 2007 FSIS survey data discussed below, 
the Agency estimates that the number of animals that would become non-
ambulatory disabled after arriving at a custom operation is so small as 
to be de minimis.
    Comment: Most of the private citizen, animal welfare advocacy 
organization, and consumer advocacy organization comments that 
supported the proposed prohibition on the slaughter of all non-
ambulatory disabled cattle requested that the Agency extend the ban to 
cover all livestock.
    Response: The proposed rule addressed ante-mortem inspection and 
humane handling issues related to non-ambulatory disabled cattle, not 
other livestock. This issue is outside the scope of this rulemaking. 
However, as the Agency has noted in a prior rulemaking (72 FR 38722), 
it plans to evaluate measures that may be necessary to ensure the 
humane handling of livestock.
    Comment: Most of the private citizen, animal welfare advocacy 
organization, and consumer advocacy organization comments that 
supported the ban on the slaughter of non-ambulatory disabled cattle 
requested that the Agency extend this prohibition to auction markets, 
stockyards, and transport vehicles.
    Response: FSIS is making no changes based upon these comments. The 
Agency has jurisdiction only at official establishments. FSIS has no 
authority over the handling of cattle at auction markets, stockyards, 
or in transport vehicles before they reach official establishments.
    Comment: Several of the private citizen, animal welfare advocacy 
organization, and consumer advocacy organization comments recommended 
that non-ambulatory disabled cattle be immediately euthanized. Several 
animal welfare advocacy organizations comments also recommended that 
FSIS take additional actions to ensure humane handling of livestock, 
including assigning more inspectors to enforce humane handling 
procedures, requiring video surveillance, and conducting undercover 
investigations.
    Response: The Humane Methods of Slaughter Act of 1978 (HMSA) 
(Section 1901, 1902, and 1906) requires that livestock, including non-
ambulatory disabled cattle, be humanely handled in connection with 
slaughter. Because the HMSA and regulations require that non-ambulatory 
disabled cattle be humanely handled, FSIS has determined that it is not 
necessary to amend this regulation because humane handling requires 
that such cattle be promptly euthanized. FSIS does not believe that it 
is necessary to require video surveillance. FSIS has issued 
instructions to field personnel concerning humane handling requirements 
for non-ambulatory disabled livestock (Directive 6900.1). FSIS will 
revise instructions to the field and its operational procedures as 
necessary to implement this final rule to include consideration of an 
increase, when appropriate, in the number of humane handling 
verification activities that inspection program personnel perform.
    Comment: Several industry commenters who supported the proposal 
recommended that FSIS make clear its procedure for determining when a 
bovine animal is non-ambulatory disabled.
    Response: FSIS determined that no additional changes to the 
regulations were necessary to address this comment. The regulations 
define non-ambulatory disabled livestock, which includes bovine, as, 
``livestock that cannot rise from a recumbent position or cannot walk, 
including, but not limited to, those with broken appendages, severed 
tendons or ligaments, nerve paralysis, fractured vertebral column or 
metabolic conditions'' (9 CFR 309.2(b)).
    FSIS Directive 6100.1 ``Ante-mortem Livestock Inspection'' and an 
associated ``Q and A'' document provide guidance to FSIS inspection 
personnel for determining whether an animal is non-ambulatory disabled. 
FSIS PHVs are trained to determine when a bovine is unable to rise or 
unable to walk. FSIS will, of course, revise its directives as 
necessary to ensure implementation of this final rule.
    Comment: Several industry commenters who opposed the proposed 
amendment stated that the current regulatory provision should remain 
unchanged, allowing cattle that become non-ambulatory disabled after 
passing ante-mortem inspection to be reevaluated by an FSIS PHV.
    Response: FSIS disagrees with the comment. The events at the 
Hallmark/Westland establishment demonstrate that FSIS inspection 
personnel are not always notified when cattle become non-ambulatory 
disabled after they pass ante-mortem inspection. Thus, under the former 
regulations, and specifically at Hallmark/Westland, non-ambulatory 
disabled cattle that had not consistently received proper and adequate 
ante-mortem inspection were slaughtered for human food. In addition, 
the events at Hallmark demonstrate that requiring re-inspection of 
cattle that become non-ambulatory disabled after ante-mortem inspection 
may have created an incentive for establishments to inhumanely attempt 
to force these animals to rise. Therefore, FSIS has determined that a 
change in the regulation is needed to ensure more effective and 
efficient implementation of inspection procedures and compliance with 
humane handling requirements at official establishments.
    Comment: Several industry commenters opposed the proposed amendment 
because they believed that changing the regulation would be a 
significant expense for small and very small meat processors. However, 
the comments did not include any data to support this assertion. The 
commenters stated that having FSIS PHVs re-evaluate the animal provides 
the establishments with the ability to salvage an animal that may have 
slipped and broken a leg, or temporarily became too exhausted to move 
to slaughter.
    Response: As noted above, FSIS inspection personnel have not always

[[Page 11465]]

been notified when cattle become non-ambulatory disabled after they 
pass ante-mortem inspection. In addition, requiring re-inspection of 
cattle that become non-ambulatory disabled after ante-mortem inspection 
may have created an incentive for establishments to inhumanely attempt 
to force these animals to rise. Allowing this re-inspection may have 
encouraged establishments or livestock producers to hold ill or injured 
cattle from slaughter longer in an attempt to allow them to 
sufficiently recover to pass the initial ante-mortem inspection before 
collapsing.
    Further, the re-inspection rule may have provided an incentive for 
livestock producers to hold cattle until they were already weakened. 
Holding dairy cattle until they become exceptionally old or weak before 
sending them to slaughter allows producers to extract as much milk as 
possible in the hope that they are able to pass the initial ante-mortem 
inspection before going down. Sending such weakened cattle to slaughter 
increases the chances that they will go down and then be subjected to 
conditions that are inhumane. This revision of the rule removes the 
incentive to send such weakened cattle to slaughter and decreases the 
chances of inhumane conditions.
    Therefore, the amendments in this rule are needed to ensure the 
effective implementation of ante-mortem inspection and humane handling 
requirements at all official establishments, including small or very 
small facilities. Also, as discussed below, the Agency's analysis of 
the estimated cost of this rule to small and very small establishments 
would be about $883,500 to $1,342,600 annually, which is insignificant 
compared to the value of their annual production of about $8.4 billion. 
These commenters did not explain the basis for their assertion or offer 
alternative data demonstrating the inadequacy of the data used by the 
Agency to estimate the costs of this rule.
    Comment: Several industry commenters who opposed the proposed 
amendment stated that the risk of BSE is very low because of 
interlocking safeguards that the U.S. has implemented, and that, thus, 
the change to current policies is unnecessary.
    Response: This final rule may help to reinforce the existing 
prohibition on the slaughter of non-ambulatory disabled cattle by 
ensuring the humane disposition of such animals at official 
establishments. In addition, FSIS has concluded that this final rule 
will better ensure more efficient and effective implementation of 
inspection and humane handling requirements at official establishments.
    Comment: One industry commenter criticized the economic analysis 
because FSIS stated that it is difficult to estimate the passing-
through of industry cost to consumers.
    Response: FSIS calculated the cost impact using the best data that 
are available to the Agency, which includes both survey data and market 
data. The cost impact is at most 0.01% of small and very small 
establishments' annual production. Therefore, there is strong evidence 
for concluding that the cost of the rule is not significant. The costs 
that industry will pass through to consumers do not affect the total 
cost estimate. In the proposed and final Executive Order 12866 and 
Regulatory Flexibility Act analyses, FSIS recognizes that industry will 
pass some of its costs to consumers.
    The commenter did not explain the basis for concluding that the 
data used by FSIS was inadequate. In addition, the Agency did not 
receive any data suggesting the cost estimates that it presented in the 
proposal were inaccurate. Therefore, the Agency is not revising its 
original cost estimates.
    Comment: One meat association that supported the proposal stated 
that the Agency should make clear that the amendments in this final 
rule that prohibit the slaughter of non-ambulatory disabled cattle, 
including those that become non-ambulatory disabled after passing ante-
mortem inspection, do not affect the current regulatory provisions 
concerning the setting aside of non-ambulatory veal calves.
    Response: The provisions of this final rule do not affect 9 CFR 
309.13. Under the final rule, all non-ambulatory disabled cattle that 
are offered for slaughter, including non-ambulatory veal calves, must 
be condemned and disposed of in accordance with 9 CFR 309.13. Section 
309.13 of 9 CFR applies after livestock, including veal calves, have 
been condemned. Among other provisions, 9 CFR 309.13(b) provides that 
veal calves that are unable to rise from a recumbent position and walk 
because they are tired or cold may be set apart and held for treatment 
but only under appropriate FSIS supervision.
    Comment: One industry commenter requested that the Agency clarify 
that the prohibition of the slaughter of non-ambulatory disabled cattle 
has no bearing on the stunning of some breeds in the outside pen prior 
to entering the slaughter facility.
    Response: All cattle, regardless of the breed, are subject to ante-
mortem inspection at official establishments. Some cattle breeds, such 
as Longhorns and Watusis, are typically stunned in outside pens after 
ante-mortem inspection because the width of their horns prevents them 
from entering slaughter facilities. After stunning, these animals are 
then moved inside the facility. This proposed rule has no effect on 
this practice. However, if such cattle are non-ambulatory disabled, 
they cannot proceed to slaughter and must be condemned and properly 
disposed of.

Executive Order 12988

    This final rule has been reviewed under the Executive Order 12988, 
Civil Justice Reform. Under this rule: (1) All State and local laws and 
regulations that are inconsistent with this rule will be preempted; (2) 
no retroactive effect will be given to this rule; and (3) no 
retroactive proceedings will be required before parties may file suit 
in court challenging this rule. Following the proposed rule, FSIS did 
not obtain any new data or receive specific comments concerning the 
effects of this rule that would lead FSIS to change its estimates in 
the proposed Executive Order 12866 and Regulatory Flexibility Act 
analysis. Therefore, the Executive Order 12866 and the Regulatory 
Flexibility Act analysis below are consistent with the analyses in the 
proposed rule (73 FR 50891).

Executive Order 12866 and the Regulatory Flexibility Act

    This rule was reviewed by the Office of Management and Budget under 
Executive Order 12866 and was determined to be significant.
    This rule will require that all cattle that are non-ambulatory 
disabled at any time prior to slaughter in official establishments, 
including those that become non-ambulatory disabled after passing ante-
mortem inspection, be condemned and disposed of properly. This rule is 
necessary to better ensure effective and efficient implementation of 
inspection procedures and of humane handling requirements.

Cost of the Final Action

    Under this rule, the beef industry will lose the market value of 
certain non-ambulatory disabled cattle that the establishments could 
have slaughtered for human food after the cattle passed the re-
inspection. Based on the Agency's 2007 survey data, out of the 
approximately 33.7 million cattle slaughtered in 2007,\1\ FSIS 
estimates that about 1,300 cattle--about 600 cull cattle (i.e., mostly 
cows and bulls) and

[[Page 11466]]

700 steers and heifers--were in this category.\2\ Data from the 
Agricultural Marketing Service (AMS) indicate that the market value for 
a cull cattle carcass and parts is between $500 and $1,000, and the 
market value for a steer or heifer carcass and parts is between $900 
and $1,100 (National Weekly Cattle and Beef Summary and National Weekly 
Cow and Boneless Beef Summary, USDA Livestock & Grain Market News 
(http://www.ams.usda.gov/LSMarketNews), June 2008). Therefore, the 
estimated total market value of the carcasses and parts from cattle 
that would be condemned under this final rule would be in the range of 
$930,000 to $1,370,000 per year. This estimate is conservative in that 
it does not take into account the salvage value less the cost for 
handling and disposal of the condemned carcasses.
---------------------------------------------------------------------------

    \1\ FSIS Animal Disposition Reporting System (ADRS) database, 
2007. Number does not include veal calves or other calves.
    \2\ To estimate the number of such cattle, FSIS conducted two 
surveys on the number of cattle that became non-ambulatory after 
ante-mortem inspection then passed the re-inspection in July through 
December 2007. One survey focused on establishments that slaughter 
predominantly cull cattle, and the other focused on ones that 
slaughter steers and heifers. FSIS extrapolated the 6-month data to 
annual figures.
---------------------------------------------------------------------------

    Although the above analysis focuses on costs to the beef industry, 
the industry eventually will pass at least some part of the additional 
cost to consumers through higher prices or reduced production. This is 
an indirect cost to the consumers and is difficult to estimate ex-ante 
without data.

Benefits of the Final Rule

    This final rule is intended to ensure more effective and efficient 
implementation of inspection procedures and improve compliance with 
humane handling requirements. This action will provide efficiencies to 
food safety inspection by removing the regulatory provision that 
permits establishments to seek re-inspection to determine whether 
certain non-ambulatory cattle can be tagged as ``U.S. Suspect'' if 
those cattle become non-ambulatory disabled after passing ante-mortem 
inspection.

Regulatory Flexibility Analysis

    The FSIS Administrator has determined that this final rule will not 
have a significant impact on a substantial number of small entities, as 
defined by the Regulatory Flexibility Act (5 U.S.C. 601). In the Final 
Regulatory Impact Analysis of SRM final rule,\3\ the Agency estimated 
that the rule would possibly affect 2,026 small and very small beef 
slaughter establishments. This includes 680 federally inspected 
establishments and 1,346 state inspected establishments. Such potential 
effects are not, however, expected to be significant given the very 
small number of cattle involved.
---------------------------------------------------------------------------

    \3\ See Economic Analysis: Final Regulatory Impact Analysis 
Final Rule, Prohibition of the Use of Specified Risk Materials for 
Human Food and Requirements for the Disposition of Non-Ambulatory 
Disabled Cattle Offered for Slaughter, and Prohibition of the Use of 
Certain Stunning Devices Used to Immobilize Cattle during Slaughter 
(FSIS Docket No. 03-025F), FSIS/USDA, June 28, 2007. http://www.fsis.usda.gov/Regulations_&_Policies/2007_Interim_&_Final_Rules_Index/index.asp.
---------------------------------------------------------------------------

    The estimated total annual cost of this rule of $930,000 to 
$1,370,000 is for the entire beef industry. The Agency estimates that 
small and very small establishments slaughter about 95% to 98% of the 
1,300 non-ambulatory disabled cattle estimated from the survey. 
Therefore, the estimated annual cost to the small and very small 
establishments would be about $883,500 to $1,342,600, which is 
insignificant compared to the value of their annual production of about 
$8.4 billion.\4\
---------------------------------------------------------------------------

    \4\ The value is measured by dressed carcass equivalent, ibid., 
pp.161-169.
---------------------------------------------------------------------------

Paperwork Reduction Act

    This rule has been reviewed under the Paperwork Reduction Act and 
imposes no new paperwork or recordkeeping requirements.

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 
proposed rule, FSIS will announce it online through the FSIS Web page 
located at http://www.fsis.usda.gov/regulations_&_policies/2009Interim_&_Final_Rules_Index/index.asp. FSIS will also 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, FSIS 
public meetings, and other types of information that could affect or 
would be of interest to constituents and stakeholders. The Update is 
communicated via Listserv, a free electronic mail subscription service 
for industry, trade groups, consumer interest groups, health 
professionals, and other individuals who have asked to be included. The 
Update is also available on the FSIS Web page. Through the Listserv and 
Web page, FSIS is able to provide information to a much broader and 
more diverse audience. In addition, FSIS offers an e-mail subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/. 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 accounts.

List of Subjects in 9 CFR Part 309

    Ante-mortem inspection.

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

PART 309--ANTE-MORTEM INSPECTION

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

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


0
2. Section 309.3(e) is revised to read as follows:


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

* * * * *
    (e) Establishment personnel must notify FSIS inspection personnel 
when cattle become non-ambulatory disabled after passing ante-mortem 
inspection. Non-ambulatory disabled cattle that are offered for 
slaughter must be condemned and disposed of in accordance with Sec.  
309.13.

    Done at Washington, DC, on: March 16, 2009.
Alfred Almanza,
Administrator.
[FR Doc. E9-5987 Filed 3-16-09; 4:15 pm]
BILLING CODE 3410-DM-P