[Federal Register Volume 73, Number 169 (Friday, August 29, 2008)]
[Proposed Rules]
[Pages 50889-50892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-20159]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 73, No. 169 / Friday, August 29, 2008 / 
Proposed Rules  

[[Page 50889]]



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: Proposed rule.

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SUMMARY: On May 20, 2008, the Secretary of Agriculture announced that 
the Food Safety and Inspection Service (FSIS) would begin working on a 
proposed rule to prohibit the slaughter of all non-ambulatory disabled 
cattle, without exception. As announced by the Secretary, FSIS is 
proposing to amend the Federal meat inspection regulations to remove 
the provision that states that FSIS inspection personnel will determine 
the disposition of cattle that become non-ambulatory disabled after 
they have passed ante-mortem inspection on a case-by-case basis. This 
proposed rule will require that all cattle that are non-ambulatory 
disabled at the time they are presented for ante-mortem inspection at 
an official establishment, and all those that become non-ambulatory 
disabled after passing ante-mortem inspection, be condemned and 
properly disposed of.

DATES: Submit comments on or before September 29, 2008.

ADDRESSES: FSIS invites interested persons to submit comments on this 
proposed rule. Comments may be submitted by either of the following 
methods:
     Federal eRulemaking Portal: This Web site provides the 
ability to type short comments directly into the comment field on this 
Web page or attach a file for lengthier comments. FSIS prefers to 
receive comments through the Federal eRulemaking Portal. Go to http://www.regulations.gov and, in the ``Search for Open Regulations'' box, 
select ``Food Safety and Inspection Service'' and ``Proposed Rules'' 
from the agency drop-down menu and then click on ``Submit.'' In the 
Docket ID column, select the FDMS Docket Number to submit or view 
public comments and to view supporting and related materials available 
electronically. After the close of the comment period, the docket can 
be viewed using the ``Advanced Search'' function in Regulations.gov.
     Mail, including floppy disks or CD-ROM's, and hand- or 
courier-delivered items: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, Room 2534 South 
Agriculture Building, 1400 Independence Avenue, SW., Washington, DC 
20250. All submissions received by mail or electronic mail must include 
the Agency name and docket number FSIS-2008-0022. Documents referred to 
in this proposal, and all comments submitted in response to this notice 
will be available for public inspection in the FSIS Docket room at the 
address listed above between 8:30 a.m. and 4:30 p.m., Monday through 
Friday. Comments will also be posted on the Agency's Web site at: 
http://www.fsis.usda.gov/.
    Individuals who do not wish FSIS to post their personal contact 
information--mailing address, e-mail, telephone number--on the Internet 
may leave this information off their comments.

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 July 13, 2007, FSIS published the final rule, ``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'' (72 FR 38700). Hereafter in this preamble, that rule will 
be referred to as the Specified Risk Material (SRM) final rule. The SRM 
final rule affirmed, with certain amendments, interim regulations 
implemented by FSIS in 2004 to prevent potential human exposure to the 
bovine spongiform encephalopathy (BSE) agent (see ``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)). One of the interim measures that the SRM final rule 
affirmed was the prohibition of the slaughter of non-ambulatory 
disabled cattle offered for slaughter for human food (9 CFR 309.3(e)).
    Consistent with the interim final rule, the SRM final rule requires 
that non-ambulatory disabled cattle be condemned on ante-mortem 
inspection because these animals present a sufficient risk of 
introducing the BSE agent into the human food supply to render their 
carcasses ``unfit for human food'' under section 1(m)(3) of the Federal 
Meat Inspection Act (FMIA) (21 U.S.C. 601(m)(3)) (72 FR 38700). In the 
preamble to the SRM final rule, FSIS also acknowledged that requiring 
the condemnation of non-ambulatory disabled cattle that are offered for 
slaughter may be necessary to 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.) (72 FR 
38721).
    In addition to affirming the requirement that non-ambulatory 
disabled cattle be condemned on ante-mortem inspection, the SRM final 
rule amended 9 CFR 309.3(e) to provide that FSIS personnel would 
determine, on a case-by-case basis, the disposition of cattle that 
become non-ambulatory disabled after they have passed ante-mortem 
inspection. The Agency made this revision to codify existing practices 
formerly described in FSIS Notice 5-04 (``Interim Guidance for Non-
Ambulatory Disabled Cattle and Age Determination'') and FSIS Notice 05-
06 (``Re-examination of Bovine that become Non-Ambulatory After Passing 
Ante-mortem Inspection''). These notices instructed FSIS public health 
veterinarians (PHVs) on the actions they were to take when cattle 
became non-ambulatory disabled after passing ante-mortem inspection.
    Under the current regulations, slaughter establishments are 
expected to notify inspection personnel when cattle that have passed 
ante-mortem

[[Page 50890]]

inspection subsequently become non-ambulatory disabled before 
slaughter. If an FSIS PHV can verify that the animal became non-
ambulatory disabled because it suffered an acute injury, such as a 
broken appendage or a severed tendon or ligament, it is tagged as 
``U.S. Suspect'' (and is not tagged as ``U.S. Condemned'') and is 
eligible to proceed to slaughter (9 CFR 309.2). To ensure that non-
ambulatory disabled cattle are humanely handled, the regulations 
require that establishment personnel move the animals to slaughter on 
equipment suitable for such purposes, or that establishment personnel 
stun the animals (9 CFR 313.2(d)). FSIS inspection personnel track 
``U.S. Suspect'' cattle through the slaughter process for post-mortem 
(after slaughter) evaluation and reinspection (see FSIS Directive 
6100.1, Ante-Mortem Livestock Inspection). If the PHV cannot determine 
whether the animal became non-ambulatory disabled from a specific 
injury, the animal is tagged as ``U.S. Condemned'' and is disposed of 
as provided in 9 CFR 309.13.
    All provisions in the SRM final rule, including the prohibition on 
the slaughter of non-ambulatory disabled cattle, apply to official 
establishments and custom slaughter operations. As discussed in the 
preamble to the SRM final rule, although custom slaughter operations 
are exempt from inspection under section 23(a) of the Federal Meat 
Inspection Act, the 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). Thus, custom operators are prohibited from 
slaughtering and preparing products from non-ambulatory disabled cattle 
because the carcasses of these animals are considered unfit for human 
food (72 FR 38704). In the preamble to the SRM final rule, FSIS noted 
that FSIS inspectors are not available to determine the disposition of 
cattle that become non-ambulatory disabled in a custom operation. 
Therefore, as explained in the SRM final rule preamble, if an animal 
becomes non-ambulatory disabled 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 (72 FR 38704).

Recent Events--Non-Ambulatory Disabled Cattle

    The SRM final rule allowed a case-by-case reinspection of cattle to 
address the rare situations where an animal that is deemed by FSIS as 
fit for human food at ante-mortem inspection subsequently suffers an 
acute injury. However, a recent significant event highlighted a 
vulnerability in the inspection system that needs to be addressed. This 
event indicated that the case-by-case disposition provision in 9 CFR 
309.3(e) does not always ensure the proper disposition of cattle that 
become non-ambulatory disabled after ante-mortem inspection. 
Establishments may present weakened cattle for slaughter in the hope 
that such cattle will remain ambulatory long enough to enter the 
slaughter operation.
    Although establishments must notify FSIS inspection program 
personnel when cattle become acutely injured after ante-mortem 
inspection so that FSIS inspection personnel can determine the 
disposition of the cattle, FSIS became aware of an incident in which 
inspection personnel were not notified. On January 30, 2008, FSIS 
received allegations regarding the inhumane handling of non-ambulatory 
disabled cattle at the Hallmark/Westland Meat Packing Company. An 
investigation into the allegations found evidence that the 
establishment did not consistently notify FSIS inspection personnel 
when cattle became non-ambulatory disabled after initial ante-mortem 
inspection. Instead of notifying FSIS inspectors, the establishment 
attempted to force animals that had gone down after passing ante-mortem 
inspection to rise by using electric prods and water sprays. Under the 
FMIA (21 U.S.C. 603(b)), any cattle that are slaughtered must be 
handled in accordance with the Humane Methods of Slaughter Act (HMSA) 
(7 U.S.C. 1901 et seq.). Under the meat inspection regulations, 
establishments are required to handle cattle to minimize excitement, 
discomfort, or injury (9 CFR 313.2). FSIS found that the establishment 
had treated the cattle inhumanely.
    Also, following the Hallmark/Westland incident, on March 10, 2008, 
FSIS issued new instructions to inspection personnel concerning humane 
handling activities. FSIS Notice 16-08 instructs inspection personnel 
to vary from day-to-day the times during their tour of duty that they 
verify that animals are being handled and treated humanely. The notice 
also instructs inspection personnel to encourage establishments to 
develop and implement a systematic approach for the humane handling of 
animals.
    On April 22, 2008, FSIS received a petition submitted jointly by 
three meat and dairy industry associations requesting that the Agency 
amend its regulations to prohibit the case-by-case determination of the 
status of non-ambulatory disabled cattle that have passed ante-mortem 
inspection. According to the petition, consumer confidence in the U.S. 
beef supply has been damaged because the re-inspection of cattle did 
not occur as required under the current regulations. The petition 
asserts that the requested amendment is needed to bolster public 
confidence in the U.S. beef supply. FSIS has also received letters 
supporting this change to the regulations from an animal welfare 
organization and members of Congress.
    However, FSIS also received five letters, from State meat 
processors associations and a national meat processors association, 
opposing the petition. These letters request that the current 
regulations remain unchanged. The letters state that it is important to 
have the option for re-inspection of cattle that become non-ambulatory 
disabled after they have passed ante-mortem inspection to address 
situations where accidents may occur or animals may become exhausted 
during the stress of travel.

Proposed Amendment to 9 CFR 309.3(e)

    FSIS is proposing to remove the provision in 9 CFR 309.3(e) that 
allows FSIS inspection personnel to determine the disposition of cattle 
that become non-ambulatory disabled after they have passed ante-mortem 
inspection on a case-by-case basis. If FSIS finalizes this proposed 
rule, cattle that become non-ambulatory disabled from an acute injury 
after ante-mortem inspection will no longer be eligible to proceed to 
slaughter as ``U.S. Suspects.'' Instead, FSIS inspectors will tag these 
cattle as ``U.S. condemned'' and prohibit these animals from proceeding 
to slaughter.
    If this proposal is adopted as a final rule, all non-ambulatory 
disabled cattle would be considered unfit for human food and thus 
adulterated. Moreover, cattle that become non-ambulatory disabled 
cattle after ante-mortem inspection will always be condemned. The case-
by-case disposition determinations of non-ambulatory disabled cattle by 
inspection program personnel will be discontinued, increasing the time 
inspection program personnel can focus on other inspection activities. 
Because all non-ambulatory disabled cattle would be considered 
adulterated, FSIS would expect custom

[[Page 50891]]

operators not to slaughter cattle that become non-ambulatory disabled 
after they are delivered to the custom operation.
    In addition to proposing that all non-ambulatory disabled cattle be 
condemned, FSIS is also proposing to require in 9 CFR 309.3(e) that 
establishments notify FSIS inspection personnel when cattle become non-
ambulatory disabled after passing ante-mortem inspection. The Agency is 
doing so to make clear that establishments have an affirmative 
obligation to make FSIS personnel aware when an animal goes down. This 
regulatory requirement should preclude establishments from attempting 
to force such animals to rise.
    FSIS is proposing this rule under 21 U.S.C. 621, which gives FSIS 
the authority to adopt regulations for the efficient administration of 
the FMIA. The amendment in this proposal would better ensure effective 
implementation of ante-mortem inspection pursuant to 21 U.S.C. 603(a) 
and of humane handling requirements established pursuant to 21 U.S.C. 
603(b).

Executive Order 12988

    This proposed rule has been reviewed under the Executive Order 
12988, Civil Justice Reform. Under this proposed 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.

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 proposed rule will require that all cattle that are non-
ambulatory disabled at any time prior to slaughter, including those 
that become non-ambulatory disabled after passing ante-mortem 
inspection, be condemned and properly disposed of. This rule is 
necessary to better ensure effective implementation of ante-mortem 
inspection pursuant to 21 U.S.C. 603(a) and of humane handling 
requirements established pursuant to 21 U.S.C. 603(b).

Cost of the Proposed Action

    Under this proposed rule, the beef industry will lose the market 
value of the non-ambulatory disabled cattle that the establishments 
could have slaughtered and harvested 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 700 steers and heifers--were in this category.\2\ 
The August 2008 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. Therefore, the estimated 
total market value of the carcasses and parts from cattle that would be 
condemned under this proposed rule would be in the range of $930,000 to 
$1,370,000 per year \3.\ 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.
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    \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 pased 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.
    \3\ The survey did not include custom exempt slaughter. To 
estimate the number of non-ambulatory disabled cattle in custom 
exempt slaughter that would likely be affected by this proposed 
rule, we applied the percentage of such cattle (0.004%) to the total 
number of custom-exempt slaughter cattle, which is 192,000 annually 
(data from National Agricultural Statistical Service, USDA and 
Association of Food and Drug Officials.) The result is about eight 
cattle per year at all custom slaughter facilities. Since the number 
is very small, including custom-exempt slaughter is expected to 
minimally change the analysis.
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    Although the above discussion 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.
    This rule is expected to have an insignificant impact on U.S. 
trading partners, because the number of animals affected is extremely 
small, particularly given the existing ban on non-ambulatory disabled 
cattle and the overall quantity of animals involved in the U.S. beef 
trade.

Benefits of the Proposed Rule

    If adopted as a final rule, the proposed amendment would ensure 
effective implementation of ante-mortem inspection. This action will 
provide additional efficiencies to food safety inspection by removing 
the step that requires the inspection workforce to determine whether 
cattle can be tagged as ``U.S. Suspect'' if those cattle become non-
ambulatory disabled after passing ante-mortem inspection. Countries 
exporting beef to the U.S. would realize the same efficiencies in their 
inspection programs dedicated to the inspection of beef destined for 
the U.S. The Agency believes that the total benefits (quantifiable and 
unquantifiable) of this proposed rule exceed the cost.

Regulatory Flexibility Analysis

    The FSIS Administrator has made an initial determination that this 
proposed 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 \4\, the Agency estimated that the rule would possibly affect 
3,340 small and very small beef slaughter establishments. This includes 
680 federal inspected establishments, 1,346 state inspection 
establishments, and 1,314 custom exempt facilities. This proposed rule 
could potentially affect all these establishments because they may have 
cattle that become non-ambulatory disabled after ante-mortem 
inspection.
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    \4\ 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.
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    The estimated total annual cost of this proposed 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 downers 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.\5\
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    \5\ The value is measured by dressed carcass equivalent, ibid, 
pp.161-169.
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Paperwork Reduction Act

    This proposed rule has been reviewed under the Paperwork Reduction 
Act and imposes no new paperwork or record-keeping 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

[[Page 50892]]

this proposed rule, FSIS will announce it online through the FSIS Web 
page located at http://www.fsis.usda.gov/Regulations_&_Policies/2008_Proposed _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.
    For the reasons discussed in the preamble, FSIS is proposing to 
amend 9 CFR Chapter III as follows:

PART 309--ANTE-MORTEM INSPECTION

    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.

    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 August 25, 2008.
Alfred Almanza,
Administrator.
[FR Doc. E8-20159 Filed 8-28-08; 8:45 am]
BILLING CODE 3410-DM-P