[Federal Register: August 29, 2008 (Volume 73, Number 169)]
[Proposed Rules]
[Page 50889-50892]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au08-13]
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Proposed Rules
Federal Register
________________________________________________________________________
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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[[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