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CFR Citation: 9 CFR Part 309

Docket ID: [Docket No. FSIS-2008-0022]

RIN ID: RIN 0583-AD35

NOTICE: PROPOSED RULES

DOCUMENT ACTION: Proposed rule.

SUBJECT CATEGORY: Requirements for the Disposition of Cattle That Become Non- Ambulatory Disabled Following Ante-Mortem Inspection

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

DOCUMENT 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 nonambulatory 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 nonambulatory disabled after they have passed antemortem inspection on a casebycase basis. This proposed rule will require that all cattle that are nonambulatory disabled at the time they are presented for antemortem inspection at an official establishment, and all those that become nonambulatory disabled after passing antemortem inspection, be condemned and properly disposed of.

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

SUPPLEMENTAL INFORMATION

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 NonAmbulatory 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 NonAmbulatory 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 nonambulatory 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 nonambulatory disabled cattle be condemned on antemortem 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 nonambulatory 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 nonambulatory disabled cattle be condemned on antemortem inspection, the SRM final rule amended 9 CFR 309.3(e) to provide that FSIS personnel would determine, on a casebycase basis, the disposition of cattle that become nonambulatory disabled after they have passed antemortem inspection. The Agency made this revision to codify existing practices formerly described in FSIS Notice 504 (``Interim Guidance for Non Ambulatory Disabled Cattle and Age Determination'') and FSIS Notice 05 06 (``Reexamination of Bovine that become NonAmbulatory After Passing Antemortem Inspection''). These notices instructed FSIS public health veterinarians (PHVs) on the actions they were to take when cattle became nonambulatory disabled after passing antemortem inspection.

Under the current regulations, slaughter establishments are expected to notify inspection personnel when cattle that have passed antemortem
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inspection subsequently become nonambulatory 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 postmortem (after slaughter) evaluation and reinspection (see FSIS Directive 6100.1, AnteMortem Livestock Inspection). If the PHV cannot determine whether the animal became nonambulatory 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 nonambulatory 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 nonambulatory 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 nonambulatory disabled in a custom operation. Therefore, as explained in the SRM final rule preamble, if an animal becomes nonambulatory 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 EventsNonAmbulatory Disabled Cattle

The SRM final rule allowed a casebycase reinspection of cattle to address the rare situations where an animal that is deemed by FSIS as fit for human food at antemortem 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 casebycase disposition provision in 9 CFR 309.3(e) does not always ensure the proper disposition of cattle that become nonambulatory disabled after antemortem 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 antemortem 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 nonambulatory 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 nonambulatory disabled after initial antemortem inspection. Instead of notifying FSIS inspectors, the establishment attempted to force animals that had gone down after passing antemortem 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 1608 instructs inspection personnel to vary from daytoday 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 casebycase determination of the status of nonambulatory disabled cattle that have passed antemortem inspection. According to the petition, consumer confidence in the U.S. beef supply has been damaged because the reinspection 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 reinspection of cattle that become nonambulatory disabled after they have passed antemortem 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 nonambulatory disabled after they have passed antemortem inspection on a casebycase basis. If FSIS finalizes this proposed rule, cattle that become nonambulatory disabled from an acute injury after antemortem 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 nonambulatory disabled cattle would be considered unfit for human food and thus adulterated. Moreover, cattle that become nonambulatory disabled cattle after antemortem inspection will always be condemned. The case bycase disposition determinations of nonambulatory disabled cattle by inspection program personnel will be discontinued, increasing the time inspection program personnel can focus on other inspection activities. Because all nonambulatory disabled cattle would be considered adulterated, FSIS would expect custom
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operators not to slaughter cattle that become nonambulatory disabled after they are delivered to the custom operation.

In addition to proposing that all nonambulatory 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 antemortem 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 antemortem 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 nonambulatory disabled after passing antemortem inspection, be condemned and properly disposed of. This rule is necessary to better ensure effective implementation of antemortem 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 nonambulatory disabled cattle that the establishments could have slaughtered and harvested for human food after the cattle passed the reinspection. 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 cattleabout 600 cull cattle (i.e., mostly cows and bulls) and 700 steers and heiferswere 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.
\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 nonambulatory after antemortem inspection then pased the reinspection 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 6month data to annual figures.
\3\ The survey did not include custom exempt slaughter. To estimate the number of nonambulatory 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 customexempt 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 customexempt slaughter is expected to minimally change the analysis.

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 exante 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 nonambulatory 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 antemortem 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 antemortem 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 nonambulatory disabled after antemortem inspection.
\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 NonAmbulatory Disabled Cattle Offered for Slaughter, and Prohibition of the Use of Certain Stunning Devices Used to Immobilize Cattle during Slaughter (FSIS Docket No. 03025F), 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 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\
\5\ The value is measured by dressed carcass equivalent, ibid, pp.161169.

Paperwork Reduction Act

This proposed 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 [[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 email 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

AnteMortem Inspection.

For the reasons discussed in the preamble, FSIS is proposing to amend 9 CFR Chapter III as follows:

PART 309ANTEMORTEM INSPECTION

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

Authority: 21 U.S.C. 601695; 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 nonambulatory disabled after passing antemortem inspection. Nonambulatory 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. E820159 Filed 82808; 8:45 am]
BILLING CODE 3410DMP

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 202503700, (202) 2050495.