[Federal Register: January 12, 2004 (Volume 69, Number 7)]
[Rules and Regulations]               
[Page 1885-1891]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ja04-27]                         

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 310 and 313

[Docket No. 01-033IF]

 
Prohibition of the Use of Certain Stunning Devices Used to 
Immobilize Cattle During Slaughter

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Interim final rule with request for comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the 
Federal meat inspection regulations to prohibit the use of penetrative 
captive bolt stunning devices that deliberately inject air into the 
cranial cavity of cattle. This rulemaking responds to the findings of a 
risk assessment on bovine spongiform encephalopathy (BSE) conducted by 
the Harvard Center for Risk Analysis (referred to as the Harvard study) 
and is part of a series of actions that the USDA is taking to 
strengthen its BSE prevention programs.
    The Harvard study found that, owing to already ongoing Federal 
programs, the U.S. is highly resistant to the introduction and spread 
of the disease. Even so, the USDA response to BSE has always been 
proactive and preventive.
    Therefore, FSIS is taking this action to address the potential risk 
posed by stunning devices that may force visible pieces of brain, known 
as macro-emboli, into the circulatory system of stunned cattle.

[[Page 1886]]


DATES: Effective January 12, 2004; comments received on or before April 
12, 2004 will be considered prior to issuance of a final rule.

ADDRESSES: Send an original and two copies of comments to: FSIS Docket 
Clerk, Docket 01-033IF, Room 102, Cotton Annex, 300 C Street, 
SW., Washington, DC 20250-3700. Reference materials cited in this 
document and any comments received will be available for public 
inspection in the FSIS Docket Room from 8:30 a.m. to 4:30 p.m., Monday 
through Friday.

FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn, Ph.D., Executive 
Associate, Policy Analysis and Formulation, Office of Policy and 
Program Development, Food Safety and Inspection Service, U.S. 
Department of Agriculture, Washington, DC 20250-3700; (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    BSE is a slowly progressing, fatal degenerative disease that 
affects the central nervous system (CNS) of cattle. BSE belongs to the 
family of diseases known as the transmissible spongiform 
encephalopathies (TSEs), which include scrapie in sheep and goats, 
chronic wasting disease (CWD) in deer and elk, and Creutzfeldt-Jakob 
Disease (CJD) in humans. In 1996, following outbreaks of BSE in cattle 
in the United Kingdom, scientists found a possible link between BSE and 
a new variant of CJD, commonly referred to as variant CJD (vCJD). While 
it is not certain how BSE may be spread to humans, evidence indicates 
that humans may acquire vCJD by consuming parts of cattle that contain 
the BSE agent.
    The U.S government has taken a number of actions to prevent the 
spread of BSE into the U.S. Since 1989, the USDA's Animal and Plant 
Health Inspection Service (APHIS) has prohibited the importation of 
live cattle and certain animal products from cattle, including rendered 
protein products, from the United Kingdom and certain other countries 
where BSE is known to exist. In 1997, because of concerns about 
widespread risk factors and inadequate surveillance for BSE in many 
European countries, these importation restrictions were extended to 
include all of the countries in Europe. As of December 7, 2000, APHIS 
has prohibited all imports of rendered animal protein products, 
regardless of species, from BSE-restricted countries because of 
concerns that feed intended for cattle may have been cross-contaminated 
with the BSE agent.
    APHIS leads an ongoing, comprehensive, interagency surveillance 
system for BSE in the U.S. and, in cooperation with FSIS, has drafted 
an emergency response plan to be used in the event that BSE is 
identified in the U.S. BSE was, in fact, identified in a cow in 
Washington State on December 23, 2003; as a result, the plan was 
immediately put into effect. Other Federal agencies also have 
contingency plans that work in concert with the USDA plan. In 1997, the 
Food and Drug Administration (FDA) issued a final rule prohibiting the 
use of most mammalian protein in animal feeds for cattle and other 
ruminants. Under the FDA's rule, animal feed manufacturers must keep 
records sufficient to track any material that contains prohibited 
protein (prohibited material) throughout its receipt, processing, and 
distribution, must have processes in place to prevent co-mingling 
between ruminant feed and non-ruminant feed containing prohibited 
materials, and must ensure that non-ruminant feed containing prohibited 
materials is labeled conspicuously with the statement ``Do not feed to 
cattle and other ruminants.'' These regulations are intended to prevent 
the spread of BSE in U.S. cattle through feed contaminated with the BSE 
agent. In addition, the Centers for Disease Control and Prevention 
(CDC) leads a surveillance program for vCJD in the U.S.
    On November 30, 2001, the USDA released the results of a risk 
assessment on BSE conducted by the Harvard Center for Risk Analysis 
that evaluates the ways BSE could spread in the U.S. (Ref. 1, available 
for viewing by the public in the FSIS Docket room and on the Internet 
at http://www.fsis.usda.gov/OA/topics/bse.htm). The Harvard study also 

provides government agencies with a science-based approach to evaluate 
measures already in place to prevent the spread of BSE into the U.S. 
and to identify additional actions that should be taken to minimize the 
risk of BSE. The Harvard study shows that early prevention systems put 
into place by the USDA and the Department of Health and Human Services 
(HHS) would prevent BSE from spreading throughout the country.
    Although the Harvard study found that the U.S. was highly resistant 
to the spread of BSE, as previously mentioned, the USDA response to BSE 
has always been proactive and preventive. Therefore, in response to the 
Harvard study, on November 30, 2001, the Secretary of Agriculture 
announced a series of actions that the Department would take to 
strengthen its BSE prevention programs and to maintain the government's 
vigilance against the spread of BSE. One of these actions was to issue 
a proposed rule to prohibit the use of certain stunning devices used to 
immobilize cattle during slaughter. This action was identified because 
certain methods used to stun cattle (i.e., render them unconscious 
before they are slaughtered) have been found to force visible pieces of 
CNS tissue, known as macro-emboli, into the circulatory system of 
stunned cattle. Most of the infectivity in cattle that have BSE is 
found in the CNS tissue, i.e., brain and spinal cord.

Stunning and the Humane Methods of Slaughter Act

    Section 3(b) of the Federal Meat Inspection Act (FMIA) (21 U.S.C. 
603(b)) requires that any cattle or other livestock species slaughtered 
or handled in connection with slaughter under Federal inspection be 
handled in accordance with the provisions of the Humane Methods of 
Slaughter Act (HMSA) (7 U.S.C. 1901-1906). The HMSA states that ``* * * 
it is * * * the policy of the United States that the slaughtering of 
livestock and the handling of livestock in connection with slaughter 
shall be carried out only by humane methods'' (7 U.S.C. 1901). The HMSA 
requires that livestock be rendered insensible to pain before being 
shackled, hoisted, thrown, cast, or cut (unless they are slaughtered 
and handled in connection with slaughter in accordance with certain 
specified religious ritual requirements) (7 U.S.C. 1902, 1906). The 
HMSA also authorizes the Secretary of Agriculture (and FSIS by 
delegation) to designate methods of slaughter and handling in 
connection with slaughter that conform to the policy of the HMSA (7 
U.S.C. 1904(b)).
    Pursuant to the authority granted under the HMSA, FSIS promulgated 
regulations that prescribe requirements for the humane treatment of 
livestock. These regulations, which are codified at 9 CFR part 313, 
identify, among other things, humane methods of stunning for specified 
livestock species (see 9 CFR 313.5, 9 CFR 313.15, 9 CFR 313.30). 9 CFR 
313.15 sets forth the requirements for the use of captive bolt stunning 
for livestock. There are two types of captive bolt stunners, 
penetrative and non-penetrative. Both are permitted to be used to stun 
cattle prior to bleeding. In addition, the FSIS post-mortem inspection 
regulations, at 9 CFR 310.13, specifically list air-injection captive 
bolt stunning as an approved method for injecting air into the 
carcasses or parts of carcasses of livestock (9 CFR 
310.13(a)(2)(iv)(C)).

[[Page 1887]]

    Most slaughter establishments use penetrative captive bolt stun 
guns to render cattle unconscious, quickly and painlessly prior to 
slaughter. Penetrative captive bolt stun guns have steel bolts, powered 
by either compressed air or a blank cartridge. The bolt is driven into 
the animal's brain. In the past, captive bolt stun guns were often 
built or modified to inject compressed air into the cranium of cattle, 
so as to disrupt the brain structures and induce total and prolonged 
unconsciousness, to ensure that cattle were slaughtered in a humane 
manner. Studies have shown that penetrative captive bolt stunners that 
incorporate air-injection can force visible pieces of brain and other 
CNS tissue into the circulatory system of stunned cattle. These studies 
are discussed in greater detail below.
    The regulations in 9 CFR 313.15 do not distinguish among the 
different types of penetrative captive bolt stunners, such as those 
that inject air into the cranium of the animal and those that do not. 
Both methods of stunning are considered to be humane, and both are 
permitted to be used on cattle. Thus, under the regulations, captive 
bolt stunners that do not inject air can be used to slaughter cattle 
humanely.

Summary of Studies on Stunning Methods

    The frequency with which CNS tissue enters the circulatory system 
of stunned cattle and the size of the CNS tissue emboli depend on the 
method of stunning used. Fragments of CNS tissue that can be detected 
visually are referred to as CNS macro-emboli, while pieces of CNS 
tissue that can only be detected microscopically or with the use of CNS 
tissue markers are referred to as micro-emboli. Studies have found that 
when air-injection pneumatic stunners are used, CNS tissue emboli can 
be identified visually in the pulmonary artery and in the right 
ventricle of the heart and microscopically in the jugular venous blood 
(Refs. 2-4, available for viewing by the public in the FSIS Docket 
Room). Air-injection pneumatic stunning has also been found to result 
in a high incidence of visually observed blood clots in the right 
ventricle of the heart (Ref. 3, available for viewing by the public in 
the FSIS Docket Room).
    Other types of penetrative captive bolt stunners besides those that 
use air injection include pneumatically operated stunners that do not 
inject air and standard cartridge-fired captive bolt stunners. One 
study found that both pneumatically operated stunners that do not 
inject air and cartridge fired captive bolt stunners resulted in 
visually detectable blood clots in the right ventricle of the heart, 
although only a small number of blood clots were observed when a 
cartridge fired captive bolt was used (Ref. 3, available for viewing by 
the public in the FSIS Docket Room). The observation of visible blood 
clots cannot be used as direct evidence of the presence of CNS tissue; 
however, the presence of visible blood clots does indicate some type of 
interference with blood flow through the heart. The blood clots 
observed in the study were not analyzed for the presence of CNS tissue. 
More studies are needed to determine whether, and if so, the degree to 
which, CNS tissue may be present in blood clots observed in the heart 
of stunned cattle.
    In general, studies have not demonstrated that penetrative captive 
bolt stunning without air injection results in CNS tissue macro-emboli 
in the blood or other tissues of stunned cattle. One study detected no 
visible or microscopic fragments of brain tissue in jugular venous 
blood of cattle when a penetrative captive bolt without air injection 
was used (Ref. 4, available for viewing by the public in the FSIS 
Docket Room). This same study found no evidence of CNS tissue in 
jugular venous blood using assays for CNS markers. Another study did 
not detect CNS tissue in the lungs of cattle by gross examination or by 
histopathology of selected areas of the lung when captive bolt stunning 
without air-injection was used (Ref. 5, available for viewing by the 
public in the FSIS docket room). However, there is one study in which 
the presence of CNS tissue markers was weakly detected by assay of 
emboli found in the lungs after cattle were stunned using a penetrative 
captive bolt without air injection (Ref. 6, available for viewing by 
the public in the FSIS docket room). The authors of this study 
concluded that the results suggest that the contamination of the lung 
with CNS tissue after using a conventional cartridge-fired captive bolt 
stunner can not be excluded; however, the incidence appears to be very 
low. The authors also concluded that the presumed CNS tissue emboli, if 
present at all, are microscopically small.
    Although not documented in the published studies, in addition to 
the heart and lungs, FSIS inspection program personnel have reported 
observing CNS tissue macro-emboli in the liver and kidney of cattle 
stunned with pneumatic powered air-injection stunners. The Agency has 
photographs and histopathology reports documenting the presence of CNS 
tissue macro-emboli when hearts, lungs, livers, and kidneys from cattle 
stunned using air-injection devices are dissected.\1\
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    \1\ These are available for viewing by the public in the FSIS 
docket room.
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Risk Considerations

1. European Scientific Steering Committee Opinion

    The European Commission's (EC) Scientific Steering Committee (SSC) 
adopted an opinion on Stunning Methods and BSE Risks at its January 10-
11, 2002, meeting that, among other things, describes the tissues and 
organs that are at risk of being contaminated with CNS material when 
certain stunning methods are used on certain ruminants (Ref. 7, 
available for viewing by the public in the FSIS Docket Room). In the 
opinion, the SSC ranks these stunning methods according to the risk and 
possible level of CNS tissue contamination. The opinion was based on a 
scientific report prepared by the EC's TSE/BSE ad hoc Group (Ref. 8, 
available for viewing by the public in the FSIS Docket Room). The 
stunning methods addressed in the SSC report include: pneumatic stunner 
that injects air, pneumatic stunner that does not inject air, captive 
bolt stunner with pithing, captive bolt stunner without pithing, non-
penetrative stunner, and electro-narcosis. Pithing is the insertion of 
an elongated rod-shaped instrument into the cranial cavity of a stunned 
animal to further lacerate the CNS tissue. This stunning method is 
banned by the E.U. and has never been used in the U.S.
    The SSC concluded that if brain damage occurs during any type of 
penetrative stunning, and CNS particles are disseminated into the 
blood, the tissues and organs likely to be contaminated with CNS tissue 
are, in decreasing order of risk, the blood, pulmonary arteries and 
lung, and right atrium and ventricles of the heart. The SSC also 
concluded that the risk of CNS tissue contamination of any other tissue 
as a result of penetrative stunning was absent or negligible. However, 
in its report, the EC's TSE/BSE ad hoc committee noted that little data 
is available to determine whether CNS tissue emboli can occur in a 
homogenized form or just as structured tissue fragments.
    As stated in the report, it could be that homogenized CNS tissue 
may be able to enter arterial circulation and spread to other tissues, 
including spleen and muscle. There is one study in which marker 
bacteria placed on a captive bolt pistol was recovered from the spleen, 
and marker bacteria placed on a pithing rod was found in both

[[Page 1888]]

spleen and muscle (Ref. 9, available for viewing by the public in the 
FSIS Docket Room).
    In its opinion on stunning methods, the SSC ranked the various 
stunning methods used at slaughter in the E.U. according to the risk 
for contamination of other tissues with CNS tissue and the possible 
level of contamination. Of the stunning methods evaluated, the SSC 
concluded that pneumatic stunners that inject air present the highest 
risk of brain damage and dissemination of CNS tissue to other tissues 
and organs, followed by pneumatic stunning without air injection, 
captive bolt stunning with pithing, and captive bolt stunning without 
pithing. The SSC found that non-penetrative stunning methods and 
electro-narcosis present a negligible risk of causing CNS tissue 
emboli.
    According to the TSE/BSE ad hoc committee report, there is no 
accurate estimate of the size range of CNS emboli that occurs as a 
result of certain stunning methods or of the level of the BSE agent in 
the CNS tissues of animals incubating the disease. However, the report 
does state that `` * * * it is clearly evident that if visible CNS 
material is found * * * it is clear that if this tissue was TSE-
infected the organ in which it resides presents a TSE risk.'' Thus, 
based on the conclusions of the TSE/BSE ad hoc committee, FSIS has 
determined that methods of stunning that cause contamination of tissues 
and organs with visible CNS tissue macro-emboli are the methods most 
likely to present a risk of exposing humans to the agent that causes 
BSE if used on an animal that has BSE.
    The SSC noted that any risk to consumers from contamination of 
tissues and organs with CNS tissue depends on the level of BSE 
infectivity in the brain of the stunned animal. Thus, the importance of 
the stunning methods used becomes irrelevant if cattle brains can be 
assumed to be free of the BSE agent, which, according to the SSC, would 
be the case for all cattle under one year of age regardless of the 
country or origin. Furthermore, the SSC determined that when applied to 
cattle below 30 months of age from any country, stunning methods other 
than stunning with a pneumatic gun that injects air under pressure, or 
any stunning methods accompanied by pithing, are likely to result in a 
much lower or no significant risk of contamination with the BSE agent.

2. The Harvard Risk Assessment's Evaluation of Stunning Methods

    The Harvard risk assessment model has two stunning methods built 
in, standard captive bolt stunning and captive bolt stunning with air-
injection (Ref. 1, available for viewing by the public in the FSIS 
docket room and on the Internet at http://www.fsis.usda.gov/OA/topics/bse.htm
). The Harvard study does not differentiate between pneumatic 

powered captive bolt stunners without air-injection and cartridge fired 
captive bolt stunners without air-injection. In the risk assessment, 
Harvard estimates the probability that each method will result in CNS 
tissue emboli contamination of certain bovine tissues and organs, and 
the degree to which contamination might occur. In its model, Harvard 
assumes that if a stunning method results in CNS tissue emboli, the 
blood, heart, lungs, and liver may be contaminated.
    Harvard estimates that for each BSE-infected animal stunned with a 
standard captive bolt stunner (without air injection) there is a 50 
percent probability that a very small fraction of the BSE agent will be 
transferred to the blood. This small fraction of the BSE agent is what 
would be contained within micro-emboli that might occur. Harvard also 
estimates that for each BSE-infected animal stunned with a captive bolt 
stunner that uses air-injection, there is a 31 percent, 16 percent, 3 
percent, and 0.6 percent probability that a fraction of the BSE agent 
will transfer to the blood, heart, lung, and liver, respectively. The 
probability and amount of the BSE agent transferred varies, with the 
greatest fraction in the blood, a lower fraction in the heart and 
lungs, and the lowest in the liver.
    Harvard found that stunners that use air-injection have a potential 
to fail on occasion, which results in an increase in CNS tissue emboli 
formation. Thus, in its risk assessment model, Harvard estimates that 
when a BSE infected animal is stunned with a malfunctioning captive 
bolt stunner that uses air-injection, the probability of BSE agent 
transfer occurring can be approximately 10 times higher for the lung 
and liver, twice as high for the heart, and 50 percent higher for the 
blood. Harvard estimated that the amount of BSE agent transferred to 
these tissues would be approximately ten times higher than the amount 
transferred with a working air-injection stunner.
    When evaluating the potential impact that stunning methods may have 
on the introduction and spread of BSE in the U.S., for its ``base 
case'' scenario Harvard assumes that air-injection stunning is not used 
in the U.S., and for its ``worst case'' scenario Harvard assumes that 
air-injection stunning is used 15 percent of the time. The base case is 
based upon the present state of the U.S. cattle population, and the 
existing government regulations and prevailing agricultural practices. 
When the base case scenario is compared with the worst case scenario, 
and it is assumed that ten BSE-infected cattle have been introduced 
into the U.S. system, the number of cattle ID50s that would be 
potentially available for human exposure increases from 35 to 41 or 
approximately 17 percent. A cattle oral ID50 is the amount of BSE 
infectious tissue that would on average cause 50 percent of cattle 
exposed to develop BSE. Although the Harvard study found that the 
stunning method used is not a major potential source of human exposure 
to cattle ID50s, it still found that the number of cattle ID50s 
available for human exposure would increase with greater use of air-
injection stunning.

Prohibition of Air-Injection Stunning

    When developing this rule, FSIS reviewed the published studies on 
stunning methods and CNS tissue emboli to determine which stunning 
methods that have been used on cattle in the U.S. are likely to result 
in CNS tissue macro-emboli. The collective findings of the studies 
indicate that the only stunning technique that has been used in the 
U.S. that conclusively results in CNS tissue macro-emboli when used to 
stun cattle is pneumatic-powered captive bolt stunning with air 
injection. Furthermore, the findings of the Harvard study on BSE and 
the SSC Opinion on Stunning Methods and BSE Risks, indicate that, of 
all the stunning devices used on cattle in the U.S., pneumatic-powered 
captive bolt stunners that inject air present the highest risk of 
exposing humans to the BSE agent.
    Prohibiting the use of air-injection stunning for cattle in the 
U.S. is consistent with many international stunning requirements for 
cattle. For example, the E.U. prohibits the use of air-injection 
stunning for cattle for its member countries.\2\ The E.U. also 
prohibits the importation of meat products from cattle from the U.S., 
as well as many other countries, that have been stunned using air-
injection.\3\ Canada also prohibits the use of air-injection stunning 
for cattle.\4\ Thus,

[[Page 1889]]

prohibiting the use of air-injection stunning for cattle in the U.S. 
would help to ensure that U.S. establishments that export beef products 
to foreign countries are not using air injection stunning, which could 
promote trade with certain countries.
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    \2\ Council Directive 93/119/EC, 22 December, 1993 (Official 
Journal L 340, 31/12/1993., p. 21).
    \3\ Commission Regulation (EC) No. 999/2001, 22 May 2001, as 
amended by Regulation (EC) No. 270/2002 14 February 2002 (Official 
Journal L. 045, 15/02/2002. p. 13-14).
    \4\ Meat Hygiene Directive 2002-21, April 8, 2002.
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    Meat products exported from another country to the U.S. must meet 
all safety standards applied to meat food products produced in the U.S. 
Once this rule is in effect, foreign establishments that use air-
injection stunning for cattle would be prohibited from importing beef 
products into the U.S. Thus, prohibiting the use of air-injection 
stunning in the U.S. would also address the potential risk associated 
with imported beef products produced from cattle stunned using air-
injection.
    As noted in the E.U. SSC report on Stunning Methods and BSE Risks, 
there are relatively few studies on stunning techniques and CNS tissue 
emboli, and the methods used in the studies that have been done are 
inconsistent. Thus, if further studies indicate that stunning 
techniques used in the U.S. other than air-injection stunning result in 
CNS tissue macro-emboli, the Agency will consider prohibiting the use 
of other stunning techniques as well.
    FSIS' authority to prohibit the use of captive bolt stunning 
devices that inject air into the cranium of cattle derives from the 
FMIA (21 U.S.C. 601(m), 621). When air-injection stunners cause CNS 
tissue to become dislodged from the brains of cattle, the circulatory 
systems of the stunned cattle become contaminated with visible CNS 
macro-emboli. As noted in the E.U. SSC report and the Harvard study, 
this condition could promote the spread of the BSE agent in the carcass 
if the animal were infected with BSE because CNS tissue macro-emboli 
that contain the BSE agent could become lodged in other, edible tissues 
or organs. FSIS believes that it should not wait until BSE is detected 
in this country before putting in place appropriate prophylactic 
measures. By prohibiting the use of air-injection stunning for cattle, 
FSIS seeks to eliminate a foreseeable source of risk. This action is 
necessary to strengthen the U.S. Government's BSE prevention efforts.

Emergency Action

    Given the fact that a cow in Washington State tested as positive 
for BSE on December 23, 2003, it is necessary to issue this rule on an 
emergency basis. BSE infectivity has been confirmed in the brain, eyes, 
trigeminal ganglia, tonsils, spinal cord, dorsal root ganglia, and 
distal ileum. Furthermore, most of these tissues have demonstrated 
infectivity before experimentally infected animals developed clinical 
signs of disease. Thus, BSE infectivity in these tissues is not readily 
ascertainable. Therefore, FSIS has determined that it must take 
immediate action to ensure that materials that could present a 
significant risk to human health in beef, as a consequence of stunning 
practices, are prohibited.
    Under these circumstances, the FSIS Administrator has determined 
that prior notice and opportunity for public comment are contrary to 
the public interest, and that there is good cause under 5 U.S.C. 553 
for making this rule effective less than 30 days after publication in 
the Federal Register. FSIS will consider comments received during the 
comment period for this interim rule (see DATES above). After the 
comment period closes, the Agency will publish another document in the 
Federal Register. The document will include a discussion of any 
comments received in response to this interim rule and any amendments 
made as a result of those comments.

Executive Order 12866 and Regulatory Flexibility Act

    This interim final rule has been determined to be significant as 
defined in Executive Order 12866, and therefore, it has been reviewed 
by the Office of Management and Budget.
    FSIS is not aware of any cattle slaughter establishments that use 
air-injection stunning. Therefore, there appear to be no immediate 
quantifiable costs or benefits associated with this action. However, 
since research has shown that the practice poses a risk of exposing 
humans to materials that could contain the BSE agent, and because the 
technology was used in the U.S. as recently as the 1990's, FSIS 
believes that this prohibition is a necessary action to help strengthen 
the U.S. Government's BSE prevention programs.
    FSIS has conducted two separate surveys on the use of air injection 
stunning in official U.S. cattle slaughter establishments. The first 
survey was conducted from late 1999 to early 2000 and was limited to 72 
cattle slaughter establishments located in two FSIS Districts. The 
second survey was conducted from May 2002 to October, 2002 and involved 
270 establishments that slaughter cattle nationwide. Neither of these 
surveys detected the use of air-injection stunning devices on cattle in 
official U.S. cattle slaughter establishments. In addition, in July 
2002, the seventeen veterinarians in charge of verifying humane 
slaughter practices in U.S. slaughter plants reported to FSIS 
headquarters that that they knew of no beef slaughter establishments 
that use air-injection stunning.
    Under section 301 of the FMIA, States are permitted to operate 
their own meat inspection programs provided that State requirements are 
at least equal to those imposed by the Federal government (21 U.S.C. 
661). Meat products produced under State inspection may only be sold 
within the State. Thus, when it becomes effective, this rule could 
impact state-inspected establishments that still use air-injection 
stunning on cattle. However, FSIS is not aware of any state-inspected 
plants that use this method of stunning. In November 2002, FSIS 
conducted an informal survey of State officials on the use of air-
injection stunners in state-inspected cattle slaughter establishments. 
The survey detected no state-inspected establishments that were using 
air-injection stunning on cattle.
    FSIS is aware of only two companies that have sold air-injection 
stunning equipment to cattle slaughter establishments in the U.S. One 
of these companies informed the Agency that it no longer manufactures 
air-injection stunners, and that in the U.S. it had replaced existing 
stunners with ones that do not use air injection, at its own cost in 
the late 1990's. The other manufacturer told FSIS that, although it 
still produces air-injection stunners, it does not sell any in the U.S. 
and is in the process of phasing out production of these devices.
    The E.U. and Canada ban air-injection stunning of cattle and 
prohibit the importation of beef made from cattle stunned in this 
manner. Thus, U.S. cattle slaughter establishments that export beef 
products to these countries already can not use air-injection stunners 
on those cattle whose products are intended for export.
    Meat products exported from another country to the U.S. must meet 
all safety standards applied to food produced in the U.S. Thus, any 
foreign establishments that export meat products to the U.S. that use 
air-injection stunning on cattle may incur costs to replace or modify 
air-injection stunners or be prohibited from exporting beef products to 
the U.S. In 2000, approximately 87 percent of the beef and veal 
imported into the U.S. (fresh and frozen) came from Australia, New 
Zealand, and Canada; approximately 10 percent from Argentina, Brazil, 
and Uruguay; and approximately 3 percent from Costa Rica, Honduras, 
Mexico, and Nicaragua (Ref 10, available for viewing by the public in 
the FSIS Docket Room).

[[Page 1890]]

    As previously mentioned, Canada already prohibits the use of air 
injection stunners on cattle. Therefore, this rule would have no impact 
on Canadian establishments that export beef to the U.S. Although 
Australian law does not ban the use of air-injection stunning, to be 
used in Australia, any new stunning system must be approved by the 
Australian Quarantine and Inspection Service (AQUIS). There have been 
trials of low pressure air injection stunning in Australia. However, 
AQUIS has not approved any of these devices for general use. 
Furthermore, an AQUIS official informed FSIS that there is a high 
degree of awareness among both the regulators and the industry in 
Australia about the potential problems with this type of stunning. It 
is unlikely that its introduction in Australia will be sought. New 
Zealand food safety laws do not allow for the use of air-injection 
stunning.
    Both stunning manufacturers that have reported selling air-
injection stunning equipment in the U.S. in the past, also have 
reported that they have sold air-injection stunning equipment to cattle 
slaughter establishments in South America, and one of them still sells 
air-injection stunning equipment to cattle slaughter establishments in 
Mexico, South America, and Eastern Europe. However, FSIS international 
auditors have not detected the use of air-injection stunners during 
audits of cattle slaughter establishments in Mexico and South America 
over the past three years, and the U.S. imports very little, if any, 
beef products from Eastern Europe. The Agency is continuing to gather 
data on the international use of air-injection stunning.
    For those establishments, if any, that are using air-injection 
stunning, based on conversations with stunning equipment manufacturers, 
FSIS estimates that the cost of modifying or replacing an individual 
piece of equipment could range from $1,500.00 to $2,000.00.

Regulatory Flexibility Act

    The Administrator, FSIS, has determined that this rule will not 
have a significant economic impact, as defined by the Regulatory 
Flexibility Act (5 U.S.C. 601), on a substantial number of small 
entities.
    As discussed above, FSIS is not aware of any cattle slaughter 
establishments that use air-injection stunning, regardless of the size 
of the establishment. Thus, it is likely that this rule will have no 
economic impact on entities of any size. Any small firms that are using 
air-injection stunning on cattle would incur costs to replace or modify 
the equipment, which, as stated above, are estimated to range from 
$1,500.00 to $2,000.00 per piece of equipment.

Alternatives Considered

    FSIS announced its plan to prohibit the use of air-injection 
stunning of cattle in its current thinking paper on BSE, made available 
to the public on January 17, 2002 (67 FR 2399, Ref. 11 available for 
viewing by the public in the FSIS docket room and on the Internet at 
http://www.fsis.usda.gov/OA/topics/BSE_thinking.htm). Thus, although 

generally the Agency neither promotes nor bans specific types of 
technology used for meat and poultry slaughter, the regulatory approach 
adopted with this action of prohibiting air-injection stunners is 
consistent with earlier statements made by the Agency. In its BSE 
current thinking paper, FSIS requested comments on the policy options 
discussed in the document and received no comments that opposed banning 
the use of air-injection stunners on cattle.
    In addition to the approach that was adopted, the Agency considered 
the alternative of establishing a performance standard that stunning 
equipment would be required to meet to be used on cattle, and the 
alternative of no rulemaking.
    Under the first option, the Agency would have developed a CNS 
tissue emboli performance standard that stunners would be required to 
meet to be permitted to be used on cattle. The benefits of this option 
are that it is more consistent with FSIS regulatory policy than banning 
a specific technology, and that it would prevent all methods of 
stunning that do not comply with the performance standard from being 
used on cattle, not just air-injection stunning. Thus, this option 
would prevent the need to regulate individual pieces of equipment.
    A potential problem with this option is that there are relatively 
few studies on stunning methods and CNS tissue emboli. Thus, the Agency 
was concerned that if it were to establish a CNS tissue emboli 
performance standard for cattle stunning devices at this time, further 
studies could reveal that the performance standard selected does not 
achieve the result intended by the Agency. Therefore, FSIS decided to 
prohibit the use of the stunning method that all available studies do 
conclude result in CNS tissue macro-emboli, i.e., stunning that uses 
air-injection.
    Establishing a CNS tissue emboli performance standard would also be 
more difficult to enforce than the option that was chosen because 
inspectors would be required to verify that the performance standard 
was being met. Ensuring compliance with a CNS tissue emboli performance 
standard could involve analysis of blood or tissue samples for CNS 
tissue, either by the Agency or the establishment. On the other hand, 
enforcing a ban on air-injection stunners would simply involve visual 
verification that a certain piece of equipment is not being used. Thus, 
enforcement of a performance standard would require more resources than 
enforcement of an outright ban on air-injection stunners.
    FSIS rejected the option of no rulemaking because, as previously 
mentioned, USDA action with regard to BSE has been, and should continue 
to be, proactive and preventive. Thus, the Agency is taking this action 
to strengthen its BSE prevention programs. Furthermore, the Agency has 
already publicized its intention to prohibit the use of air-injection 
stunning on cattle. There have been no developments with regard to this 
issue that justify a change in this position.
    FSIS chose the option of prohibiting the use of air-injection 
stunning for cattle because the Harvard risk assessment and other 
recent studies indicate that of all the stunning devices that have been 
used on cattle in the U.S., pneumatic-powered captive bolt stunners 
that inject compressed air present the highest risk of exposing humans 
to bovine CNS tissue. Furthermore, unlike a performance standard, this 
option also clearly establishes which stunning methods would be 
prohibited, and it is easy to enforce. In addition, an outright 
prohibition on air-injection stunning is consistent with international 
laws and policies that did not allow the use of specific stunning 
technologies, such as air-injection.

Executive Order 12988

    This interim final rule has been reviewed under Executive Order 
12988, Civil Justice Reform. This interim final rule: (1) Preempts 
State and local laws and regulations that are inconsistent with this 
rule: (2) has no retroactive effect; and (3) does not require 
administrative proceedings before parties may file suit in court 
challenging this rule. However, the administrative procedures specified 
in 9 CFR 306.5 must be exhausted before any judicial challenge of the 
application of the provisions of this rule, if the challenge involves 
any decision of an FSIS employee relating to inspection services 
provided under the FMIA.

[[Page 1891]]

Paperwork Requirements

    There are no paperwork or recordkeeping requirements associated 
with this direct final rule under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520).

Public Notification and Request for Data

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to better ensure 
that minorities, women, and persons with disabilities are aware of this 
direct final, FSIS will announce it and make copies of this Federal 
Register publication available through the FSIS Constituent Update. 
FSIS provides a weekly Constituent Update, which is communicated via 
Listserv, a free e-mail subscription service. In addition, the update 
is available on-line through the FSIS Web page located at http://www.fsis.usda.gov.
 The update is used to provide information regarding 

FSIS policies, procedures, regulations, Federal Register notices, FSIS 
public meetings, recalls, and any other types of information that could 
affect or would be of interest to our constituents/stakeholders. The 
constituent Listserv consists of industry, trade, and farm groups, 
consumer interest groups, allied health professionals, scientific 
professionals, and other individuals that have requested to be 
included. Through the Listserv and Web page, FSIS is able to provide 
information to a much broader, more diverse audience. For more 
information contact the Congressional and Public Affairs Office, at 
(202) 720-9113. To be added to the free e-mail subscription service 
(Listserv), go to the ``Constituent Update'' page on the FSIS Web site 
at http://www.fsis.usda.gov/oa/update/update.htm. Click on the 

``Subscribe to the Constituent Update Listserv'' link, then fill out 
and submit the form.

References

    The following sources are referred to in this document. All have 
been placed on display in the FSIS Docket Room (address above) and may 
be seen by interested persons between 8:30 a.m. and 4:30 p.m., Monday 
through Friday.
    1. Harvard Center for Risk Analysis, Harvard School of Public 
Health, and Center for Computational Epidemiology, College of 
Veterinary Medicine, Tuskegee University, November 26, 2001. Evaluation 
of the Potential for Bovine Spongiform Encephalopathy in the United 
States.
    2. Garland, T., Bauer, N., Bailey, M., 1996. Brain emboli in the 
lung of cattle after stunning. The Lancet, 348:610.
    3. Schmidt, G.R., Hossner, K.E., Yemm, R.S., Gould, D.H., 1999. 
Potential for disruption of central nervous system tissue in beef 
cattle by different types of captive bolt stunners, J. Food Prot., 
62:390-393.
    4. Anil, M.H., Love, S., Williams, S., Shand, A., McKinstry, J.L., 
Helps, C.R., Waterman-Pearson, A., Seghatchian, J., and Harbour, D.A., 
1999. Potential contamination of beef carcasses with brain tissue at 
slaughter. Vet. Rec., 145: 460-462.
    5. Munro, R. 1997. Neural tissue emboli in cattle. Vet. Rec., 
145:356.
    6. Horlacher, S., Lucker, E., Eigenbrodt, E., Wenisch, S., 2002. 
ZNS-Emboli in der Rinderlunge (Brain emboli in the lungs of cattle). 
Berl Munch Tierarztl Wochenschr Jan-Feb; 115(1-2):1-5.
    7. E.C. (European Commission), 2002. Opinion of 10-11 January 2002 
of the Scientific Steering Committee on Stunning Methods and BSE Risks 
(The Risk of Dissemination of Brain Particles into the Blood and 
Carcass When Applying Certain Stunning Methods).
    8. E.C. (European Commission), 2001. Report on Stunning Methods and 
BSE Risks (The Risk of Dissemination of Brain Particles into the Blood 
and Carcass When Applying Certain Stunning Methods). Prepared by the 
TSE BSE Ad Hoc Group at its meeting of 13 December 2001.
    9. Mackey, B.M, and Derrick, C.M., 1979. Contamination of the deep 
tissues of carcasses by bacteria present on the slaughter instruments 
on in the gut. J. Appl. Bact., 46:355-366.
    10. USDA Agricultural Statistics, 2002, VII-44, Table 7-70.
    11. Food Safety and Inspection Service (FSIS), Current Thinking On 
Measures That Could Be Implemented To Minimize Human Exposure To 
Materials That Could Potentially Contain the Bovine Spongiform 
Encephalopathy Agent, January 15, 2002. Available on the internet at 
http://www.fsis.usda.gov/OA/topics/BSE_thinking.htm.


List of Subjects

9 CFR Part 310

    Animal diseases, Meat inspection.

9 CFR Part 313

    Animal welfare, Livestock, Meat inspection.

0
For the reasons discussed in the preamble, FSIS amends 9 CFR chapter 
III as follows:

PART 310--POST-MORTEM INSPECTION

0
1. The authority citation for part 310 continues to read as follows:

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


Sec.  310.13  [Amended]

0
2. Section 310.13 is amended as follows: Paragraph (a)(2)(iv)(C) is 
amended by adding the phrase ``of all livestock except cattle'' after 
``into the skull'' and before ``in conjunction with''.

PART 313--HUMANE SLAUGHTER OF LIVESTOCK

0
1. The authority citation for part 313 continues to read as follows:

    Authority: 7 U.S.C. 1901-1906; 21 U.S.C. 601-695; 7 CFR 2.17, 
2.55.


Sec.  313.15  [Amended]

0
2. Section 313.15 is amended as follows:
    Paragraph (b)(2) is amended by revising the paragraph heading, 
designating the text as paragraph (b)(2)(i), and by adding a new 
paragraph (b)(2)(ii). The added and revised text reads as follows:


Sec.  313.15  Mechanical; captive bolt.

* * * * *
    (b) * * *
    (2) Special requirements and prohibitions.
* * * * *
    (ii) Captive bolt stunners that deliberately inject compressed air 
into the cranium at the end of the penetration cycle shall not be used 
to stun cattle.

    Done at Washington, DC, on: January 7, 2004.
Garry L. McKee,
Administrator.
[FR Doc. 04-624 Filed 1-8-04; 1:43 pm]