[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]