Permission To Use Air Inflation of Meat Carcasses and Parts, 69575-69577 [2010-28650]
Download as PDF
69575
Rules and Regulations
Federal Register
Vol. 75, No. 219
Monday, November 15, 2010
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 310
[Docket No. FSIS–2007–0039]
RIN 0583–AD33
Permission To Use Air Inflation of Meat
Carcasses and Parts
Food Safety and Inspection
Service, USDA.
ACTION: Final rule.
AGENCY:
The Food Safety and
Inspection Service (FSIS) is amending
the Federal meat inspection regulations
to provide that establishments that
slaughter livestock or prepare livestock
carcasses and parts may inflate
carcasses and parts with air if they
develop, implement, and maintain
written controls to ensure that the
procedure does not cause insanitary
conditions or adulterate the product.
FSIS is requiring establishments to
incorporate these controls into their
Hazard Analysis and Critical Control
Point (HACCP) plans or Sanitation
Standard Operating Procedures
(Sanitation SOPs) or other prerequisite
programs.
In addition, FSIS is amending its
regulations to remove the approved
methods for inflating livestock carcasses
and parts by air and to remove the
requirement that establishments submit
requests to FSIS for approval of air
inflation procedures not listed in the
regulations. FSIS is also adding a
paragraph in the regulations to make
clear that the current prohibition against
injecting compressed air into the skulls
of cattle remains in force.
DATES: Effective: December 15, 2010.
FOR ADDITIONAL INFORMATION: Contact
Rachel Edelstein, Director, Policy
Issuances Division, Office of Policy and
Program Development, Food Safety and
jdjones on DSK8KYBLC1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
15:26 Nov 12, 2010
Jkt 223001
Inspection Service, U.S. Department of
Agriculture, Washington, DC 20250;
(202) 720–5627.
SUPPLEMENTARY INFORMATION:
Background
FSIS has been delegated the authority
to exercise the functions of the Secretary
of Agriculture as specified in the
Federal Meat Inspection Act (FMIA) (21
U.S.C. 601, et seq.). Under this statute,
FSIS protects the public by verifying
that meat products are safe, wholesome,
not adulterated, and properly labeled
and packaged.
On May 24, 2010, FSIS proposed to
amend the Federal meat inspection
regulations concerning air inflation. The
proposed rule explained that on October
3, 1970, the Federal Meat Inspection
regulations were revised to prohibit
inflation with air of carcasses or parts of
carcasses (35 FR 15568). On September
5, 1989, FSIS modified the prohibition
in 9 CFR 310.13(a) by providing for the
use of several air inflation procedures
that had been field tested and that the
Agency found to be acceptable (54 FR
36756). The regulations required that
establishments interested in the use of
air inflation procedures other than the
approved methods submit to FSIS a
request for experimental testing of the
unapproved procedure. The regulations
also provided that if FSIS were to find
a new method to be acceptable, it would
modify its regulations to include the
new method.
As FSIS stated in the proposed rule,
the Agency’s original intent in
disallowing the use of air inflation was
to prevent insanitary conditions from
arising and to prevent the adulteration
of carcasses or parts of carcasses.
However, the Agency recognized in the
1989 final rule that air inflation
procedures could be used in a sanitary
manner without adulterating product
and consequently approved the limited
use of air inflation procedures.
Under a waiver from FSIS, Packerland
Co. (also known as JBS Packerland) used
an air inflation methodology to separate
the brisket and round portions from beef
carcasses to increase the efficiency of its
fabrication. In July 2007, Packerland Co.
petitioned FSIS to amend its regulations
to allow for this air inflation
methodology. In support of its petition,
Packerland Co. presented aerobic
bacteria plate count data that showed
that the use of Packerland’s air inflation
PO 00000
Frm 00001
Fmt 4700
Sfmt 4700
procedure did not cause insanitary
conditions or adulterate product.
Based on the Agency’s accumulated
experience with air inflation procedures
and on its evaluation of Packerland’s
petition, FSIS decided to grant
Packerland’s petition and proposed to
permit establishments that slaughter
livestock carcasses and parts to inflate
carcasses and parts with air if they
develop, implement, and maintain
written controls to ensure that the
procedure does not cause insanitary
conditions or adulterate product. FSIS
proposed to require that establishments
incorporate these controls into their
HACCP plans or Sanitation SOPs or
other prerequisite programs. FSIS also
proposed to amend its regulations to
remove the approved methods for
inflating livestock carcasses and parts
by air and to remove the requirement
that establishments submit requests to
FSIS for approval of air inflation
procedures not listed in the regulations.
Comments and FSIS Response
The Agency received three comments
on the proposal.
One trade association supported the
proposed rule and stated that the
proposed action will enhance slaughter
house safety programs, reduce repetitive
motion injuries, and create economic
benefits through better use of
employees. In addition, the commenter
stated that the proposal will facilitate
adoption of new air inflation
technology.
A large corporation also supported the
proposal. The commenter stated that air
from air inflation procedures is present
in the finished food at insignificant
levels and does not have any technical
or functional effect in that food after the
use of those procedures. The commenter
stated that, therefore, these procedures
meet the definition of incidental
additives as defined in 21 CFR
101.100(a)(3) and are exempt from
labeling requirements.
The question presented in this
rulemaking is whether FSIS should
provide for air inflation in its
regulations. How products produced
using air inflation technology need to be
labeled is a separate question that FSIS
did not address in the proposed rule.
Such product would not be required to
be labeled to indicate that it has been
produced using air inflation. In
addition, FSIS does not agree that air
used to inflate carcasses and parts
E:\FR\FM\15NOR1.SGM
15NOR1
69576
Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Rules and Regulations
jdjones on DSK8KYBLC1PROD with RULES
constitutes an incidental additive as
defined in 21 CFR 101.100 (a)(3)
because air is a gas mixture that is being
used to separate muscle tissue, and
there is no residual of any of the gases
in the tissue after use.
An individual commenter stated that
a reference in the preamble to the
proposed rule to the disallowance of air
injection into the skull of cattle appears
to be incorrect. The comment pointed
out that the reference should be 9 CFR
310.13 (a)(2)(iv)(C), not 9 CFR
310.13(a)(2)(iv)(D).
The Agency agrees that 9 CFR
310.13(a)(2)(iv)(C) is the correct citation.
Therefore, nothing presented by the
comments would cause the Agency to
not adopt the proposed rule.
The Final Rule
FSIS is amending 9 CFR 310.13(a) to
permit establishments that slaughter
livestock or prepare livestock carcasses
and parts to inflate carcasses or parts of
carcasses with air if they develop,
implement, and maintain controls to
ensure that those procedures do not
cause insanitary conditions or
adulterate product. Under the new rule,
all methods of air inflation will be
permitted if establishments develop,
implement, and maintain controls to
ensure that these procedures do not
cause insanitary conditions or
adulterate product. Therefore, FSIS is
also removing the approved methods for
inflating meat carcasses and parts from
the regulations. For the same reason, the
Agency is removing the requirement
that establishments submit requests to
FSIS for approval of air inflation
procedures not listed in the regulations.
Under this final rule, establishments
that are using an approved air inflation
procedure can continue to do so, but
they will be required to incorporate
their air inflation procedures into their
HACCP plans or Sanitation SOPs or
other prerequisite programs.
As part of their HACCP plans and
hazard analysis, establishments are
required to prepare a flow chart
describing the steps of each process and
product flow in the establishment (9
CFR 417.2(a)(2)). Under the final rule, if
an establishment uses air inflation
procedures, the flow chart will need to
include those procedures. Under the
HACCP regulations, establishments are
also required to consider whether air
inflation may make biological hazards,
such as contamination with certain
pathogens, reasonably likely to occur
(9 CFR 417.2(a)(1)).
Also under the HACCP regulations, if
an establishment determines that air
inflation procedures do not introduce
any hazards, it is to document the
VerDate Mar<15>2010
15:26 Nov 12, 2010
Jkt 223001
reasons for its determination in its
decision-making documents (9 CFR
417.5). Under this final rule, if
establishments that use air inflation
maintain controls outside of their
HACCP plans to ensure that air inflation
procedures do not cause insanitary
conditions or adulterate product, they
are to incorporate such controls into
their Sanitation SOPs or another
prerequisite program.
FSIS will verify that establishments
that choose to use air inflation
procedures implement and maintain
controls that are adequate and effective
to ensure that the procedures do not
cause insanitary conditions or
adulterate product. The Agency will
verify the effectiveness of these controls
by reviewing establishment records and
directly observing the air inflation
procedures. It will also verify that
establishments that use air inflation
have incorporated their procedures for
inflating meat carcasses and parts into
their HACCP plan or Sanitation SOP or
other prerequisite program. In addition,
FSIS will assess whether these
establishments verify on an ongoing
basis that their controls are effectively
preventing insanitary conditions and
adulteration during air inflation.
This rule will provide establishments
with more production options and will
encourage the development of new
technology without diminishing food
safety.
The proposed rule noted that on
January 12, 2004, FSIS amended 9 CFR
310.13(a)(2)(iv)(D) to prohibit the use of
compressed air injection into the skull
of cattle in conjunction with a captive
bolt stunner (75 FR 28763). The 2004
rule also amended FSIS’s humane
slaughter regulations (9 CFR 313.15
(b)(2)(ii)) to prohibit the use of captive
bolt stunners that deliberately inject
compressed air into the cranium of
cattle. In this final rule, FSIS is adding
a new paragraph (310.13(b)(2)) to the
regulations stating that establishments
may not inject compressed air into the
skulls of cattle in conjunction with a
captive bolt stunner to hold the animal
still for dressing operations. The Agency
is adding this paragraph to clarify that
the prohibition against injecting
compressed air into the skulls of cattle
remains in force and to ensure that the
prohibition is retained in both sections
of the FSIS regulations that apply to air
injection procedures.
Executive Order 12866 and the
Regulatory Flexibility Act
This action has been reviewed for
compliance with Executive Order
12866. The Office of Management and
Budget has designated this proposed
PO 00000
Frm 00002
Fmt 4700
Sfmt 4700
rule ‘‘non-significant’’ and therefore has
not reviewed it.
Meat Industry Overview
Excluding slaughtering only and rawground meat processing only, there are
about 2,818 federally inspected
establishments, which, under this rule,
could adopt air inflation technology to
process raw-not-ground meat.1
Furthermore, of the 2,818 federally
inspected establishments,
approximately 1,541 are considered
very small (with less than 10
employees), 1,153 are considered small
(with between 10 and 500 employees),
and 124 are considered large (with more
than 500 employees).2
Estimated Benefits
Allowing for greater ease in
introducing new air inflation technology
and procedures will likely spur
technological innovation that will
provide this new technology to
additional meat establishments. Greater
technological innovation more widely
used by industry would likely result in
increased net higher-value meat yields,
which would lead to consumer savings.
Estimated Costs
Under this rule, establishments will
be required to incorporate their controls
for air inflation procedures into their
HACCP plan or Sanitation SOP or other
prerequisite program. FSIS does not
anticipate any new costs associated with
this rule because the HACCP regulations
already require that establishments
consider the steps of each process,
including procedures such as air
inflation, as part of their hazard analysis
and HACCP plan. Because the use of air
inflation procedures is voluntary,
establishments would not incur any
costs associated with the use of air
inflation procedures unless they
expected to realize net benefits from the
use of the new technology. Therefore,
this rule will result in negligible costs
but would provide benefits.
Regulatory Flexibility Analysis
As required by the Regulatory
Flexibility Act (5 U.S.C. 601–612), the
FSIS Administrator has examined the
economic implications of the rule and
has determined that it will not have a
significant impact on a substantial
number of small entities. Under the
rule, no establishments are required to
use air inflation procedures to inflate
meat carcasses or parts, and
establishments are only likely to do so
1 Performance
2 Ibid.
E:\FR\FM\15NOR1.SGM
15NOR1
Based Inspection System. 2009.
Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Rules and Regulations
if they would expect to realize profits by
employing such methods.
Executive Order 12988
This rule has been reviewed under
Executive Order 12988, Civil Justice
Reform. Under this 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.
Paperwork Requirements
FSIS has reviewed this rule under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520) and has determined
that the information collection related to
HACCP plans, Sanitation SOPs, and
prerequisite programs has been
approved by OMB under OMB Control
Number 0583–0103.
E-Government Act
FSIS and USDA are committed to
achieving the purposes of the
E-Government Act (44 U.S.C. 3601, et
seq.) by, among other things, promoting
the use of the Internet and other
information technologies and providing
increased opportunities for citizen
access to government information and
services, and for other purposes.
Executive Order 13175
The policies contained in this rule do
not have Tribal Implications that
preempt Tribal Law.
jdjones on DSK8KYBLC1PROD with RULES
USDA Nondiscrimination Statement
The U.S. Department of Agriculture
(USDA) prohibits discrimination in all
its programs and activities on the basis
of race, color, national origin, gender,
religion, age, disability, political beliefs,
sexual orientation, and marital or family
status. (Not all prohibited bases apply to
all programs.)
Persons with disabilities who require
alternative means for communication of
program information (Braille, large
print, audiotape, etc.) should contact
USDA’s Target Center at 202–720–2600
(voice and TTY).
To file a written complaint of
discrimination, write USDA, Office of
the Assistant Secretary for Civil Rights,
1400 Independence Avenue, SW.,
Washington, DC 20250–9410 or call
202–720–5964 (voice and TTY). USDA
is an equal opportunity provider and
employer.
Additional Public Notification
Public awareness of all segments of
rulemaking and policy development is
important. Consequently, in an effort to
VerDate Mar<15>2010
15:26 Nov 12, 2010
Jkt 223001
ensure that the public and in particular
minorities, women, and persons with
disabilities, are aware of this final rule,
FSIS will announce it on-line through
the FSIS Web page located at https://
www.fsis.usda.gov/regulations/
2010_Interim _&_Final_Rules_Index.
FSIS also will 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 our constituents and
stakeholders. The Update is
communicated via Listserv, a free e-mail
subscription service consisting of
industry, trade, and farm groups,
consumer interest groups, allied health
professionals, scientific professionals,
and other individuals who have
requested to be included. The Update
also is available on the FSIS Web page.
Through Listserv and the Web page,
FSIS is able to provide information to a
much broader, more diverse audience.
In addition, FSIS offers an e-mail
subscription service which provides
automatic and customized access to
selected food safety news and
information. This service is available at
https://www.fsis.usda.gov/
news_&_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 310
Meat inspection.
■ Accordingly, the Food Safety and
Inspection Service amends 9 CFR part
310 as follows:
PART 310—POST-MORTEM
INSPECTION
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.
2. Amend § 310.13 by revising
paragraph (a), redesignating paragraph
(b) as paragraph (b)(1), and adding
paragraph (b)(2) to read as follows:
■
§ 310.13 Inflating carcasses or parts
thereof; transferring caul or other fat.
(a) Establishments that slaughter
livestock and prepare livestock
carcasses and parts may inflate
carcasses or parts of carcasses with air
if they develop, implement, and
maintain controls to ensure that the air
inflation procedure does not cause
PO 00000
Frm 00003
Fmt 4700
Sfmt 4700
69577
insanitary conditions or adulterate
product. Establishments shall
incorporate these controls into their
HACCP plans or Sanitation SOPs or
other prerequisite programs.
(b)(1) * * *
(2) Injecting compressed air into the
skulls of cattle in conjunction with a
captive bolt stunner to hold the animal
still for dressing operations is
prohibited.
*
*
*
*
*
Done at Washington, DC, on October 29,
2010.
Alfred V. Almanza,
Administrator.
[FR Doc. 2010–28650 Filed 11–12–10; 8:45 am]
BILLING CODE 3410–DM–P
FEDERAL DEPOSIT INSURANCE
CORPORATION
12 CFR Part 330
RIN 3064–AD65
Deposit Insurance Regulations;
Unlimited Coverage for NoninterestBearing Transaction Accounts
Federal Deposit Insurance
Corporation (FDIC).
ACTION: Final rule.
AGENCY:
The FDIC is adopting a final
rule amending its deposit insurance
regulations to implement section 343 of
the Dodd-Frank Wall Street Reform and
Consumer Protection Act (‘‘Dodd-Frank
Act’’),1 providing for unlimited deposit
insurance for ‘‘noninterest-bearing
transaction accounts’’ for two years
starting December 31, 2010.
DATES: Effective Date: The final rule is
effective December 31, 2010.
FOR FURTHER INFORMATION CONTACT:
Joseph A. DiNuzzo, Supervisory
Counsel, Legal Division (202) 898–7349
or jdinuzzo@fdic.gov; Mike Figge,
Honors Attorney, Legal Division (202)
898–6750 or mfigge@fdic.gov; or James
V. Deveney, Chief, Deposit Insurance
Section, Division of Supervision and
Consumer Protection (202) 898–6687 or
jdeveney@fdic.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. The Proposed Rule
On September 30, 2010, the FDIC
published a proposed rule (‘‘proposed
rule’’) to implement section 343 of the
Dodd-Frank Act (‘‘Section 343’’).2
Section 343 amended the deposit
insurance provisions of the FDI Act (12
U.S.C. 1821(a)(1)) to provide temporary
1 Public
2 75
E:\FR\FM\15NOR1.SGM
Law 111–203 (July 21, 2010).
FR 60341 (Sept. 30, 2010).
15NOR1
Agencies
[Federal Register Volume 75, Number 219 (Monday, November 15, 2010)]
[Rules and Regulations]
[Pages 69575-69577]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28650]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 /
Rules and Regulations
[[Page 69575]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 310
[Docket No. FSIS-2007-0039]
RIN 0583-AD33
Permission To Use Air Inflation of Meat Carcasses and Parts
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the
Federal meat inspection regulations to provide that establishments that
slaughter livestock or prepare livestock carcasses and parts may
inflate carcasses and parts with air if they develop, implement, and
maintain written controls to ensure that the procedure does not cause
insanitary conditions or adulterate the product. FSIS is requiring
establishments to incorporate these controls into their Hazard Analysis
and Critical Control Point (HACCP) plans or Sanitation Standard
Operating Procedures (Sanitation SOPs) or other prerequisite programs.
In addition, FSIS is amending its regulations to remove the
approved methods for inflating livestock carcasses and parts by air and
to remove the requirement that establishments submit requests to FSIS
for approval of air inflation procedures not listed in the regulations.
FSIS is also adding a paragraph in the regulations to make clear that
the current prohibition against injecting compressed air into the
skulls of cattle remains in force.
DATES: Effective: December 15, 2010.
FOR ADDITIONAL INFORMATION: Contact Rachel Edelstein, Director, Policy
Issuances Division, Office of Policy and Program Development, Food
Safety and Inspection Service, U.S. Department of Agriculture,
Washington, DC 20250; (202) 720-5627.
SUPPLEMENTARY INFORMATION:
Background
FSIS has been delegated the authority to exercise the functions of
the Secretary of Agriculture as specified in the Federal Meat
Inspection Act (FMIA) (21 U.S.C. 601, et seq.). Under this statute,
FSIS protects the public by verifying that meat products are safe,
wholesome, not adulterated, and properly labeled and packaged.
On May 24, 2010, FSIS proposed to amend the Federal meat inspection
regulations concerning air inflation. The proposed rule explained that
on October 3, 1970, the Federal Meat Inspection regulations were
revised to prohibit inflation with air of carcasses or parts of
carcasses (35 FR 15568). On September 5, 1989, FSIS modified the
prohibition in 9 CFR 310.13(a) by providing for the use of several air
inflation procedures that had been field tested and that the Agency
found to be acceptable (54 FR 36756). The regulations required that
establishments interested in the use of air inflation procedures other
than the approved methods submit to FSIS a request for experimental
testing of the unapproved procedure. The regulations also provided that
if FSIS were to find a new method to be acceptable, it would modify its
regulations to include the new method.
As FSIS stated in the proposed rule, the Agency's original intent
in disallowing the use of air inflation was to prevent insanitary
conditions from arising and to prevent the adulteration of carcasses or
parts of carcasses. However, the Agency recognized in the 1989 final
rule that air inflation procedures could be used in a sanitary manner
without adulterating product and consequently approved the limited use
of air inflation procedures.
Under a waiver from FSIS, Packerland Co. (also known as JBS
Packerland) used an air inflation methodology to separate the brisket
and round portions from beef carcasses to increase the efficiency of
its fabrication. In July 2007, Packerland Co. petitioned FSIS to amend
its regulations to allow for this air inflation methodology. In support
of its petition, Packerland Co. presented aerobic bacteria plate count
data that showed that the use of Packerland's air inflation procedure
did not cause insanitary conditions or adulterate product.
Based on the Agency's accumulated experience with air inflation
procedures and on its evaluation of Packerland's petition, FSIS decided
to grant Packerland's petition and proposed to permit establishments
that slaughter livestock carcasses and parts to inflate carcasses and
parts with air if they develop, implement, and maintain written
controls to ensure that the procedure does not cause insanitary
conditions or adulterate product. FSIS proposed to require that
establishments incorporate these controls into their HACCP plans or
Sanitation SOPs or other prerequisite programs. FSIS also proposed to
amend its regulations to remove the approved methods for inflating
livestock carcasses and parts by air and to remove the requirement that
establishments submit requests to FSIS for approval of air inflation
procedures not listed in the regulations.
Comments and FSIS Response
The Agency received three comments on the proposal.
One trade association supported the proposed rule and stated that
the proposed action will enhance slaughter house safety programs,
reduce repetitive motion injuries, and create economic benefits through
better use of employees. In addition, the commenter stated that the
proposal will facilitate adoption of new air inflation technology.
A large corporation also supported the proposal. The commenter
stated that air from air inflation procedures is present in the
finished food at insignificant levels and does not have any technical
or functional effect in that food after the use of those procedures.
The commenter stated that, therefore, these procedures meet the
definition of incidental additives as defined in 21 CFR 101.100(a)(3)
and are exempt from labeling requirements.
The question presented in this rulemaking is whether FSIS should
provide for air inflation in its regulations. How products produced
using air inflation technology need to be labeled is a separate
question that FSIS did not address in the proposed rule. Such product
would not be required to be labeled to indicate that it has been
produced using air inflation. In addition, FSIS does not agree that air
used to inflate carcasses and parts
[[Page 69576]]
constitutes an incidental additive as defined in 21 CFR 101.100 (a)(3)
because air is a gas mixture that is being used to separate muscle
tissue, and there is no residual of any of the gases in the tissue
after use.
An individual commenter stated that a reference in the preamble to
the proposed rule to the disallowance of air injection into the skull
of cattle appears to be incorrect. The comment pointed out that the
reference should be 9 CFR 310.13 (a)(2)(iv)(C), not 9 CFR
310.13(a)(2)(iv)(D).
The Agency agrees that 9 CFR 310.13(a)(2)(iv)(C) is the correct
citation.
Therefore, nothing presented by the comments would cause the Agency
to not adopt the proposed rule.
The Final Rule
FSIS is amending 9 CFR 310.13(a) to permit establishments that
slaughter livestock or prepare livestock carcasses and parts to inflate
carcasses or parts of carcasses with air if they develop, implement,
and maintain controls to ensure that those procedures do not cause
insanitary conditions or adulterate product. Under the new rule, all
methods of air inflation will be permitted if establishments develop,
implement, and maintain controls to ensure that these procedures do not
cause insanitary conditions or adulterate product. Therefore, FSIS is
also removing the approved methods for inflating meat carcasses and
parts from the regulations. For the same reason, the Agency is removing
the requirement that establishments submit requests to FSIS for
approval of air inflation procedures not listed in the regulations.
Under this final rule, establishments that are using an approved air
inflation procedure can continue to do so, but they will be required to
incorporate their air inflation procedures into their HACCP plans or
Sanitation SOPs or other prerequisite programs.
As part of their HACCP plans and hazard analysis, establishments
are required to prepare a flow chart describing the steps of each
process and product flow in the establishment (9 CFR 417.2(a)(2)).
Under the final rule, if an establishment uses air inflation
procedures, the flow chart will need to include those procedures. Under
the HACCP regulations, establishments are also required to consider
whether air inflation may make biological hazards, such as
contamination with certain pathogens, reasonably likely to occur (9 CFR
417.2(a)(1)).
Also under the HACCP regulations, if an establishment determines
that air inflation procedures do not introduce any hazards, it is to
document the reasons for its determination in its decision-making
documents (9 CFR 417.5). Under this final rule, if establishments that
use air inflation maintain controls outside of their HACCP plans to
ensure that air inflation procedures do not cause insanitary conditions
or adulterate product, they are to incorporate such controls into their
Sanitation SOPs or another prerequisite program.
FSIS will verify that establishments that choose to use air
inflation procedures implement and maintain controls that are adequate
and effective to ensure that the procedures do not cause insanitary
conditions or adulterate product. The Agency will verify the
effectiveness of these controls by reviewing establishment records and
directly observing the air inflation procedures. It will also verify
that establishments that use air inflation have incorporated their
procedures for inflating meat carcasses and parts into their HACCP plan
or Sanitation SOP or other prerequisite program. In addition, FSIS will
assess whether these establishments verify on an ongoing basis that
their controls are effectively preventing insanitary conditions and
adulteration during air inflation.
This rule will provide establishments with more production options
and will encourage the development of new technology without
diminishing food safety.
The proposed rule noted that on January 12, 2004, FSIS amended 9
CFR 310.13(a)(2)(iv)(D) to prohibit the use of compressed air injection
into the skull of cattle in conjunction with a captive bolt stunner (75
FR 28763). The 2004 rule also amended FSIS's humane slaughter
regulations (9 CFR 313.15 (b)(2)(ii)) to prohibit the use of captive
bolt stunners that deliberately inject compressed air into the cranium
of cattle. In this final rule, FSIS is adding a new paragraph
(310.13(b)(2)) to the regulations stating that establishments may not
inject compressed air into the skulls of cattle in conjunction with a
captive bolt stunner to hold the animal still for dressing operations.
The Agency is adding this paragraph to clarify that the prohibition
against injecting compressed air into the skulls of cattle remains in
force and to ensure that the prohibition is retained in both sections
of the FSIS regulations that apply to air injection procedures.
Executive Order 12866 and the Regulatory Flexibility Act
This action has been reviewed for compliance with Executive Order
12866. The Office of Management and Budget has designated this proposed
rule ``non-significant'' and therefore has not reviewed it.
Meat Industry Overview
Excluding slaughtering only and raw-ground meat processing only,
there are about 2,818 federally inspected establishments, which, under
this rule, could adopt air inflation technology to process raw-not-
ground meat.\1\ Furthermore, of the 2,818 federally inspected
establishments, approximately 1,541 are considered very small (with
less than 10 employees), 1,153 are considered small (with between 10
and 500 employees), and 124 are considered large (with more than 500
employees).\2\
---------------------------------------------------------------------------
\1\ Performance Based Inspection System. 2009.
\2\ Ibid.
---------------------------------------------------------------------------
Estimated Benefits
Allowing for greater ease in introducing new air inflation
technology and procedures will likely spur technological innovation
that will provide this new technology to additional meat
establishments. Greater technological innovation more widely used by
industry would likely result in increased net higher-value meat yields,
which would lead to consumer savings.
Estimated Costs
Under this rule, establishments will be required to incorporate
their controls for air inflation procedures into their HACCP plan or
Sanitation SOP or other prerequisite program. FSIS does not anticipate
any new costs associated with this rule because the HACCP regulations
already require that establishments consider the steps of each process,
including procedures such as air inflation, as part of their hazard
analysis and HACCP plan. Because the use of air inflation procedures is
voluntary, establishments would not incur any costs associated with the
use of air inflation procedures unless they expected to realize net
benefits from the use of the new technology. Therefore, this rule will
result in negligible costs but would provide benefits.
Regulatory Flexibility Analysis
As required by the Regulatory Flexibility Act (5 U.S.C. 601-612),
the FSIS Administrator has examined the economic implications of the
rule and has determined that it will not have a significant impact on a
substantial number of small entities. Under the rule, no establishments
are required to use air inflation procedures to inflate meat carcasses
or parts, and establishments are only likely to do so
[[Page 69577]]
if they would expect to realize profits by employing such methods.
Executive Order 12988
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. Under this 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.
Paperwork Requirements
FSIS has reviewed this rule under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501-3520) and has determined that the information
collection related to HACCP plans, Sanitation SOPs, and prerequisite
programs has been approved by OMB under OMB Control Number 0583-0103.
E-Government Act
FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things,
promoting the use of the Internet and other information technologies
and providing increased opportunities for citizen access to government
information and services, and for other purposes.
Executive Order 13175
The policies contained in this rule do not have Tribal Implications
that preempt Tribal Law.
USDA Nondiscrimination Statement
The U.S. Department of Agriculture (USDA) prohibits discrimination
in all its programs and activities on the basis of race, color,
national origin, gender, religion, age, disability, political beliefs,
sexual orientation, and marital or family status. (Not all prohibited
bases apply to all programs.)
Persons with disabilities who require alternative means for
communication of program information (Braille, large print, audiotape,
etc.) should contact USDA's Target Center at 202-720-2600 (voice and
TTY).
To file a written complaint of discrimination, write USDA, Office
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue,
SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY).
USDA is an equal opportunity provider and employer.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that the
public and in particular minorities, women, and persons with
disabilities, are aware of this final rule, FSIS will announce it on-
line through the FSIS Web page located at https://www.fsis.usda.gov/regulations/2010_Interim --&--Final--Rules--Index.
FSIS also will 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 our constituents and
stakeholders. The Update is communicated via Listserv, a free e-mail
subscription service consisting of industry, trade, and farm groups,
consumer interest groups, allied health professionals, scientific
professionals, and other individuals who have requested to be included.
The Update also is available on the FSIS Web page. Through Listserv and
the Web page, FSIS is able to provide information to a much broader,
more diverse audience.
In addition, FSIS offers an e-mail subscription service which
provides automatic and customized access to selected food safety news
and information. This service is available at https://www.fsis.usda.gov/news_&_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 310
Meat inspection.
0
Accordingly, the Food Safety and Inspection Service amends 9 CFR part
310 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.
0
2. Amend Sec. 310.13 by revising paragraph (a), redesignating
paragraph (b) as paragraph (b)(1), and adding paragraph (b)(2) to read
as follows:
Sec. 310.13 Inflating carcasses or parts thereof; transferring caul
or other fat.
(a) Establishments that slaughter livestock and prepare livestock
carcasses and parts may inflate carcasses or parts of carcasses with
air if they develop, implement, and maintain controls to ensure that
the air inflation procedure does not cause insanitary conditions or
adulterate product. Establishments shall incorporate these controls
into their HACCP plans or Sanitation SOPs or other prerequisite
programs.
(b)(1) * * *
(2) Injecting compressed air into the skulls of cattle in
conjunction with a captive bolt stunner to hold the animal still for
dressing operations is prohibited.
* * * * *
Done at Washington, DC, on October 29, 2010.
Alfred V. Almanza,
Administrator.
[FR Doc. 2010-28650 Filed 11-12-10; 8:45 am]
BILLING CODE 3410-DM-P