[Federal Register: November 15, 2010 (Volume 75, Number 219)]
[Rules and Regulations]
[Page 69575-69577]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15no10-1]
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Rules and Regulations
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[[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.
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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\
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\1\ Performance Based Inspection System. 2009.
\2\ Ibid.
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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 http://www.fsis.usda.gov/regulations/2010_Interim_&_Final_Rules_Index/index.asp.
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 http://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]
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