[Federal Register Volume 75, Number 219 (Monday, November 15, 2010)]
[Rules and Regulations]
[Pages 69575-69577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28650]



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Rules and Regulations
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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.

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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.
    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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