[Federal Register: May 24, 2010 (Volume 75, Number 99)]
[Proposed Rules]               
[Page 28763-28765]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24my10-9]                         

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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[[Page 28763]]



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: Proposed Rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
revise the Federal meat inspection regulations to permit establishments 
that slaughter livestock or prepare 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 is proposing to 
require that establishments 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 proposing 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.

DATES: Comments must be received on or before June 23, 2010.

ADDRESSES: FSIS invites interested persons to submit comments on this 
proposed rule. Comments may be submitted by either of the following 
methods:
     Federal eRulemaking Portal: This Web site provides the 
ability to type short comments directly into the comment field on this 
Web page or attach a file for lengthier comments. Go to http://
www.regulations.gov. Follow the online instructions at that site for 
submitting comments.
     Mail, including floppy disks or CD-ROMs, and hand- or 
courier-delivered items: Send to Docket Clerk, USDA, FSIS, Room 2-2175 
George Washington Carver Center, 5601 Sunnyside Avenue, Mailstop 5272, 
Beltsville, MD 20705.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2007-0039. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or comments received, go 
to the FSIS Docket Room at the address listed above between 8:30 a.m. 
and 4:30 p.m., Monday through Friday.

FOR FURTHER 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: 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 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 were acceptable. These methods involve inflating carcasses and 
parts of carcasses with compressed air during dressing operations to 
facilitate head skinning and the removal of hides and foot hair (54 FR 
36755).
    Establishments interested in the use of air inflation procedures 
for other than the approved methods are required to submit to FSIS a 
request for experimental testing of any unapproved procedure (9 CFR 
310.13(a)(2)). The regulations require that these requests state the 
purpose of the use of air, provide a detailed description of the 
procedure, and include evidence that the procedure can be performed in 
a sanitary manner. The regulations also provide that if FSIS finds a 
new method to be acceptable, it will modify its regulations to include 
the new method.
    In the 1989 final rule, FSIS stated that its 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 (54 FR 36755). However, the Agency recognized in 
that final rule that air inflation procedures could be used in a 
sanitary manner without adulterating product and consequently approved 
limited use of air inflation procedures. On July 20, 1990, FSIS amended 
9 CFR 310.13(a)(2)(iv) to allow for the use of compressed air injected 
into the abdominal cavity of swine to facilitate the skinning operation 
and to minimize the loss of body fat (55 FR 29564).\1\
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    \1\ 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 (69 FR 1891).
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    Under 9 CFR 303.1(h), the Administrator may waive specific 
regulations for limited periods to permit experimentation so that new 
procedures, equipment, or processing techniques may be tested to 
facilitate definite improvements. Under a waiver that FSIS has granted, 
Packerland Co.\2\ is using air inflation methodology to separate the 
brisket and round portions from beef carcasses for more efficient 
fabrication. FSIS requested that Packerland collect aerobic bacteria 
plate counts (APC) and submit the data to FSIS as a means of 
determining whether the use of air inflation would cause insanitary 
conditions or adulterate product. APC data are meaningful measures of 
bacteria levels on carcasses. Packerland Co. has petitioned FSIS to 
amend its regulations to allow for this air inflation methodology and 
presented APC data in the petition. The data submitted in the petition 
show that there is no significant difference between treated (injected 
with air) and untreated carcasses with regards to APC. Hence, the data 
show that the use of Packerland's air inflation procedure does not 
cause insanitary conditions or adulterate product.
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    \2\ Packerland Co. is also known as JBS Packerland.

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[[Page 28764]]

    Based on the Agency's accumulated experience with air inflation 
procedures and in response to Packerland's petition, FSIS is proposing 
to amend 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. FSIS is proposing to require that 
establishments incorporate these controls into their HACCP plans or 
Sanitation SOPs or other prerequisite programs. In addition, FSIS is 
proposing to amend its regulations to remove the requirement that 
establishments submit requests to FSIS for approval of air inflation 
procedures not listed in the regulations.
    FSIS is also proposing to remove the approved methods for inflating 
meat carcasses and parts from the regulations. Establishments that are 
using an approved air inflation procedure could continue to do so, but 
they would be required to incorporate their air inflation procedures 
into their HACCP plans or Sanitation SOPs or other prerequisite 
programs. This proposal is consistent with the HACCP regulations. 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)). If the 
establishment uses air inflation procedures, under this proposed rule, 
the flow chart would 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 the establishment determines 
that air inflation procedures do not introduce any hazards, it is to 
document the reasons for this determination in its decision-making 
documents that are associated with the hazard analysis (9 CFR 417.5). 
Under these regulations, 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 would be required to incorporate such controls in their 
Sanitation SOPs or another prerequisite program.
    If this proposed rule becomes final, FSIS will verify that 
establishments that choose to use air inflation procedures have 
implemented and maintain written controls that are adequate and 
effective to ensure that the procedures do not cause insanitary 
conditions or adulterate product. FSIS will verify the effectiveness of 
these controls by reviewing establishment records and directly 
observing the air inflation procedures. FSIS will verify that 
establishments using air inflation have incorporated their procedures 
for inflating meat carcasses and parts with air into their HACCP plan 
or Sanitation SOP or other prerequisite program. In addition, FSIS will 
assess whether establishments verify on an ongoing basis that their 
controls are effectively preventing insanitary conditions and 
adulteration during air inflation.
    This proposed rule would provide establishments with more 
production options and would encourage the development of new 
technology without diminishing food safety.

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 proposed rule could adopt air inflation technology to process raw-
not-ground meat.\3\ 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).\4\
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    \3\ Performance Based Inspection System. 2009.
    \4\ Ibid.
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Estimated Benefits

    Allowing for greater ease in introducing new air inflation 
technology and procedures would likely spur technological innovation 
that will provide these new technologies and procedures 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. Because the rule is 
voluntary, it is difficult for the Agency to quantify benefits of the 
rule to the industry of the rule and to consumers. FSIS requests 
information about the likely net benefits, and the likely adoption 
rates of these types of air inflation procedures in meat operations.

Estimated Costs

    Under this proposal, establishments would be required to 
incorporate their controls for air inflation procedures into their 
HACCP plan, Sanitation SOP or other prerequisite program. FSIS does not 
anticipate any new costs associated with this analysis because the 
HACCP regulations already require that establishments consider the 
steps of each process, including procedures such as air inflation, as 
part of their HACCP plan and hazard analysis. Since 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 would 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 
proposed rule and has determined that it would not have a significant 
impact on a substantial number of small entities. Under the proposed 
rule, no establishments are required to use air inflation procedures to 
inflate meat carcasses or parts, and establishments are only likely to 
do so if they would expect to realize profits by employing such 
methods.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. Under this proposed 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 proposed 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

[[Page 28765]]

information technologies and providing increased opportunities for 
citizen access to Government information and services, and for other 
purposes.

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 proposed rule, FSIS will announce it 
on-line through the FSIS Web page located at http://www.fsis.usda.gov/
regulations/2010_Proposed_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_and_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 proposes to 
amend 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 Sec.  310.13(a) to revise paragraph (a) 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 must incorporate these controls into 
their HACCP plans or Sanitation SOPs or other prerequisite programs.
* * * * *

    Done at Washington, DC, on May 14, 2010.
Alfred V. Almanza,
Administrator.
[FR Doc. 2010-12337 Filed 5-21-10; 8:45 am]
BILLING CODE 3410-DM-P