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Rules and Regulations Federal Register

69575 

Vol. 75, No. 219 

Monday, November 15, 2010 

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 


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69576 Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Rules and Regulations 

1Performance Based Inspection System. 2009. 

2 Ibid. 

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 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 


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Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Rules and Regulations 69577 

1Public Law 111–203 (July 21, 2010). 

2 75 FR 60341 (Sept. 30, 2010). 

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. 

■ 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 

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 

AGENCY: Federal Deposit Insurance 

Corporation (FDIC). 

ACTION: Final rule. 

SUMMARY: 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: 

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 


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