[Federal Register Volume 62, Number 120 (Monday, June 23, 1997)]
[Rules and Regulations]
[Pages 33744-33746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16392]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR 318 and 381

[Docket No. 96-010DF]
RIN 0583-AC11


Use of Sodium Acetate and Sodium Diacetate as Flavoring Agents in 
Meat and Poultry Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Direct final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the 
Federal meat and poultry products inspection regulations to permit the 
use of sodium acetate at the level of 0.12 percent of the product 
formulation and sodium diacetate at the level of 0.1 percent of the 
product formulation as flavoring agents in meat and poultry products. 
Sodium acetate and sodium diacetate are listed in the Food and Drug 
Administration's (FDA) regulations as substances generally recognized 
as safe for several uses in accordance with good manufacturing 
practice. This direct final rule is in response to a petition.

DATES: This rule will be effective on August 22, 1997 unless the Agency 
receives written adverse comments within the scope of the rulemaking or 
written notice of intent to submit adverse comments within the scope of 
the rulemaking on or before July 23, 1997.

ADDRESSES: Please send an original and two copies of written adverse 
comments or notice of intent to submit written adverse comments to the 
FSIS Docket Clerk, Docket #96-010DF, Room 102 Cotton Annex, Food Safety 
and Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250.

FOR FURTHER INFORMATION CONTACT: Charles R. Edwards, Director, 
Facilities, Equipment, Labeling, and Compound Review Division, Office 
of Policy, Program Development and Evaluation, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250; (202) 48-8900.

SUPPLEMENTARY INFORMATION:

Background

    FSIS was petitioned by Armour Swift-Eckrich to allow the use of 
sodium acetate and sodium diacetate as flavoring agents in meat and 
poultry products to improve the overall flavor and consumer acceptance. 
Sodium acetate is the sodium salt of vinegar and sodium diacetate is a 
blend of vinegar and salt of vinegar. Both ingredients are used as 
flavoring agents and adjuvants, and as pH control agents. The 
petitioner requested that FSIS amend the regulations to permit sodium 
acetate at the level of 0.12 percent of the product formulation and 
sodium diacetate at the level of 0.1 percent of the product formulation 
as flavoring agents in meat and poultry products. Data and information 
submitted by the petitioner showed that after products are prepared in 
sauces, spices, and seasoning blends that are made using these 
ingredients, the overall flavor is improved and the products are more 
acceptable to the consumer. Levels of sodium acetate and sodium 
diacetate higher than those indicated were not shown to be effective. 
Therefore, the levels in the direct final rule represent the lowest 
necessary to achieve the intended effect.
    After reviewing the petitioner's data and information, FSIS 
determined that the charts of approved substances in the meat and 
poultry regulations should be amended to allow the use of sodium 
acetate at the level of 0.12 percent and sodium diacetate at the level 
of 0.1 percent of formulation weight as flavoring agents in meat and 
poultry products. The technical data demonstrate the efficacy of sodium 
acetate and sodium diacetate for these uses.
    FDA lists sodium acetate (21 CFR 184.1721) and sodium diacetate (21 
CFR 184.1754) as generally recognized as safe for several uses when 
used in accordance with good manufacturing practice at maximum levels 
of 0.12 percent for sodium acetate and 0.1 percent for sodium 
diacetate. Therefore, FSIS is amending the charts of approved 
substances in 9 CFR 318.7(c)(4) and 381.147(f)(4) to allow the use of 
sodium acetate at the level of 0.12 percent of the formulation by 
weight and sodium diacetate at a level of 0.1 percent of the 
formulation by weight as flavoring agents in meat and poultry products.
    FSIS expects no adverse public reaction resulting from the changes 
in regulatory language, because the compounds have received FDA 
approval for various other uses, as here, in small amounts for 
flavoring only. Therefore, unless the Agency receives written adverse 
comments within the scope of this rulemaking or a written notice of 
intent to submit adverse comments within the scope of the rulemaking 
within 30 days, the action will become final 60 days after publication 
in the Federal Register. If written adverse comments within the scope 
of the rulemaking are received, the final rulemaking notice will be 
withdrawn and a proposed rulemaking notice will establish a comment 
period.

Executive Order 12988

    This direct final rule has been reviewed under Executive Order 
12988, Civil Justice Reform. This rule: (1) Preempts all State and 
local laws and regulations that are in conflict with this rule; (2) has 
no retroactive effect; and (3) does not require administrative 
proceedings before parties may file suit in court challenging this 
rule.

Executive Order 12866 and Regulatory Flexibility Act

    This direct final rule has been determined to be not significant 
and, therefore, has not been reviewed by the Office of Management and 
Budget.
    The Administrator has made an initial determination that this 
direct final rule will not have a significant economic impact on a 
substantial number of small entities, as defined by the Regulatory 
Flexibility Act (5 U.S.C. 601). The direct final rule will permit the 
use of sodium acetate at a level of 0.12 percent of the product 
formulation and sodium diacetate at a level of 0.1 percent of the 
product formulation as flavoring agents in meat and poultry products. 
This direct final rule will impose no new requirements on small 
entities.

[[Page 33745]]

Paperwork Requirements

    Abstract: FSIS has reviewed the paperwork and recordkeeping 
requirements in this direct final rule in accordance with the Paperwork 
Reduction Act. Manufacturers opting to use sodium acetate and/or sodium 
diacetate as flavoring agents in meat or poultry products are required 
to revise their product label and submit such labeling to FSIS for 
approval.
    Estimate of Burden: FSIS estimates that it takes 60 minutes to 
design and modify a label in accordance with these regulations. For 
label submissions, FSIS estimates a 15 minute response time to prepare 
the label application form, submit it, along with the label, to FSIS or 
to a label expediter who will deliver the form and label to FSIS.
    Respondents: Meat and poultry establishments.
    Estimated Number of Respondents: 50 meat and poultry 
establishments.
    Estimated Number of Responses per Respondent: FSIS estimates that 
each establishment would modify about 10 product labels.
    Estimated Total Annual Burden on Respondents: 625 hours.
    Copies of this information collection assessment can be obtained 
from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection 
Service, USDA, Room 109, Cotton Annex, Washington DC 20250-3700.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the Agency, including whether the information will have practical 
utility; (b) the accuracy of the Agency's estimate of the burden of the 
proposed collection of information including the validity of the method 
and the assumptions used; (c) ways to enhance the quality, utility, and 
clarity of the information to be collected; (d) ways to minimize the 
burden of the collection of information on those who are to respond; 
including through use of appropriate automated, electronic, mechanical, 
or other technological collection techniques or other forms of 
information technology. Comments may be sent to Lee Puricelli, 
Paperwork Specialist, see the address above, and Desk Officer for 
Agriculture, Office of Information and Regulatory Affairs, Office of 
Management and Budget (OMB),Washington, DC 20253.
    Comments are requested by August 22, 1997. To be most effective, 
comments should be sent to OMB within 30 days of the publication date 
of this final rule.

List of Subjects

9 CFR Part 318

    Food additives, Meat inspection.

9 CFR Part 381

    Food additives, Poultry and poultry products.

    For the reasons discussed in this preamble, FSIS is amending 9 CFR 
parts 318 and 381 of the Federal meat and poultry products inspection 
regulations as follows:

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND 
PREPARATION OF PRODUCTS

    1. The authority citation for part 318 continues to read as 
follows:

    Authority: 7 U.S.C. 450,1901-1906; 21 U.S.C. 601-695; 7 CFR 
2.18, 2.53.

    2. Section 318.7(c)(4) is amended by adding at the end of the chart 
of substances, under the Class of Substance ``Flavoring Agents, 
Protectors and Developers,'' new entries for ``sodium acetate'' and 
``sodium diacetate'' to read as follows:


Sec. 318.7  Approval of substances for use in the preparation of 
products.

* * * * *
    (c) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
  Class of                                                                                                      
 substance           Substance                 Purpose                  Products                 Amounts        
----------------------------------------------------------------------------------------------------------------
                                                                                                                
                                                                                                                
*                  *                  *                  *                  *                  *                
                                                        *                                                       
             Sodium acetate..........  To flavor product......  Various................  Not to exceed 0.12     
                                                                                          percent of formulate  
                                                                                          in accordance         
             Sodium diacetate........  ......do...............  ......do...............  Not to exceed 0.1      
                                                                                          percent of formulate  
                                                                                          in accordance with 21 
                                                                                          CFR 184.1754.         
                                                                                                                
*                  *                  *                  *                  *                  *                
                                                        *                                                       
----------------------------------------------------------------------------------------------------------------

* * * * *

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    3. The authority citation for part 381 continues to read as 
follows:

    Authority: 7 U.S.C. 138f; 7 U.S.C. 450; 221 U.S.C. 451-470; 7 
CFR 2.18, 1.53.

    4. Section 381.147(f)(4) is amended by adding at the end of the 
chart of substances, under the Class of Substance ``Flavoring agents; 
Protectors and Developers,'' the substances ``sodium acetate'' and 
``sodium diacetate'' to read as follows:


Sec. 381.147  Restriction on the use of substances of in poultry 
products.

* * * * *
    (f) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
  Class of                                                                                                      
 substance           Substance                 Purpose                  Products                 Amounts        
----------------------------------------------------------------------------------------------------------------
                                                                                                                
                                                                                                                
*                  *                  *                  *                  *                  *                
                                                        *                                                       
             Sodium Acetate..........  To flavor product......  Various................  Not to exceed 0.12     
                                                                                          percent of formulate  
                                                                                          in accordance with 21 
                                                                                          CFR 184.1721.         
             Sodium Diacetate........  To flavor product......  Various................  Not to exceed 0.1      
                                                                                          percent of formulate  
                                                                                          in accordance with 21 
                                                                                          CFR 184.1754.         
                                                                                                                
*                  *                  *                  *                  *                  *                
                                                        *                                                       
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[[Page 33746]]

    Done at Washington, DC, on: June 11, 1997.
Thomas J. Billy,
Administrator.
[FR Doc. 97-16392 Filed 6-20-97; 8:45 am]
BILLING CODE 3410-DM-P