[Federal Register Volume 59, Number 3 (Wednesday, January 5, 1994)]
[Proposed Rules]
[Pages 550-551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-105]


[[Page Unknown]]

[Federal Register: January 5, 1994]


                                                     VOL. 59, NO. 3

                                         Wednesday, January 5, 1994
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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 318

[Docket No. 92-029P]
RIN 0583-AB66

 

Sodium Citrate as a Tripe Denuding Agent

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 
amend the Federal meat inspection regulations to permit the use of 
sodium citrate in solution to denude beef stomachs of mucous membranes. 
In 1990, a manufacturer of processing aids and other direct food 
ingredients petitioned the Food and Drug Administration and FSIS to 
approve the use of several compounds, including sodium citrate, for use 
in denuding tripe. FSIS has reviewed the data and other information 
submitted by the petitioner and has determined that the proposed use of 
sodium citrate would not result in product adulteration or misbranding. 
The proposed regulation would make available to meat processors an 
additional, alternative tripe-denuding formulation that would contain 
sodium citrate as an ingredient. The sodium citrate solution would be 
as effective as existing tripe-denuding agents, but would be less 
objectionable to workers than the agents now in use. The sodium 
citrate-containing formulation would contribute to improved tripe 
production.

DATES: Comments must be submitted on or before March 7, 1994.

ADDRESSES: Written comments to: Policy Office, Attn. Diane Moore, FSIS 
Hearing Clerk, room 3171 South Agriculture Building, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250.

FOR FURTHER INFORMATION CONTACT:
Dr. Bill James, Director, Slaughter Inspection Standards and Procedures 
Division, Science and Technology, Food Safety and Inspection Service, 
U.S. Department of Agriculture, Washington, DC 20250, (202) 720-3219.

SUPPLEMENTARY INFORMATION:

Executive Order 12866

    This proposed rule is in conformance with Executive Order 12866, 
and the Assistant Secretary has determined that it is not a 
``significant regulatory action.'' This proposed rule: (1) Would have 
an effect on the economy of less than $100 million; (2) would not 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health and safety, or State, local or tribal governments or 
communities; (3) would not create a serious inconsistency or otherwise 
interfere with an action taken or planned by another agency; (4) would 
not alter the budgetary impact of entitlements, grants, user fees, or 
loan programs or rights or obligations or recipients thereof; and (5) 
would not raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or principles set forth in 
Executive Order 12866.

Executive Order 12778

    This proposed rule has been reviewed under Executive Order 12778, 
Civil Justice Reform. States and local jurisdictions are preempted 
under the Federal Meat Inspection Act (FMIA) and the Poultry Products 
Inspection Act (PPIA) from imposing requirements with respect to 
premises, facilities, and operations of federally inspected meat or 
poultry products, and any marking, labeling, packaging, or ingredient 
requirements on federally inspected meat and poultry products that are 
in addition to, or different than, those imposed under the FMIA and 
PPIA. States and local jurisdictions may, however, exercise concurrent 
jurisdiction over meat and poultry products that are outside official 
establishments for the purpose of preventing the distribution of meat 
and poultry products that are misbranded or adulterated under the FMIA 
or PPIA, or in the case of imported articles, which are not at such an 
establishment, after their entry into the United States. The States 
may, however, impose more stringent requirements on such State 
inspected products and establishments.
    This proposed rule is not intended to have retroactive effect, and 
no applicable administrative procedures must be exhausted before any 
judicial challenge to the provisions of this rule. However, the 
applicable administrative procedures specified in 9 CFR 306.5 must be 
exhausted prior to any judicial challenge to the application of the 
provisions of this rule, if the challenge involves any decision of an 
inspector relating to inspection services provided under the FMIA. The 
applicable administrative procedures specified in 9 CFR part 335 must 
be exhausted prior to any judicial challenge to the application of the 
provisions of this rule with respect to labeling decisions.

Effect on Small Entities

    The Administrator has determined that this proposed rule will not 
have a significant impact on a substantial number of small entities, as 
defined by the Regulatory Flexibility Act (5 U.S.C. 601). The proposed 
regulation would make available to meat processors an additional, 
alternative tripe-denuding formulation that would contain sodium 
citrate as an ingredient. The sodium citrate formulation could be 
manufactured and sold in liquid form and used in existing or newly 
developed tripe denuding equipment. The sodium citrate-containing 
formulation could be used most efficiently in the new equipment and 
contribute to improved tripe production. Small establishments could 
benefit from the use of the sodium citrate product.

Background

    Under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), FSIS 
provides for mandatory inspection of meat and meat food products 
shipped in interstate and foreign commerce. The Act prohibits the 
addition of any substance to any meat or meat food product that may 
render the product adulterated (21 U.S.C. 601). Section 318.7(a)(1) of 
the Federal meat inspection regulations (9 CFR 318.7) prohibits the use 
of any substance in the preparation of any product unless its use is 
approved in Sec. 318.7(c)(4) of the Federal meat inspection regulations 
(9 CFR 318.7), which is the chart of substances acceptable for use in 
the preparation of products, or unless it is approved elsewhere in the 
regulations or it is approved by the Administrator.
    In 1990, a manufacturer of processing aids and other direct food 
ingredients petitioned the Food and Drug Administration (FDA) and FSIS 
to approve the use of several compounds, including sodium citrate, for 
use in denuding tripe. Tripe denudation--the removal of mucous 
membranes from beef stomachs--is a necessary step in the cleaning and 
preparation of tripe for use as human food. FSIS has reviewed the data 
and other information submitted by the petitioner and has determined 
that the proposed use of sodium citrate would not result in product 
adulteration or misbranding.
    FDA lists sodium citrate as generally recognized as safe when used 
in accordance with good manufacturing practice in an amount not in 
excess of that required to achieve its intended effect (21 CFR 
182.1751). In an August 24, 1992, letter to the petitioner, FDA 
reported this fact and stated that it would have ``no objection to 
[sodium citrate's] addition to the tripe-denuding mixture [contemplated 
by the petitioner] providing that it is used in accordance with good 
manufacturing practice.''1 FDA further stipulated that the sodium 
citrate used be of food-grade quality and that the quantity used not be 
in excess of the amount reasonably required to accomplish its intended 
effect.
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    \ \A copy of this letter is available from the FSIS Hearing 
Clerk, USDA, 14th & Independence Avenue, SW., room 3175, South 
Agriculture Building, Washington, DC 20250.
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    FSIS is proposing to amend Sec. 318.7(c)(4) of the Federal meat 
inspection regulations to permit the use of sodium citrate as a tripe 
denuding agent in combination with other approved agents, in an amount 
sufficient to accomplish the intended effect. Use of sodium citrate for 
this purpose would be subject to the condition that the substance be 
removed from the denuded tripe by rinsing with potable water.

List of Subjects in 9 CFR Part 318

    Food additives, Meat inspection.

    For the reasons set out in the preamble, 9 CFR part 318 is proposed 
to be amended as follows:

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

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


    Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 
2.17, 2.55.


    2. Section 318.7(c)(4) would be amended by adding to the chart of 
substances, under the Class of substance ``Denuding agents; may be used 
in combination. Must be removed from tripe by rinsing with potable 
water.'' the substance sodium citrate in alphabetical order as follows:


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

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

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       Class of substances             Substances            Purpose            Products             Amount     
----------------------------------------------------------------------------------------------------------------
                                                                                                                
                                                    ****** *                                                    
Denuding Agents; may be used in    Sodium Citrate....  ......do..........  ......do..........  Do.              
 combination. Must be removed                                                                                   
 from tripe by rinsing with                                                                                     
 potable water.                                                                                                 
                                                                                                                
                                                    ****** *                                                    
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    Done at Washington, DC, on December 27, 1993.
Eugene Branstool,
Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-105 Filed 1-4-94; 8:45 am]
BILLING CODE 3410-DM-M