[Federal Register Volume 59, Number 156 (Monday, August 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19833]


[[Page Unknown]]

[Federal Register: August 15, 1994]


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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service

9 CFR Part 318

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

 

Sodium Citrate as a Tripe Denuding Agent

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 permit the use of sodium citrate 
in solution to denude beef stomachs of mucous membranes (tripe). This 
regulation makes available to meat processors an additional, 
alternative tripe-denuding formulation containing sodium citrate as an 
ingredient. The sodium citrate solution is as effective as existing 
tripe-denuding agents, but is less objectionable to workers than the 
agents now in use. The sodium citrate-containing formulation 
contributes to improved tripe production.

EFFECTIVE DATE: September 14, 1994.

FOR FURTHER INFORMATION CONTACT: Dr. William James, Director, Slaughter 
Inspection Standards and Procedures Division, Science and Technology, 
Food Safety and Inspection Service, U.S. Department of Agriculture, 
Washington, DC 20250-3700, (202) 720-3219.

SUPPLEMENTARY INFORMATION:

Background

    Under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), FSIS 
provides mandatory inspection of meat and meat food products prepared 
for distribution in 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, 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, Birko Corporation, a manufacturer of processing aids and 
other direct food ingredients, petitioned the Food and Drug 
Administration (FDA) and us 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. We 
reviewed the data and other information submitted by the petitioner and 
determined that the proposed use of sodium citrate did 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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    \1\A copy of this letter is available for review in the office 
of the FSIS Docket Clerk, U.S. Department of Agriculture, Food 
Safety and Inspection Service, Room 3171-S, Washington, DC 20250-
3700.
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    On January 5, 1994, we published a proposal in the Federal Register 
(59 FR 550-551) to permit the use of sodium citrate, in combination 
with other approved agents, to denude beef stomachs of mucous 
membranes, in an amount sufficient to accomplish the intended effect. 
We received no comments in response to the proposed rule.
    Therefore, we are amending 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 will be subject to the condition that the substance be 
removed from the denuded tripe by rinsing with potable water.

Executive Order 12866 and Regulatory Flexibility Act

    This 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 determined that this final 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). This 
regulation makes available to meat processors an additional, 
alternative tripe-denuding formulation containing 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 will benefit from the use of the 
sodium citrate product because it provides them a more efficient, less 
expensive, alternate means of tripe preparation than is currently 
available.

Executive Order 12778

    This final rule was 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 final 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.

List of Subjects in 9 CFR Part 318

    Meat inspection, Food additives.

    For the reasons set out in the preamble, 9 CFR part 318 is amended 
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 
2.17, 2.55.

    2. Section 318.7(c)(4) is 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) * * * 

----------------------------------------------------------------------------------------------------------------
       Class of substance              Substance            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 August 4, 1994.
Patricia Jensen,
Acting Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-19833 Filed 8-12-94; 8:45 am]
BILLING CODE 3410-DM-P