Sodium Citrate as a Tripe Denuding Agent

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) * * *

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Class of substance Substance Purpose Products Amount

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* * * * * * *

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