Sodium Citrate as a Tripe Denuding Agent

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

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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 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