Ascorbic Acid, Erythorbic Acid, Citric Acid, Sodium Ascorbate, and Sodium Citrate on Beef, Lamb, and Pork Cuts

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317 and 318

[Docket No. 89-022F]

RIN 0583-AB15

Ascorbic Acid, Erythorbic Acid, Citric Acid, Sodium Ascorbate,

and Sodium Citrate on Beef, Lamb, and Pork Cuts

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 application of

ascorbic acid, erythorbic acid, citric acid, sodium ascorbate, and

sodium citrate, singly or in combination, to the surface of fresh beef

cuts or fresh lamb cuts to delay discoloration of such cuts. Use of

these substances will result in the preservation of a fresh color and

appearance throughout the product's microbiological shelf life. This

action is in response to petitions submitted by Wilson Foods

Corporation. In addition, FSIS is amending the regulations to clarify

the permitted use and levels of such substances on fresh pork cuts, and

revise the purpose of these substances from ``to maintain color'' to

``to delay discoloration'' for clarification. Preserving the fresh

color and appearance of beef and lamb cuts increases the marketability

of such products; therefore, losses to manufacturers due to color

deterioration will be reduced. In addition, FSIS is removing and

reserving 9 CFR 317.8(b)(37), which requires qualifying statements on

fresh pork cuts.

EFFECTIVE DATE: April 18, 1994.

FOR FURTHER INFORMATION CONTACT:

Charles R. Edwards, Director, Product Assessment Division, Regulatory

Programs, Food Safety and Inspection Service, U.S. Department of

Agriculture, Washington, DC 20250, (202) 254-2565.

SUPPLEMENTARY INFORMATION:

Executive Order 12866

This final rule has been reviewed under Executive Order 12866.

Executive Order 12778

This final rule has been reviewed under Executive Order 12778,

Civil Justice Reform. States and local jurisdictions are preempted

under the Federal Meat Inspection Act (FMIA) from imposing any marking,

labeling, packing, or ingredient requirement on federally inspected

meat products that are in addition to, or different than, those imposed

under FMIA. States and local jurisdictions may, however, exercise

concurrent jurisdictions over meat products that are outside official

establishments for the purpose of preventing the distribution of meat

products that are misbranded or adulterated under the FMIA, or, in the

case of imported articles, which are not at such an establishment,

after their entry into the United States. Under the FMIA, States that

maintain meat inspection programs must impose requirements that are at

least equal to those required under the FMIA. The States may, however,

impose more stringent requirements on such State inspected products and

establishments.

No retroactive effect will be given to this rule. There are no

applicable administrative procedures that must be exhausted prior to

any judicial challenge to the provisions of this rule.

Effect on Small Entities

The Administrator, FSIS, has made a determination that this final

rule will not have a significant economic impact on a substantial

number of small entities. The final rule allows the application of

ascorbic acid, erythorbic acid, citric acid, sodium ascorbate, and

sodium citrate, singly or in combination, to the surface of fresh beef

cuts or fresh lamb cuts to delay discoloration. This final rule will

impose no new requirements on small entities. Current regulations

already allow these substances to be applied to the surface of fresh

pork cuts. Currently, approximately 20 percent to 25 percent of meat

packaging companies are producing red meat cuts. FSIS estimates that

less than 3 percent of these companies will be affected by this final

rule. Also, the Agency estimates the cost of applying these substances

to the surface of fresh beef cuts or fresh lamb cuts is between $.03

and $.04 per pound. However, if production of fresh beef cuts or fresh

lamb cuts treated in this manner increases and a sustained market

develops for these products, the cost will decrease.

The meat industry will benefit from this final action because the

preservation of the fresh color and appearance of beef cuts and lamb

cuts for a longer period of time should increase the marketability of

these products, thereby reducing the losses to manufacturers due to

color deterioration of beef cuts and lamb cuts. Manufacturers, both

large and small, opting to use such substances will be required to

revise the ingredients statement on product labels to show the presence

of ascorbic acid, erythorbic acid, citric acid, sodium ascorbate, and/

or sodium citrate. However, the use of these substances will be

voluntary, and any costs associated with new label applications will be

covered under existing approved paperwork requirements of FSIS's prior

label approval system.

Manufacturers choosing to apply ascorbic acid, erythorbic acid,

citric acid, sodium ascorbate, and sodium citrate, singly or in

combination, to fresh beef cuts and fresh lamb cuts will be required to

develop and maintain an approved partial quality control (PQC) program,

and would thus incur expenses associated with maintaining the PQC

program. Decisions by individual manufacturers on whether to use such

substances on the surface of fresh beef and fresh lamb cuts will be

based on their conclusions that the benefits will outweigh the costs of

maintaining the required PQC program. Current regulations already

require manufacturers of fresh pork cuts using those substances to

develop and maintain an approved PQC program.

Paperwork Requirements

Manufacturers opting to apply ascorbic acid, erythorbic acid,

citric acid, sodium ascorbate, or sodium citrate to fresh beef and lamb

cuts will be required to develop and maintain a partial quality control

(PQC) program. FSIS will receive, evaluate, and either approve or

disapprove requests for such PQC programs. The PQC program will be

placed on file in the establishment, and be available to any duly

authorized representative of the Secretary. The information collection

requirements contained in this final rule have been approved by the

Office of Management and Budget under approval number 0583-0087.

Background

Wilson Foods Petitions

On December 13, 1988, and October 24, 1991, Wilson Foods

Corporation, Oklahoma City, Oklahoma, submitted petitions, along with

supporting technical data, to FSIS to permit the application of

ascorbic acid, erythorbic acid, sodium ascorbate, citric acid and

sodium citrate, singly or in combination, to fresh beef cuts and fresh

lamb cuts to delay discoloration of the meat cuts.\1\ The intended

effect of ascorbic acid, erythorbic acid, and sodium ascorbate is to

serve as antioxidants; the intended effect of citric acid and sodium

citrate is to serve as sequestrants. The petitioner's data demonstrate

that the required amount to accomplish the intended effects, singly or

in combination, would be at levels not to exceed 500 ppm or 1.8

milligrams (mg) per square inch of the product's surface of ascorbic

acid, erythorbic acid, or sodium ascorbate, and/or not to exceed 250

ppm or 0.9 mg per square inch of the product's surface of citric acid

or sodium citrate. The data submitted by the petitioner were the

results of experiments on products which were packaged in a modified

atmosphere of carbon dioxide, oxygen, and nitrogen. It is the Agency's

understanding that the benefits provided by the addition of these

substances occur regardless of packaging conditions. However, this

rulemaking concerns the addition of substances, rather than packaging

gases, which are not a part of this rule.

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\1\Copies of the petitions and supporting technical data are

available for review in the FSIS Hearing Clerk's office.

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The petitioner's data further demonstrate that such treatments

result in delaying undesirable discoloration of the product for a

period of time that does not exceed the product's microbiological shelf

life. Fresh beef cuts and fresh lamb cuts treated with the substances

mentioned above and stored at refrigerator temperature will remain

wholesome for up to 21 days. Loss of the ``fresh'' color and

marketability of beef cuts and lamb cuts occurs before the product

becomes microbiologically unsafe. Some consumers are reluctant to

purchase fresh beef or lamb cuts because of the change to a darker

color of the product before spoilage.

Current Regulations

Section 318.7(c)(4) of the Federal meat inspection regulations (9

CFR 318.7(c)(4)) allows the use of ascorbic acid, erythorbic acid,

citric acid, sodium ascorbate, and sodium citrate on fresh pork cuts to

maintain color at levels not to exceed either 500 ppm or 1.8 mg/sq inch

of surface of ascorbic acid, erythorbic acid or sodium ascorbate,

singly or in combination, and/or not to exceed either 250 ppm or 0.9

mg/sq inch of surface of citric acid or sodium citrate, singly or in

combination. In addition, 9 CFR 318.7(c)(4) requires the use of such

substances under an approved PQC program under 9 CFR 318.4(d) and (e).

Section 317.8(b)(37) of the Federal meat inspection regulations (9 CFR

317.8(b)(37)) requires that when ascorbic acid, erythorbic acid, citric

acid, sodium ascorbate, and sodium citrate, singly or in combination,

are added to fresh pork cuts, there shall appear on the label of that

product, in letters of the same style and type and not less than one-

fourth the size of letters in the product name, contiguous to the name

of the product, a statement identifying the specific approved

substance(s) by its common name and the purpose for which it is added

such as ``Sprayed with a solution of water, ascorbic acid and citric

acid to maintain color.''

The Food and Drug Administration (FDA) lists ascorbic acid in 21

CFR 182.3013, erythorbic acid in 21 CFR 182.3041, and sodium ascorbate

in 21 CFR 182.3731 as generally recognized as safe (GRAS) when used in

accordance with good manufacturing practices for use as preservatives.

FDA lists citric acid in 21 CFR 182.6033 and sodium citrate in 21 CFR

182.6751 as GRAS when used in accordance with good manufacturing

practices for use as sequestrants.

Proposed Rule

On October 4, 1993, FSIS published a proposed rule in the Federal

Register (58 FR 51581) to permit the application of ascorbic acid,

erythorbic acid, citric acid, sodium ascorbate, and sodium citrate,

singly or in combination, to the surface of fresh beef cuts or fresh

lamb cuts to delay discoloration of such meat cuts. The proposed rule

would allow these substances to be used, singly or in combination, at

levels of not more than 500 ppm or 1.8 milligrams per square inch of

product surface area for ascorbic acid, erythorbic acid or sodium

ascorbate, and/or not more than 250 ppm or 0.9 milligrams per square

inch of surface area for citric acid or sodium citrate to achieve the

intended technical effects.

FSIS also proposed that processors who apply these substances to

cuts of fresh beef and lamb be required to follow an approved PQC

program as set forth in 9 CFR 318.4(d). Neither processing of such

products nor distribution of such products in commerce would be

permitted until such PQC programs are approved and utilized according

to the requirements set forth in 9 CFR 318.4(e). All such PQC programs

would cover certain critical control points, including: (1) The

condition of the meat before treatment (it must be fresh or previously

frozen and maintained in a wholesome condition, evidenced by time and

temperature records from the point of slaughter), (2) solution

formulation control, (3) single application control, (4) finished

product ingredient analysis monitoring, and (5) integrity of the

packaging during storage, transportation, and distribution. This would

ensure that these substances applied to the surface of the meat cuts to

delay discoloration would not be applied in excessive amounts;

therefore, the discoloration of the cuts would occur before the onset

of microbiological spoilage.

Cuts of fresh pork treated with ascorbic acid, erythorbic acid,

sodium ascorbate, sodium citrate, and citric acid are currently

required by 9 CFR 317.8(b)(37) to be labeled with a statement

identifying these substances by their common and usual name and the

purpose for which they are used; e.g., ``Sprayed with a solution of

water, ascorbic acid and citric acid to maintain color.'' This

statement is required to be shown on the label in a prominent manner,

contiguous to the product name, in letters of the same style and type

and not less than one-fourth the size of the largest letter in the

product name. After reassessing its overall policy regarding prominent

labeling, FSIS set forth in the proposed rule that 9 CFR 317.8(b)(37)

requiring qualifying statements on fresh pork cuts would be removed and

reserved.

In addition, on November 4, 1992, the Agency published in the

Federal Register a proposed rule (57 FR 52596) to eliminate those

prominent disclosure requirements for product name qualifiers where the

inclusion of a substance does not significantly alter the basic

identity of the finished product or where the prominently disclosed

information can be found in the ingredients statement. Such rule, in

part, would eliminate product name qualifiers on fresh pork cuts

treated with ascorbic acid, erythorbic acid, sodium ascorbate, sodium

citrate, and citric acid. FSIS is considering the publication of a

final rule on prominent labeling which would become effective in the

near future. FSIS believes that such action would not deprive consumers

of informative labeling because all substances used in the preparation

of a product are required to be listed in the ingredients statement (9

CFR 317.2(f)(1)). However, as indicated in the proposed rule on

ascorbic acid and other substances, FSIS is removing and reserving 9

CFR 318.7(b)(37). Therefore, as of the effective date of this final

rule, qualifying statements, which identify the presence of ascorbic

acid, erythorbic acid, sodium ascorbate, sodium citrate, and citric

acid on fresh port cuts, are no longer required on the labeling of

fresh pork cuts which contain such substances.

FSIS also stated in the preamble to the proposed rule that 9 CFR

317.8(b)(6) prohibits the word ``fresh'' on labels to designate product

which has been salted for preservation. Therefore, FSIS would not allow

the word ``fresh'' to be used on the labels of products treated with

ascorbic acid, erythorbic acid, sodium ascorbate, sodium citrate, and

citric acid.

FSIS proposed to amend the table of approved substances in 9 CFR

318.7 by revising the current entry for the Class of substance titled

``Miscellaneous,'' under the Substance column for ``Ascorbic,

erythorbic acid, citric acid, sodium ascorbate, and sodium citrate'' to

include such use on fresh beef and lamb cuts, along with the existing

use on fresh pork cuts. In addition, FSIS proposed that the entry be

revised to clarify the permitted use and levels of such substances on

fresh pork cuts. The Agency also proposed to revise the purpose of

these substances from ``to maintain color'' to ``to delay

discoloration'' for clarification.

Discussion of Comments

FSIS received three comments in response to the proposed rule. The

comments were submitted by a consultant and two food manufacturers. The

commenters fully supported the proposed rule.

After review of the comments and other information, the

Administrator has determined that the application of ascorbic acid,

erythorbic acid, citric acid, sodium ascorbate, and sodium citrate to

the surface of fresh beef and lamb cuts, as permitted in the rule, will

not render the products in which they are used adulterated or

misbranded or otherwise not in compliance with the Federal Meat

Inspection Act. The Administrator has further determined that these

substances will be functional and suitable for the products and will be

permitted for use on the surface of fresh beef and lamb cuts as the

lowest level necessary to accomplish the stated technical effect.

List of Subjects

9 CFR Part 317

Meat inspection, Food labeling.

9 CFR Part 318

Meat inspection, Food additives.

Final Rule

For reasons discussed in the preamble, FSIS is amending 9 CFR parts

317 and 318 of the Federal meat inspection regulations as follows:

PART 317--LABELING, MARKING DEVICES, AND CONTAINERS

1. The authority citation for part 317 continues to read as

follows:

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

2. Section 317.8 is amended by removing and reserving paragraph

(b)(37).

PART 318--ENTRY OFFICIAL ESTABLISHMENTS; REINSPECTION AND

PREPARATION OF PRODUCTS

3. 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.

4. In the table in Sec. 318.7(c)(4) under the Class of substance

``Miscellaneous,'' the entry under the Substance ``Ascorbic Acid,

erythorbic acid, citric acid, sodium ascorbate, and sodium citrate'' is

revised to read 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 Product Amount

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* * * * * * *

Miscellaneous....... Ascorbic acid, To delay Fresh beef cuts, Not to exceed, singly or

erythorbic acid, discoloration. fresh lamb cuts, in combination, 500 ppm

citric acid, sodium and fresh pork cuts. or 1.8 mg/sq inch of

ascorbate and product surface of

sodium citrate, ascorbic acid (in

singly or in accordance with 21 CFR

combination, under 182.3013), erythorbic

an approved partial acid (in accordance

quality control with 21 CFR 182.3041),

(PQC) program (9 or sodium ascorbate (in

CFR 318.4 (d) & accordance with 21 CFR

(e)). 182.3731); and/or not

to exceed, singly or in

combination, 250 ppm or

0.9 mg/sq inch of

product surface of

citric acid (in

accordance with 21 CFR

182.6033), or sodium

citrate (in accordance

with 21 CFR 182.6751).

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Done at Washington, DC, on: March 11, 1994.

Patricia Jensen,

Acting Assistant Secretary, Marketing & Inspection Services.

[FR Doc. 94-6242 Filed 3-16-94; 8:45 am]

BILLING CODE 3410-DM-M