[Federal Register Volume 59, Number 52 (Thursday, March 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6242]


[[Page Unknown]]

[Federal Register: March 17, 1994]


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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