[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