[Federal Register Volume 62, Number 120 (Monday, June 23, 1997)]
[Rules and Regulations]
[Pages 33744-33746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16392]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR 318 and 381
[Docket No. 96-010DF]
RIN 0583-AC11
Use of Sodium Acetate and Sodium Diacetate as Flavoring Agents in
Meat and Poultry Products
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Direct final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the
Federal meat and poultry products inspection regulations to permit the
use of sodium acetate at the level of 0.12 percent of the product
formulation and sodium diacetate at the level of 0.1 percent of the
product formulation as flavoring agents in meat and poultry products.
Sodium acetate and sodium diacetate are listed in the Food and Drug
Administration's (FDA) regulations as substances generally recognized
as safe for several uses in accordance with good manufacturing
practice. This direct final rule is in response to a petition.
DATES: This rule will be effective on August 22, 1997 unless the Agency
receives written adverse comments within the scope of the rulemaking or
written notice of intent to submit adverse comments within the scope of
the rulemaking on or before July 23, 1997.
ADDRESSES: Please send an original and two copies of written adverse
comments or notice of intent to submit written adverse comments to the
FSIS Docket Clerk, Docket #96-010DF, Room 102 Cotton Annex, Food Safety
and Inspection Service, U.S. Department of Agriculture, Washington, DC
20250.
FOR FURTHER INFORMATION CONTACT: Charles R. Edwards, Director,
Facilities, Equipment, Labeling, and Compound Review Division, Office
of Policy, Program Development and Evaluation, Food Safety and
Inspection Service, U.S. Department of Agriculture, Washington, DC
20250; (202) 48-8900.
SUPPLEMENTARY INFORMATION:
Background
FSIS was petitioned by Armour Swift-Eckrich to allow the use of
sodium acetate and sodium diacetate as flavoring agents in meat and
poultry products to improve the overall flavor and consumer acceptance.
Sodium acetate is the sodium salt of vinegar and sodium diacetate is a
blend of vinegar and salt of vinegar. Both ingredients are used as
flavoring agents and adjuvants, and as pH control agents. The
petitioner requested that FSIS amend the regulations to permit sodium
acetate at the level of 0.12 percent of the product formulation and
sodium diacetate at the level of 0.1 percent of the product formulation
as flavoring agents in meat and poultry products. Data and information
submitted by the petitioner showed that after products are prepared in
sauces, spices, and seasoning blends that are made using these
ingredients, the overall flavor is improved and the products are more
acceptable to the consumer. Levels of sodium acetate and sodium
diacetate higher than those indicated were not shown to be effective.
Therefore, the levels in the direct final rule represent the lowest
necessary to achieve the intended effect.
After reviewing the petitioner's data and information, FSIS
determined that the charts of approved substances in the meat and
poultry regulations should be amended to allow the use of sodium
acetate at the level of 0.12 percent and sodium diacetate at the level
of 0.1 percent of formulation weight as flavoring agents in meat and
poultry products. The technical data demonstrate the efficacy of sodium
acetate and sodium diacetate for these uses.
FDA lists sodium acetate (21 CFR 184.1721) and sodium diacetate (21
CFR 184.1754) as generally recognized as safe for several uses when
used in accordance with good manufacturing practice at maximum levels
of 0.12 percent for sodium acetate and 0.1 percent for sodium
diacetate. Therefore, FSIS is amending the charts of approved
substances in 9 CFR 318.7(c)(4) and 381.147(f)(4) to allow the use of
sodium acetate at the level of 0.12 percent of the formulation by
weight and sodium diacetate at a level of 0.1 percent of the
formulation by weight as flavoring agents in meat and poultry products.
FSIS expects no adverse public reaction resulting from the changes
in regulatory language, because the compounds have received FDA
approval for various other uses, as here, in small amounts for
flavoring only. Therefore, unless the Agency receives written adverse
comments within the scope of this rulemaking or a written notice of
intent to submit adverse comments within the scope of the rulemaking
within 30 days, the action will become final 60 days after publication
in the Federal Register. If written adverse comments within the scope
of the rulemaking are received, the final rulemaking notice will be
withdrawn and a proposed rulemaking notice will establish a comment
period.
Executive Order 12988
This direct final rule has been reviewed under Executive Order
12988, Civil Justice Reform. This rule: (1) Preempts all State and
local laws and regulations that are in conflict with this rule; (2) has
no retroactive effect; and (3) does not require administrative
proceedings before parties may file suit in court challenging this
rule.
Executive Order 12866 and Regulatory Flexibility Act
This direct 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 made an initial determination that this
direct final rule will not have a significant economic impact on a
substantial number of small entities, as defined by the Regulatory
Flexibility Act (5 U.S.C. 601). The direct final rule will permit the
use of sodium acetate at a level of 0.12 percent of the product
formulation and sodium diacetate at a level of 0.1 percent of the
product formulation as flavoring agents in meat and poultry products.
This direct final rule will impose no new requirements on small
entities.
[[Page 33745]]
Paperwork Requirements
Abstract: FSIS has reviewed the paperwork and recordkeeping
requirements in this direct final rule in accordance with the Paperwork
Reduction Act. Manufacturers opting to use sodium acetate and/or sodium
diacetate as flavoring agents in meat or poultry products are required
to revise their product label and submit such labeling to FSIS for
approval.
Estimate of Burden: FSIS estimates that it takes 60 minutes to
design and modify a label in accordance with these regulations. For
label submissions, FSIS estimates a 15 minute response time to prepare
the label application form, submit it, along with the label, to FSIS or
to a label expediter who will deliver the form and label to FSIS.
Respondents: Meat and poultry establishments.
Estimated Number of Respondents: 50 meat and poultry
establishments.
Estimated Number of Responses per Respondent: FSIS estimates that
each establishment would modify about 10 product labels.
Estimated Total Annual Burden on Respondents: 625 hours.
Copies of this information collection assessment can be obtained
from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection
Service, USDA, Room 109, Cotton Annex, Washington DC 20250-3700.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Agency, including whether the information will have practical
utility; (b) the accuracy of the Agency's estimate of the burden of the
proposed collection of information including the validity of the method
and the assumptions used; (c) ways to enhance the quality, utility, and
clarity of the information to be collected; (d) ways to minimize the
burden of the collection of information on those who are to respond;
including through use of appropriate automated, electronic, mechanical,
or other technological collection techniques or other forms of
information technology. Comments may be sent to Lee Puricelli,
Paperwork Specialist, see the address above, and Desk Officer for
Agriculture, Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB),Washington, DC 20253.
Comments are requested by August 22, 1997. To be most effective,
comments should be sent to OMB within 30 days of the publication date
of this final rule.
List of Subjects
9 CFR Part 318
Food additives, Meat inspection.
9 CFR Part 381
Food additives, Poultry and poultry products.
For the reasons discussed in this preamble, FSIS is amending 9 CFR
parts 318 and 381 of the Federal meat and poultry products inspection
regulations 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
2.18, 2.53.
2. Section 318.7(c)(4) is amended by adding at the end of the chart
of substances, under the Class of Substance ``Flavoring Agents,
Protectors and Developers,'' new entries for ``sodium acetate'' and
``sodium diacetate'' 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 Products Amounts
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* * * * * *
*
Sodium acetate.......... To flavor product...... Various................ Not to exceed 0.12
percent of formulate
in accordance
Sodium diacetate........ ......do............... ......do............... Not to exceed 0.1
percent of formulate
in accordance with 21
CFR 184.1754.
* * * * * *
*
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* * * * *
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
3. The authority citation for part 381 continues to read as
follows:
Authority: 7 U.S.C. 138f; 7 U.S.C. 450; 221 U.S.C. 451-470; 7
CFR 2.18, 1.53.
4. Section 381.147(f)(4) is amended by adding at the end of the
chart of substances, under the Class of Substance ``Flavoring agents;
Protectors and Developers,'' the substances ``sodium acetate'' and
``sodium diacetate'' to read as follows:
Sec. 381.147 Restriction on the use of substances of in poultry
products.
* * * * *
(f) * * *
(4) * * *
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Class of
substance Substance Purpose Products Amounts
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* * * * * *
*
Sodium Acetate.......... To flavor product...... Various................ Not to exceed 0.12
percent of formulate
in accordance with 21
CFR 184.1721.
Sodium Diacetate........ To flavor product...... Various................ Not to exceed 0.1
percent of formulate
in accordance with 21
CFR 184.1754.
* * * * * *
*
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[[Page 33746]]
Done at Washington, DC, on: June 11, 1997.
Thomas J. Billy,
Administrator.
[FR Doc. 97-16392 Filed 6-20-97; 8:45 am]
BILLING CODE 3410-DM-P