Use of Sodium Acetate and Sodium Diacetate as Flavoring Agents in Meat and Poultry Products

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.

-----------------------------------------------------------------------

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) * * *

----------------------------------------------------------------------------------------------------------------

Class of

substance Substance Purpose Products Amounts

----------------------------------------------------------------------------------------------------------------

* * * * * *

*

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.

* * * * * *

*

----------------------------------------------------------------------------------------------------------------

* * * * *

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) * * *

----------------------------------------------------------------------------------------------------------------

Class of

substance Substance Purpose Products Amounts

----------------------------------------------------------------------------------------------------------------

* * * * * *

*

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.

* * * * * *

*

----------------------------------------------------------------------------------------------------------------

[[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