Use of Sorbitol in Cooked Roast Beef Products

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 318

[Docket No. 95-052DF]

RIN 0583-AC02

Use of Sorbitol in Cooked Roast Beef 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 inspection regulations to add cooked roast beef products

to the list of products in which sorbitol is permitted. This action is

being taken in response to a petition requesting that FSIS allow the

use of up to 2 percent sorbitol both as a sweetener and to reduce

charring in cooked roast beef products. The sorbitol will be added to a

solution of ingredients that are pumped into the beef prior to cooking.

DATES: This rule will be effective on April 29, 1996 unless FSIS

receives written adverse comments or written notice of intent to submit

adverse comments on or before March 28, 1996. If critical comments are

received, the final rulemaking document will be withdrawn and a

proposed rulemaking document will be published.

ADDRESSES: Submit adverse comments or notice of intent to submit

adverse comments to: FSIS Docket Clerk, Docket #95-052DF, U.S.

Department of Agriculture, Food Safety and Inspection Service, Room

4352, South Agriculture Building, 14th and Independence Avenue SW.,

Washington, DC 20250-3700. Please submit one original and two copies of

written adverse comments.

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: Under the Federal Meat Inspection Act (21

U.S.C. 601 et seq.), FSIS provides mandatory inspection of meat and

meat food products prepared for distribution in commerce. The Act

prohibits the addition of any substance to any meat or meat food

product that may render the product adulterated (21 U.S.C. 610).

Section 318.7(a)(1) of the Federal meat inspection regulations (9 CFR

318.7) prohibits the use of any substance in the preparation of any

product unless its use is approved in section 318.7(c)(4) of the

Federal meat inspection regulations, which is the chart of substances

acceptable for use in the preparation of products, or unless it is

approved elsewhere in the regulations or by the Administrator, FSIS.

FSIS was petitioned to approve the use of sorbitol in cooked roast

beef products in the same amount currently approved for other meat and

meat food products. The petitioner requested that FSIS amend

Sec. 318.7(c)(4) of the Federal meat inspection regulations to allow

the use of up to 2 percent sorbitol both as a sweetener and to reduce

charring in cooked roast beef products, excluding the formula weight of

water or ice. The sorbitol will be added to a solution of ingredients

that are pumped into beef prior to cooking.

Charring is an adverse effect that occurs when sugar-related

substances are subjected to prolonged heat treatment. Sorbitol is a

common sugar alcohol; it can be found in foods like apples and pears.

It is about half as sweet as sucrose and is often used as a substitute

sweetener in reduced-sugar food products, such as sugar-free candy and

other food products for diabetics. Sorbitol is listed in 21 CFR

184.1835 as a substance generally recognized as safe for use as an

anticaking agent, humectant, flavoring agent, and for various other

uses, when used in accordance with good manufacturing practices.

Sorbitol does not posses the same chemical makeup as do sugars that

carmelize, i.e., brown and char in the presence of high heat. It is

this characteristic of sorbitol that reduces charring in cooked roast

beef products and other meat products.

The petitioner conducted informal sensory testing using various

levels of sorbitol in roast beef product formulations.\1\ Tests were

conducted by using informal visual and taste panels. The visual panel

measured the amount of charring that took place on roast beef products

treated with sorbitol by evaluating the browning of products after they

were treated and cooked. The sweetness was measured by a separate

panel; that panel tasted the test products after they were treated and

cooked. The test data show that 2 percent sorbitol accomplishes both

charring reduction and suitable sweetness.

\1\ Information regarding the informal sensory testing is

available in the FSIS Docket Room, USDA, 14th & Independence Avenue,

SW., Room 4352, South Agriculture Building, Washington, DC 20250-

3700.

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After reviewing the petitioner's technical data and information,

the Administrator, FSIS determined that the chart of approved

substances in 9 CFR 318.7(c)(4) should be amended to allow

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the use of sorbitol for the purposes and in the amounts requested by

the petitioner. The technical data demonstrates the efficacy of

sorbitol for these uses. Sorbitol is a substance generally recognized

as safe by the Food and Drug Administration. The Administrator, FSIS,

has determined that the use of sorbitol (1) will not render the product

adulterated or misbranded or otherwise not in compliance with the

requirements of the Act; and (2) is functional and suitable for the

product, and is permitted at the lowest level necessary to accomplish

the stated effect. Accordingly, FSIS is amending the chart of approved

substances in 9 CFR 318.7(c)(4) to allow the use of sorbitol as a

sweetener and to reduce charring in cooked roast beef products at a

level not more than 2 percent of the weight of the formula, excluding

the formula weight of water or ice.

FSIS expects no adverse public reaction resulting from this change

in regulatory language. Therefore, unless adverse or critical comments,

or a notice of intent to submit adverse comments are received within 30

days, the action will become final 60 days after publication in the

Federal Register. The proposed rulemaking notice will establish a

comment period.

Executive Order 12866

This direct final rule has been determined to be not significant

and therefore and was not reviewed by the Office of Management and

Budget under Executive Order 12866.

Executive Order 12778

This direct final rule has been have reviewed under Executive Order

12778, Civil Justice Reform. States and local jurisdictions are

preempted by the Federal Meat Inspection Act (FMIA) from imposing any

marking or packaging requirements on federally inspected meat products

that are in addition to, or different than, those imposed under the

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

jurisdiction 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.

This direct final rule is not intended to have retroactive effect.

There are no applicable administrative procedures that must be

exhausted prior to any judicial challenge to the provisions of this

direct final rule. However, the administrative procedures specified in

9 CFR Secs. 306.5 must be exhausted prior to any judicial challenge of

the application of the provisions of this direct final rule, if the

challenge involves any decision of an FSIS employee relating to

inspection services provided under the FMIA.

Effect on Small Entities

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 sorbitol as a sweetener and to reduce charring in cooked roast

beef products. The sorbitol will be added to a solution of ingredients

that are pumped into the beef prior to cooking. This amendment will

provide cooked roast beef processors with an additional, alternative

substance that can be used to sweeten their product while at the same

time reducing charring that may occur during the cooking process. The

use of sorbitol as a sweetener and to reduce charring in cooked roast

beef products will be voluntary. Small manufacturers opting to use

sorbitol for these purposes will be required to revise their product

labels. Decisions by individual manufacturers on whether to do so will

be based on their conclusions that the benefits outweigh the costs.

Paperwork Requirements

Abstract: FSIS has reviewed the paperwork and recordkeeping

requirements in this direct final rule in accordance with the Paperwork

Reduction Act. This rule requires manufacturers opting to use sorbitol

as a sweetener and to reduce charring in cooked roast beef products to

revise their product labels and submit such labeling to FSIS for

approval.

Estimate of Burden: Establishments must develop product labels in

accordance with the regulations. To receive approval of the labels,

establishments must complete FSIS Form 7234-1. FSIS program employees

review FSIS Form 7234-1 to ensure that information on the labels

complies with the regulations. FSIS estimates that it will take 60

minutes to design and develop modified product labels in accordance

with the proposed regulations and 15 minutes to prepare FSIS Form 7234-

1 and submit it, along with the label, to FSIS or to a label expediter

who will deliver the form and label to FSIS.

Respondents: Meat establishments.

Estimated Number of Respondents: 315 meat establishments.

Estimated Number of Responses per Respondent: FSIS estimates that

each establishment would modify about 2 product labels.

Estimated Total Annual Burden on Respondents: 788 hours.

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

methodology and 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 address above, and Desk Officer for

Agriculture, Office of Information and Regulatory Affairs, Office of

Management and Budget, Washington, DC 20253.

List of Subjects in 9 CFR Part 318

Food additives, Meat inspection.

For the reasons set out in the preamble, 9 CFR part 318 is amended

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 to the chart of

substances, under the Class of Substance ``Flavoring agents; protectors

and developers,'' the substance sorbitol to read as follows:

Sec. 318.7 Approval of substances for use in the preparation of

products.

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(c) * * *

(4) * * *

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Class of substance Substance Purpose Products Amount

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* * * * * *

*

Flavoring Agents; protectors Sorbitol . . ...... To flavor, to As provided in Not to exceed 2

and developers. facilitate the part 319 of this percent of the

removal of subchapter, weight of the

casings from cooked roast formula, excluding

product, and to beef, cured pork the formula weight

reduce products, and of water or ice,

carmelization and cooked sausage when used in

charring. labeled accordance with 21

frankfurter, CFR 184.1835.

frank, furter,

wiener, and

knockwurst.

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*

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Done at Washington, DC, on: February 20, 1996.

Michael R. Taylor,

Acting Under Secretary for Food Safety.

[FR Doc. 96-4303 Filed 2-26-96; 8:45 am]

BILLING CODE 3410-DM-M