Use of Sorbitol in Cooked Roast Beef Products

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 318

[Docket No. 95-052P]

RIN 0583-AC02

Use of Sorbitol in Cooked Roast Beef Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to

amend the Federal meat inspection regulations to add cooked roast beef

products to the list of products in which sorbitol is permitted. FSIS

proposes this action in response to a petition requesting that FSIS

allow the use of sorbitol, both to sweeten and to reduce charring in

cooked roast beef products, at the level of up to 2 percent of the

product formulation. The sorbitol would be added to a solution of

ingredients that are pumped into the beef prior to cooking.

DATES: Comments must be received on or before May 13, 1997.

ADDRESSES: Send an original and two copies of written comments to: FSIS

Docket Clerk, Docket 95-052P, Room 3806, South Agriculture

Building, 1400 Independence Avenue, SW., Washington, DC 20250-3700.

Reference material cited in this document and any comments received in

response to this proposal will be available for public inspection in

the FSIS Docket Room from 8:30 a.m. to 1:00 p.m., and from 2:00 p.m. to

4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Charles R. Edwards, Director, Product

Assessment Division, Regulatory Programs, (202) 418-8900.

SUPPLEMENTARY INFORMATION:

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

beef products in the amount currently approved for use in 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 sorbitol both to sweeten and to reduce charring in cooked

roast beef products in an amount not to exceed two percent of the

product formulation, excluding the formula weight of water or ice. The

sorbitol would be added to a solution of ingredients that are pumped

into the beef prior to cooking.

Sorbitol is a common sugar alcohol; it can be found in apples,

pears, and other foods. About half as sweet as sucrose (i.e., sugar),

it is often used as a

[[Page 12118]]

substitute sweetener in reduced-sugar products such as sugar-free candy

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

184.1835 by the Food and Drug Administration (FDA) as a substance

affirmed as 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

possess the same chemical makeup as do sugars that caramelize, 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 in which it is used.

The petitioner conducted informal sensory testing using various

levels of sorbitol in roast beef product formulations. Tests were

conducted by using informal visual and taste panels. A panel of eight

people 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. Another panel of eight measured the

sweetness of the products by tasting the test products after they were

treated and cooked. The test data show that two percent sorbitol both

reduces charring and achieves a suitable level of sweetness.

After reviewing the petitioner's technical data and information,

the Administrator, FSIS, determined that the technical data and

information submitted with the petition demonstrated the efficacy of

sorbitol for these uses at the level not to exceed two percent of

product formulation.

The Administrator determined that these uses of sorbitol (1) will

not render the product adulterated or misbranded, or otherwise not in

compliance with the requirements of the Federal Meat Inspection Act and

(2) is functional and suitable for the product, and is permitted at the

lowest level necessary to accomplish the stated effect. To permit these

uses of sorbitol, the chart of approved substances in the meat

inspection regulations (9 CFR 318.7(c)(4)) must be amended.

FSIS published a direct final rule in the Federal Register on

February 27, 1996 (61 FR 7207), that would have added new uses of

sorbitol both to sweeten and to reduce charring in cooked roast beef

products up to a level of two percent of the product formulation.

FSIS solicited comments concerning the direct final rule for a 30-

day period ending March 28, 1996. FSIS stated that the effective date

of the proposed amendment would be 60 days after publication of the

direct final rule in the Federal Register, unless the Agency received

written adverse comments or a notice of intent to submit adverse

comments by the close of the comment period. FSIS also stated that if

it received written adverse comments or a notice of intent to submit

adverse comments, it would publish a document in the Federal Register

withdrawing the direct final rule before the scheduled effective date

and would publish a proposed rule for public comment.

On April 16, 1996 (61 FR 16617), FSIS withdrew the direct final

rule because it received one adverse comment from a consumer who

opposed adding cooked roast beef to the list of products in which

sorbitol is permitted. The comment contended that, while sorbitol is

generally recognized as safe, increasing numbers of people have

reactions to ingredients ``hidden in prepared foods.'' The currently

permitted use of this substance, as specified in the regulations,

complies with applicable requirements of the Food and Drug

Administration (FDA).

Its proposed use in roast beef would also be in compliance with those

requirements, as are current allowances for cured pork products and

sausages. FSIS is aware of the needs of consumers who are sensitive to

certain ingredients and requires the labels of all products under its

jurisdiction to convey information that is useful to consumers,

including the common or usual names of all ingredients used to make the

food. Under this proposal, sorbitol would have to be listed in the

ingredients statements of cooked roast beef products as well as in

ingredients statements of the other products in which it is already

permitted. This listing would provide sufficient information to

consumers who are sensitive to sorbitol or who have other reasons for

selecting sorbitol-free products. Therefore, FSIS is proposing to amend

the chart of approved substances in 9 CFR 318.7 (c)(4) to add the use

of sorbitol both to sweeten and to reduce charring in cooked roast beef

products at a level of up to two percent of product formulation.

Executive Order 12988

This proposed rule has been reviewed under Executive Order 12988,

Civil Justice Reform. If this proposed rule is adopted: (1) all state

and local laws and regulations that are inconsistent with this rule

will be preempted; (2) no retroactive effect will be given to this

rule; and (3) administrative proceedings will not be required before

parties may file suit in court challenging this rule.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been determined to be not significant and

has not been reviewed by the Office of Management and Budget.

The Administrator has made an initial determination that this

proposed rule would 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 proposed rule would permit the use

of sorbitol to sweeten and to reduce charring in cooked roast beef

products. The sorbitol would be added to a solution of ingredients that

are pumped into the beef prior to cooking. This amendment would provide

cooked roast beef processors with an additional, alternative substance

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

reduce charring that may occur during the cooking process. The use of

sorbitol to sweeten and to reduce charring in cooked roast beef

products would be voluntary. Small manufacturers opting to use sorbitol

for these purposes would be required to revise their product labels.

Decisions by individual manufacturers on whether to do so would be

based on their conclusions that the benefits outweigh the costs.

Paperwork Requirements

Abstract: FSIS has reviewed the paperwork and recordkeeping

requirements in this proposed rule in accordance with the Paperwork

Reduction Act. This rule would require manufacturers opting to use

sorbitol to sweeten 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 would have to develop product

labels in accordance with the proposed rule. To receive approval of the

labels, establishments would complete FSIS Form 7234-1. FSIS program

employees would review FSIS Form 7234-1 to ensure that information on

the labels complies with the regulations. FSIS estimates that it would

take 60 minutes to design and develop modified product labels in

accordance with the proposed regulation and 15 minutes to prepare FSIS

Form 7234-1 and submit it, along with the label, to FSIS or to a label

expediter who would 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

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establishment would modify about 2 product labels.

Estimated Total Annual Burden on Respondents: 788 hours.

Copies of this information collection assessment can be obtained

from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection

Service, USDA, Room 3812, South Agriculture Building, 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

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. Send comments to both Lee Puricelli,

Paperwork Specialist, at the address provided above, and the Desk

Officer for Agriculture, Office of Information and Regulatory Affairs,

Office of Management and Budget, Washington, DC 20253.

Comments are requested by May 13, 1997. To be most effective,

comments should be sent to OMB within 30 days of the publication date

of this proposed rule.

List of Subjects in 9 CFR Part 318

Food additives, Meat inspection.

For the reasons discussed in the preamble, FSIS is proposing to

amend 9 CFR part 318 of the Federal meat inspection regulations as

follows:

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND

PREPARATION OF PRODUCTS

1. The authority citation for part 318 would be revised to read as

follows:

Authority: 7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 601-695; 7

CFR 2.18, 2.53.

2. Section 318.7(c)(4) would be amended by adding to the chart of

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

and developers,'' the substance sorbitol 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 Amount

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* * * * * *

*

Flavoring agents; Sorbitol....... To flavor, to As provided in part Not to exceed 2

protectors and facilitate the 319 of this percent of the weight

developers. removal of casings subchapter, cooked of the formula,

from product, and to roast beef, cured excluding the formula

reduce caramelization pork products, and weight of water or

and charring. cooked sausage ice, when used in

labeled frankfurter, accord-ance with 21

frank, furter, CFR 184.1835.

wiener, and

knockwurst.

* * * * * *

*

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Done at Washington, DC, on March 7, 1997.

Thomas J. Billy,

Administrator.

[FR Doc. 97-6447 Filed 3-13-97; 8:45 am]

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