[Federal Register Volume 62, Number 50 (Friday, March 14, 1997)]
[Proposed Rules]
[Pages 12117-12119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6447]


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

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.

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

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

[[Page 12119]]

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) * * *

----------------------------------------------------------------------------------------------------------------
   Class of substance       Substance             Purpose                Products                 Amount        
----------------------------------------------------------------------------------------------------------------
                                                                                                                
*                  *                  *                  *                  *                  *                
                                                        *                                                       
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.                                  
                                                                                                                
*                  *                  *                  *                  *                  *                
                                                        *                                                       
----------------------------------------------------------------------------------------------------------------

    Done at Washington, DC, on March 7, 1997.
Thomas J. Billy,
Administrator.
[FR Doc. 97-6447 Filed 3-13-97; 8:45 am]
BILLING CODE 3410-DM-P