[Federal Register Volume 61, Number 39 (Tuesday, February 27, 1996)]
[Rules and Regulations]
[Pages 7207-7209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4303]



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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received, the final rulemaking document will be withdrawn and a 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 

[[Page 7208]]
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.

* * * * *
    (c) * * *
    (4) * * *

[[Page 7209]]


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