[Federal Register Volume 62, Number 223 (Wednesday, November 19, 1997)]
[Rules and Regulations]
[Pages 61619-61620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30324]



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Rules and Regulations
                                                Federal Register
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This section of the FEDERAL REGISTER contains regulatory documents 
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Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / 
Rules and Regulations

[[Page 61619]]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 318

[Docket No. 96-014DF]
RIN 0583-AC16


Carrageenan, Locust Bean Gum and Xanthan Gum Blend Used as a 
Binder in Certain Cured Pork 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 permit the use of a blend of 
carrageenan, locust bean gum, and xanthan gum as a binder in cured pork 
products labeled ``Ham Water Added'' and ``Ham and Water Product--X% of 
Weight is Added Ingredients.'' FSIS currently permits the use of other 
specified binders in these cured pork products. The maximum use level 
of 0.5 percent will prevent purging of the pumped brine solution from 
the products, thereby retaining product moisture and enhancing texture.

DATES: This rule will be effective January 20, 1998 unless FSIS 
receives written adverse comments within the scope of this rulemaking 
or written notice of intent to submit adverse comments within the scope 
of this rulemaking on or before December 19, 1997. If written adverse 
comments or notice of intent to submit adverse comments is received, 
FSIS will publish timely notice of the withdrawal of this rule in the 
Federal Register.

ADDRESS: Submit adverse comments or notice of intent to submit adverse 
comments within the scope of this rulemaking to: FSIS Docket Clerk, 
Docket #96-014DF, U.S. Department of Agriculture, Food Safety and 
Inspection Service, Room 102, Cotton Annex, 300 12th Street, SW, 
Washington, DC 20250-3700. Reference materials cited in this document 
will be available for public inspection in the FSIS Docket Room from 
8:30 a.m. to 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Post, Labeling and 
Compounds Review Division, Office of Policy, Program Development and 
Evaluation; (202) 418-8900.

SUPPLEMENTARY INFORMATION: On July 18, 1995, FSIS was petitioned by 
Vedeqsa, S.A., to approve the use of a blend of carrageenan, locust 
bean gum, and xanthan gum as a binder in cured pork products labeled 
``Ham Water Added'' and ``Ham and Water Product--X% of Weight is Added 
Ingredients,'' in an amount not exceeding 0.5 percent of product 
formulation, to prevent purging of the brine solution. During 
manufacturing, these ham products are pumped with a brine solution, the 
ultimate level of which is controlled by a protein-fat-free (PFF) 
standard described in 9 CFR 319.104. PFF is the minimum meat protein 
which is indigenous to the raw, unprocessed pork, expressed as a 
percent of the nonfat portion of the finished product. These products 
are normally packaged in clear plastic and enclosed by a vacuum seal. 
Subsequent to the curing process, the brine purges from the products, 
settling in the products' packages, reducing the moisture content of 
the products and negatively affecting their appearance and quality.
    FSIS currently permits the use of carrageenan as an extender and 
stabilizer in breading mixes and sauces for use in meat products at a 
level sufficient for that purpose, and in ``Ham Water Added'' and ``Ham 
and Water Product--X% of Weight is Added Ingredients'' up to 1.5 
percent of product formulation to prevent purging of brine solution. 
FSIS also permits the use of xanthan gum as an emulsifier, stabilizer, 
or thickener in meat sauces, gravies, canned or frozen meat salads or 
stews, canned chili, pizza topping mixes, and batter and breading 
mixes, at a level sufficient for that purpose.
    The Food and Drug Administration (FDA) lists locust (carob) bean 
gum as generally recognized as safe as a stabilizer and thickener with 
a maximum usage level of 0.5 percent when used in meat products (21 CFR 
184.1343). FDA has provided FSIS with a letter dated October 13, 1995, 
concurring with FSIS's determination that the petitioned use of a blend 
of carrageenan, locust bean gum, and xanthan gum in combination is 
acceptable for use as a binder matrix (blend) to prevent purging of 
added brine solution in certain cured pork products.
    The petitioner submitted data to show that at a use level of 0.5 
percent, a blend consisting of 70 percent carrageenan, 15 percent 
locust bean gum and 15 percent xanthan gum reduces the purge of brine 
in water-added hams as well as carrageenan alone. After reviewing this, 
and the petitioner's other technical data and information, FSIS has 
determined that 9 CFR 318.7(c)(4) should be amended to permit the use 
of any blend of carrageenan, locust bean gum, and xanthan gum in ``Ham 
Water Added'' and ``Ham and Water Product--X% of Weight is Added 
Ingredients'' products at a level not to exceed 0.5 percent of the 
product formulation weight. Such use will reduce the amount of purge 
from the ham products during storage. This binder is not permitted to 
be used in combination with any other binder approved for use in cured 
pork products. This binder shall be designated in the ingredients 
statement, as provided in 9 CFR 319.104(d).
    FSIS expects no adverse public reaction resulting from this change 
in regulatory language. Therefore, unless the Agency receives adverse 
comments within the scope of the rulemaking, or 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 adverse comments within the scope of the 
rulemaking are received, the direct 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. If this direct final 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

[[Page 61620]]

required 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 OMB.

Effect on Small Entities

    The Administrator, FSIS, has made a 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). This direct final rule permits the use of an additional 
binder matrix, a blend of carrageenan, locust bean gum, and xanthan 
gum, in ``Ham Water Added'' and ``Ham and Water Product--X% of Weight 
is Added Ingredients.'' Manufacturers opting to use the binder blend 
would incur labeling expenses in revising the ingredients statements of 
their labels to show the presence of the blend. Decisions by individual 
manufacturers on whether to use the binder blend in these cured pork 
products would be based on their conclusions that the benefits outweigh 
the implementation costs.

Paperwork Requirements

    Manufacturers opting to use a blend of carrageenan, locust bean 
gum, and xanthan gum as a binder in specific pork products must revise 
their product labels. Such labeling changes will be generically 
approved in accordance with 9 CFR 317.5. Any burden associated with 
labeling changes are approved under OMB number 0583-0092.

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. In section 318.7(c)(4), under the Class of substance ``Binders 
and extenders,'' a new entry for the substance ``Carrageenan, Locust 
Gum Bean, and Xanthan Gum Blend'' is added at the end to read 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        
----------------------------------------------------------------------------------------------------------------
                                                                                                                
*                  *                  *                  *                  *                  *                
Binders and extenders..........  Carrageenan,       To prevent         Cured pork         In combination, not to
                                  Locust bean gum,   purging of brine   products as        exceed 0.5 percent of
                                  and Xanthan gum    solution.          provided in 9      product formulation; 
                                  blend.                                CFR 319.104(d).    not permitted in     
                                                                                           combination with     
                                                                                           other binders        
                                                                                           approved for use in  
                                                                                           cured pork products; 
                                                                                           in accordance with 21
                                                                                           CFR 172.620, 172.623,
                                                                                           172.626, 184.1343,   
                                                                                           and 172.695          
*                  *                  *                  *                  *                  *                
                                                        *                                                       
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    Done at Washington, DC, on November 10, 1997.
Thomas J. Billy,
Administrator.
[FR Doc. 97-30324 Filed 11-18-97; 8:45 am]
BILLING CODE 3410-DM-P