[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
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
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The Code of Federal Regulations is sold by the Superintendent of 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
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* * * * * *
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
