Carrageenan, Locust Bean Gum and Xanthan Gum Blend Used as a Binder in Certain Cured Pork Products

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