Use of Binders in ``Ham With Natural Juices'' Products

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 319

[Docket No. 96-040F]

RIN 0583-AC29

Use of Binders in ``Ham With Natural Juices'' Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: 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 binders in

``Ham with Natural Juices'' products. FSIS currently permits the use of

certain binders in cured pork products labeled ``Ham Water Added'' and

``Ham and Water Product-X% of Weight is Added Ingredients.'' FSIS is

taking this action in response to a petition submitted by Hormel Foods

Corporation, requesting the Agency to allow modified food starch (or

``food starch, modified'') to be used as a binder in ``Ham with Natural

Juices'' products, in an amount not exceeding 2 percent of product

formulation, to prevent purging of the brine solution, thereby

retaining product moisture and enhancing texture.

EFFECTIVE DATE: March 6, 1998.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Post, Director, Labeling

and Compounds Review Division, Office of Policy, Program Development,

and Evaluation; (202) 205-0279.

SUPPLEMENTARY INFORMATION:

Background

On April 25, 1997, FSIS published a proposed rule in the Federal

Register (62 FR 20130) to permit the use of modified food starch in

``Ham with Natural Juices'' products, in an amount not exceeding 2

percent of product formulation, to prevent purging of the brine

solution. As noted in the proposal, FSIS does not permit the use of

binders in ``Ham with Natural Juices'' products. FSIS has prohibited

their use in ``Ham with Natural Juices'' products to prevent economic

adulteration. FSIS believes that consumers consider ham products

labeled ``Ham with Natural Juices'' to be premium products because they

do not contain ``fillers,'' such as binders, and thus, are typically

priced higher than the ``binders and water added'' ham products.

Furthermore, in accordance with 9 CFR 319.104, ``Ham with Natural

Juices'' products must meet a higher protein fat-free (PFF) value than

other cured pork products, such as ``Ham Water Added'' and ``Ham and

Water Product-X% of Weight is Added Ingredients,'' which reflects less

added substances, including water.

The petitioner has developed a new process for producing its ``Ham

with Natural Juices'' product in response to what they view as consumer

demand for an improved ham product. The new process includes the use of

modified food starch, which is currently prohibited in a ``Ham with

Natural Juices'' product. According to the petitioner, its new ``Ham

with Natural Juices'' process requires the use of modified food starch

in order to enhance the characteristics of texture and, more

importantly, moisture retention that consumers associate with the

product.

Comments

FSIS received 9 comments during the public comment period that

ended June 9, 1997. Six were from food companies and three were from

trade associations. Six commenters expressed support for the proposal

while three commenters opposed it.

Commenters in favor of the proposal generally stated that they

believe it will allow the manufacture of products that meet the needs

of consumers and enhance their satisfaction with ``Ham with Natural

Juices'' products. They agreed with the petitioner that a ``Ham with

Natural Juices'' product which contains a binder can be made to meet

the PFF requirements for ``Ham with Natural Juices'' products without

significantly changing the nutrient content of the product.

Commenters opposed to the proposal, however, felt strongly that, if

implemented, it will compromise the quality of ``Ham with Natural

Juices'' products and that the addition of modified food starch into

the product will significantly change its expected characteristics. One

commenter stated that the modified food starch will artificially retain

moisture. As a result, the juices in the product will no longer be

``natural juices.'' The commenter pointed out that the product thus

created is altered from the traditional product. Further, because the

new brine binding technology as described in the proposal does not

indicate whether the product is minimally processed or maintained in a

natural state, the product does not meet the criteria for the term

``natural.'' In this commenter's opinion, the new product deviates from

the current product identity expectation and does not, in fact, meet

the consumer's expectations.

Another commenter expressed similar views. This commenter stated

that, under natural conditions, a muscle will hold only a certain

amount of moisture. The commenter further stated that, if this level is

not acceptable to the petitioner and it feels it needs to alter the

natural process by adding a binder, then the product should be labeled

accordingly; however, the entire category of ``Ham with Natural

Juices'' products should not be modified to permit the use of binders.

One commenter felt that the justification supplied for the addition

of binders to ``Ham with Natural Juices'' products (to prevent purging

of the brine solution) is weak. This commenter stated that properly

processed ``Ham with Natural Juices'' products will have little, if

any, purge.

The Final Rule

After reviewing the comments received, the Agency has concluded

that ``Ham with Natural Juices'' remains an acceptable product

identity. FSIS agrees with the petitioners and comments in favor of the

proposal that ``Ham with Natural Juices'' products which contain a

binder can, and must, meet the PFF requirements for ``Ham with Natural

Juices'' products without significantly changing the nutrient content

of the product. As indicated in the proposal, the petitioner has

submitted technical data and other information demonstrating that the

finished product does not fall below the minimum regulated PFF value

with an acceptable yield loss, as illustrated by purged value

differences over time. Because the product adheres to the minimum PFF

value, even with the addition of modified food starch and other

permitted binders, consumers will be receiving a ``Ham with Natural

Juices'' product with essentially the same protein content and other

nutrients as they do with a ``Ham with Natural Juices'' without

binders. The concern of the commenters that the product no longer

contains ``natural'' juices is diminished because of the adherence to

the PFF value and the fact that no solutions are added that result in a

cooked product that weighs more than its uncooked, cured green weight.

If a manufacturer decides to make a ``Ham with Natural Juices''

product that includes a binder, but which adheres to the PFF value for

a ``Ham with Natural Juices'' product, it will have to be labeled

accordingly. Modified food starch and the other permitted binders will

have to appear in the ingredients statement to inform consumers of

their presence. Because the PFF value for a ``Ham with Natural Juices''

product is

[[Page 148]]

unchanged, FSIS will not require the binder name to appear in the name

of the product; its appearance in the ingredients statement should be

sufficient to inform consumers of its presence. For these reasons, FSIS

is permitting the use of binders in ``Ham with Natural Juices''

products in an amount not exceeding 2 percent of product formulation,

to prevent purging of the brine solution.

Executive Order 12988

This final rule has been reviewed under Executive Order 12988,

Civil Justice Reform. This final rule: (1) Preempts all state and local

laws and regulations that are inconsistent with this rule; (2) has no

retroactive effect; and (3) does not require administrative proceedings

before parties may file suit in court challenging this rule.

Executive Order 12866 and Regulatory Flexibility Act

This final rule has been determined to be not significant and

therefore has not been reviewed by OMB under Executive Order 12866.

The Administrator has made an initial determination that this 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 final rule permits the use of any one of the

approved binders listed in 9 CFR 318.7(c)(4) in ``Ham with Natural

Juices'' products. Manufacturers opting to use the approved binders in

``Ham with Natural Juices'' products will incur labeling expenses in

revising the ingredients statements of their labels to show the

presence of the approved binders. Decisions by individual manufacturers

whether to use any one of the approved binders in ``Ham with Natural

Juices'' products will be based on their conclusion that the benefits

outweigh the implementation costs.

Paperwork Requirements

Abstract: FSIS has reviewed the paperwork and recordkeeping

requirements in this final rule in accordance with the Paperwork

Reduction Act. This rule requires manufacturers opting to use one of

the approved binders in ``Ham with Natural Juices'' products to revise

their product labels. The labels will not be submitted to FSIS for

approval because they are generically approved in accordance with 9 CFR

317.5. This information collection is approved under OMB number 0583-

0094.

List of Subjects in 9 CFR Part 319

Food grades and standards, Food labeling.

For the reasons set out in the preamble, 9 CFR part 319 is amended

as follows:

PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION

1. The authority citation for part 319 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. The first sentence of paragraph (d) of section 319.104 is

revised to read as follows:

Sec. 319.104 Cured pork products.

* * * * *

(d) The binders provided in Sec. 318.7(c)(4) of this subchapter for

use in cured pork products may be used singly in those cured pork

products labeled as ``Ham Water Added,'' ``Ham and Water Product-X% of

Weight is Added Ingredients,'' and ``Ham with Natural Juices.'' * * *

Done at Washington, DC, on December 22, 1997.

Thomas J. Billy,

Administrator.

[FR Doc. 98-064 Filed 1-2-98; 8:45 am]

BILLING CODE 3410-DM-P