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[Federal Register Volume 63, Number 2 (Monday, January 5, 1998)]
[Rules and Regulations]
[Pages 147-148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-064]

[[Page 147]]

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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
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