Federal Register / Vol. 63, No. 2 / Monday, January 5, 1998 / Rules and Regulations 147

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.

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
148 Federal Register / Vol. 63, No. 2 / Monday, January 5, 1998 / Rules and Regulations

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:

§ 319.104 Cured pork products.

* * * * *

(d) The binders provided in

§ 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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Prednisolone Tablets

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a supplemental new animal

drug application (NADA) filed by Lloyd,

Inc. The supplemental NADA provides

for an additional strength prednisolone

tablet for dogs for use as an antiinflammatory agent.

EFFECTIVE DATE: January 5, 1998.

FOR FURTHER INFORMATION CONTACT:

Dennis M. Bensley, Center for

Veterinary Medicine (HFV–143), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1705.

SUPPLEMENTARY INFORMATION: Lloyd,

Inc., 604 West Thomas Ave.,

Shenandoah, IA 51601, is the sponsor of

NADA 140–921 that provides for use of

prednisolone tablets for dogs as an antiinflammatory agent. Lloyd, Inc., filed a

supplemental NADA that provides for

use of a 20 milligram (mg) prednisolone

tablet in addition to the currently

approved 5 mg tablet. The supplemental

NADA is approved as of November 20,

1997, and the regulations are amended

in § 520.1880(a) (21 CFR 520.1880(a)) to

reflect the approval. The basis for

approval is discussed in the freedom of

information summary.

In addition, the drug’s name in

§ 520.1880(a) is amended to read

‘‘prednisolone.’’

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

9 a.m. and 4 p.m., Monday through

Friday.

The agency has determined under 21

CFR 25.33(d)(1) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

List of Subjects in 21 CFR Part 520

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under the

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: 21 U.S.C. 360b.

§ 520.1880 [Amended]

2. Section 520.1880 Prednisolone

tablets is amended in paragraph (a) by

removing ‘‘5 milligrams prednisolene’’

and adding in its place ‘‘5 or 20

milligrams prednisolone.’’

Dated: December 17, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–74 Filed 1–2–98; 8:45 am]

BILLING CODE 4160–01–F