This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

19866

Vol. 60, No. 77

Friday, April 21, 1995

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 146

[Docket No. 94N–0452]

RIN 0905–AC48

Canned Fruit Nectars; Proposal to

Revoke the Stayed Standard of Identity

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

revoke the standard of identity for

canned fruit nectars. This standard has

never gone into effect, having been

stayed by the filing of objections. This

proposal is based in part on a letter from

the organization that petitioned for the

nectar standard. This organization now

states that the standard is not necessary

in view of the FDA regulations that

require declaration of the percentage of

juice in beverage products that purport

to contain juice. The agency tentatively

concludes that revocation of the stayed

standard will minimize confusion in the

labeling of canned fruit nectars and will

facilitate the marketing of these foods.

DATES: Written comments by July 5,

1995. The agency proposes that any

final rule that may issue based on this

proposal become effective on the date of

publication of the final rule in the

Federal Register.

ADDRESSES: Submit written comments,

data, or information to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Nannie H. Rainey, Center for Food

Safety and Applied Nutrition (HFS–

158), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–5099.

SUPPLEMENTARY INFORMATION:

I. Background

A. Introduction

In the Federal Register of October 1,

1964 (29 FR 13535), FDA published a

proposal to establish a standard of

identity for canned fruit nectars in

§ 146.113 (21 CFR 146.113) (formerly 21

CFR 27.126) (42 FR 14302, March 15,

1977). The proposal responded to a

petition filed by the National Canners

Association (now the National Food

Processors Association (NFPA)). FDA

issued the final regulation adopting the

proposed standard in the Federal

Register of May 7, 1968 (33 FR 6862).

Several organizations filed objections to

the standard and requested a hearing,

based principally on the minimum

soluble solids (Brix) values to be

applied to the fruit ingredients of the

unconcentrated or reconstituted singlestrength fruit nectars. Consequently,

FDA published a notice staying the

regulation in its entirety in the Federal

Register of July 27, 1968 (33 FR 10713),

pending resolution of issues raised by

the objections. No hearing on the

objections has been held.

Even though the canned fruit nectars

standard was stayed, FDA has often

referred to the standard for guidance in

the naming of diluted juice products

with the term ‘‘nectar.’’ The standard

defined canned fruit nectars as the

pulpy, liquid foods prepared from one

or more of the optional fruit ingredients

listed in the standard (i.e., apple,

apricot, blackberry, boysenberry, cherry,

guava, loganberry, mango, nectarine,

papaya, passion fruit, peach, pear,

pineapple, or plum in various forms:

Fruit puree, pulp, juice, or concentrated

juice), water, and sweeteners. The

standard also specified minimum

requirements for consistency, minimum

Brix values for the fruits, and the level

of such fruit, depending on fruit type or

combination, that must be in the

finished food.

B. The Nutrition Labeling Act of 1990

(the 1990 Amendments)

On November 8, 1990, President Bush

signed into law the Nutrition Labeling

and Education Act of 1990 (the 1990

amendments). Section 7 of the 1990

amendments amended section 403(i) of

the Federal Food, Drug, and Cosmetic

Act to provide that: ‘‘a food * * * shall

be deemed to be misbranded unless its

label bears (1) The common and usual

name of the food * * * and if the food

purports to be a beverage containing

vegetable or fruit juice, a statement with

appropriate prominence on the

information panel of the total

percentage of such fruit or vegetable

juice in the food * * *.’’ This provision

in the 1990 amendments provided the

framework for a requirement for label

declaration of information on the juice

content of products, including diluted

juices such as nectars, that permits

consumers to make purchasing

decisions based on the level of juice in

these foods. This requirement also led to

the termination of a number of

rulemaking actions pertaining to the

labeling of diluted juice products (see

56 FR 30452, July 2, 1991). However,

FDA took no action with respect to the

stayed standard for canned fruit nectars.

C. Agency’s Response to the 1990

Amendments

In the Federal Register of July 2,

1991, FDA proposed requirements for

declaration of the percentage of juice in

foods that purport to be beverages

containing fruit or vegetable juice. This

proposal was based on section 7 of the

1990 amendments and on a petition

from the National Food Processors

Association (Docket No. 80N–0140). In

addition to a requirement for percentage

juice declaration in a new § 101.30 (21

CFR 101.30), FDA also proposed to

establish minimum Brix values for 100

percent juice products that would serve

as a basis for accurate and consistent

percentage juice declarations and that

would assist the agency in its

enforcement actions. The Brix values

were based primarily on information

that FDA received from the National

Juice Products Association. The agency

also proposed to delete the similar

provision for percent juice declaration

from an existing common or usual name

regulation for diluted fruit or vegetable

juice beverages in § 102.33 (21 CFR

102.33) and to revise the provisions of

that regulation regarding establishment

of common or usual names for juice

products. In addition, FDA proposed to

revoke the common or usual name

regulation for noncarbonated beverage

products containing no fruit or

vegetable juice in § 102.30 because these

products would be covered by the

labeling provisions in proposed

§§ 101.30 and 102.33.

In the Federal Register of January 6,

1993 (58 FR 2897), FDA published a
Federal Register / Vol. 60, No. 77 / Friday, April 21, 1995 / Proposed Rules 19867

final rule on the July 2, 1991, proposal.

As proposed, FDA adopted minimum

Brix values in § 101.30 for 51 fruit and

vegetable juice products, including

values for all of the fruits listed in the

canned fruit nectars standard. In

adopting the final Brix values, FDA

considered the minimum Brix values in

the stayed canned fruit nectars standard

along with the information received in

comments on the proposal. Thus, the

agency concludes that the Brix values in

the canned fruit nectars standard have

been effectively superceded by the

values in § 101.30. Moreover, § 101.30

requires that the label of products that

purport to contain fruit or vegetable

juice, including canned fruit nectars,

declare the total percentage of juice

contained in such products. This

provision ensures that consumers will

be able to make value comparisons

based on the level of juice used in the

beverage.

Finally, in the January 6, 1993, final

rule, FDA adopted § 102.33 on the

common or usual names of juice

beverages that purport to contain fruit or

vegetable juice. Canned fruit nectars are

among the foods that must be labeled in

accordance with § 102.33. This

regulation permits products that

traditionally have been considered to be

canned fruit nectars to continue to bear

the term ‘‘nectar.’’

D. Conclusions and Proposal

The agency points out that the stayed

standard of identity for canned fruit

nectars was established under section

701(e) of the act (21 U.S.C. 371(e)),

which required formal rulemaking in

any action for the establishment,

amendment, or repeal of a food

standard. However, the 1990

amendments removed food standards

rulemaking proceedings, except for the

amendment or repeal of standards of

identity for dairy products and maple

syrup, from the formal rulemaking

requirements of section 701(e) of the act

(see section 8 of the 1990 amendments).

Therefore, rulemaking proceedings to

revise or repeal the stayed standard for

canned fruit nectars are subject to

section 701(a) of the act.

In considering its options with respect

to the stayed standard, the agency

considered proposing to amend it to

incorporate the revised Brix values as a

means of responding to the objections

on the canned nectars final rule. FDA

rejected this option because the Brix

values in the standard would duplicate

the provisions in § 101.30. In addition,

§ 102.33 provides for the use of an

appropriately descriptive name for

diluted juice beverages, including fruit

nectars. FDA believes that use of an

appropriately descriptive name, along

with a declaration of the percentage of

juice, will provide adequate information

to consumers regarding the nature of

fruit nectars, and that a separate

standard of identity for canned fruit

nectars is not necessary. Thus, the

agency tentatively concludes that the

stayed standard of identity for canned

fruit nectars should be removed.

The agency’s tentative view is

supported by the petitioner for the

canned fruit nectars standard. In a letter

to the agency dated July 8, 1994, and

filed under Docket No. 80N–0140,

NFPA stated that the opinion of its

members is that, with the advent of

mandatory percent juice labeling for any

food that purports to be a beverage that

contains a fruit or vegetable juice

(§ 101.30), the stayed standard is no

longer necessary and should be removed

from the Code of Federal Regulations.

Accordingly, NFPA requested that the

agency take such action.

Thus, in view of the petitioner’s

request and of the existing requirements

for percent juice declaration in § 101.30

and for naming diluted juice beverages

in § 102.33, FDA tentatively concludes

that the standard of identity for canned

fruit nectars in § 146.113 is not needed,

and that no further action on the

objections filed to the May 7, 1968, final

rule establishing that standard is

warranted. Therefore, FDA is proposing

to revoke the stayed standard of identity

for canned fruit nectars.

II. Economic Impact

As required by Executive Order 12866

and the Regulatory Flexibility Act (Pub.

L. 354), FDA has examined the

economic implications of this proposed

rule that would remove the stayed

standard of identity for canned fruit

nectars in 21 CFR part 164. Executive

Order 12866 directs agencies to assess

all costs and benefits of available

regulatory alternatives and, when

regulation is necessary, to select

regulatory approaches that maximize

net benefits (including potential

economic, environmental, public health,

and safety effects; distributive impacts;

and equity). The Regulatory Flexibility

Act requires that the agency analyze

options for regulatory relief for small

businesses.

FDA believes that there will be no

economic impact on the juice

processing industry from this proposed

rule because the removal of the stayed

standard will not result in any new

costs or requirements. Canned fruit

nectars, currently marketed as

nonstandardized foods, will continue to

be named and labeled in accordance

with the existing requirements of

§§ 101.30 and 102.33. Removal of the

stayed standard will eliminate

confusion regarding the compositional

requirements for juice products named

by use of the term ‘‘nectar.’’

Thus, FDA concludes that this is not

a significant regulatory action as defined

by Executive Order 12866. In

compliance with the Regulatory

Flexibility Act, the agency certifies that

the final rule will not have a significant

impact on a substantial number of small

businesses.

III. Environmental Impact

The agency has determined under 21

CFR 25.24(b)(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.

IV. Request for Comments

Interested persons may, on or before

June 20, 1995, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

List of Subjects in 21 CFR Part 146

Food grades and standards, Fruit

juices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, and redelegated to

the Director, Center for Food Safety and

Applied Nutrition, it is proposed that 21

CFR part 146 be amended as follows:

PART 146—CANNED FRUIT JUICES

1. The authority citation for 21 CFR

part 146 continues to read as follows:

Authority: Secs. 201, 401, 403, 409, 701,

721 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 341, 343, 348, 371, 379e).

§ 146.113 [Removed]

2. Section 146.113 Canned fruit

nectars is removed from subpart B.

Dated: February 8, 1995.

Fred R. Shank,

Director, Center for Food Safety and Applied

Nutrition.

[FR Doc. 95–9949 Filed 4–20–95; 8:45 am]

BILLING CODE 4160–01–F