[Federal Register Volume 60, Number 217 (Thursday, November 9, 1995)]
[Rules and Regulations]
[Pages 56513-56514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-27713]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 146

[Docket No. 94N-0452]
RIN 0905-AC48


Canned Fruit Nectars; Revocation of the Stayed Standard of 
Identity

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is revoking the 
standard of identity for canned fruit nectars. This standard has never 
gone into effect, having been stayed by the filing of objections. In 
view of the FDA regulations that require declaration of the percentage 
of juice in beverage products that purport to contain juice and 
comments in letters from the petitioner for the canned fruit nectars 
standard and from other interested parties, the agency has concluded 
that the standard is unnecessary and should be revoked. The revocation 
of the stayed standard will minimize confusion in the labeling of 
canned fruit nectars and will facilitate the marketing of these foods.

DATES: Effective November 9, 1995.
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 Sec. 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). 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 single-strength 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 

[[Page 56514]]
resolution of issues raised by the objections. No hearing on the 
objections was held.

B. The Nutrition Labeling and Education Act of 1990

    Section 7 of the Nutrition Labeling and Education Act of 1990 (the 
1990 amendments) amended section 403(i) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 343(i)) 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 * * *.''
In response to this provision, FDA adopted Sec. 101.30 Percent juice 
declaration for foods purporting to be beverages that contain fruit or 
vegetable juice (21 CFR 101.30) on declaring the juice content of 
certain food products (58 FR 2897, January 6, 1993). Section 101.30 
establishes minimum Brix values for 51 fruit and vegetable juice 
products, including values for all of the fruits listed in the canned 
fruit nectars standard to which objections had been raised. The Brix 
values are minimum values for 100 percent juice products and serve as a 
basis for accurate and consistent percentage juice declarations. In 
addition, FDA adopted Sec. 102.33 Beverages that contain fruit or 
vegetable juice (21 CFR 102.33) setting forth requirements for 
establishing common or usual names for juice beverages that purport to 
contain fruit or vegetable juice, including beverages such as canned 
fruit nectars.

C. The Proposal to Revoke the Canned Fruit Nectars Standard

    In the Federal Register of April 21, 1995 (60 FR 19866), FDA 
proposed to revoke the standard of identity for canned fruit nectars. 
In the preamble to that proposal (60 FR 19866 at 19867), the agency 
pointed out that it had adopted the stayed standard of identity under 
section 701(e) of the act (21 U.S.C. 371(e)), which required formal 
rulemaking in any action for the establishment or amendment of a food 
standard. However, the agency also pointed out that the 1990 amendments 
removed food standards rulemaking proceedings for most foods from the 
coverage of section 701(e) of the act, and that, as a result, further 
rulemaking on the stayed standard was subject to section 701(a) of the 
act.
    The agency initiated the proposed action in response to the 
petitioner's request that it revoke the stayed standard, and because it 
had tentatively concluded that the standard was no longer needed. 
Canned fruit nectars are adequately provided for as nonstandardized 
foods under the regulations for percent juice declaration in 
Sec. 101.30 and the common or usual name regulation for beverages that 
purport to contain fruit or vegetable juice in Sec. 102.33. FDA 
proposed that if it were to revoke the standard, that action would be 
effective on the date of publication of the final rule in the Federal 
Register. Interested persons were given until July 5, 1995, to comment 
on the proposal.

II. The Revocation

    Four letters, one each from the petitioner, a second industry trade 
association, a juice processor, and several consumers (commenting 
jointly), were received in response to the proposal. All expressed 
support for revocation on the standard of identity for canned fruit 
nectars.
    Thus, in view of the support expressed by the comments and the 
existing requirements for percent juice declaration in Sec. 101.30 and 
for naming diluted juice beverages in Sec. 102.33, FDA concludes that 
the standard of identity for canned fruit nectars in Sec. 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 revoking the stayed standard of identity for canned 
fruit nectars. Products traditionally considered to be canned fruit 
nectars may continue to be labeled with the term ``nectar'' provided 
that they also comply with the applicable sections for the food 
labeling regulations set forth in parts 101 and 102 (21 CFR parts 101 
and 102).

III. Economic Impact

    As required by Executive Order 12866 and the Regulatory Flexibility 
Act (Pub. L. 96-354), FDA has examined the economic implications of the 
proposed rule that would remove the stayed standard of identity for 
canned fruit nectars. 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 tentatively concluded that there will be no economic impact on 
the juice processing industry from the 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 Secs. 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 tentatively concluded that the proposed rule will not 
constitute a significant regulatory action as defined by Executive 
Order 12866. In compliance with the Regulatory Flexibility Act, the 
agency certified that the final rule will not have a significant impact 
on a substantial number of small businesses. FDA has not received any 
information or data that will change the tentative conclusions that it 
set forth in the proposal. Therefore, FDA concludes that this final 
rule is not a significant regulatory action, and that it will not have 
a significant impact on a substantial number of small businesses.

IV. 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.

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, 21 CFR part 
146 is

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).


Sec. 146.113  [Removed]

    2. Section 146.113 Canned fruit nectars is removed from subpart B.

    Dated: October 18, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-27713 Filed 11-8-95; 8:45 am]
BILLING CODE 4160-01-F