[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