[Federal Register Volume 60, Number 77 (Friday, April 21, 1995)]
[Proposed Rules]
[Pages 19866-19867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9949]
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Proposed Rules
Federal Register
________________________________________________________________________
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.
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Federal Register / Vol. 60, No. 77 / Friday, April 21, 1995 /
Proposed Rules
[[Page 19866]]
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.
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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 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 (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 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 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 Sec. 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
Sec. 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 Sec. 102.30 because these products would be covered
by the labeling provisions in proposed Secs. 101.30 and 102.33.
In the Federal Register of January 6, 1993 (58 FR 2897), FDA
published a [[Page 19867]] final rule on the July 2, 1991, proposal. As
proposed, FDA adopted minimum Brix values in Sec. 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 Sec. 101.30. Moreover, Sec. 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
Sec. 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 Sec. 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 Sec. 101.30. In addition,
Sec. 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 (Sec. 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 Sec. 101.30 and for
naming diluted juice beverages in Sec. 102.33, FDA tentatively
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 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 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 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).
Sec. 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
