[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]



 ========================================================================
 Proposed Rules
                                                 Federal Register
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 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