95-9949. Canned Fruit Nectars; Proposal to Revoke the Stayed Standard of Identity  

  • [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
    
    

Document Information

Published:
04/21/1995
Department:
Food and Drug Administration
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
95-9949
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.
Pages:
19866-19867 (2 pages)
Docket Numbers:
Docket No. 94N-0452
RINs:
0905-AC48
PDF File:
95-9949.pdf
CFR: (2)
21 CFR 102.33
21 CFR 146.113