95-7132. Determination of Nonregulated Status for Additional Calgene, Inc., Genetically Engineered FLAVR SAVRSUPTM Tomato Lines  

  • [Federal Register Volume 60, Number 56 (Thursday, March 23, 1995)]
    [Notices]
    [Page 15284]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 95-7132]
    
    
    
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    Notices
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    Federal Register / Vol. 60, No. 56 / Thursday, March 23, 1995 / 
    Notices
    [[Page 15284]]
    
    DEPARTMENT OF AGRICULTURE
    
    Animal and Plant Health Inspection Service
    [Docket No. 95-015-1]
    
    
    Determination of Nonregulated Status for Additional Calgene, 
    Inc., Genetically Engineered FLAVR SAVRTM Tomato Lines
    
    AGENCY: Animal and Plant Health Inspection Service, USDA.
    
    ACTION: Notice.
    
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    SUMMARY: The Animal and Plant Health Inspection Service is announcing 
    that it has added 20 additional genetically engineered tomato lines to 
    those subject to its October 19, 1992, interpretive ruling that the 
    subject FLAVR SAVRTM lines need no longer be regulated. The effect 
    of this action is that 20 additional delayed softening tomato lines, 
    which have been modified by the incorporation of genetic material 
    described by Calgene, Inc., in its initial request for an interpretive 
    ruling, will no longer be subject to regulation under 7 CFR part 340.
    
    FOR FURTHER INFORMATION CONTACT: Dr. Keith Reding, Biotechnologist, 
    Animal and Plant Health Inspection Service, Biotechnology, Biologics, 
    and Environmental Protection, Biotechnology Permits, 4700 River Road 
    Unit 147, Riverdale, MD 20737-1228; (301) 734-7612.
    
    SUPPLEMENTARY INFORMATION: On October 19, 1992, the Animal and Plant 
    Health Inspection Service (APHIS) published in the Federal Register (57 
    FR 47608-47616, Docket No. 92-087-2) a notice announcing the issuance 
    of an interpretive ruling that the Calgene, Inc., FLAVR SAVRTM 
    tomato does not present a plant pest risk and is not a regulated 
    article under the regulations contained in 7 CFR part 340. This action 
    was in response to a petition submitted by Calgene seeking a 
    determination from APHIS that its FLAVR SAVRTM tomato no longer be 
    deemed a regulated article, based on an absence of plant pest risk. The 
    effect of the action was that previously field tested lines of the 
    FLAVR SAVRTM tomato and their progeny would no longer be regulated 
    under these regulations.
        FLAVR SAVRTM tomatoes were defined by Calgene in its initial 
    petition to include any tomatoes transformed with one of seven 
    identified plasmid vectors that all carry an antisense copy of the 
    tomato polygalacturonase gene and a bacterial neomycin 
    phosphotransferase gene with associated regulatory sequences. Calgene's 
    initial request to APHIS in 1992 was for a determination pertaining to 
    all FLAVR SAVRTM transformants produced in tomatoes using any one 
    of the seven plasmid vectors. Calgene indicated in its petition that 
    data provided to the Agency were representative of the data gathered 
    for all lines tested up to that time. The initial determination 
    announced by APHIS on October 19, 1992, only applied to those lines 
    that had already been field tested. However, APHIS indicated that new 
    lines were likely to exhibit properties similar to those of lines 
    already field tested under permit. The determination also allowed for 
    cross-breeding of the identified FLAVR SAVRTM tomato lines with 
    any other lines or cultivars of tomato without a permit. One additional 
    FLAVR SAVRTM tomato line was added to the original determination 
    on October 3, 1994 (59 FR 50220, Docket No. 94-096-1), and nine 
    additional FLAVR SAVRTM tomato lines were added to the original 
    determination on November 18, 1994 (59 FR 59746, Docket No. 94-125-1).
        Seventeen of the 20 additional FLAVR SAVRTM--tomato lines that 
    are the subject of this notice were constructed using the plasmid 
    vector pCGN4109, and the remaining three lines were constructed using 
    the plasmid vector pCGN1436. These two vectors were among the seven 
    included in Calgene's initial petition to APHIS. In our determination 
    of October 19, 1992, the lines using these vectors were not deregulated 
    because they had not been field tested. These lines have since been 
    field tested in accordance with APHIS regulations at 7 CFR part 340, 
    and data provided to APHIS indicate that the new transformants, 
    produced in a manner identical to the earlier transformant lines, 
    behave similarly to those earlier FLAVR SAVRTM tomato lines to 
    which the determination initially applied. Reports from field trials 
    and other data indicate that the new tomato lines grow normally, 
    exhibit the expected morphological, reproductive, and physiological 
    properties, and do not have unexpected pest or disease susceptibility 
    or symptoms. Therefore, the APHIS determination of nonregulated status 
    of October 19, 1992, applies as well to the new transformed lines.
    
        Done in Washington, DC, this 16th day of March 1995.
    Terry L. Medley,
    Acting Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 95-7132 Filed 3-22-95; 8:45 am]
    BILLING CODE 3410-34-P
    
    

Document Information

Published:
03/23/1995
Department:
Animal and Plant Health Inspection Service
Entry Type:
Notice
Action:
Notice.
Document Number:
95-7132
Pages:
15284-15284 (1 pages)
Docket Numbers:
Docket No. 95-015-1
PDF File:
95-7132.pdf