[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
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

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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 SAVR<SUP>TM 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 SAVR<SUP>TM 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 SAVR<SUP>TM 
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 SAVR<SUP>TM 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 SAVR<SUP>TM tomato and their progeny would no longer be regulated 
under these regulations.
    FLAVR SAVR<SUP>TM 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 SAVR<SUP>TM 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 SAVR<SUP>TM tomato lines with 
any other lines or cultivars of tomato without a permit. One additional 
FLAVR SAVR<SUP>TM tomato line was added to the original determination 
on October 3, 1994 (59 FR 50220, Docket No. 94-096-1), and nine 
additional FLAVR SAVR<SUP>TM 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 SAVR<SUP>TM--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 SAVR<SUP>TM 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]
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