[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 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]
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